Effectiveness of a Mobile App for Managing Chemotherapy Side Effects and Enhancing Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial

Effectiveness of a Mobile App for Managing Chemotherapy Side Effects and Enhancing Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effectiveness of a Mobile App for Managing Chemotherapy Side Effects and Enhancing Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial Marziyeh Raei Mehneh, Khalil Kimiafar, Seyyedeh Fatemeh Mousavi Baigi, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7462740/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Breast cancer patients undergoing chemotherapy often face numerous side effects that reduce their health-related quality of life (HRQoL). While conventional follow-up care is limited in continuity, mobile health (mHealth) interventions, particularly smartphone applications, may offer scalable, real-time support for symptom self-management. Objective This randomized controlled trial (RCT) evaluated the effectiveness of a mobile app designed to manage chemotherapy-related side effects in breast cancer patients. Methods Seventy-two participants receiving chemotherapy at Omid Hospital (Mashhad, Iran) were randomly assigned to an intervention group (app + standard care) or control group (standard care only). The app included 20 modules targeting common chemotherapy-related complications, developed through expert consensus and clinical guidelines. Primary outcomes were changes in HRQoL measured by the EORTC QLQ-C30 and QLQ-BR23 at baseline and after four weeks. App usability was assessed using the System Usability Scale (SUS). Results Fifty-seven participants completed the study (27 in the intervention, 30 in control). The intervention group demonstrated statistically significant improvement in QoL scores compared to controls (p < 0.001), even after adjusting for baseline differences. The app received a SUS score of 73.07%, indicating high usability. The highest user engagement was observed in modules addressing nausea, sleep disturbances, and anxiety. Conclusions The mobile app proved effective in reducing chemotherapy side effects and enhancing QoL among breast cancer patients. Its usability and engagement metrics support further implementation in oncology care, especially in low-resource settings. Trial registration IRCT20230402057801N1 [Registration date 20230512] Breast cancer mHealth quality of life chemotherapy mobile app RCT Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Introduction Breast cancer remains the most common malignancy among women worldwide, including in Iran, and is a major contributor to cancer-related mortality [1, 2]. While chemotherapy improves survival, it often leads to physical, psychological, and social side effects that compromise quality of life (QoL) [3–5]. Despite the necessity of effective side effect management, patients frequently lack tools for symptom tracking between clinical visits [6, 7]. In this context, mobile health (mHealth) apps offer scalable, real-time, and patient-centered solutions that enhance self-management and QoL [1, 8, 9]. Evidence from RCTs supports the efficacy of mHealth in reducing symptom burden and improving adherence [8–10]. For example, Basch et al. linked patient-reported outcome systems to increased survival through early detection of adverse events [11]. Several apps have targeted breast cancer needs—ranging from wound care [12] and sleep [13] to psychological support [14], dosing [15], and education [16]—yielding improved satisfaction and fewer hospital visits [17, 18]. Iranian studies have shown similar benefits, including reduced anxiety and enhanced self-esteem [1, 19]. Nonetheless, local gaps persist in culturally tailored app design and rigorous evaluations [7, 20]. Critically, there is a lack of RCTs in Iran evaluating the dual impact of such apps on both side effect management and QoL. This study addresses that gap by assessing the effectiveness of a mobile app using a randomized controlled design. Statement of Significance (1) Problem or Issue: Breast cancer patients undergoing chemotherapy often suffer from debilitating side effects that significantly impair their health-related quality of life (HRQoL). In low-resource settings, continuity of care and symptom monitoring between clinical visits remain limited. (2) What is Already Known: Mobile health (mHealth) applications have shown promise in improving self-management and QoL in oncology care, primarily in high-income countries. However, there is a lack of randomized controlled evidence from culturally and linguistically tailored mHealth interventions in developing nations. (3) What this Paper Adds: This study presents the first randomized controlled trial in Iran evaluating a mobile app designed for managing chemotherapy-related symptoms in breast cancer patients. The app significantly improved QoL scores and demonstrated high usability and patient engagement, especially for symptoms like nausea and anxiety. (4) Who Would Benefit: This evidence will benefit oncologists, mHealth developers, clinical researchers, and healthcare policymakers interested in scalable digital interventions for supportive cancer care in resource-constrained environments. Methods Study Design and Setting This open-label, two-arm randomized controlled trial (RCT) was conducted with a 1:1 allocation ratio at Omid Hospital, a major cancer center in Mashhad, Iran. The trial aimed to evaluate the structure and impact of a mobile app for managing chemotherapy-induced side effects and improving quality of life (QoL) in breast cancer patients. This study was conducted and reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines for randomized controlled trials. The completed CONSORT checklist is provided in Supplementary Material 1 . Participants Eligible participants were women aged 20–60 with a confirmed diagnosis of breast cancer, receiving chemotherapy at Omid Hospital, literate in Persian, and owners of compatible smartphones. Exclusion criteria included psychiatric disorders, major comorbidities, simultaneous radiotherapy or biotherapy, or participation in similar studies. App Development App content was derived from guidelines by the National Cancer Institute, American Cancer Society, and Cancer Council Australia. A multidisciplinary team (oncologists, nurses, health informatics, biostatistics) refined the app through focus groups. The app featured 20 modules targeting symptoms like nausea, fatigue, anxiety, etc., and was designed with social-media-like interactivity. A secure one-time activation code prevented unauthorized use. Randomization and Blinding Participants were randomly assigned using block randomization via www.randomize.com. Allocation was concealed using opaque envelopes. Due to the app-based nature, the study was not blinded. Intervention The intervention group received app access for four weeks, with onboarding and a follow-up support call. The control group received standard hospital care and generic educational web resources. Outcome Measures Primary Outcome: Health-related QoL, measured using validated Persian versions of the following: EORTC QLQ-C30 : A 30-item questionnaire assessing five functional domains, nine symptoms, and global health status [21]. Higher function scores indicate better QoL, while higher symptom scores reflect greater burden. EORTC QLQ-BR23 : A 23-item breast cancer-specific module addressing body image, sexual function, treatment side effects, and arm/breast symptoms [22, 23]. Persian versions were validated by Montazeri et al., confirming high reliability and construct validity [24]. Secondary Outcome: App usability was assessed via the Persian version of the System Usability Scale (SUS) [25], a 10-item instrument with Likert scaling. Scores range from 0–100, with ≥70 indicating acceptable usability. The version used was validated for Iranian health technology contexts by Dianat et al. [26]. Sample Size Based on Kim et al. [14] and Ariza-Garcia et al. [27], assuming an effect size of 0.334, 85% power, and α=0.05, the required sample size was calculated as 72 (36 per group). Data Collection and Timeline Baseline data were gathered at the third chemotherapy session. Post-intervention assessments occurred after four weeks. Statistical Analysis Data analysis was performed using SPSS v16.0. Normality was tested via Shapiro–Wilk. Between-group comparisons used independent t-tests and Mann–Whitney U tests. Chi-square tests analyzed categorical variables. ANCOVA adjusted for baseline QoL differences. Significance was set at p<0.05, CI at 95%. Ethical Considerations The study was approved by the Mashhad University of Medical Sciences Ethics Committee (IR.MUMS.FHMPM.REC.1401.198) and registered in the Iranian Registry of Clinical Trials (IRCT20230402057801N1). Written informed consent was obtained from all participants. Results Participant Flow Out of 72 eligible breast cancer patients at Omid Hospital, all consented and were randomized equally (n = 36 per group). In the control group, 6 participants dropped out due to lack of interest. In the intervention group, 9 dropped out: 3 without reason, 2 due to travel, 2 due to technical incompatibility (Android→iOS), and 1 due to severe side effects. Thus, 57 participants (27 intervention, 30 control) completed the study. A CONSORT diagram (Fig. 1 ) details recruitment and follow-up. Baseline Characteristics of Participants Baseline demographics (Table 1 ) showed no statistically significant differences between groups in age, marital status, education, occupation, cancer stage, or surgical history. This indicates successful randomization and comparability at baseline. Table 1 Baseline Characteristics of Participants Variable All Participants Intervention Group (n = 27) Control Group (n = 30) P-value Age (mean ± SD) 40.44 ± 6.82 years 48.44 ± 6.00 33.44 ± 7.59 0.41 Marital Status, n (%) 0.21 Single 24 (42.1%) 13 (48.1%) 11 (36.6%) Married 33 (57.9%) 14 (51.9%) 19 (63.4%) Educational Level, n (%) 0.32 Less than high school 14 (24.6%) 7 (25.9%) 7 (23.3%) High school diploma 23 (40.4%) 11 (40.7%) 12 (40.0%) Associate degree 13 (22.8%) 6 (22.2%) 7 (23.3%) Bachelor’s degree or higher 7 (12.3%) 3 (11.2%) 4 (13.4%) Occupation, n (%) 0.36 Homemaker 35 (61.4%) 15 (55.6%) 20 (66.6%) Employed 22 (38.6%) 12 (44.4%) 10 (33.3%) Disease Duration (days, mean ± SD) 80.51 ± 37.73 79.81 ± 6.21 81.13 ± 7.77 0.57 Cancer Stage (Grade), n (%) 0.32 Grade 1 9 (15.8%) 2 (7.4%) 6 (20%) Grade 2 42 (73.7%) 20 (74.1%) 22 (73.3%) Grade 3 6 (10.5%) 4 (14.8%) 2 (6.7%) History of Surgical Treatment, n (%) 0.42 Yes 21 (36.8%) 10 (37%) 11 (36.7%) No 36 (63.2%) 17 (63%) 19 (63.3%) Content Development and App Design The app's content was grounded in findings from a previously conducted systematic review of RCTs, as reported in our earlier publications [ 9 , 10 ]. To ensure clinical relevance and maximize user engagement, two structured focus group sessions (each lasting approximately two hours) were conducted with a multidisciplinary expert panel. The panel consisted of three radiation oncologists, one health information management specialist, and one medical informatics expert. Through a consensus-driven process, the panel finalized the content framework and approved 20 key categories addressing chemotherapy-induced side effects commonly experienced by breast cancer patients. These categories encompassed: Anemia, appetite changes, bleeding disorders, constipation, fatigue, memory impairment, infections, hair loss, diarrhea, sexual and fertility changes, urinary symptoms, edema, skin and nail changes, pain, neurological symptoms, nausea and vomiting, oral/nasal/throat issues, anxiety and stress, depression, and sleep disturbances. The app was designed as a dual-platform system, comprising a mobile application for patients and a web-based management dashboard for monitoring user engagement and backend analytics. The mobile platform was developed in Android Studio, employing JavaScript and HTML for interactive design and dynamic content presentation. The dashboard was built using JavaScript and integrated with Google Apps Script for secure, real-time data management. Figma was utilized during the UI/UX design phase to prototype and test the visual interface. Following initial development, two additional expert review sessions were conducted, expanding the panel to include three radiation oncologists, three oncology nurses, two health information specialists, one medical informatics expert, one biostatistician, and one graduate student in health information technology. The app underwent evaluation for content accuracy, educational value, usability, and user engagement. Revisions were made based on expert feedback to optimize the app's pedagogical effectiveness and visual design. The final version of the app was refined to ensure functional reliability, clinical credibility, and user-friendliness for patients undergoing chemotherapy (Fig. 2 – 4 ). Primary Outcome Results: Change in QoL Scores As summarized in Table 2 , the results revealed a statistically significant improvement in post-intervention mean QoL scores for the intervention group compared to the control group (P < 0.001). Additionally, baseline QoL scores were found to significantly influence the post-intervention outcomes (P = 0.007), highlighting the importance of adjusting for initial differences in patient-reported quality of life. This justified the application of analysis of covariance (ANCOVA) to control for potential confounding effects of baseline variability. These findings indicate that the mobile app intervention exerted a robust positive effect on QoL among breast cancer patients undergoing chemotherapy. Table 2 ANCOVA results comparing post-intervention QoL scores between groups, adjusted for baseline values Source Type III Sum of Squares df Mean Square F P-value Model 144.495 3 48.165 2367.333 < 0.001 Group 0.373 2 0.186 9.162 < 0.001 Baseline QoL Score 0.163 1 0.163 7.994 0.007 Error 1.099 54 0.020 — — Total 145.594 57 — — — a. R² = 0.992 (Adjusted R² = 0.992) Figure 5 presents a visual comparison of standardized mean QoL scores and their associated standard deviations for both study groups at baseline and post-intervention. In the control group, the mean QoL score exhibited a marginal increase from 1.50 ± 0.22 at baseline to 1.53 ± 0.26 following the intervention period. Conversely, the intervention group showed a more substantial improvement, with mean QoL scores rising from 1.51 ± 0.21 at baseline to 1.66 ± 0.18 post-intervention. These results further support the effectiveness of the app-based intervention in enhancing patients’ health-related QoL during chemotherapy. Secondary Outcome Results: Usability Evaluation of the Mobile App Usability assessed via the SUS showed a mean score of 73.07, indicating acceptable usability. Scoring followed standard SUS methodology [ 25 ], with interpretation based on validated Persian version [ 26 ]. No significant correlation was found between SUS score and patient age (P = 0.909), education (P = 0.560), occupation (P = 0.750), or cancer grade (P = 0.381), suggesting broad usability. Table 3 shows individual item means, highlighting strong ratings for learnability, ease of use, and confidence. Table 3 Mean Item Scores from the SUS Completed by the Intervention Group Item No. SUS Statement Mean Score 1 I think that I would like to use this app frequently. 4.5 2 I found the app unnecessarily complex. 1.2 3 I thought the app was easy to use. 4.5 4 I think that I would need the support of a technical person to use this app. 1.8 5 I found the various functions in this app were well integrated. 4.0 6 I thought there was too much inconsistency in this app. 2.5 7 I would imagine that most people would learn to use this app very quickly. 3.5 8 I found the app very cumbersome to use. 1.7 9 I felt very confident using the app. 4.3 10 I needed to learn a lot of things before I could get going with this app. 2.7 Additional Secondary Outcome: In-App Feedback and User Interaction Metrics Engagement metrics retrieved from the app’s backend analytics indicated varying levels of user interaction across the 20 educational modules. The module addressing nausea and vomiting received the highest number of likes (132) and views (459), suggesting strong perceived relevance. In contrast, the memory changes module showed the lowest engagement, with only 10 likes and no star ratings. These findings indicate that modules addressing commonly experienced and distressing symptoms—such as nausea, sleep disturbances, and diarrhea—were more frequently accessed and rated positively. This pattern underscores the importance of aligning content with patients’ immediate concerns. Discussion A growing body of evidence supports the role of mobile health (mHealth) apps in reducing treatment-related side effects and improving QoL among patients with breast cancer [ 12 , 13 , 15 , 16 , 18 , 28 – 34 ]. However, to the best of our knowledge, the present study represents the first RCT in Iran to evaluate the effectiveness of a mobile-based app in enhancing QoL by addressing chemotherapy-related symptom burden. While the majority of prior mHealth interventions in oncology have been conducted in high-income settings [ 9 ], this study was uniquely implemented in Iran, a low- to middle-income country (LMIC), offering valuable insight into the feasibility and impact of digital health tools in resource-constrained environments. The findings of this RCT demonstrated that the self-management app had a statistically significant positive effect on the mean QoL scores in the intervention group compared to the control group (P < 0.001). These results underscore the app’s clinical relevance and effectiveness in enhancing QoL among patients undergoing chemotherapy. In contrast, a similar RCT conducted in Japan found no significant improvements in anxiety, depression, or health literacy between patients using a breast cancer support app and those in the control group [ 35 ]. This divergence may be explained by the control group's concurrent access to alternative informational resources, which may have diluted the app’s measurable impact. Furthermore, the Japanese study confined app usage to the hospital setting and later recommended its integration into outpatient care for more effective symptom monitoring beyond the clinical environment. While other studies have reported limited efficacy of mobile-based interventions such as SMS messaging in reducing symptom burden [ 36 , 37 ], the app in the present study yielded notable QoL improvements, likely due to its comprehensive, symptom-specific educational modules and structured, ongoing monitoring features. The usability score of the app, as reported by patients using the SUS, was 73.07%, indicating a satisfactory level of usability. Moreover, the app’s interface and overall design were systematically reviewed and approved by a multidisciplinary panel of clinical experts during structured focus group sessions. These results emphasize the importance of user-centered design and demonstrate the app’s ability to effectively address both the informational and functional needs of breast cancer patients undergoing chemotherapy. In a comparable study conducted in South Korea, 76 patients with metastatic breast cancer undergoing cytotoxic chemotherapy participated in an intervention designed to assess the effectiveness of a mobile-based educational game. The primary objectives were to improve medication adherence, reduce physical side effects of chemotherapy, and enhance psychological well-being. Participants in the intervention group engaged with approximately 40% of the game’s content and reported an overall satisfactory level of user experience. Notably, the majority expressed interest in reusing the game in future chemotherapy sessions and were willing to recommend it to fellow patients. Furthermore, patients in the game-based group showed significantly higher levels of educational engagement and adherence to prescribed treatments compared to those in the control group. These outcomes were likely facilitated by the app’s built-in reminder system and medication-tracking features, which improved awareness of disease, treatment regimens, and potential adverse effects [ 14 ]. Taken together, these findings underscore a growing body of evidence that supports the usability and acceptance of mHealth interventions among breast cancer patients. The high usability score observed in our study aligns with prior international experiences, suggesting that when digital health tools are designed with clinical and patient-centered perspectives in mind, they can transcend demographic or cultural boundaries [ 9 , 10 ]. Moreover, incorporating interactive components and feedback mechanisms—as demonstrated in both our app and the Korean game-based model—appears to significantly enhance user engagement and therapeutic adherence. This reinforces the need for integrative design frameworks that merge clinical guidelines with behavioral science to optimize digital solutions in oncology care. Our previous cross-sectional study conducted in northeastern Iran revealed that although breast cancer patients undergoing chemotherapy generally demonstrated an adequate level of knowledge, several critical domains still required targeted educational and empowerment interventions. Enhancing patient knowledge through such structured interventions can mitigate anxiety, improve treatment adherence, and ultimately enhance both the quality of care and overall QoL [ 20 ]. Furthermore, our systematic review highlighted that mobile health (mHealth) interventions are not only comparable to traditional face-to-face care but, in many cases, may outperform them in delivering supportive oncology services [ 9 ]. Collectively, these prior findings established a strong theoretical and empirical foundation for the development of the current digital intervention. Specifically, the unmet need for structured education and patient empowerment, as identified in our cross-sectional study, combined with the demonstrated efficacy of mHealth approaches, directly shaped the content and architecture of the app. Findings from the current trial further reinforce the effectiveness of such digital health solutions by demonstrating high levels of satisfaction and acceptance, independent of patients’ demographic or clinical characteristics. This constitutes a significant strength of the intervention, especially in contrast to earlier studies suggesting that factors such as age and educational level may influence the adoption and usability of digital health tools [ 38 ]. For example, one study on a cancer symptom management app observed higher satisfaction among more educated users, while older patients exhibited greater resistance to adopting the technology. In contrast, the intuitive, user-centered design of our app appears to have neutralized these barriers, facilitating equitable engagement across diverse patient subgroups. Beyond overall satisfaction ratings, detailed user engagement analytics provided nuanced insights into patient interaction with individual app content modules. Notably, the "Nausea and Vomiting" module emerged as the most frequently accessed and highly rated section, garnering 132 likes and an average rating of 3.5 out of 5 stars. This emphasizes the salience of addressing acute and commonly experienced chemotherapy-related symptoms. These patterns underscore the importance of aligning content with users’ immediate concerns to maximize engagement and perceived utility. Conversely, the “Memory Changes” module received only 10 likes and no star ratings, indicating low interaction and perceived relevance. This may reflect either reduced awareness of cognitive side effects or a perception that such symptoms are less disruptive during active treatment. These disparities in engagement highlight the necessity of revisiting underperforming modules. We recommend that content in these areas be redesigned using direct patient feedback to better meet user expectations. Moreover, employing more dynamic and engaging formats—such as instructional videos, animations, or infographics—may improve comprehension, boost interaction, and enhance the effectiveness of less-utilized content domains. In alignment with our findings, a systematic review by Nuo Shi underscored the pivotal role of intervention components in enhancing self-efficacy among breast cancer patients undergoing chemotherapy through mHealth-based self-management programs. The intervention elements identified were mapped to the four domains of the Omaha System: (1) teaching, guidance, and counseling; (2) treatments and procedures; (3) case management; and (4) surveillance. Notably, self-monitoring—categorized under the “treatments and procedures” domain—was the most frequently utilized strategy across interventions targeting this population. These observations are consistent with emerging evidence highlighting the centrality of patient-reported outcomes as integral to the design and implementation of effective mHealth solutions in breast cancer care [ 8 ]. Building on this foundation, the results of the present study further reinforce the utility of mHealth apps in improving HRQoL, reducing chemotherapy-induced side effects, and supporting self-management behaviors among patients with breast cancer [ 14 , 17 , 27 , 28 , 31 , 39 – 45 ]. The principle of technological synergy suggests that combining multiple advanced modalities—such as intelligent mobile apps, virtual reality (VR), remote monitoring platforms, and automated symptom-reporting systems like ASyMS—can potentiate the efficacy of digital interventions [ 46 , 47 ]. Accordingly, the development of hybrid models that integrate communication-rich and interactive functionalities may offer more comprehensive and scalable pathways for rehabilitation and supportive cancer care [ 48 , 49 ]. Future research should therefore prioritize the evaluation of these integrated approaches in real-world clinical settings to validate their impact and ensure effective implementation. Our findings lend further empirical support to this perspective. The app used in this study significantly improved the QoL of breast cancer patients receiving chemotherapy, aligning with prior literature that emphasizes the value of digital symptom tracking and real-time management. A distinguishing strength of the current study was the app’s evidence-based development process, informed by a systematic review and multidisciplinary expert input. Moreover, the use of a RCT design—adhering rigorously to CONSORT guidelines [ 50 ]—strengthens the internal validity and generalizability of the findings. Importantly, the absence of significant differences in key demographic variables (e.g., age, marital status, education level) between the intervention and control groups indicates successful randomization and allocation, minimizing the risk of confounding bias. Additionally, the app’s user-centered design—shaped by iterative feedback from both clinicians and patients—was instrumental in achieving high levels of usability and acceptability, reinforcing its practical applicability in routine oncology care. Despite the promising findings, this study was not without limitations. First, due to the progressive nature of cancer, some participants may have experienced a loss of motivation during the intervention as a result of sudden disease exacerbation. To minimize this risk, we attempted to exclude patients with critically advanced stages of illness at the point of enrollment. Second, participant attrition posed a potential challenge; however, this was mitigated by estimating an initial sample size that accounted for potential dropout rates. Third, blinding of participants and study personnel was not feasible given the close interaction among patients, which increased the risk of contamination through app sharing. To address this, each participant in the intervention group received a unique, single-use activation code, which became invalid after installation—effectively preventing unauthorized distribution of the app. Although participant and investigator blinding could not be implemented, outcome assessment bias was minimized by ensuring that data analysis was conducted by a blinded statistician. Fourth, the intervention period was limited to four weeks, which may have constrained the evaluation of longer-term effects. Moreover, the relatively small sample size and single-site design limit the external validity and generalizability of the findings. To overcome these limitations, future studies should include extended follow-up periods and adopt multi-center designs to assess the durability and scalability of such interventions across diverse clinical settings. Looking ahead, the expansion of this app for self-management in patients with other cancer types presents a valuable opportunity for broader clinical impact. In particular, recent advancements in artificial intelligence (AI) hold transformative potential for personalized digital health interventions [ 51 ]. A next-generation intelligent app could leverage AI-driven clustering algorithms to identify individual knowledge deficits, content preferences, and informational needs. This adaptive delivery of tailored educational and self-management modules would enable more personalized learning pathways and facilitate the realization of precision oncology. Furthermore, it is strongly recommended that future trials incorporate larger, heterogeneous populations to enhance generalizability and evaluate additional clinical outcomes—such as treatment adherence, PRO, and long-term quality-of-life trajectories. Such efforts will be crucial in advancing the evidence base for mobile health applications in oncology care. Conclusion This study successfully developed and tested an app for managing chemotherapy side effects, demonstrating high levels of satisfaction among both clinicians and patients. The RCT findings support its efficacy in improving QoL and symptom control among breast cancer patients undergoing chemotherapy. Abbreviations HRQoL: Health-Related Quality of Life mHealth: Mobile Health RCT: Randomized Controlled Trial QoL: Quality of Life SUS: System Usability Scale EORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 EORTC QLQ-BR23: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Breast Cancer Module UI/UX: User Interface / User Experience SPSS: Statistical Package for the Social Sciences IRCT: Iranian Registry of Clinical Trials MUMS: Mashhad University of Medical Sciences LMIC: Low- and Middle-Income Country PRO: Patient-Reported Outcome AI: Artificial Intelligence Declarations Competing Interests : The writers have stated that they have no competing interests. Funding: None Clinical trial number: IRCT20230402057801N1 IRCT Registration date: 2023-05-12 Ethics approval and consent to participate : The study protocol was approved by the Ethics Committee of Mashhad University of Medical Sciences (Approval ID: IR.MUMS.FHMPM.REC.1401.198) and registered with the Iranian Registry of Clinical Trials (IRCT20230402057801N1). Written informed consent was obtained from all participants prior to enrollment. All participants were aged between 20 and 60 years; therefore, parental or guardian consent was not required. All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Consent for publication: Not applicable – this study does not contain any individual person’s identifiable data. Transparency statement: The [Masoumeh Sarbaz] certifies that the study reported in this manuscript is honest, accurate, and transparent; that no significant study components have been left out; and that any deviations from the planned study (and, if applicable, registered) have been described. Availability of data and materials : Due to the sensitive nature of patient-reported outcomes and the ethical commitments outlined in our ethics approval protocol, the datasets are not publicly available. However, researchers may obtain access to anonymized data by contacting the corresponding author upon reasonable request and subject to institutional review. Acknowledgments: The authors would like to thank the Research Deputy of MUMS for its financial and administrative support in this study. We extend our sincere gratitude to the “Student Research Committee” and the “Research & Technology Chancellor” of Mashhad University of Medical Sciences for their support of this study. We also wish to thank the specialists and patients who participated in this study and contributed to the completion of the research. Additionally, the authors acknowledge the assistance of ChatGPT (OpenAI) in providing English translation and improving the linguistic clarity of the manuscript. The final responsibility for the content of the manuscript lies solely with the authors. Authors' contributions: Marziyeh Raei Mehneh (M.RM): Conceptualization, Investigation, Data Curation, Software, Writing – Original Draft. Khalil Kimiafar (K.K): Methodology, Validation, Supervision, Writing – Review & Editing. Seyyedeh Fatemeh Mousavi Baigi (SF.MB): Methodology, Visualization, Writing – Original Draft, Writing – Review & Editing. Parviz Marouzi (P.M): Formal Analysis, Validation, Writing – Review & Editing. Soodabeh Shahidsales (S.S): Resources, Investigation, Supervision, Writing – Review & Editing. 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Automated monitoring of symptoms during ambulatory chemotherapy and oncology providers’ use of the information: a randomized controlled clinical trial. Support Care Cancer 2014;22:2343–50. Maguire R, McCann L, Kotronoulas G, Kearney N, Ream E, Armes J, et al. Real-time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). BMJ 2021;374:n1647. Blinder VS, Patil S, Finik J, Makower D, Muppidi M, Lichtenthal WG, et al. An interactive mobile application versus an educational booklet to promote job retention in women undergoing adjuvant chemotherapy for breast cancer: a randomized controlled trial. Trials 2022;23(1):840. Post DM, Shapiro CL, Cegala DJ, David P, Katz ML, Krok JL, et al. Improving symptom communication through personal digital assistants: the CHAT (Communicating Health Assisted by Technology) project. J Natl Cancer Inst Monogr 2013;2013(47):153–61. Kearney N, McCann L, Norrie J, Taylor L, Gray P, McGee-Lennon M, et al. Evaluation of a mobile phone-based, advanced symptom management system (ASyMS©) in the management of chemotherapy-related toxicity. Support Care Cancer 2009;17:437–44. McCann L, Maguire R, Miller M, Kearney N. Patients' perceptions and experiences of using a mobile phone-based advanced symptom management system (ASyMS©) to monitor and manage chemotherapy-related toxicity. Eur J Cancer Care (Engl) 2009;18(2):156–64. Maguire R, Miller M, Sage M, Norrie J, McCann L, Taylor L, et al. Results of a UK-based pilot study of a mobile phone-based advanced symptom management system (ASyMS) in the remote monitoring of chemotherapy-related toxicity. Clin Eff Nurs 2005;9(3–4):202–10. Mousavi Baigi SF, Sarbaz M, Ghaddaripouri K, Ghaddaripouri M, Mousavi AS, Kimiafar K. Attitudes, knowledge, and skills towards artificial intelligence among healthcare students: a systematic review. Health Sci Rep 2023;6(3):e1138. Baigi SFM, Kimiafar K, Ghaddaripouri K, Mehneh MR, Mousavi AS, Sarbaz M. The effect of telerehabilitation on improving the physical activity of patients with osteoarthritis: a systematic review. J Educ Health Promot 2023;12(1):408. Baigi SFM, Sarbaz M, Sobhani-Rad D, Mousavi AS, Kimiafar K. Rehabilitation registration systems: current recommendations and challenges. Front Health Inform 2022;11(1):124. Mousavi Baigi SF, Mousavi AS, Kimiafar K, Sarbaz M. Evaluating the cost effectiveness of tele-rehabilitation: a systematic review of randomized clinical trials. Front Health Inform 2022;11:118. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother 2010;1(2):100–7. Kimiafar K, Sarbaz M, Tabatabaei SM, Ghaddaripouri K, Mousavi AS, Mehneh MR, et al. Artificial intelligence literacy among healthcare professionals and students: a systematic review. Front Health Inform 2023;12:168. Additional Declarations No competing interests reported. Supplementary Files SupplementaryMaterial1.doc GraphicalAbstract.png Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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While chemotherapy improves survival, it often leads to physical, psychological, and social side effects that compromise quality of life (QoL) [3–5].\u003c/p\u003e\n\u003cp\u003eDespite the necessity of effective side effect management, patients frequently lack tools for symptom tracking between clinical visits [6, 7]. In this context, mobile health (mHealth) apps offer scalable, real-time, and patient-centered solutions that enhance self-management and QoL [1, 8, 9]. Evidence from RCTs supports the efficacy of mHealth in reducing symptom burden and improving adherence [8–10]. For example, Basch et al. linked patient-reported outcome systems to increased survival through early detection of adverse events [11].\u003c/p\u003e\n\u003cp\u003eSeveral apps have targeted breast cancer needs—ranging from wound care [12] and sleep [13] to psychological support [14], dosing [15], and education [16]—yielding improved satisfaction and fewer hospital visits [17, 18]. Iranian studies have shown similar benefits, including reduced anxiety and enhanced self-esteem [1, 19]. Nonetheless, local gaps persist in culturally tailored app design and rigorous evaluations [7, 20].\u003c/p\u003e\n\u003cp\u003eCritically, there is a lack of RCTs in Iran evaluating the dual impact of such apps on both side effect management and QoL. This study addresses that gap by assessing the effectiveness of a mobile app using a randomized controlled design.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatement of Significance\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(1) Problem or Issue:\u003c/p\u003e\n\u003cp\u003eBreast cancer patients undergoing chemotherapy often suffer from debilitating side effects that significantly impair their health-related quality of life (HRQoL). In low-resource settings, continuity of care and symptom monitoring between clinical visits remain limited.\u003c/p\u003e\n\u003cp\u003e(2) What is Already Known:\u003c/p\u003e\n\u003cp\u003eMobile health (mHealth) applications have shown promise in improving self-management and QoL in oncology care, primarily in high-income countries. However, there is a lack of randomized controlled evidence from culturally and linguistically tailored mHealth interventions in developing nations.\u003c/p\u003e\n\u003cp\u003e(3) What this Paper Adds:\u003c/p\u003e\n\u003cp\u003eThis study presents the first randomized controlled trial in Iran evaluating a mobile app designed for managing chemotherapy-related symptoms in breast cancer patients. The app significantly improved QoL scores and demonstrated high usability and patient engagement, especially for symptoms like nausea and anxiety.\u003c/p\u003e\n\u003cp\u003e(4) Who Would Benefit:\u003c/p\u003e\n\u003cp\u003eThis evidence will benefit oncologists, mHealth developers, clinical researchers, and healthcare policymakers interested in scalable digital interventions for supportive cancer care in resource-constrained environments.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy Design and Setting\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis open-label, two-arm randomized controlled trial (RCT) was conducted with a 1:1 allocation ratio at Omid Hospital, a major cancer center in Mashhad, Iran. The trial aimed to evaluate the structure and impact of a mobile app for managing chemotherapy-induced side effects and improving quality of life (QoL) in breast cancer patients. This study was conducted and reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines for randomized controlled trials. The completed CONSORT checklist is provided in \u003cstrong\u003eSupplementary Material 1\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;Eligible participants were women aged 20\u0026ndash;60 with a confirmed diagnosis of breast cancer, receiving chemotherapy at Omid Hospital, literate in Persian, and owners of compatible smartphones. Exclusion criteria included psychiatric disorders, major comorbidities, simultaneous radiotherapy or biotherapy, or participation in similar studies.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eApp Development\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eApp content was derived from guidelines by the National Cancer Institute, American Cancer Society, and Cancer Council Australia. A multidisciplinary team (oncologists, nurses, health informatics, biostatistics) refined the app through focus groups. The app featured 20 modules targeting symptoms like nausea, fatigue, anxiety, etc., and was designed with social-media-like interactivity. A secure one-time activation code prevented unauthorized use.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRandomization and Blinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants were randomly assigned using block randomization via www.randomize.com. Allocation was concealed using opaque envelopes. Due to the app-based nature, the study was not blinded.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;The intervention group received app access for four weeks, with onboarding and a follow-up support call. The control group received standard hospital care and generic educational web resources.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcome Measures\u003c/strong\u003e\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003ePrimary Outcome:\u003c/strong\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eHealth-related QoL, measured using validated Persian versions of the following:\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cul type=\"circle\"\u003e\n \u003cli\u003e\u003cstrong\u003eEORTC QLQ-C30\u003c/strong\u003e: A 30-item questionnaire assessing five functional domains, nine symptoms, and global health status [21]. Higher function scores indicate better QoL, while higher symptom scores reflect greater burden.\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eEORTC QLQ-BR23\u003c/strong\u003e: A 23-item breast cancer-specific module addressing body image, sexual function, treatment side effects, and arm/breast symptoms [22, 23].\u003cbr\u003e\u0026nbsp;Persian versions were validated by Montazeri et al., confirming high reliability and construct validity [24].\u003c/li\u003e\n \u003c/ul\u003e\n \u003cli\u003e\u003cstrong\u003eSecondary Outcome:\u003c/strong\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eApp usability was assessed via the Persian version of the \u003cstrong\u003eSystem Usability Scale (SUS)\u003c/strong\u003e [25], a 10-item instrument with Likert scaling. Scores range from 0\u0026ndash;100, with \u0026ge;70 indicating acceptable usability. The version used was validated for Iranian health technology contexts by Dianat et al. [26].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample Size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBased on Kim et al. [14] and Ariza-Garcia et al. [27], assuming an effect size of 0.334, 85% power, and \u0026alpha;=0.05, the required sample size was calculated as 72 (36 per group).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection and Timeline\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBaseline data were gathered at the third chemotherapy session. Post-intervention assessments occurred after four weeks.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData analysis was performed using SPSS v16.0. Normality was tested via Shapiro\u0026ndash;Wilk. Between-group comparisons used independent t-tests and Mann\u0026ndash;Whitney U tests. Chi-square tests analyzed categorical variables. ANCOVA adjusted for baseline QoL differences. Significance was set at p\u0026lt;0.05, CI at 95%.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Considerations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was approved by the Mashhad University of Medical Sciences Ethics Committee (IR.MUMS.FHMPM.REC.1401.198) and registered in the Iranian Registry of Clinical Trials (IRCT20230402057801N1). Written informed consent was obtained from all participants.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\u003ch2\u003eParticipant Flow\u003c/h2\u003e\u003cp\u003eOut of 72 eligible breast cancer patients at Omid Hospital, all consented and were randomized equally (n\u0026thinsp;=\u0026thinsp;36 per group). In the control group, 6 participants dropped out due to lack of interest. In the intervention group, 9 dropped out: 3 without reason, 2 due to travel, 2 due to technical incompatibility (Android\u0026rarr;iOS), and 1 due to severe side effects.\u003c/p\u003e\u003cp\u003eThus, 57 participants (27 intervention, 30 control) completed the study. A CONSORT diagram (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) details recruitment and follow-up.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\u003ch2\u003eBaseline Characteristics of Participants\u003c/h2\u003e\u003cp\u003eBaseline demographics (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) showed no statistically significant differences between groups in age, marital status, education, occupation, cancer stage, or surgical history. This indicates successful randomization and comparability at baseline.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eBaseline Characteristics of Participants\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eAll Participants\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eIntervention Group (n\u0026thinsp;=\u0026thinsp;27)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eControl Group (n\u0026thinsp;=\u0026thinsp;30)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eP-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAge (mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e40.44\u0026thinsp;\u0026plusmn;\u0026thinsp;6.82 years\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e48.44\u0026thinsp;\u0026plusmn;\u0026thinsp;6.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e33.44\u0026thinsp;\u0026plusmn;\u0026thinsp;7.59\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.41\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eMarital Status, n (%)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.21\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSingle\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e24 (42.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e13 (48.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e11 (36.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMarried\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e33 (57.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e14 (51.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e19 (63.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eEducational Level, n (%)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.32\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLess than high school\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e14 (24.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e7 (25.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e7 (23.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHigh school diploma\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e23 (40.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e11 (40.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e12 (40.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAssociate degree\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13 (22.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e6 (22.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e7 (23.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBachelor\u0026rsquo;s degree or higher\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7 (12.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e3 (11.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e4 (13.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eOccupation, n (%)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.36\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHomemaker\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e35 (61.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e15 (55.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e20 (66.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEmployed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e22 (38.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e12 (44.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e10 (33.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eDisease Duration (days, mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e80.51\u0026thinsp;\u0026plusmn;\u0026thinsp;37.73\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e79.81\u0026thinsp;\u0026plusmn;\u0026thinsp;6.21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e81.13\u0026thinsp;\u0026plusmn;\u0026thinsp;7.77\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.57\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eCancer Stage (Grade), n (%)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.32\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGrade 1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e9 (15.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e2 (7.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e6 (20%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGrade 2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e42 (73.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e20 (74.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e22 (73.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGrade 3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (10.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (14.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2 (6.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eHistory of Surgical Treatment, n (%)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.42\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e21 (36.8%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e10 (37%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e11 (36.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e36 (63.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e17 (63%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e19 (63.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\u003ch2\u003eContent Development and App Design\u003c/h2\u003e\u003cp\u003eThe app's content was grounded in findings from a previously conducted systematic review of RCTs, as reported in our earlier publications [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. To ensure clinical relevance and maximize user engagement, two structured focus group sessions (each lasting approximately two hours) were conducted with a multidisciplinary expert panel. The panel consisted of three radiation oncologists, one health information management specialist, and one medical informatics expert. Through a consensus-driven process, the panel finalized the content framework and approved 20 key categories addressing chemotherapy-induced side effects commonly experienced by breast cancer patients. These categories encompassed:\u003c/p\u003e\u003cp\u003e\u003cem\u003eAnemia, appetite changes, bleeding disorders, constipation, fatigue, memory impairment, infections, hair loss, diarrhea, sexual and fertility changes, urinary symptoms, edema, skin and nail changes, pain, neurological symptoms, nausea and vomiting, oral/nasal/throat issues, anxiety and stress, depression, and sleep disturbances.\u003c/em\u003e\u003c/p\u003e\u003cp\u003eThe app was designed as a dual-platform system, comprising a mobile application for patients and a web-based management dashboard for monitoring user engagement and backend analytics. The mobile platform was developed in Android Studio, employing JavaScript and HTML for interactive design and dynamic content presentation. The dashboard was built using JavaScript and integrated with Google Apps Script for secure, real-time data management. Figma was utilized during the UI/UX design phase to prototype and test the visual interface.\u003c/p\u003e\u003cp\u003eFollowing initial development, two additional expert review sessions were conducted, expanding the panel to include three radiation oncologists, three oncology nurses, two health information specialists, one medical informatics expert, one biostatistician, and one graduate student in health information technology. The app underwent evaluation for content accuracy, educational value, usability, and user engagement. Revisions were made based on expert feedback to optimize the app's pedagogical effectiveness and visual design.\u003c/p\u003e\u003cp\u003eThe final version of the app was refined to ensure functional reliability, clinical credibility, and user-friendliness for patients undergoing chemotherapy (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec20\" class=\"Section2\"\u003e\u003ch2\u003ePrimary Outcome Results: Change in QoL Scores\u003c/h2\u003e\u003cp\u003eAs summarized in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, the results revealed a statistically significant improvement in post-intervention mean QoL scores for the intervention group compared to the control group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Additionally, baseline QoL scores were found to significantly influence the post-intervention outcomes (P\u0026thinsp;=\u0026thinsp;0.007), highlighting the importance of adjusting for initial differences in patient-reported quality of life. This justified the application of analysis of covariance (ANCOVA) to control for potential confounding effects of baseline variability.\u003c/p\u003e\u003cp\u003eThese findings indicate that the mobile app intervention exerted a robust positive effect on QoL among breast cancer patients undergoing chemotherapy.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eANCOVA results comparing post-intervention QoL scores between groups, adjusted for baseline values\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSource\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eType III Sum of Squares\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003edf\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMean Square\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eF\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eP-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eModel\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e144.495\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e48.165\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e2367.333\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eGroup\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.373\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.186\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e9.162\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBaseline QoL Score\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.163\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.163\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e7.994\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e0.007\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eError\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1.099\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e54\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e0.020\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026mdash;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u0026mdash;\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTotal\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e145.594\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e57\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u0026mdash;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026mdash;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u0026mdash;\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003ea.\u003c/b\u003e R\u0026sup2; = 0.992 (Adjusted R\u0026sup2; = 0.992)\u003c/p\u003e\u003cp\u003eFigure \u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e5\u003c/span\u003e presents a visual comparison of standardized mean QoL scores and their associated standard deviations for both study groups at baseline and post-intervention. In the control group, the mean QoL score exhibited a marginal increase from 1.50\u0026thinsp;\u0026plusmn;\u0026thinsp;0.22 at baseline to 1.53\u0026thinsp;\u0026plusmn;\u0026thinsp;0.26 following the intervention period. Conversely, the intervention group showed a more substantial improvement, with mean QoL scores rising from 1.51\u0026thinsp;\u0026plusmn;\u0026thinsp;0.21 at baseline to 1.66\u0026thinsp;\u0026plusmn;\u0026thinsp;0.18 post-intervention.\u003c/p\u003e\u003cp\u003eThese results further support the effectiveness of the app-based intervention in enhancing patients\u0026rsquo; health-related QoL during chemotherapy.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e\u003ch2\u003eSecondary Outcome Results: Usability Evaluation of the Mobile App\u003c/h2\u003e\u003cp\u003eUsability assessed via the SUS showed a mean score of 73.07, indicating acceptable usability. Scoring followed standard SUS methodology [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e], with interpretation based on validated Persian version [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. No significant correlation was found between SUS score and patient age (P\u0026thinsp;=\u0026thinsp;0.909), education (P\u0026thinsp;=\u0026thinsp;0.560), occupation (P\u0026thinsp;=\u0026thinsp;0.750), or cancer grade (P\u0026thinsp;=\u0026thinsp;0.381), suggesting broad usability. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e shows individual item means, highlighting strong ratings for learnability, ease of use, and confidence.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eMean Item Scores from the SUS Completed by the Intervention Group\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eItem No.\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSUS Statement\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eMean Score\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI think that I would like to use this app frequently.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e4.5\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI found the app unnecessarily complex.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1.2\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI thought the app was easy to use.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e4.5\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI think that I would need the support of a technical person to use this app.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1.8\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI found the various functions in this app were well integrated.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e4.0\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI thought there was too much inconsistency in this app.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2.5\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI would imagine that most people would learn to use this app very quickly.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e3.5\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI found the app very cumbersome to use.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1.7\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI felt very confident using the app.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e4.3\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e10\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eI needed to learn a lot of things before I could get going with this app.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2.7\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec22\" class=\"Section2\"\u003e\u003ch2\u003eAdditional Secondary Outcome: In-App Feedback and User Interaction Metrics\u003c/h2\u003e\u003cp\u003eEngagement metrics retrieved from the app\u0026rsquo;s backend analytics indicated varying levels of user interaction across the 20 educational modules. The module addressing nausea and vomiting received the highest number of likes (132) and views (459), suggesting strong perceived relevance. In contrast, the memory changes module showed the lowest engagement, with only 10 likes and no star ratings.\u003c/p\u003e\u003cp\u003eThese findings indicate that modules addressing commonly experienced and distressing symptoms\u0026mdash;such as nausea, sleep disturbances, and diarrhea\u0026mdash;were more frequently accessed and rated positively. This pattern underscores the importance of aligning content with patients\u0026rsquo; immediate concerns.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eA growing body of evidence supports the role of mobile health (mHealth) apps in reducing treatment-related side effects and improving QoL among patients with breast cancer [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan additionalcitationids=\"CR29 CR30 CR31 CR32 CR33\" citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. However, to the best of our knowledge, the present study represents the first RCT in Iran to evaluate the effectiveness of a mobile-based app in enhancing QoL by addressing chemotherapy-related symptom burden. While the majority of prior mHealth interventions in oncology have been conducted in high-income settings [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e], this study was uniquely implemented in Iran, a low- to middle-income country (LMIC), offering valuable insight into the feasibility and impact of digital health tools in resource-constrained environments.\u003c/p\u003e\u003cp\u003eThe findings of this RCT demonstrated that the self-management app had a statistically significant positive effect on the mean QoL scores in the intervention group compared to the control group (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001). These results underscore the app\u0026rsquo;s clinical relevance and effectiveness in enhancing QoL among patients undergoing chemotherapy. In contrast, a similar RCT conducted in Japan found no significant improvements in anxiety, depression, or health literacy between patients using a breast cancer support app and those in the control group [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e]. This divergence may be explained by the control group's concurrent access to alternative informational resources, which may have diluted the app\u0026rsquo;s measurable impact. Furthermore, the Japanese study confined app usage to the hospital setting and later recommended its integration into outpatient care for more effective symptom monitoring beyond the clinical environment. While other studies have reported limited efficacy of mobile-based interventions such as SMS messaging in reducing symptom burden [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e], the app in the present study yielded notable QoL improvements, likely due to its comprehensive, symptom-specific educational modules and structured, ongoing monitoring features.\u003c/p\u003e\u003cp\u003eThe usability score of the app, as reported by patients using the SUS, was 73.07%, indicating a satisfactory level of usability. Moreover, the app\u0026rsquo;s interface and overall design were systematically reviewed and approved by a multidisciplinary panel of clinical experts during structured focus group sessions. These results emphasize the importance of user-centered design and demonstrate the app\u0026rsquo;s ability to effectively address both the informational and functional needs of breast cancer patients undergoing chemotherapy.\u003c/p\u003e\u003cp\u003e In a comparable study conducted in South Korea, 76 patients with metastatic breast cancer undergoing cytotoxic chemotherapy participated in an intervention designed to assess the effectiveness of a mobile-based educational game. The primary objectives were to improve medication adherence, reduce physical side effects of chemotherapy, and enhance psychological well-being. Participants in the intervention group engaged with approximately 40% of the game\u0026rsquo;s content and reported an overall satisfactory level of user experience. Notably, the majority expressed interest in reusing the game in future chemotherapy sessions and were willing to recommend it to fellow patients. Furthermore, patients in the game-based group showed significantly higher levels of educational engagement and adherence to prescribed treatments compared to those in the control group. These outcomes were likely facilitated by the app\u0026rsquo;s built-in reminder system and medication-tracking features, which improved awareness of disease, treatment regimens, and potential adverse effects [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eTaken together, these findings underscore a growing body of evidence that supports the usability and acceptance of mHealth interventions among breast cancer patients. The high usability score observed in our study aligns with prior international experiences, suggesting that when digital health tools are designed with clinical and patient-centered perspectives in mind, they can transcend demographic or cultural boundaries [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Moreover, incorporating interactive components and feedback mechanisms\u0026mdash;as demonstrated in both our app and the Korean game-based model\u0026mdash;appears to significantly enhance user engagement and therapeutic adherence. This reinforces the need for integrative design frameworks that merge clinical guidelines with behavioral science to optimize digital solutions in oncology care.\u003c/p\u003e\u003cp\u003eOur previous cross-sectional study conducted in northeastern Iran revealed that although breast cancer patients undergoing chemotherapy generally demonstrated an adequate level of knowledge, several critical domains still required targeted educational and empowerment interventions. Enhancing patient knowledge through such structured interventions can mitigate anxiety, improve treatment adherence, and ultimately enhance both the quality of care and overall QoL [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. Furthermore, our systematic review highlighted that mobile health (mHealth) interventions are not only comparable to traditional face-to-face care but, in many cases, may outperform them in delivering supportive oncology services [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Collectively, these prior findings established a strong theoretical and empirical foundation for the development of the current digital intervention. Specifically, the unmet need for structured education and patient empowerment, as identified in our cross-sectional study, combined with the demonstrated efficacy of mHealth approaches, directly shaped the content and architecture of the app.\u003c/p\u003e\u003cp\u003eFindings from the current trial further reinforce the effectiveness of such digital health solutions by demonstrating high levels of satisfaction and acceptance, independent of patients\u0026rsquo; demographic or clinical characteristics. This constitutes a significant strength of the intervention, especially in contrast to earlier studies suggesting that factors such as age and educational level may influence the adoption and usability of digital health tools [\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. For example, one study on a cancer symptom management app observed higher satisfaction among more educated users, while older patients exhibited greater resistance to adopting the technology. In contrast, the intuitive, user-centered design of our app appears to have neutralized these barriers, facilitating equitable engagement across diverse patient subgroups.\u003c/p\u003e\u003cp\u003eBeyond overall satisfaction ratings, detailed user engagement analytics provided nuanced insights into patient interaction with individual app content modules. Notably, the \"Nausea and Vomiting\" module emerged as the most frequently accessed and highly rated section, garnering 132 likes and an average rating of 3.5 out of 5 stars. This emphasizes the salience of addressing acute and commonly experienced chemotherapy-related symptoms. These patterns underscore the importance of aligning content with users\u0026rsquo; immediate concerns to maximize engagement and perceived utility.\u003c/p\u003e\u003cp\u003eConversely, the \u0026ldquo;Memory Changes\u0026rdquo; module received only 10 likes and no star ratings, indicating low interaction and perceived relevance. This may reflect either reduced awareness of cognitive side effects or a perception that such symptoms are less disruptive during active treatment. These disparities in engagement highlight the necessity of revisiting underperforming modules. We recommend that content in these areas be redesigned using direct patient feedback to better meet user expectations. Moreover, employing more dynamic and engaging formats\u0026mdash;such as instructional videos, animations, or infographics\u0026mdash;may improve comprehension, boost interaction, and enhance the effectiveness of less-utilized content domains.\u003c/p\u003e\u003cp\u003e In alignment with our findings, a systematic review by Nuo Shi underscored the pivotal role of intervention components in enhancing self-efficacy among breast cancer patients undergoing chemotherapy through mHealth-based self-management programs. The intervention elements identified were mapped to the four domains of the Omaha System: (1) teaching, guidance, and counseling; (2) treatments and procedures; (3) case management; and (4) surveillance. Notably, self-monitoring\u0026mdash;categorized under the \u0026ldquo;treatments and procedures\u0026rdquo; domain\u0026mdash;was the most frequently utilized strategy across interventions targeting this population. These observations are consistent with emerging evidence highlighting the centrality of patient-reported outcomes as integral to the design and implementation of effective mHealth solutions in breast cancer care [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eBuilding on this foundation, the results of the present study further reinforce the utility of mHealth apps in improving HRQoL, reducing chemotherapy-induced side effects, and supporting self-management behaviors among patients with breast cancer [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e, \u003cspan additionalcitationids=\"CR40 CR41 CR42 CR43 CR44\" citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. The principle of technological synergy suggests that combining multiple advanced modalities\u0026mdash;such as intelligent mobile apps, virtual reality (VR), remote monitoring platforms, and automated symptom-reporting systems like ASyMS\u0026mdash;can potentiate the efficacy of digital interventions [\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e, \u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e]. Accordingly, the development of hybrid models that integrate communication-rich and interactive functionalities may offer more comprehensive and scalable pathways for rehabilitation and supportive cancer care [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e, \u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e]. Future research should therefore prioritize the evaluation of these integrated approaches in real-world clinical settings to validate their impact and ensure effective implementation.\u003c/p\u003e\u003cp\u003eOur findings lend further empirical support to this perspective. The app used in this study significantly improved the QoL of breast cancer patients receiving chemotherapy, aligning with prior literature that emphasizes the value of digital symptom tracking and real-time management. A distinguishing strength of the current study was the app\u0026rsquo;s evidence-based development process, informed by a systematic review and multidisciplinary expert input. Moreover, the use of a RCT design\u0026mdash;adhering rigorously to CONSORT guidelines [\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e]\u0026mdash;strengthens the internal validity and generalizability of the findings.\u003c/p\u003e\u003cp\u003eImportantly, the absence of significant differences in key demographic variables (e.g., age, marital status, education level) between the intervention and control groups indicates successful randomization and allocation, minimizing the risk of confounding bias. Additionally, the app\u0026rsquo;s user-centered design\u0026mdash;shaped by iterative feedback from both clinicians and patients\u0026mdash;was instrumental in achieving high levels of usability and acceptability, reinforcing its practical applicability in routine oncology care.\u003c/p\u003e\u003cp\u003eDespite the promising findings, this study was not without limitations. First, due to the progressive nature of cancer, some participants may have experienced a loss of motivation during the intervention as a result of sudden disease exacerbation. To minimize this risk, we attempted to exclude patients with critically advanced stages of illness at the point of enrollment. Second, participant attrition posed a potential challenge; however, this was mitigated by estimating an initial sample size that accounted for potential dropout rates. Third, blinding of participants and study personnel was not feasible given the close interaction among patients, which increased the risk of contamination through app sharing. To address this, each participant in the intervention group received a unique, single-use activation code, which became invalid after installation\u0026mdash;effectively preventing unauthorized distribution of the app. Although participant and investigator blinding could not be implemented, outcome assessment bias was minimized by ensuring that data analysis was conducted by a blinded statistician.\u003c/p\u003e\u003cp\u003eFourth, the intervention period was limited to four weeks, which may have constrained the evaluation of longer-term effects. Moreover, the relatively small sample size and single-site design limit the external validity and generalizability of the findings. To overcome these limitations, future studies should include extended follow-up periods and adopt multi-center designs to assess the durability and scalability of such interventions across diverse clinical settings.\u003c/p\u003e\u003cp\u003eLooking ahead, the expansion of this app for self-management in patients with other cancer types presents a valuable opportunity for broader clinical impact. In particular, recent advancements in artificial intelligence (AI) hold transformative potential for personalized digital health interventions [\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e]. A next-generation intelligent app could leverage AI-driven clustering algorithms to identify individual knowledge deficits, content preferences, and informational needs. This adaptive delivery of tailored educational and self-management modules would enable more personalized learning pathways and facilitate the realization of precision oncology.\u003c/p\u003e\u003cp\u003eFurthermore, it is strongly recommended that future trials incorporate larger, heterogeneous populations to enhance generalizability and evaluate additional clinical outcomes\u0026mdash;such as treatment adherence, PRO, and long-term quality-of-life trajectories. Such efforts will be crucial in advancing the evidence base for mobile health applications in oncology care.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study successfully developed and tested an app for managing chemotherapy side effects, demonstrating high levels of satisfaction among both clinicians and patients. The RCT findings support its efficacy in improving QoL and symptom control among breast cancer patients undergoing chemotherapy.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eHRQoL: Health-Related Quality of Life\u003c/p\u003e\n\u003cp\u003emHealth: Mobile Health\u003c/p\u003e\n\u003cp\u003eRCT: Randomized Controlled Trial\u003c/p\u003e\n\u003cp\u003eQoL: Quality of Life\u003c/p\u003e\n\u003cp\u003eSUS: System Usability Scale\u003c/p\u003e\n\u003cp\u003eEORTC QLQ-C30: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \u0026ndash; Core 30\u003c/p\u003e\n\u003cp\u003eEORTC QLQ-BR23: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \u0026ndash; Breast Cancer Module\u003c/p\u003e\n\u003cp\u003eUI/UX: User Interface / User Experience\u003c/p\u003e\n\u003cp\u003eSPSS: Statistical Package for the Social Sciences\u003c/p\u003e\n\u003cp\u003eIRCT: Iranian Registry of Clinical Trials\u003c/p\u003e\n\u003cp\u003eMUMS: Mashhad University of Medical Sciences\u003c/p\u003e\n\u003cp\u003eLMIC: Low- and Middle-Income Country\u003c/p\u003e\n\u003cp\u003ePRO: Patient-Reported Outcome\u003c/p\u003e\n\u003cp\u003eAI: Artificial Intelligence\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e: The writers have stated that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial number:\u003c/strong\u003e IRCT20230402057801N1\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIRCT Registration date:\u0026nbsp;\u003c/strong\u003e2023-05-12\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e: The study protocol was approved by the Ethics Committee of Mashhad University of Medical Sciences (Approval ID: IR.MUMS.FHMPM.REC.1401.198) and registered with the Iranian Registry of Clinical Trials (IRCT20230402057801N1). Written informed consent was obtained from all participants prior to enrollment. All participants were aged between 20 and 60 years; therefore, parental or guardian consent was not required. All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u0026nbsp;\u003c/strong\u003eNot applicable \u0026ndash; this study does not contain any individual person\u0026rsquo;s identifiable data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTransparency statement:\u003c/strong\u003e The [Masoumeh Sarbaz] certifies that the study reported in this manuscript is honest, accurate, and transparent; that no significant study components have been left out; and that any deviations from the planned study (and, if applicable, registered) have been described.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e: Due to the sensitive nature of patient-reported outcomes and the ethical commitments outlined in our ethics approval protocol, the datasets are not publicly available. However, researchers may obtain access to anonymized data by contacting the corresponding author upon reasonable request and subject to institutional review.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eThe authors would like to thank the Research Deputy of MUMS for its financial and administrative support in this study. We extend our sincere gratitude to the \u0026ldquo;Student Research Committee\u0026rdquo; and the \u0026ldquo;Research \u0026amp; Technology Chancellor\u0026rdquo; of Mashhad University of Medical Sciences for their support of this study. We also wish to thank the specialists and patients\u003cspan dir=\"RTL\"\u003e\u0026nbsp;\u003c/span\u003ewho participated in this study and contributed to the completion of the research. Additionally, the authors acknowledge the assistance of ChatGPT (OpenAI) in providing English translation and improving the linguistic clarity of the manuscript. The final responsibility for the content of the manuscript lies solely with the authors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions:\u0026nbsp;\u003c/strong\u003eMarziyeh Raei Mehneh (M.RM): Conceptualization, Investigation, Data Curation, Software, Writing \u0026ndash; Original Draft. Khalil Kimiafar (K.K): Methodology, Validation, Supervision, Writing \u0026ndash; Review \u0026amp; Editing. Seyyedeh Fatemeh Mousavi Baigi (SF.MB): Methodology, Visualization, Writing \u0026ndash; Original Draft, Writing \u0026ndash; Review \u0026amp; Editing. Parviz Marouzi (P.M): Formal Analysis, Validation, Writing \u0026ndash; Review \u0026amp; Editing. Soodabeh Shahidsales (S.S): Resources, Investigation, Supervision, Writing \u0026ndash; Review \u0026amp; Editing. Masoumeh Sarbaz (M.S): Conceptualization, Project Administration, Supervision, Funding Acquisition, Writing \u0026ndash; Review \u0026amp; Editing.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eGhanbari E, Yektatalab S, Mehrabi M. Effects of psychoeducational interventions using mobile apps and mobile-based online group discussions on anxiety and self-esteem in women with breast cancer: a randomized controlled trial. \u003cem\u003eJMIR Mhealth Uhealth\u003c/em\u003e 2021;9(5):e19262.\u003c/li\u003e\n\u003cli\u003eSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. \u003cem\u003eCA Cancer J Clin\u003c/em\u003e 2021;71(3):209\u0026ndash;49.\u003c/li\u003e\n\u003cli\u003eMontazeri A. 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Artificial intelligence literacy among healthcare professionals and students: a systematic review. \u003cem\u003eFront Health Inform\u003c/em\u003e 2023;12:168.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Breast cancer, mHealth, quality of life, chemotherapy, mobile app, RCT","lastPublishedDoi":"10.21203/rs.3.rs-7462740/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7462740/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eBreast cancer patients undergoing chemotherapy often face numerous side effects that reduce their health-related quality of life (HRQoL). While conventional follow-up care is limited in continuity, mobile health (mHealth) interventions, particularly smartphone applications, may offer scalable, real-time support for symptom self-management.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003eThis randomized controlled trial (RCT) evaluated the effectiveness of a mobile app designed to manage chemotherapy-related side effects in breast cancer patients.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eSeventy-two participants receiving chemotherapy at Omid Hospital (Mashhad, Iran) were randomly assigned to an intervention group (app\u0026thinsp;+\u0026thinsp;standard care) or control group (standard care only). The app included 20 modules targeting common chemotherapy-related complications, developed through expert consensus and clinical guidelines. Primary outcomes were changes in HRQoL measured by the EORTC QLQ-C30 and QLQ-BR23 at baseline and after four weeks. App usability was assessed using the System Usability Scale (SUS).\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eFifty-seven participants completed the study (27 in the intervention, 30 in control). The intervention group demonstrated statistically significant improvement in QoL scores compared to controls (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), even after adjusting for baseline differences. The app received a SUS score of 73.07%, indicating high usability. The highest user engagement was observed in modules addressing nausea, sleep disturbances, and anxiety.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e\u003cp\u003eThe mobile app proved effective in reducing chemotherapy side effects and enhancing QoL among breast cancer patients. Its usability and engagement metrics support further implementation in oncology care, especially in low-resource settings.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e\u003cp\u003eIRCT20230402057801N1 [Registration date 20230512]\u003c/p\u003e","manuscriptTitle":"Effectiveness of a Mobile App for Managing Chemotherapy Side Effects and Enhancing Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-17 05:13:53","doi":"10.21203/rs.3.rs-7462740/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ed886616-a0f3-4a50-b991-ffab10c5ad3f","owner":[],"postedDate":"September 17th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-05-06T11:41:02+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-17 05:13:53","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7462740","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7462740","identity":"rs-7462740","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}