Role of pharmacists in providing information on cancer genome medicine and patient decision making：open-label randomized controlled study

Role of pharmacists in providing information on cancer genome medicine and patient decision making：open-label randomized controlled study | 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 Role of pharmacists in providing information on cancer genome medicine and patient decision making：open-label randomized controlled study Orie Saigo, Shuko Nojiri, Kota Asakura, Shoji Koshiba, Uki Saito, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4913510/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 Cancer genome medicine based on genetic mutations is developing globally, and comprehensive genome profiling (CGP) are now routinely performed in Japan. Patient expectations are high for new treatment modalities based on genetic testing, but these are mostly unknown in Japan. The role of pharmacists in cancer genome medicine has not yet been established, but they can be a potential source of reliable information on cancer genome medicine, thus improving the health literacy of patients and supporting their decision making. Methods This was an open-label randomized controlled study. Subjects were randomly assigned 1:1 to the intervention and non-intervention groups, with treatment objective (preoperative and postoperative/advanced recurrence) as a stratification factor. In the non-intervention group, the pharmacist provided explanations about the drugs as done in usual care. In addition, the intervention group was provided with information on CGP. The primary endpoint was the impact of the pharmacist’s intervention on the patient’s decision making, measured by the Decisional Conflict Scale (DCS). As a secondary endpoint, factors influencing patient’s decision making were also analyzed. Results The analysis included responses from 180 patients. The pharmacist interview lasted 19.9 ± 6.9 and 10.4 ± 4.3 minutes for the intervention and non-intervention groups, respectively. The percentage of patients whose DCS scores decreased before and after the pharmacist interview was not significant between the intervention versus non-intervention groups (49.4% vs. 41.9%; p = 0.313, test of proportions). However, the DCS score of the intervention and non-intervention groups increased by 1.98 ± 16.5 and 3.61 ± 17.3, respectively. Both groups exhibited an increase in decisional conflict about receiving treatment, including CGP, but the change was significantly smaller in the intervention group (p = 0.026, unpaired t-test). Factors that influenced patient’s decision making through pharmacist intervention included age, chemotherapy being the primary treatment and having no history of nonsurgical treatment, such as chemotherapy, radiofrequency ablation, transcatheter arterial chemoembolization, and microwave ablation. Conclusions Increased conflicts is reduced when pharmacists provide information about CGP to patients undergoing cancer chemotherapy. This can help patients make informed decisions about their treatment choices. cancer genome medicine precision medicine comprehensive genome profiling pharmacist decision making information provision Figures Figure 1 Introduction Cancer is the leading cause of death worldwide, with approximately 10 million deaths by 2022 [ 1 ]. Lung cancer is the most common form of cancer, followed by breast, colorectal, and prostate cancers. In Japan, approximately 380,000 people died in 2021 [ 2 ], mostly from lung, colorectal, and gastric cancers, and disease progression due to distant metastasis will be the main cause of death [ 3 ]. Hereditary cancer predisposition syndromes also account for 5–10% of all cancers [ 4 ]. The main treatments for cancer include surgery and radiation therapy, forms of local therapies, along with drug therapy, a form of systemic therapy. Depending on the stage of the disease, these treatments may be administered alone or in combination with the help of a multidisciplinary team. However, in cases of advanced recurrence and where the disease has spread throughout the body, drug therapy is the mainstay treatment used. Drug therapy for metastatic, recurrent, and advanced solid tumors rarely cure the disease; hence, improving treatment outcomes is one of the major challenges in cancer treatment. One approach to overcome this challenge is the development of molecular targeted therapy based on the molecular biology of cancer. Trastuzumab [ 5 ] and imatinib [ 6 ] were developed as specific inhibitors of tumor cell-causing driver mutations in early 2000s. Many driver mutations have been identified and molecular targeted drugs been developed since then. Furthermore, it has become clear that driver mutations, which were initially identified in each organ, are commonly found across organs [ 7 ]. This gave rise to a new treatment approach based on genetic mutations, or tumor-agnostic therapy, which led to the development of various therapeutic methods. However, to determine the indication for such molecularly targeted agents, it is necessary to perform a comprehensive analysis of gene mutation profiling extracted from tumor specimens of individual patients. Given this background, in November 2017, comprehensive genome profiling (CGP) was adopted in the United States as a method to comprehensively collect mutation profiles in tumor cells of patients with advanced recurrent solid tumors [ 8 ]. American Society of Health-System Pharmacists has published a statement on the Pharmacist’s Role in Clinical Pharmacogenomics [ 9 ]. The statement recommends the choice of drug treatment based on the results of pharmacogenomic testing. In addition, it mentions the need for information provision and empowering patients to help them performing pharmacogenomic testing and understanding the results. However, these are views on genetic discrimination by health insurers or employers [ 10 ], it is unclear the association between patient health literacy and decision making. Furthermore, the role of pharmacists in the precision oncology, as a member of a multidisciplinary team, has reported [ 11 ], on the other hand, there are little involvement for patients who consider undergoing CGP. Subsequently, in June 2019, CGP was covered by insurance in Japan. As of 2024, cancer genome medicine is available in 268 institutions, designated by the Ministry of Health, Labour, and Welfare; with their roles divided into core cancer genome hospitals, hub hospitals, and cooperative hospitals [ 12 ]. Facilities not designated by Ministry cannot provide cancer genomic medicine. Therefore, cancer genome medicine is not yet widely known in Japan. Since CGP is intended for patients with completed standard treatment and those with rare cancers, patients have high expectations of curing from the test. However, even if a genetic mutation is found, an effective drug may not be found. Furthermore, even if a candidate drug is found, it may not be approved and administered in Japan. Drugs under development, such as investigational drugs, may also act as candidate drugs. It takes several weeks from the time of application for the test until the availability of results. Considering the general condition of patients with completed standard treatment, it is highly unlikely that treatment will be available. Currently, it is estimated that 10–15% of patients who undergo CGP actually receive treatment [ 13 ]. Some patients may be hesitant to perform CGP for financial reasons as expensive cost at 560,000 yen (about 3,700 USD). In addition, the timing of CGP is important since insurance reimbursement allows only one CGP per cancer. Information on precautions for such tests is provided on patient-oriented websites and other sources. However, it is unclear whether patients have access to this information or correctly understand it. In a public opinion survey on cancer control conducted by the Cabinet Office in 2019, most respondents (66.4%) cited doctors and nurses at hospitals and clinics as their source of information on treatment and hospitals when diagnosed with cancer, followed by the internet (36.9%) and family, friends, and acquaintances (33.8%) [ 14 ]. The most recent survey, conducted in 2023, had a different survey methodology due to the COVID-19 pandemic, and thus, it is difficult to compare it with past reports. Nevertheless, the latest report still had majority citing doctors and nurses at hospitals and clinics (56.2%), followed again by the internet (26.2%) and by family, friends, and acquaintances (36.7%) [ 14 ]. In Japan, medical institutions have established consultation support centers and other contact points. However, it is expected that many patients will not use such contact points, but rather, rely on the doctors and nurses involved in their visit as their source of information. In Japan, pharmacists have many opportunities to work directly with cancer patients. Both inpatients and outpatients can have their chemotherapy explained by a pharmacist. There are also many opportunities for patients and pharmacists to get involved in community pharmacies. Some pharmacies have pharmacists with cancer-related training at the hospital. They can also serve as a resource in various places when patients want to learn about CGP. However, the timing and patient population that would benefit the most from their assistance remains unclear. Considering the time required for CGP and the patient's general condition, it is desirable to inform the patient about CGP at an early stage, then the patient fully understands the contents of CGP and decides promptly to undergo it. It is anticipated that being better informed about CGP before deciding to take the test can improve patient health literacy and empowering them to participate in decisions about their own treatment. Therefore, we decided to examine the impact on patient decision making if pharmacists provide information about CGP earlier than the end of standard treatment. A known measure of patient decisional conflict is the Decisional Conflict Scale (DCS) developed by O'Connor et al [ 15 ]–[ 29 ]. The DCS consists of 16 items and is calculated on a score of 0–100, with smaller numbers indicating less conflict. In this study, DCS scores were measured before and after information was provided by the pharmacist in order to quantitatively evaluate changes in patient awareness. A secondary search was also conducted for factors that influence changes in attitudes. Methods Study design Patients who received chemotherapy at Juntendo University Hospital, Tokyo, Japan, from March 2022 to July 2023 were included in this open-label, randomized, controlled study. Eligibility Criteria The eligibility criteria are as follows: at least 20 years old, receiving standard insurance care, and may be eligible for CGP if standard care has been completed or is expected to be completed. Patients having difficulty making decisions on their own due to psychiatric symptoms or cognitive decline were excluded. Sample size The sample size was calculated to detect significant differences in the percentage decrease in the change in DCS score (the primary endpoint) before and after the pharmacist interviews. We estimated that 88 patients in each group were needed for an effect size of 0.2, a power of 80%, and a significance level of 0.05 (test of proportions). Randomization Patients were randomly assigned 1:1 to the intervention and non-intervention groups, with treatment objective (preoperative and postoperative/advanced recurrence) as a stratification factor. The staffs responsible for randomization will obtain the group allocation code from the Medical Technology Innovation Center Clinical Research and Trial Center Juntendo University. Interventions In the non-intervention group, the pharmacist provided explanations about the drugs as done in usual care. In addition, the intervention group was provided with general information on cancer genome medicine. Intervention group were guided to the Center for Cancer genomics and Advanced Therapeutics website, established for patients. Data collection Five pharmacists with 14.8 ± 5.8 years of experience were involved in data collection. All of them were certified in cancer chemotherapy and received training on cancer genome medicine. The time required for pharmacist interviews was also measured. The following patient demographic information was recorded: age, gender, type of cancer, family history, clinical stage, treatment line, history of nonsurgical treatment [chemotherapy, radiofrequency ablation (RFA), transcatheter arterial chemoembolization (TACE), and microwave ablation (MWA)], marital status, presence of children, employment status, last education, income, and sources of medical-related information. Questionnaires were administered 2–6 weeks before and after the pharmacist interview to measure the DCS score, which was calculated according to the User Manual. The reason for setting the 2–6 week is that many outpatients visit for chemotherapy every 2–3 weeks. The Genomics Literacy Score (GLS) was also measured to ascertain the health literacy of patients in relation to genomics, and this was calculated according to previous reports [ 30 ]. After the pharmacist interview, patients were asked whether they wished to undergo CGP and the source of information they used in choosing their response. They were also asked how much they would be willing to pay for the provision of information on cancer genome medicine. Supplemental data 1 and 2 were the questionnaire used before pharmacist interview, and supplemental data 2 and 3 were used after pharmacist interview. Supplemental data 2 is DCS [ 15 ]–[ 29 ]. Study outcomes The primary endpoint of this study was the impact of the pharmacist’s intervention on the patient’s decision making, as measured by the DCS score. As a secondary endpoint, relationship between patient factors influencing decision making and DCS scores were also analyzed. Statistical analysis The percentage of patients with decreased DCS score before and after the pharmacist interview was determined. A test of proportions was used to compare the percentage decrease in DCS score between the intervention and non-intervention groups. Changes in DCS score were determined before and after the pharmacist interview. Changes in DCS scores between the intervention and non-intervention groups were compared using unpaired t-test. The DCS scores of all patients prior to the pharmacist interview were divided into two groups based on the median value, and the trends of each patient’s background were examined. Additionally, the intervention group was divided into two groups (with decreased and increased scores), and the trends in each patient’s background were examined. Age between the two groups was analyzed using t-test. Relationship between patient factors influencing decision making and DCS scores were analyzed using Chi-square test or Fisher's exact test. Statistical Analysis Software (SAS) (version 9.4, SAS Institute Inc., Cary, North Carolina) was used for statistical analysis. Registration Results Written consent was obtained from 192 patients who received chemotherapy at Juntendo University Hospital from March 2022 to July 2023. However, 4 patients withdrew their consent, and 8 patients were unable to complete the entire questionnaire. The analysis included responses from 180 patients (Fig. 1). Patient background was examined to identify factors that might influence decision making while choosing a genome-related treatment (Table 1), but no significant differences were found between the groups. Sources of information of the patients were identified. Most common response of patients was the internet, followed by friends and acquaintances (Table 1). The pharmacist interview lasted 19.9 ± 6.9 and 10.4 ± 4.3 minutes for the intervention and non-intervention group, respectively. The DCS score decreased after the pharmacist interview in 49.4% and 41.9% of the intervention and non-intervention groups, respectively, a nonsignificant difference (p = 0.313, test of proportions) (Table 2). However, the DCS score increased after the pharmacist interview by 1.98 ± 16.5 and 3.61 ± 17.3 in the intervention and non-intervention groups, respectively (Table 2). Both groups showed an increase in decisional conflict about receiving treatment, including undergoing CGP, but the change was significantly smaller in the intervention group compared to the non-intervention group (p = 0.026, unpaired t-test). GLS scores before and after the pharmacist interview were 10.1 ± 3.55 vs. 10.8 ± 3.57 in the intervention group and 10.2 ± 3.34 in the non-intervention group, with no significant difference. The background factors which influenced the decision to receive treatment, including CGP were analyzed. All patients were divided into two groups based on the median DCS score before the pharmacist interview, and the differences in patient background between each group were analyzed (Supplemental data 4). None of the items demonstrated a significant difference between the two groups. The patient factors that influenced decision making after the pharmacist’s intervention were assessed. The intervention group was divided into two groups (those whose DCS scores decreased and increased after the interview), and the differences in patient backgrounds were analyzed (Table 3). A trend toward younger age was observed in the group with decreased DCS scores compared to the group with increased DCS scores. In the group with decreased DCS scores, there were 21 and 18 patients in primary and secondary treatment, respectively. In comparison, the group with increased DCS scores had 33 patients in the primary treatment group; there were also more patients with no history of nonsurgical treatment (chemotherapy, RFA, TACE, and MWA) (31 patients). On the other hand, no characteristic patient factors were observed in the non-intervention group (Supplemental data 5). The respondents were asked about their desire to take a CGP after the pharmacist interview. There were no significant differences between the two groups (Supplemental data 6). The cost was assessed that how much people would be willing to pay for information. In both groups, most respondents answered 600–1,000 yen (about 4–6 USD), followed by those who reported more than 1,000 yen (about 6 USD or more). There were no significant differences between the two groups (Supplemental data 7). Discussion The number of patients in the intervention group with decreased DCS scores was higher compared to the non-intervention group after the pharmacist interview, but the difference was nonsignificant. However, DCS scores increased in both groups, but the degree of increase in DCS scores was significantly lower in the intervention group. Increased DCS scores indicate increased conflict in decision making regarding treatment, including CGP, regardless of patient wishing to receive treatments or not. Only the intervention group was briefed about CGP, but the non-intervention group heard the word “CGP” at the time of obtaining consent. Thus, it is possible that hearing a new word may have caused hesitation in imagining new possible treatment options. Information from the internet and media may also cause hesitation. This survey revealed that a high percentage of respondents receive medical information from the internet and media, along with family and friends. With recent advancements in online information, such as in social media, more people can now easily access variety of information. However, information from the internet or friends and acquaintances is often ambiguous than information from TV or newspapers, and thus the patient’s own information literacy is important. The intervention group showed a significantly lower increase in conflict; more patients referred to the pharmacist’s explanation while choosing whether they wanted to take a CGP. Patients in the intervention group received information on eligibility of patients for CGP, treatment outcomes and other perspectives. This suggests on importance of gathering information from various sources such as the media and internet, along with a two-way exchange of information between patients and pharmacists, who are highly reliable sources of information. The time required for the pharmacist interview was approximately 10 minutes longer in the intervention group, indicating that information about the CGP could be provided in this time. This is a reasonable amount of time in actual medical practice. The GLS did not change after the pharmacist interview. This shows that patient health literacy did not improve. Although the information provided did not directly improve genomic knowledge, it was believed that the content could support patient decision making. To identify patients who felt conflicted about their decision to undergo treatment, including CGP consultation, the patients’ demographic information was analyzed after dividing the patients into two groups based on median DCS score before the pharmacist interview. The results were not different between the two groups, and did not show any characteristics of patients who were more or less likely to experience conflicts in decision making. Health care providers tend to consider of factors that influence decision making, such as having a hereditary cancer or a family history, these findings suggest that it is not necessary to focus on a specific patient population when providing information about CGP. To identify patients who were more likely to change their conflicts regarding decision making to receive treatment, including CGP consultation, the patients’ background information was analyzed after dividing the intervention group into those whose DCS scores decreased and increased after the pharmacist interview. In the group with decreased DCS scores, age was younger compared to the other group. It shows that younger age decreased their conflicts in decision making, therefore providing information from pharmacist was considered effective. Patients undergoing first-line chemotherapy tended to have increased DCS scores. These patients are often not eligible for CGP in Japan today. However, the information provided about CGP may have given the impression that there were more treatment options available, causing unnecessary confusion. Alternatively, there were patients whose DCS scores decreased despite being on first- and second-line of chemotherapy. The information provided by the pharmacist could have convinced patients that the treatment they were receiving at the time they responded to the survey was appropriate for their stage of disease, resulting in a decrease in their DCS score. There was also a tendency for DCS scores to increase in patients with no history of nonsurgical treatment. Thus, although some patients may benefit from being presented with future-oriented treatment options since the beginning of treatment, in actual medical practice, uniform information provision may cause some patients to feel more confused and therefore, should be discouraged. No significant difference was found between the two groups in terms of patients wishing to undergo CGP. About 58.6% and 54.8% of patients answered no, whereas 26.4% and 30.1% of patients in the intervention and non-intervention groups, respectively, did not respond. These patients are expected to include those who answered no or considered were indecisive as a result of being convinced that it was not the right time to take the CGP yet. About the cost of providing information, most respondents in both groups said 600–1,000 yen (about 4–6 USD), followed by those who said more than 1,000 yen (about 6 USD or more). In Japan, due to the universal health insurance system, pharmacists currently charge 600–1,000 yen (about 4–6 USD) for chemotherapy patients actually. Many respondents revealed their willingness to pay more than 1,000 yen (about 6 USD or more), indicating many patients are willing to pay for appropriate information. The primary role of pharmacist in cancer care is to support drug therapy and management of side effects [ 31 ]. In cancer genome medicine, the results of CGP can be used to search for effective drugs and clinical trial information. These results can also support drug therapy while drug administration [ 7 ]–[ 9 ]. However, since many treatments performed based on CGP results in Japan are clinical trials, only pharmacists at a particular medical institution can be directly involved in many situations [ 32 ] [ 33 ]. Nevertheless, the results of this study suggest that pharmacists can assist in the decision making process through appropriate patient education, even in facilities not conducting clinical trials. Pharmacists can contribute to cancer care in future by correctly understanding CGP, which may lead to drug therapy, and by providing timely information to patients. One limitation of this study is that it is a single-center study. In addition, differences in accessibility to genomic medical facilities, such as in urban centers versus rural areas, may influence patient backgrounds and lead to different results. Conclusions Increased conflicts are reduced when pharmacists provide information about CGP to patients undergoing cancer chemotherapy. This can assist patients in making decisions about their treatment choices. Abbreviations CGP comprehensive genome profiling DCS Decisional Conflict Scale RFA radiofrequency ablation TACE transcatheter arterial chemoembolization MWA microwave ablation GLS Genomics Literacy Score SAS Statistical Analysis Software Declarations Ethics approval and consent to participate This study was conducted according to the ethical guidelines for life science and medical research involving human subjects and the Declaration of Helsinki. Written informed consent was taken from all patients. The study was approved by Research Ethics Committee, Faculty of Medicine, Juntendo University (E21-0016). Consent for publication Not applicable Competing interests The authors declare that they have no competing interests. Funding This study was supported by the scholarship program of Daiichi Sankyo Co., Ltd. Author Contribution OS designed this study, assisted in analysis, and drafted the manuscript. SKa was involved in the design of the study and assisted in drafting the manuscript. SN performed all analyses, was involved in the design of the study design, and assisted in editing the manuscript. KS, SKo, US, and SI participated in data collection. TK, and SKa provided oversaw the drafting of the manuscript. All authors read and approved the final manuscript. Acknowledgement I would like to thank the member of the Medical Technology Innovation Center, Juntendo University for advice on data collection. 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Tables Tables 1-4 are available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Tables.docx Supplementaldata4to7.docx 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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University","correspondingAuthor":false,"prefix":"","firstName":"Shuko","middleName":"","lastName":"Nojiri","suffix":""},{"id":357250017,"identity":"cbf90eef-4350-42a9-b670-2af2eb05fd33","order_by":2,"name":"Kota Asakura","email":"","orcid":"","institution":"Juntendo University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Kota","middleName":"","lastName":"Asakura","suffix":""},{"id":357250018,"identity":"8907719d-0f22-40c7-8d4f-5cb731cf88fc","order_by":3,"name":"Shoji Koshiba","email":"","orcid":"","institution":"Juntendo University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Shoji","middleName":"","lastName":"Koshiba","suffix":""},{"id":357250019,"identity":"72812793-a87e-4186-89a0-3564d0ef770d","order_by":4,"name":"Uki Saito","email":"","orcid":"","institution":"Juntendo University 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Kato","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABBUlEQVRIiWNgGAWjYBACCRDB2MDAwM9wgAHGBgIefFqYIcokG4BaDpCkxQBkCUILHiDZfv7gw587DucZHzxj9vhDxR3Zfgbmhx8YZO7g1CLNk8xszHvmcLHZgTPmBgfOPDOe2cBmLMHA8wynFjmGZDZpxrbDidsOnDGTOAhkbDjAYAb0y2HcWvgfs0n+BKrc3ADS8g+khf0bXi3SEslsErwgwxlAWhpAWnjw2yI547GxMW9beuKMA8fKJM4cO2w8s5mnWCIBj18kzic+fPizzTqxf8bhbRIVNYdl+9nbN3742IM7xJA0H4AygBHFkNhzALdKOOBvQOb9IEbLKBgFo2AUjBAAAK+QXsEbv0llAAAAAElFTkSuQmCC","orcid":"","institution":"Juntendo University Graduate School of Medicine","correspondingAuthor":true,"prefix":"","firstName":"Shunsuke","middleName":"","lastName":"Kato","suffix":""}],"badges":[],"createdAt":"2024-08-14 12:08:29","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4913510/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4913510/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":66674739,"identity":"47b5aaa3-c9fc-476d-851b-2ef24067d197","added_by":"auto","created_at":"2024-10-15 11:01:00","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":152943,"visible":true,"origin":"","legend":"\u003cp\u003eStudy protocol\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4913510/v1/c2ffe97f80c1033019751564.jpg"},{"id":84499931,"identity":"1e65f41a-d6d6-4990-b402-580b3c8325a8","added_by":"auto","created_at":"2025-06-12 16:31:45","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":701249,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4913510/v1/00f2e3e4-5825-4016-8862-19812b0507a6.pdf"},{"id":66675806,"identity":"b41409f1-bfd9-4efa-9539-557eca28b698","added_by":"auto","created_at":"2024-10-15 11:09:00","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":36855,"visible":true,"origin":"","legend":"","description":"","filename":"Tables.docx","url":"https://assets-eu.researchsquare.com/files/rs-4913510/v1/484b397829a7890f96cad90c.docx"},{"id":66674736,"identity":"e284478b-8112-4fa8-8372-be9fa9ffa546","added_by":"auto","created_at":"2024-10-15 11:01:00","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":36040,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaldata4to7.docx","url":"https://assets-eu.researchsquare.com/files/rs-4913510/v1/7dd3805219a73568d5843f69.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Role of pharmacists in providing information on cancer genome medicine and patient decision making：open-label randomized controlled study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCancer is the leading cause of death worldwide, with approximately 10\u0026nbsp;million deaths by 2022 [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Lung cancer is the most common form of cancer, followed by breast, colorectal, and prostate cancers. In Japan, approximately 380,000 people died in 2021 [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], mostly from lung, colorectal, and gastric cancers, and disease progression due to distant metastasis will be the main cause of death [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Hereditary cancer predisposition syndromes also account for 5\u0026ndash;10% of all cancers [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe main treatments for cancer include surgery and radiation therapy, forms of local therapies, along with drug therapy, a form of systemic therapy. Depending on the stage of the disease, these treatments may be administered alone or in combination with the help of a multidisciplinary team. However, in cases of advanced recurrence and where the disease has spread throughout the body, drug therapy is the mainstay treatment used. Drug therapy for metastatic, recurrent, and advanced solid tumors rarely cure the disease; hence, improving treatment outcomes is one of the major challenges in cancer treatment. One approach to overcome this challenge is the development of molecular targeted therapy based on the molecular biology of cancer. Trastuzumab [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] and imatinib [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] were developed as specific inhibitors of tumor cell-causing driver mutations in early 2000s. Many driver mutations have been identified and molecular targeted drugs been developed since then. Furthermore, it has become clear that driver mutations, which were initially identified in each organ, are commonly found across organs [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. This gave rise to a new treatment approach based on genetic mutations, or tumor-agnostic therapy, which led to the development of various therapeutic methods. However, to determine the indication for such molecularly targeted agents, it is necessary to perform a comprehensive analysis of gene mutation profiling extracted from tumor specimens of individual patients.\u003c/p\u003e \u003cp\u003eGiven this background, in November 2017, comprehensive genome profiling (CGP) was adopted in the United States as a method to comprehensively collect mutation profiles in tumor cells of patients with advanced recurrent solid tumors [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. American Society of Health-System Pharmacists has published a statement on the Pharmacist\u0026rsquo;s Role in Clinical Pharmacogenomics [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. The statement recommends the choice of drug treatment based on the results of pharmacogenomic testing. In addition, it mentions the need for information provision and empowering patients to help them performing pharmacogenomic testing and understanding the results. However, these are views on genetic discrimination by health insurers or employers [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], it is unclear the association between patient health literacy and decision making. Furthermore, the role of pharmacists in the precision oncology, as a member of a multidisciplinary team, has reported [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e], on the other hand, there are little involvement for patients who consider undergoing CGP.\u003c/p\u003e \u003cp\u003eSubsequently, in June 2019, CGP was covered by insurance in Japan. As of 2024, cancer genome medicine is available in 268 institutions, designated by the Ministry of Health, Labour, and Welfare; with their roles divided into core cancer genome hospitals, hub hospitals, and cooperative hospitals [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Facilities not designated by Ministry cannot provide cancer genomic medicine. Therefore, cancer genome medicine is not yet widely known in Japan. Since CGP is intended for patients with completed standard treatment and those with rare cancers, patients have high expectations of curing from the test. However, even if a genetic mutation is found, an effective drug may not be found. Furthermore, even if a candidate drug is found, it may not be approved and administered in Japan. Drugs under development, such as investigational drugs, may also act as candidate drugs. It takes several weeks from the time of application for the test until the availability of results. Considering the general condition of patients with completed standard treatment, it is highly unlikely that treatment will be available. Currently, it is estimated that 10\u0026ndash;15% of patients who undergo CGP actually receive treatment [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Some patients may be hesitant to perform CGP for financial reasons as expensive cost at 560,000 yen (about 3,700 USD). In addition, the timing of CGP is important since insurance reimbursement allows only one CGP per cancer.\u003c/p\u003e \u003cp\u003eInformation on precautions for such tests is provided on patient-oriented websites and other sources. However, it is unclear whether patients have access to this information or correctly understand it. In a public opinion survey on cancer control conducted by the Cabinet Office in 2019, most respondents (66.4%) cited doctors and nurses at hospitals and clinics as their source of information on treatment and hospitals when diagnosed with cancer, followed by the internet (36.9%) and family, friends, and acquaintances (33.8%) [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. The most recent survey, conducted in 2023, had a different survey methodology due to the COVID-19 pandemic, and thus, it is difficult to compare it with past reports. Nevertheless, the latest report still had majority citing doctors and nurses at hospitals and clinics (56.2%), followed again by the internet (26.2%) and by family, friends, and acquaintances (36.7%) [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. In Japan, medical institutions have established consultation support centers and other contact points. However, it is expected that many patients will not use such contact points, but rather, rely on the doctors and nurses involved in their visit as their source of information.\u003c/p\u003e \u003cp\u003eIn Japan, pharmacists have many opportunities to work directly with cancer patients. Both inpatients and outpatients can have their chemotherapy explained by a pharmacist. There are also many opportunities for patients and pharmacists to get involved in community pharmacies. Some pharmacies have pharmacists with cancer-related training at the hospital. They can also serve as a resource in various places when patients want to learn about CGP. However, the timing and patient population that would benefit the most from their assistance remains unclear. Considering the time required for CGP and the patient's general condition, it is desirable to inform the patient about CGP at an early stage, then the patient fully understands the contents of CGP and decides promptly to undergo it. It is anticipated that being better informed about CGP before deciding to take the test can improve patient health literacy and empowering them to participate in decisions about their own treatment. Therefore, we decided to examine the impact on patient decision making if pharmacists provide information about CGP earlier than the end of standard treatment.\u003c/p\u003e \u003cp\u003eA known measure of patient decisional conflict is the Decisional Conflict Scale (DCS) developed by O'Connor et al [\u003cspan additionalcitationids=\"CR16 CR17 CR18 CR19 CR20 CR21 CR22 CR23 CR24 CR25 CR26 CR27 CR28\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u0026ndash;[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. The DCS consists of 16 items and is calculated on a score of 0\u0026ndash;100, with smaller numbers indicating less conflict. In this study, DCS scores were measured before and after information was provided by the pharmacist in order to quantitatively evaluate changes in patient awareness. A secondary search was also conducted for factors that influence changes in attitudes.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003ePatients who received chemotherapy at Juntendo University Hospital, Tokyo, Japan, from March 2022 to July 2023 were included in this open-label, randomized, controlled study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eEligibility Criteria\u003c/h2\u003e \u003cp\u003eThe eligibility criteria are as follows: at least 20 years old, receiving standard insurance care, and may be eligible for CGP if standard care has been completed or is expected to be completed. Patients having difficulty making decisions on their own due to psychiatric symptoms or cognitive decline were excluded.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSample size\u003c/h2\u003e \u003cp\u003eThe sample size was calculated to detect significant differences in the percentage decrease in the change in DCS score (the primary endpoint) before and after the pharmacist interviews. We estimated that 88 patients in each group were needed for an effect size of 0.2, a power of 80%, and a significance level of 0.05 (test of proportions).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eRandomization\u003c/h2\u003e \u003cp\u003ePatients were randomly assigned 1:1 to the intervention and non-intervention groups, with treatment objective (preoperative and postoperative/advanced recurrence) as a stratification factor. The staffs responsible for randomization will obtain the group allocation code from the Medical Technology Innovation Center Clinical Research and Trial Center Juntendo University.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eInterventions\u003c/h2\u003e \u003cp\u003eIn the non-intervention group, the pharmacist provided explanations about the drugs as done in usual care. In addition, the intervention group was provided with general information on cancer genome medicine. Intervention group were guided to the Center for Cancer genomics and Advanced Therapeutics website, established for patients.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eFive pharmacists with 14.8\u0026thinsp;\u0026plusmn;\u0026thinsp;5.8 years of experience were involved in data collection. All of them were certified in cancer chemotherapy and received training on cancer genome medicine. The time required for pharmacist interviews was also measured.\u003c/p\u003e \u003cp\u003eThe following patient demographic information was recorded: age, gender, type of cancer, family history, clinical stage, treatment line, history of nonsurgical treatment [chemotherapy, radiofrequency ablation (RFA), transcatheter arterial chemoembolization (TACE), and microwave ablation (MWA)], marital status, presence of children, employment status, last education, income, and sources of medical-related information. Questionnaires were administered 2\u0026ndash;6 weeks before and after the pharmacist interview to measure the DCS score, which was calculated according to the User Manual. The reason for setting the 2\u0026ndash;6 week is that many outpatients visit for chemotherapy every 2\u0026ndash;3 weeks. The Genomics Literacy Score (GLS) was also measured to ascertain the health literacy of patients in relation to genomics, and this was calculated according to previous reports [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAfter the pharmacist interview, patients were asked whether they wished to undergo CGP and the source of information they used in choosing their response. They were also asked how much they would be willing to pay for the provision of information on cancer genome medicine.\u003c/p\u003e \u003cp\u003eSupplemental data 1 and 2 were the questionnaire used before pharmacist interview, and supplemental data 2 and 3 were used after pharmacist interview. Supplemental data 2 is DCS [\u003cspan additionalcitationids=\"CR16 CR17 CR18 CR19 CR20 CR21 CR22 CR23 CR24 CR25 CR26 CR27 CR28\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u0026ndash;[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eStudy outcomes\u003c/h2\u003e \u003cp\u003eThe primary endpoint of this study was the impact of the pharmacist\u0026rsquo;s intervention on the patient\u0026rsquo;s decision making, as measured by the DCS score. As a secondary endpoint, relationship between patient factors influencing decision making and DCS scores were also analyzed.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eThe percentage of patients with decreased DCS score before and after the pharmacist interview was determined. A test of proportions was used to compare the percentage decrease in DCS score between the intervention and non-intervention groups. Changes in DCS score were determined before and after the pharmacist interview. Changes in DCS scores between the intervention and non-intervention groups were compared using unpaired t-test.\u003c/p\u003e \u003cp\u003eThe DCS scores of all patients prior to the pharmacist interview were divided into two groups based on the median value, and the trends of each patient\u0026rsquo;s background were examined. Additionally, the intervention group was divided into two groups (with decreased and increased scores), and the trends in each patient\u0026rsquo;s background were examined. Age between the two groups was analyzed using t-test. Relationship between patient factors influencing decision making and DCS scores were analyzed using Chi-square test or Fisher's exact test. Statistical Analysis Software (SAS) (version 9.4, SAS Institute Inc., Cary, North Carolina) was used for statistical analysis.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eRegistration\u003c/h2\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eWritten consent was obtained from 192 patients who received chemotherapy at Juntendo University Hospital from March 2022 to July 2023. However, 4 patients withdrew their consent, and 8 patients were unable to complete the entire questionnaire. The analysis included responses from 180 patients (Fig.\u0026nbsp;1).\u003c/p\u003e\n\u003cp\u003ePatient background was examined to identify factors that might influence decision making while choosing a genome-related treatment (Table\u0026nbsp;1), but no significant differences were found between the groups.\u003c/p\u003e\n\u003cp\u003eSources of information of the patients were identified. Most common response of patients was the internet, followed by friends and acquaintances (Table 1).\u003c/p\u003e\n\u003cp\u003eThe pharmacist interview lasted 19.9\u0026thinsp;\u0026plusmn;\u0026thinsp;6.9 and 10.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.3 minutes for the intervention and non-intervention group, respectively.\u003c/p\u003e\n\u003cp\u003eThe DCS score decreased after the pharmacist interview in 49.4% and 41.9% of the intervention and non-intervention groups, respectively, a nonsignificant difference (p\u0026thinsp;=\u0026thinsp;0.313, test of proportions) (Table\u0026nbsp;2).\u003c/p\u003e\n\u003cp\u003eHowever, the DCS score increased after the pharmacist interview by 1.98\u0026thinsp;\u0026plusmn;\u0026thinsp;16.5 and 3.61\u0026thinsp;\u0026plusmn;\u0026thinsp;17.3 in the intervention and non-intervention groups, respectively (Table\u0026nbsp;2). Both groups showed an increase in decisional conflict about receiving treatment, including undergoing CGP, but the change was significantly smaller in the intervention group compared to the non-intervention group (p\u0026thinsp;=\u0026thinsp;0.026, unpaired t-test). GLS scores before and after the pharmacist interview were 10.1\u0026thinsp;\u0026plusmn;\u0026thinsp;3.55 vs. 10.8\u0026thinsp;\u0026plusmn;\u0026thinsp;3.57 in the intervention group and 10.2\u0026thinsp;\u0026plusmn;\u0026thinsp;3.34 in the non-intervention group, with no significant difference.\u003c/p\u003e\n\u003cp\u003eThe background factors which influenced the decision to receive treatment, including CGP were analyzed. All patients were divided into two groups based on the median DCS score before the pharmacist interview, and the differences in patient background between each group were analyzed (Supplemental data 4). None of the items demonstrated a significant difference between the two groups.\u003c/p\u003e\n\u003cp\u003eThe patient factors that influenced decision making after the pharmacist\u0026rsquo;s intervention were assessed. The intervention group was divided into two groups (those whose DCS scores decreased and increased after the interview), and the differences in patient backgrounds were analyzed (Table\u0026nbsp;3). A trend toward younger age was observed in the group with decreased DCS scores compared to the group with increased DCS scores. In the group with decreased DCS scores, there were 21 and 18 patients in primary and secondary treatment, respectively. In comparison, the group with increased DCS scores had 33 patients in the primary treatment group; there were also more patients with no history of nonsurgical treatment (chemotherapy, RFA, TACE, and MWA) (31 patients).\u003c/p\u003e\n\u003cp\u003eOn the other hand, no characteristic patient factors were observed in the non-intervention group (Supplemental data 5).\u003c/p\u003e\n\u003cp\u003eThe respondents were asked about their desire to take a CGP after the pharmacist interview. There were no significant differences between the two groups (Supplemental data 6).\u003c/p\u003e\n\u003cp\u003eThe cost was assessed that how much people would be willing to pay for information. In both groups, most respondents answered 600\u0026ndash;1,000 yen (about 4\u0026ndash;6 USD), followed by those who reported more than 1,000 yen (about 6 USD or more). There were no significant differences between the two groups (Supplemental data 7).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe number of patients in the intervention group with decreased DCS scores was higher compared to the non-intervention group after the pharmacist interview, but the difference was nonsignificant. However, DCS scores increased in both groups, but the degree of increase in DCS scores was significantly lower in the intervention group. Increased DCS scores indicate increased conflict in decision making regarding treatment, including CGP, regardless of patient wishing to receive treatments or not. Only the intervention group was briefed about CGP, but the non-intervention group heard the word \u0026ldquo;CGP\u0026rdquo; at the time of obtaining consent. Thus, it is possible that hearing a new word may have caused hesitation in imagining new possible treatment options. Information from the internet and media may also cause hesitation. This survey revealed that a high percentage of respondents receive medical information from the internet and media, along with family and friends. With recent advancements in online information, such as in social media, more people can now easily access variety of information. However, information from the internet or friends and acquaintances is often ambiguous than information from TV or newspapers, and thus the patient\u0026rsquo;s own information literacy is important.\u003c/p\u003e \u003cp\u003eThe intervention group showed a significantly lower increase in conflict; more patients referred to the pharmacist\u0026rsquo;s explanation while choosing whether they wanted to take a CGP. Patients in the intervention group received information on eligibility of patients for CGP, treatment outcomes and other perspectives. This suggests on importance of gathering information from various sources such as the media and internet, along with a two-way exchange of information between patients and pharmacists, who are highly reliable sources of information.\u003c/p\u003e \u003cp\u003eThe time required for the pharmacist interview was approximately 10 minutes longer in the intervention group, indicating that information about the CGP could be provided in this time. This is a reasonable amount of time in actual medical practice.\u003c/p\u003e \u003cp\u003eThe GLS did not change after the pharmacist interview. This shows that patient health literacy did not improve. Although the information provided did not directly improve genomic knowledge, it was believed that the content could support patient decision making.\u003c/p\u003e \u003cp\u003eTo identify patients who felt conflicted about their decision to undergo treatment, including CGP consultation, the patients\u0026rsquo; demographic information was analyzed after dividing the patients into two groups based on median DCS score before the pharmacist interview. The results were not different between the two groups, and did not show any characteristics of patients who were more or less likely to experience conflicts in decision making. Health care providers tend to consider of factors that influence decision making, such as having a hereditary cancer or a family history, these findings suggest that it is not necessary to focus on a specific patient population when providing information about CGP.\u003c/p\u003e \u003cp\u003eTo identify patients who were more likely to change their conflicts regarding decision making to receive treatment, including CGP consultation, the patients\u0026rsquo; background information was analyzed after dividing the intervention group into those whose DCS scores decreased and increased after the pharmacist interview. In the group with decreased DCS scores, age was younger compared to the other group. It shows that younger age decreased their conflicts in decision making, therefore providing information from pharmacist was considered effective. Patients undergoing first-line chemotherapy tended to have increased DCS scores. These patients are often not eligible for CGP in Japan today. However, the information provided about CGP may have given the impression that there were more treatment options available, causing unnecessary confusion. Alternatively, there were patients whose DCS scores decreased despite being on first- and second-line of chemotherapy. The information provided by the pharmacist could have convinced patients that the treatment they were receiving at the time they responded to the survey was appropriate for their stage of disease, resulting in a decrease in their DCS score. There was also a tendency for DCS scores to increase in patients with no history of nonsurgical treatment. Thus, although some patients may benefit from being presented with future-oriented treatment options since the beginning of treatment, in actual medical practice, uniform information provision may cause some patients to feel more confused and therefore, should be discouraged.\u003c/p\u003e \u003cp\u003eNo significant difference was found between the two groups in terms of patients wishing to undergo CGP. About 58.6% and 54.8% of patients answered no, whereas 26.4% and 30.1% of patients in the intervention and non-intervention groups, respectively, did not respond. These patients are expected to include those who answered no or considered were indecisive as a result of being convinced that it was not the right time to take the CGP yet.\u003c/p\u003e \u003cp\u003eAbout the cost of providing information, most respondents in both groups said 600\u0026ndash;1,000 yen (about 4\u0026ndash;6 USD), followed by those who said more than 1,000 yen (about 6 USD or more). In Japan, due to the universal health insurance system, pharmacists currently charge 600\u0026ndash;1,000 yen (about 4\u0026ndash;6 USD) for chemotherapy patients actually. Many respondents revealed their willingness to pay more than 1,000 yen (about 6 USD or more), indicating many patients are willing to pay for appropriate information.\u003c/p\u003e \u003cp\u003eThe primary role of pharmacist in cancer care is to support drug therapy and management of side effects [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. In cancer genome medicine, the results of CGP can be used to search for effective drugs and clinical trial information. These results can also support drug therapy while drug administration [\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u0026ndash;[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. However, since many treatments performed based on CGP results in Japan are clinical trials, only pharmacists at a particular medical institution can be directly involved in many situations [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e] [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e]. Nevertheless, the results of this study suggest that pharmacists can assist in the decision making process through appropriate patient education, even in facilities not conducting clinical trials. Pharmacists can contribute to cancer care in future by correctly understanding CGP, which may lead to drug therapy, and by providing timely information to patients.\u003c/p\u003e \u003cp\u003eOne limitation of this study is that it is a single-center study. In addition, differences in accessibility to genomic medical facilities, such as in urban centers versus rural areas, may influence patient backgrounds and lead to different results.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIncreased conflicts are reduced when pharmacists provide information about CGP to patients undergoing cancer chemotherapy. This can assist patients in making decisions about their treatment choices.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCGP\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ecomprehensive genome profiling\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eDCS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDecisional Conflict Scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRFA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eradiofrequency ablation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTACE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003etranscatheter arterial chemoembolization\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMWA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003emicrowave ablation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eGLS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eGenomics Literacy Score\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSAS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eStatistical Analysis Software\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e \u003cp\u003e This study was conducted according to the ethical guidelines for life science and medical research involving human subjects and the Declaration of Helsinki. Written informed consent was taken from all patients. The study was approved by Research Ethics Committee, Faculty of Medicine, Juntendo University (E21-0016).\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eConsent for publication\u003c/strong\u003e \u003cp\u003eNot applicable\u003c/p\u003e \u003c/p\u003e\u003cp\u003e \u003ch2\u003eCompeting interests\u003c/h2\u003e \u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThis study was supported by the scholarship program of Daiichi Sankyo Co., Ltd.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eOS designed this study, assisted in analysis, and drafted the manuscript. SKa was involved in the design of the study and assisted in drafting the manuscript. SN performed all analyses, was involved in the design of the study design, and assisted in editing the manuscript. KS, SKo, US, and SI participated in data collection. TK, and SKa provided oversaw the drafting of the manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\u003ch2\u003eAcknowledgement\u003c/h2\u003e\u003cp\u003eI would like to thank the member of the Medical Technology Innovation Center, Juntendo University for advice on data collection.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe raw dataset and supplemental data 1-3 are public available in the dropboxhttps://www.dropbox.com/scl/fo/jlpifrjjg3gxx1m9riito/AAfZBhA66rQr3b795NicGRw?rlkey=a6t5vl3ub0ysh4d1v1ubgi7q5\u0026amp;st=9w5wourn\u0026amp;dl=0\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eFerlay J, Ervik M, Lam F, Colombet M, Mery L, Pi\u0026ntilde;eros M et al. Global Cancer Observatory: Cancer Today. 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Am J Med Genet Part A. 2008;146A:1696\u0026ndash;706.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLisa MH, Eve MS, Kate DJ. The Expanding Role of the Oncology Pharmacist. Pharm (Basal). 2020;8(3):130. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3390/pharmacy8030130\u003c/span\u003e\u003cspan address=\"10.3390/pharmacy8030130\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTerada T. Roles of Pharmacists in Cancer Genomic Medicine. Yakugaku Zasshi. 2020;140:663\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAimono E, Iguchi A, Mochida K, Imai M, Hayashi H, Nishihara H. Learning from My Experience: Outpatient Care for Cancer Multigene Genomic Testing. Yakugaku Zasshi. 2020;140:667\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1-4 are available in the Supplementary Files section.\u003c/p\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":"cancer genome medicine, precision medicine, comprehensive genome profiling, pharmacist, decision making, information provision","lastPublishedDoi":"10.21203/rs.3.rs-4913510/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4913510/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eCancer genome medicine based on genetic mutations is developing globally, and comprehensive genome profiling (CGP) are now routinely performed in Japan. Patient expectations are high for new treatment modalities based on genetic testing, but these are mostly unknown in Japan. The role of pharmacists in cancer genome medicine has not yet been established, but they can be a potential source of reliable information on cancer genome medicine, thus improving the health literacy of patients and supporting their decision making.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis was an open-label randomized controlled study. Subjects were randomly assigned 1:1 to the intervention and non-intervention groups, with treatment objective (preoperative and postoperative/advanced recurrence) as a stratification factor. In the non-intervention group, the pharmacist provided explanations about the drugs as done in usual care. In addition, the intervention group was provided with information on CGP. The primary endpoint was the impact of the pharmacist\u0026rsquo;s intervention on the patient\u0026rsquo;s decision making, measured by the Decisional Conflict Scale (DCS). As a secondary endpoint, factors influencing patient\u0026rsquo;s decision making were also analyzed.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe analysis included responses from 180 patients. The pharmacist interview lasted 19.9\u0026thinsp;\u0026plusmn;\u0026thinsp;6.9 and 10.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.3 minutes for the intervention and non-intervention groups, respectively. The percentage of patients whose DCS scores decreased before and after the pharmacist interview was not significant between the intervention versus non-intervention groups (49.4% vs. 41.9%; p\u0026thinsp;=\u0026thinsp;0.313, test of proportions). However, the DCS score of the intervention and non-intervention groups increased by 1.98\u0026thinsp;\u0026plusmn;\u0026thinsp;16.5 and 3.61\u0026thinsp;\u0026plusmn;\u0026thinsp;17.3, respectively. Both groups exhibited an increase in decisional conflict about receiving treatment, including CGP, but the change was significantly smaller in the intervention group (p\u0026thinsp;=\u0026thinsp;0.026, unpaired t-test). Factors that influenced patient\u0026rsquo;s decision making through pharmacist intervention included age, chemotherapy being the primary treatment and having no history of nonsurgical treatment, such as chemotherapy, radiofrequency ablation, transcatheter arterial chemoembolization, and microwave ablation.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eIncreased conflicts is reduced when pharmacists provide information about CGP to patients undergoing cancer chemotherapy. This can help patients make informed decisions about their treatment choices.\u003c/p\u003e","manuscriptTitle":"Role of pharmacists in providing information on cancer genome medicine and patient decision making：open-label randomized controlled study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-10-15 11:00:55","doi":"10.21203/rs.3.rs-4913510/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":"e0dac767-e883-4c3a-b026-2c8ca9f10095","owner":[],"postedDate":"October 15th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-06-12T16:23:39+00:00","versionOfRecord":[],"versionCreatedAt":"2024-10-15 11:00:55","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4913510","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4913510","identity":"rs-4913510","version":["v1"]},"buildId":"_2-kVJe1T_tPrBINL-cwx","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}