Effectiveness of a personalised 6-month programme on frailty in older patients treated for bladder or kidney cancer – FRAGECO program – Multicenter, controlled, randomized study protocol

Effectiveness of a personalised 6-month programme on frailty in older patients treated for bladder or kidney cancer – FRAGECO program – Multicenter, controlled, randomized study protocol | 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 Study protocol Effectiveness of a personalised 6-month programme on frailty in older patients treated for bladder or kidney cancer – FRAGECO program – Multicenter, controlled, randomized study protocol Evolène Fayolle, Amandine Baudot, Anne-Françoise Chanelière-Sauvant, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8558120/v1 This work is licensed under a CC BY 4.0 License Status: Under Revision Version 1 posted 9 You are reading this latest preprint version Abstract Background: Older adults with bladder or kidney cancer are particularly vulnerable to functional decline and postoperative complications that can exacerbate frailty. Conventional care models focus mainly on surgery and postoperative recovery, with limited continuity of support, resulting in suboptimal long-term functional outcomes.The aim is to evaluate the effectiveness of a personalized 6-month care pathway on reducing frailty in older adults undergoing surgery for bladder or kidney cancer, compared with standard care. Methods: FRAGECO is a multicenter, controlled, randomized trial includes a personalized intervention combining two weekly 60-minute adapted physical activity sessions for one month before and one month after surgery, integrating moderate-intensity endurance, strength, and balance exercises. Optional patient education addresses physical activity, nutrition, treatments, and fatigue. Patients are then referred to local Devices for Adapted Physical Activity Practice (DAPAP) for 12 weeks to support long-term adherence. The primary outcome is frailty at 6 months, assessed using the six-minute walk test (6MWT). Secondary outcomes include: frailty, nutritional status, memory, quality of life, fatigue, depression, muscular strength and balance. A qualitative analysis will explore barriers, facilitators, and contextual factors influencing implementation. Discussion: The results of this study could be used to develop the management of older cancer patients in current practice in order to limit their post-operative frailty. Protocol version n°2 09/04/2025 Trial registration:ClinicalTrials.gov NCT07073703, registered on 10 July 2025, https://clinicaltrials.gov/study/NCT07073703 frailty older adult physical activity surgery cancer kidney bladder Figures Figure 1 Figure 2 BACKGROUND Cancer incidence increases with age, and in France, more than 62% of all new cases diagnosed in 2017 occurred in individuals aged 65 years and older ( 1 ). The mean age at diagnosis is approximately 70 years for bladder cancer ( 2 ), and 65 years for kidney cancer ( 3 ), with surgery remaining the primary treatment approach ( 4 ). For older patients, the French National Cancer Institute (INCa) recommends a preoperative frailty assessment and, when needed, referral to oncogeriatric care ( 5 ). Oncogeriatric coordination units (UCOGs) offer comprehensive geriatric evaluations and multidisciplinary decision-making for patients aged 75 years and over, but no personalized pre- or postoperative care pathway currently exists to address frailty and preserve autonomy. Frailty and its related manifestations, including fatigue, loss of strength and endurance, reduced mobility and undernutrition, are frequent and disabling in older cancer patients ( 6 ). Cancer-related fatigue, often accompanied by up to a 30% decline in cardiorespiratory capacity, accelerates functional decline and loss of independence ( 6 ). Undernutrition affects more than one-third of older patients and is associated with increased postoperative mortality, treatment toxicity, and reduced functional capacity ( 7 – 10 ). Together with comorbidities, polypharmacy, and cognitive or balance impairments ( 10 , 11 )these factors promote sedentary behavior and postoperative complications, which affect 35–50% of elderly surgical patients ( 9 , 12 ). According to Fried’s criteria, frailty is defined by inintentional weight loss, fatigue, slow gait speed, decreased grip strength, and physical inactivity. Among older adults with urological cancers, 40% are frail and 35% are pre-frail ( 13 ). The six-minute walk test (6MWT) provides an objective measure of functional capacity and frailty, reflecting lower-limb strength and walking speed, key determinants of autonomy ( 14 ), and avoids reliance on subjective components of frailty scores. Although frailty becomes more prevalent with age, it remains a potentially reversible condition. Physical activity (PA) is one of the most effective strategies to counteract frailty ( 10 ), improving strength, cardiorespiratory fitness, gait speed ( 15 ), and reducing cancer-related fatigue ( 16 ). PA practiced after surgery is also associated with reduced recurrence and improved quality of life ( 6 ). Patient education further supports autonomy, self-management and long-term healthy behaviors ( 17 ). Recent evidence supports multimodal prehabilitation programs combining PA, nutrition, and relaxation. In bladder cancer patients (mean age 69.7 years), such programs improved 6MWT performance four weeks post-surgery, although benefits were not maintained beyond eight weeks ( 18 ), highlighting the need for sustained and individualized interventions. To fill this gap, we propose the FRAGECO program, a comprehensive multimodal pathway combining adapted physical activity (APA) and patient education before and after surgery, and evaluated in comparison with a control group receiving usual care. The objective is to reduce frailty, preserve autonomy, and maintain quality of life in older adults with bladder or kidney cancer. To promote long-term adherence, patients will be referred to Auvergne Rhône-Alpes Devices for Adapted Physical Activity Practice (AURA DAPAPs), facilitating continuity of training and maximizing long-term benefits ( 19 ). METHODS AND ANALYSIS This is a randomized, controlled trial using a mixed-methods approach, combining quantitative and qualitative methodologies. Study Setting and recruitment Patients will be recruited by clinicians from the oncogeriatric units of Saint-Etienne University Hospital and the Loire Private Hospital, France. All patients aged 65 years and older diagnosed with bladder or kidney cancer and scheduled for surgery will be identified during multidisciplinary tumor board meetings. Eligible patients will be informed about the study during a follow-up consultation. The investigator will present the study objectives, provide an information leaflet, and obtain written informed consent from those who agree to participate. Participants are free to withdraw from the study at any time without any consequence to their medical care. Participants will be excluded from the study if the planned surgery is not performed (due to treatment modification) or if surgical complications occur that make continuation in the study impossible. The study protocol was approved by the Institutional Review Board (n°24.04790.000316#1, CPP Est III, France) and the trial is sponsored by Saint-Etienne University Hospital. Eligibility criteria Inclusion criteria: patients must be aged ≥65 years, have a diagnosis of bladder or kidney cancer, be scheduled for surgery, have no severe cognitive impairment that would prevent understanding of the protocol, be affiliated with the French social security system, and provide informed consent. Exclusion criteria: patients will be excluded if they have previously undergone the same type of surgery, present major comorbidities contraindicating PA (e.g., severe cardiac, respiratory, or disabling musculoskeletal conditions), are under legal guardianship or deprived of liberty, or are already engaged in a private prehabilitation program prescribed by a physiotherapist. Intervention Control group Patients in the control group will receive standard care. This includes a comprehensive geriatric assessment conducted by an oncogeriatrician, followed by surgery approximately four weeks later. Postoperative management consists of referral to a rehabilitation center for functional recovery, in line with usual clinical practice. Intervention group: FRAGECO program Patients in the intervention arm will follow the FRAGECO program: a six-month personalized care pathway combining APA and patient education, in addition to standard care (Figure 1). The program begins with a comprehensive multidisciplinary preoperative assessment carried out by an oncogeriatrician and an APA specialist. The evaluation covers functional, nutritional, and psychological domains, as well as an initial educational assessment to tailor the intervention to each patient’s needs. Based on this evaluation, an individualized six-month plan is developed, including APA sessions, patient education, and referral to the AURA DAPAP. APA component The APA program consists of two one-month supervised exercise periods: one preoperative and one postoperative (following rehabilitation). Each period includes two 60-minute sessions per week, led by trained APA teacher. Each session is tracked in a logbook for each participant. The program is individualized, progressive, and multimodal, integrating endurance, strength, and balance exercises using stationary bikes, treadmills, elastic bands, and light weights. Exercise intensity will be gradually increased and monitored using the modified Borg scale (0–10), with a target perceived exertion (RPE) between 3 and 7. Sessions are conducted face-to-face in small groups to promote motivation and peer support. Patient education component The patient education module also consists of two one-month cycles, scheduled before and after surgery. Topics are tailored to each patient’s needs and interests, identified during the initial and third evaluations. Themes may include PA, nutrition, fatigue management, sleep, treatment adherence, and cognition. - PA: risks of inactivity and sedentary behaviour and benefits of regular exercise. - Nutrition: dietary needs during and after treatment, with particular focus on undernutrition in older adults. - Fatigue and sleep: strategies to manage cancer-related fatigue and improve sleep quality. - Treatment adherence: safe medication management and understanding treatment side effect - Cognition: cognitive remediation and strategies to support memory, attention, and executive functioning. Each educational session lasts 60 minutes and is delivered by a multidisciplinary team (nurses, dietitians, sports medicine physicians, APA teachers). Education is provided in a hybrid format, combining in-person sessions at Saint-Étienne University Hospital with remote sessions to facilitate accessibility and adherence. Transition to long-term activity – AURA DAPAP referral At the end of the six-month personalized program, patients will be referred to the AURA DAPAP near their home. These community-based facilities provide supervised APA sessions once per week, supporting long-term adherence and the maintenance of regular PA beyond the study period. Fig. 1 Study design of FRAGECO Assessment measures As part of the study protocol, patients in the control group will undergo additional follow-up assessments alongside their usual care. These follow-ups conducted at baseline and at 1, 2, 3 months, and at the final endpoint at 6months, will mirror the assessment schedule of the intervention group (Figure 2). Participants will be informed in advance of all scheduled study visits and provided with a detailed information sheet outlining the study procedures. Fig. 2 Assessment measures timetable Primary objective The primary objective of this study is to assess the effectiveness of a personalized 6-month care pathway in reducing frailty among older patients with bladder or kidney cancer, compared with standard care. The primary outcome is frailty at 6 months, assessed using the six-minute walk test (6MWT). Secondary objective: Secondary outcomes include: - Frailty using Fried frailty phenotype (20) and Cumulative Illness Rating Scale for Geriatrics (CIRS-G) - Level of physical activity and sedentary behavior using (1) objective measures of PA (in MET-hours/week) and sedentary time (in h/d) via accelerometry (Actigraph GT3x, Pensacola, Florida, USA) and (2) subjective measurements of PA (in MET-hours/week) and sedentary behavior (in hours/day) using the e-Adult Physical Activity Questionnaire (EA SNA-EPIS, Université Jean Monnet, Saint-Etienne, France). - Nutritional status with the Mini Nutritional Assessment (MNA) and albumin analysis in g/l, a level <35g/l: undernutrition, <30g/l: severe undernutrition - Memory using the Mini-Mental State Examination (MMSE), which consists of 30 questions and is scored out of 30. The severity of memory impairment is considered mild if the score is above 20, moderate if the score is between 10 and 20, and severe if the score is below 10. - Healthy quality of life with the EORTC-QLC30 version 3. This 30-item questionnaire assesses 15 dimensions of quality of life (5 functional scales: physical, cognitive, social, emotional or psychological and limitations in daily activities; 1 global health/quality of life scale; 9 symptom scales: fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation and diarrhea, financial problems related to the disease). - Fatigue with the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F). The questionnaire consists of 13 questions, each of which corresponds to a Likert scale ranging from 0 to 4 (0 = not at all, 4 = very much). A score is obtained out of 52, with the higher the score, the less fatigued the patient is. - Depression using the Mini Geriatric Depression Scale (GDS) to 4 questions. If the score is greater than 1: high probability of depression, if the score is 0: high probability of no depression. - Muscular strength by biceps muscle strength (in kilogram) on the handgrip. - Balance is assessed using the time (in seconds) taken to complete the Timed Up and Go (TUG). A time ≥ 20 seconds is associated with a risk of falling. Details of timetable are shown in Figure 2. We will evaluate the implementation process of the FRAGECO program using a qualitative approach, aiming to understand the conditions under which the intervention was effective or faced challenges. This qualitative component will explore both the contextual factors influencing implementation and the perceptions of professionals directly involved in the program. Semi-structured interviews will be conducted with key stakeholders, including APA teachers, oncogeriatricians, nurses, and healthcare managers. An interview guide will be developed based on the Consolidated Framework for Implementation Research (CFIR) (21), allowing for a structured exploration of the following themes: 1. Barriers and facilitators to the delivery of the personalized program; 2. Potential adjustments or improvements to consider; 3. Knowledge, beliefs, and perceptions regarding frailty; 4. Strategies for interprofessional collaboration; 5. Roles and contributions of the different stakeholders involved. All interviews will be recorded, transcribed verbatim, and analyzed using thematic content analysis following the six-step process described by Braun and Clarke (22): data familiarization, initial code generation, organization of codes into themes, review and refinement of themes, and final definition and illustration of results. Data management and analysis will be conducted with Dedoose software (Version 10.0.35) (SocioCultural Research Consultants, Los Angeles, CA), a platform dedicated to the organization, analysis, and visualization of qualitative and mixed-methods research data. Sample Size Based on various studies (23–25) we have assumed that the minimum clinically important difference for this target population at 6MWT is 30 metres with a 95% confidence interval to demonstrate the efficacy of our intervention. Thus, based on the hypothesis of a difference of 30 ±45 m (21–23) between the 2 groups (intervention vs. control), with an alpha risk of 5% and a power of 90%, it is necessary to include 48 patients per group. Because of the frailty of the population and the interruptions due to surgery and stay in rehabilitation centre, we consider the possibility of 10% of patients being lost to follow-up. We therefore recommend including 53 subjects in each group, for a total of 106 subjects. Randomisation and data collection The randomisation list will be a computer-generated pseudo-random sequence, prepared prior to the start of the study by a statistician independent of the study team. Randomisation will be stratified by study center to account for potential site-specific differences. The details of block sizes and sequence restrictions will be kept in a separate document, inaccessible to investigators enrolling participants or assigning interventions. Randomisation and data collection will be centralized via the Redcap platform and completed by the referring doctor and the APA teacher. Only the study investigators have access to this data. Data analysis The population included will first be described overall and by group (intervention vs control). The evolution of the 6MWT will be estimated using a Student's t-test, if the normality of the distribution is verified. If not, a rank test will be used. Normality will first be tested using a Shapiro-Wilk test. In the event of imbalance between the groups at inclusion, an analysis adjusted for the imbalanced covariate will be carried out for the main criterion, using an ANCOVA. The secondary outcomes are measures repeated over time to authenticate any improvement. In order to compare these criteria between the two treatment groups, an ANOVA for repeated measures will be used, if the distribution follows a Normal distribution. In the opposite case, a Friedman test will be used. If the result of the ANOVA for repeated measures is statistically significant, post-hoc tests will be carried out. The results will be considered significant at the 5% threshold. DISCUSSION The FRAGECO programme represents an innovative approach to the management of older adults with cancer. This is particularly relevant in the current context, as cancer prevalence continues to rise in France and older people remain the most affected. Surgery is the most common treatment for bladder and kidney cancer, yet older adults are often affected to postoperative complications that compromise quality of life and autonomy. The challenge is therefore to develop strategies that limit the adverse effects of cancer and its treatment, while considering age-related vulnerabilities such as frailty. The originality of this approach lies in the integration of both prehabilitation and rehabilitation within a single, continuous care pathway, specifically designed for older adults undergoing surgery for bladder or kidney cancer, populations highly susceptible to functional decline. Unlike conventional models, where postoperative recovery is often managed outside the structured cancer pathway, this integrated approach aims to reduce frailty, optimize functional recovery, and close a critical gap current oncogeriatric management. A recent study showed that two weekly 60-minute sessions of moderate-intensity PA significantly reduced frailty in older adults (mean age 84.9) identified as frail ( 26 ). Guided by these findings, the FRAGECO programme adopts a comparable training frequency and intensity to ensure both safety and clinical relevance. Building on this exercise-based foundation, the integration of patient education seeks to strengthen patient engagement, self-management, and long-term adherence. Recent evidence suggests that combining empowering education with exercise yields significant improvements in frailty among frail and pre-frail older adults ( 27 ). The inclusion of patient education is therefore intended not only to support short-term participation but also to promote lasting behavioural change. To ensure care continuity and sustained PA, patients are referred to the DAPAP at the end of the FRAGECO program. This transition supports long-term adherence, bridges the gap between hospital-based interventions and community care, and promotes durable lifestyle changes. Another key innovation is the assessment of the programmes’s implementation. This will allow the identification of barriers and facilitators to integrating personalized APA and patient education within oncogeriatric care. It will provide valuable insights into contextual, professional and organizational factors influencing feasibility, acceptability, and sustainability, information essential for scaling and optimizing similar interventions. A foreseeable challenge lies in both patient recruitment and maintaining adherence after surgery, as postoperative fatigue, complications or treatment-related side effects may reduce participation. Previous studies have identified comorbidities, physical symptoms, functional limitations, anxiety, and unfamiliarity with APA as common barriers during the perioperative period ( 28 ). The results of this study could support the implementation of APA and patient education within oncogeriatric units, and more widely in oncology, where such interventions remain insufficiently developed and may provide a scalable model for routine integration of PA in cancer care pathways. Abbreviations 6MWT Six-minute walk test APA Adapted physical activity AURA DAPAPs Auvergne Rhône-Alpes Devices for Adapted Physical Activity Practice CFIR Consolidated Framework for Implementation Research CIRS-G Cumulative Illness Rating Scale for Geriatrics eAPAQ e-Adult Physical Activity Questionnaire GDS Geriatric Depression Scale INCa French National Cancer Institute MMSE Memory using the Mini-Mental State Examination PA Physical activity RPE Rated perceived exertion TUG Timed Up and Go UCOGs Oncogeriatric coordination units Declarations Ethics approval and consent to participate: The study protocol was approved by the Institutional Review Board (n° 24.04790.000316#1, CPP Est III, France). Participants are provided with a study information sheet and are required to give their written informed consent. Consent for publication : Not applicable Availability of data and materials: Not applicable Competing Interest: None declared. Funding: The trial is sponsored by Saint-Etienne University Hospital. Authors' contributions: EF, BA, DH, AFCS, and TC designed the study. EmF, AFCS, FT, FR, EF, DH, and AB implemented the protocol. EF conducted the adapted physical activity sessions. DH served as the principal investigator. EF wrote the manuscript, with DH and AB reviewing and revising it. All authors approved the final version. Acknowledgments: The authors thank all the co-investigators and participating physicians of FRAGECO, as well as Thérence Dumont for his contribution to the development of the project. References Épidémiologie des cancers chez les patients de 65 ans et plus - Oncogériatrie [Internet]. [cité 23 oct 2023]. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8558120","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":573738787,"identity":"e8535ead-8666-496c-8de1-c30e7f304def","order_by":0,"name":"Evolène 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Baudot","email":"","orcid":"","institution":"Univ Jean Monnet, URC, INSERM CIC 1408, University Hospital of Saint-Etienne, Mines Saint-Etienne, INSERM, U 1059","correspondingAuthor":false,"prefix":"","firstName":"Amandine","middleName":"","lastName":"Baudot","suffix":""},{"id":573738792,"identity":"87891f0f-3525-4b0d-93fb-6ebecf2db33d","order_by":2,"name":"Anne-Françoise Chanelière-Sauvant","email":"","orcid":"","institution":"Univ Jean Monnet, Department of Geriatrics and Clinical Gerontology, University Hospital of Saint-Etienne, Mines Saint-Etienne, INSERM, U 1059","correspondingAuthor":false,"prefix":"","firstName":"Anne-Françoise","middleName":"","lastName":"Chanelière-Sauvant","suffix":""},{"id":573738793,"identity":"f0539dd1-0385-419e-996c-e018c4605879","order_by":3,"name":"Emilie Favier","email":"","orcid":"","institution":"Loire Private Hospital, Medical oncology","correspondingAuthor":false,"prefix":"","firstName":"Emilie","middleName":"","lastName":"Favier","suffix":""},{"id":573738795,"identity":"a03ab665-ed0d-43a1-a207-1776ce7962d7","order_by":4,"name":"Florianne Rambaud","email":"","orcid":"","institution":"Univ Jean Monnet, URC, University Hospital of Saint-Etienne, Mines Saint-Etienne","correspondingAuthor":false,"prefix":"","firstName":"Florianne","middleName":"","lastName":"Rambaud","suffix":""},{"id":573738799,"identity":"1870b324-ff00-478a-9737-355c14943e51","order_by":5,"name":"Fatah Torche","email":"","orcid":"","institution":"Univ Jean Monnet, URC, University Hospital of Saint-Etienne, Mines Saint-Etienne","correspondingAuthor":false,"prefix":"","firstName":"Fatah","middleName":"","lastName":"Torche","suffix":""},{"id":573738800,"identity":"ed944c5a-6635-44fb-8a71-95f2912dd925","order_by":6,"name":"Thomas Celarier","email":"","orcid":"","institution":"Univ Jean Monnet, Department of Geriatrics and Clinical Gerontology, University Hospital of Saint-Etienne, Mines Saint-Etienne, INSERM, U 1059","correspondingAuthor":false,"prefix":"","firstName":"Thomas","middleName":"","lastName":"Celarier","suffix":""},{"id":573738801,"identity":"5e64bb4f-06b7-470d-8177-f95bb3aadad9","order_by":7,"name":"David Hupin","email":"","orcid":"","institution":"Univ Jean Monnet, Department of Clinical and Exercise Physiology, University Hospital of Saint-Etienne, Mines Saint-Etienne, INSERM, U 1059","correspondingAuthor":false,"prefix":"","firstName":"David","middleName":"","lastName":"Hupin","suffix":""}],"badges":[],"createdAt":"2026-01-09 07:39:58","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8558120/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8558120/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":100401295,"identity":"22c23fa3-6c58-43b2-9769-27bfcad7d2e9","added_by":"auto","created_at":"2026-01-16 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1","display":"","copyAsset":false,"role":"figure","size":96847,"visible":true,"origin":"","legend":"\u003cp\u003eStudy design of FRAGECO\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8558120/v1/07fcd829d411e8b93392088b.png"},{"id":100401460,"identity":"3f6fc68a-d3a8-48a3-843b-bd0cbac22ea3","added_by":"auto","created_at":"2026-01-16 11:58:56","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":22869,"visible":true,"origin":"","legend":"\u003cp\u003eAssessment measures timetable\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-8558120/v1/5cee3b3d8dbc4c5bef0dfd21.png"},{"id":100422866,"identity":"72fbb00a-b64f-49aa-ab51-fc910526eaa4","added_by":"auto","created_at":"2026-01-16 14:11:54","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":645306,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8558120/v1/8b252215-bfab-46df-938c-069a6b00cac4.pdf"},{"id":100399540,"identity":"c8ea3612-4dfe-48de-b03d-ad762a4a31a4","added_by":"auto","created_at":"2026-01-16 11:57:12","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":34519,"visible":true,"origin":"","legend":"","description":"","filename":"SPIRITFRAGECOchecklist2.docx","url":"https://assets-eu.researchsquare.com/files/rs-8558120/v1/9e35e09f65a12fd744d739be.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effectiveness of a personalised 6-month programme on frailty in older patients treated for bladder or kidney cancer – FRAGECO program – Multicenter, controlled, randomized study protocol","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eCancer incidence increases with age, and in France, more than 62% of all new cases diagnosed in 2017 occurred in individuals aged 65 years and older (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). The mean age at diagnosis is approximately 70 years for bladder cancer (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e), and 65 years for kidney cancer (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e), with surgery remaining the primary treatment approach (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eFor older patients, the French National Cancer Institute (INCa) recommends a preoperative frailty assessment and, when needed, referral to oncogeriatric care (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Oncogeriatric coordination units (UCOGs) offer comprehensive geriatric evaluations and multidisciplinary decision-making for patients aged 75 years and over, but no personalized pre- or postoperative care pathway currently exists to address frailty and preserve autonomy.\u003c/p\u003e \u003cp\u003eFrailty and its related manifestations, including fatigue, loss of strength and endurance, reduced mobility and undernutrition, are frequent and disabling in older cancer patients (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Cancer-related fatigue, often accompanied by up to a 30% decline in cardiorespiratory capacity, accelerates functional decline and loss of independence (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Undernutrition affects more than one-third of older patients and is associated with increased postoperative mortality, treatment toxicity, and reduced functional capacity (\u003cspan additionalcitationids=\"CR8 CR9\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e). Together with comorbidities, polypharmacy, and cognitive or balance impairments (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e)these factors promote sedentary behavior and postoperative complications, which affect 35\u0026ndash;50% of elderly surgical patients (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAccording to Fried\u0026rsquo;s criteria, frailty is defined by inintentional weight loss, fatigue, slow gait speed, decreased grip strength, and physical inactivity. Among older adults with urological cancers, 40% are frail and 35% are pre-frail (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). The six-minute walk test (6MWT) provides an objective measure of functional capacity and frailty, reflecting lower-limb strength and walking speed, key determinants of autonomy (\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e), and avoids reliance on subjective components of frailty scores.\u003c/p\u003e \u003cp\u003eAlthough frailty becomes more prevalent with age, it remains a potentially reversible condition. Physical activity (PA) is one of the most effective strategies to counteract frailty (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e), improving strength, cardiorespiratory fitness, gait speed (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e), and reducing cancer-related fatigue (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). PA practiced after surgery is also associated with reduced recurrence and improved quality of life (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). Patient education further supports autonomy, self-management and long-term healthy behaviors (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eRecent evidence supports multimodal prehabilitation programs combining PA, nutrition, and relaxation. In bladder cancer patients (mean age 69.7 years), such programs improved 6MWT performance four weeks post-surgery, although benefits were not maintained beyond eight weeks (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e), highlighting the need for sustained and individualized interventions.\u003c/p\u003e \u003cp\u003eTo fill this gap, we propose the FRAGECO program, a comprehensive multimodal pathway combining adapted physical activity (APA) and patient education before and after surgery, and evaluated in comparison with a control group receiving usual care. The objective is to reduce frailty, preserve autonomy, and maintain quality of life in older adults with bladder or kidney cancer. To promote long-term adherence, patients will be referred to Auvergne Rh\u0026ocirc;ne-Alpes Devices for Adapted Physical Activity Practice (AURA DAPAPs), facilitating continuity of training and maximizing long-term benefits (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e).\u003c/p\u003e"},{"header":"METHODS AND ANALYSIS","content":"\u003cp\u003eThis is a randomized, controlled trial using a mixed-methods approach, combining quantitative and qualitative methodologies.\u003c/p\u003e\n\u003cp\u003eStudy Setting and recruitment\u003c/p\u003e\n\u003cp\u003ePatients will be recruited by clinicians from the oncogeriatric units of Saint-Etienne University Hospital and the Loire Private Hospital, France. All patients aged 65 years and older diagnosed with bladder or kidney cancer and scheduled for surgery will be identified during multidisciplinary tumor board meetings. Eligible patients will be informed about the study during a follow-up consultation. The investigator will present the study objectives, provide an information leaflet, and obtain written informed consent from those who agree to participate. Participants are free to withdraw from the study at any time without any consequence to their medical care. Participants will be excluded from the study if the planned surgery is not performed (due to treatment modification) or if surgical complications occur that make continuation in the study impossible.\u003c/p\u003e\n\u003cp\u003eThe study protocol was approved by the Institutional Review Board (n\u0026deg;24.04790.000316#1, CPP Est III, France) and the trial is sponsored by Saint-Etienne University Hospital.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInclusion criteria: patients must be aged \u0026ge;65 years, have a diagnosis of bladder or kidney cancer, be scheduled for surgery, have no severe cognitive impairment that would prevent understanding of the protocol, be affiliated with the French social security system, and provide informed consent.\u003c/p\u003e\n\u003cp\u003eExclusion criteria: patients will be excluded if they have previously undergone the same type of surgery, present major comorbidities contraindicating PA (e.g., severe cardiac, respiratory, or disabling musculoskeletal conditions), are under legal guardianship or deprived of liberty, or are already engaged in a private prehabilitation program prescribed by a physiotherapist.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eControl group\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients in the control group will receive standard care. This includes a comprehensive geriatric assessment conducted by an oncogeriatrician, followed by surgery approximately four weeks later. Postoperative management consists of referral to a rehabilitation center for functional recovery, in line with usual clinical practice.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eIntervention group: FRAGECO program\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients in the intervention arm will follow the FRAGECO program: a six-month personalized care pathway combining APA and patient education, in addition to standard care (Figure 1).\u003c/p\u003e\n\u003cp\u003eThe program begins with a comprehensive multidisciplinary preoperative assessment carried out by an oncogeriatrician and an APA specialist. The evaluation covers functional, nutritional, and psychological domains, as well as an initial educational assessment to tailor the intervention to each patient\u0026rsquo;s needs. Based on this evaluation, an individualized six-month plan is developed, including APA sessions, patient education, and referral to the AURA DAPAP.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAPA component\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe APA program consists of two one-month supervised exercise periods: one preoperative and one postoperative (following rehabilitation).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEach period includes two 60-minute sessions per week, led by trained APA teacher. Each session is tracked in a logbook for each participant.\u003c/p\u003e\n\u003cp\u003eThe program is individualized, progressive, and multimodal, integrating endurance, strength, and balance exercises using stationary bikes, treadmills, elastic bands, and light weights. Exercise intensity will be gradually increased and monitored using the modified Borg scale (0\u0026ndash;10), with a target perceived exertion (RPE) between 3 and 7. Sessions are conducted face-to-face in small groups to promote motivation and peer support.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePatient education component\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe patient education module also consists of two one-month cycles, scheduled before and after surgery. Topics are tailored to each patient\u0026rsquo;s needs and interests, identified during the initial and third evaluations. Themes may include PA, nutrition, fatigue management, sleep, treatment adherence, and cognition.\u003c/p\u003e\n\u003cp\u003e- PA: risks of inactivity and sedentary behaviour and benefits of regular exercise.\u003c/p\u003e\n\u003cp\u003e- Nutrition: dietary needs during and after treatment, with particular focus on undernutrition in older adults.\u003c/p\u003e\n\u003cp\u003e- Fatigue and sleep: strategies to manage cancer-related fatigue and improve sleep quality.\u003c/p\u003e\n\u003cp\u003e- Treatment adherence: safe medication management and understanding treatment side effect\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e- Cognition: cognitive remediation and strategies to support memory, attention, and executive functioning.\u003c/p\u003e\n\u003cp\u003eEach educational session lasts 60 minutes and is delivered by a multidisciplinary team (nurses, dietitians, sports medicine physicians, APA teachers). Education is provided in a hybrid format, combining in-person sessions at Saint-\u0026Eacute;tienne University Hospital with remote sessions to facilitate accessibility and adherence.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTransition to long-term activity \u0026ndash; AURA DAPAP referral\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAt the end of the six-month personalized program, patients will be referred to the AURA\u0026nbsp;DAPAP near their home. These community-based facilities provide supervised APA sessions once per week, supporting long-term adherence and the maintenance of regular PA beyond the study period.\u003c/p\u003e\n\u003cp\u003eFig. 1\u0026nbsp;Study design of FRAGECO\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssessment measures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAs part of the study protocol, patients in the control group will undergo additional follow-up assessments alongside their usual care. These follow-ups conducted at baseline and at 1, 2, 3 months, and at the final endpoint at 6months, will mirror the assessment schedule of the intervention group (Figure 2). Participants will be informed in advance of all scheduled study visits and provided with a detailed information sheet outlining the study procedures.\u003c/p\u003e\n\u003cp\u003eFig. 2\u0026nbsp;Assessment measures timetable\u003c/p\u003e\n\u003cp\u003e\u003cem\u003ePrimary objective\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe primary objective of this study is to assess the effectiveness of a personalized 6-month care pathway in reducing frailty among older patients with bladder or kidney cancer, compared with standard care.\u0026nbsp;The primary outcome is frailty at 6 months, assessed using the six-minute walk test (6MWT).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSecondary objective:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSecondary outcomes include:\u003c/p\u003e\n\u003cp\u003e- Frailty using Fried frailty phenotype\u0026nbsp;(20)\u0026nbsp;and Cumulative Illness Rating Scale for Geriatrics (CIRS-G)\u003c/p\u003e\n\u003cp\u003e- Level of physical activity and sedentary behavior\u0026nbsp;using (1) objective measures of PA (in MET-hours/week) and sedentary time (in h/d) via accelerometry (Actigraph GT3x, Pensacola, Florida, USA) and (2) subjective measurements of PA (in MET-hours/week) and sedentary behavior (in hours/day) using the e-Adult Physical Activity Questionnaire (EA SNA-EPIS, Universit\u0026eacute; Jean Monnet, Saint-Etienne, France).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e- Nutritional status with the Mini Nutritional Assessment (MNA) and albumin analysis in g/l, a level \u0026lt;35g/l: undernutrition, \u0026lt;30g/l: severe undernutrition\u003c/p\u003e\n\u003cp\u003e- Memory using the Mini-Mental State Examination (MMSE), which consists of 30 questions and is scored out of 30. The severity of memory impairment is considered mild if the score is above 20, moderate if the score is between 10 and 20, and severe if the score is below 10.\u003c/p\u003e\n\u003cp\u003e- Healthy quality of life with the EORTC-QLC30 version 3. This 30-item questionnaire assesses 15 dimensions of quality of life (5 functional scales: physical, cognitive, social, emotional or psychological and limitations in daily activities; 1 global health/quality of life scale; 9 symptom scales: fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation and diarrhea, financial problems related to the disease).\u003c/p\u003e\n\u003cp\u003e- Fatigue with the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F). The questionnaire consists of 13 questions, each of which corresponds to a Likert scale ranging from 0 to 4 (0 = not at all, 4 = very much). A score is obtained out of 52, with the higher the score, the less fatigued the patient is.\u003c/p\u003e\n\u003cp\u003e- Depression using the Mini Geriatric Depression Scale (GDS)\u0026nbsp;to 4 questions. If the score is greater than 1: high probability of depression, if the score is 0: high probability of no depression.\u003c/p\u003e\n\u003cp\u003e- Muscular strength\u0026nbsp;by biceps muscle strength (in kilogram) on the handgrip.\u003c/p\u003e\n\u003cp\u003e- Balance is assessed using the time (in seconds) taken to complete the Timed Up and Go (TUG). A time \u0026ge; 20 seconds is associated with a risk of falling.\u003c/p\u003e\n\u003cp\u003eDetails of timetable are shown in Figure 2.\u003c/p\u003e\n\u003cp\u003eWe will evaluate the\u0026nbsp;implementation process\u0026nbsp;of the FRAGECO program using a\u0026nbsp;qualitative approach, aiming to understand the conditions under which the intervention was effective or faced challenges. This qualitative component will explore both the contextual factors influencing implementation and the perceptions of professionals directly involved in the program.\u003c/p\u003e\n\u003cp\u003eSemi-structured interviews will be conducted with key stakeholders, including APA teachers, oncogeriatricians, nurses, and healthcare managers. An interview guide will be developed based on the Consolidated Framework for Implementation Research (CFIR)\u0026nbsp;(21), allowing for a structured exploration of the following themes:\u003c/p\u003e\n\u003cp\u003e1. Barriers and facilitators to the delivery of the personalized program;\u003c/p\u003e\n\u003cp\u003e2. Potential adjustments or improvements to consider;\u003c/p\u003e\n\u003cp\u003e3. Knowledge, beliefs, and perceptions regarding frailty;\u003c/p\u003e\n\u003cp\u003e4. Strategies for interprofessional collaboration;\u003c/p\u003e\n\u003cp\u003e5. Roles and contributions of the different stakeholders involved.\u003c/p\u003e\n\u003cp\u003eAll interviews will be recorded, transcribed verbatim, and analyzed using thematic content analysis following the six-step process described by Braun and Clarke\u0026nbsp;(22): data familiarization, initial code generation, organization of codes into themes, review and refinement of themes, and final definition and illustration of results.\u003c/p\u003e\n\u003cp\u003eData management and analysis will be conducted with Dedoose software (Version 10.0.35)\u0026nbsp;(SocioCultural Research Consultants, Los Angeles, CA), a platform dedicated to the organization, analysis, and visualization of qualitative and mixed-methods research data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample Size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBased on various studies\u0026nbsp;(23\u0026ndash;25)\u0026nbsp;we have assumed that the minimum clinically important difference for this target population at 6MWT is 30 metres with a 95% confidence interval to demonstrate the efficacy of our intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThus, based on the hypothesis of a difference of 30 \u0026plusmn;45 m (21\u0026ndash;23) \u0026nbsp;between the 2 groups (intervention vs. control), with an alpha risk of 5% and a power of 90%, it is necessary to include 48 patients per group. Because of the frailty of the population and the interruptions due to surgery and stay in rehabilitation centre, we consider the possibility of 10% of patients being lost to follow-up. We therefore recommend including 53 subjects in each group, for a total of 106 subjects.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eRandomisation and data collection\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe randomisation list will be a computer-generated pseudo-random sequence, prepared prior to the start of the study by a statistician independent of the study team. Randomisation will be stratified by study center to account for potential site-specific differences. The details of block sizes and sequence restrictions will be kept in a separate document, inaccessible to investigators enrolling participants or assigning interventions. Randomisation and data collection will be centralized via the \u003cem\u003eRedcap\u003c/em\u003e platform and completed by the referring doctor and the APA teacher. Only the study investigators have access to this data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eData analysis\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe population included will first be described overall and by group (intervention vs control).\u003c/p\u003e\n\u003cp\u003eThe evolution of the 6MWT will be estimated using a Student\u0026apos;s t-test, if the normality of the distribution is verified. If not, a rank test will be used. Normality will first be tested using a Shapiro-Wilk test. In the event of imbalance between the groups at inclusion, an analysis adjusted for the imbalanced covariate will be carried out for the main criterion, using an ANCOVA.\u003c/p\u003e\n\u003cp\u003eThe secondary outcomes are measures repeated over time to authenticate any improvement. In order to compare these criteria between the two treatment groups, an ANOVA for repeated measures will be used, if the distribution follows a Normal distribution. In the opposite case, a Friedman test will be used. If the result of the ANOVA for repeated measures is statistically significant, post-hoc tests will be carried out.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe results will be considered significant at the 5% threshold.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe FRAGECO programme represents an innovative approach to the management of older adults with cancer. This is particularly relevant in the current context, as cancer prevalence continues to rise in France and older people remain the most affected. Surgery is the most common treatment for bladder and kidney cancer, yet older adults are often affected to postoperative complications that compromise quality of life and autonomy. The challenge is therefore to develop strategies that limit the adverse effects of cancer and its treatment, while considering age-related vulnerabilities such as frailty.\u003c/p\u003e \u003cp\u003eThe originality of this approach lies in the integration of both prehabilitation and rehabilitation within a single, continuous care pathway, specifically designed for older adults undergoing surgery for bladder or kidney cancer, populations highly susceptible to functional decline. Unlike conventional models, where postoperative recovery is often managed outside the structured cancer pathway, this integrated approach aims to reduce frailty, optimize functional recovery, and close a critical gap current oncogeriatric management.\u003c/p\u003e \u003cp\u003eA recent study showed that two weekly 60-minute sessions of moderate-intensity PA significantly reduced frailty in older adults (mean age 84.9) identified as frail (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). Guided by these findings, the FRAGECO programme adopts a comparable training frequency and intensity to ensure both safety and clinical relevance.\u003c/p\u003e \u003cp\u003eBuilding on this exercise-based foundation, the integration of patient education seeks to strengthen patient engagement, self-management, and long-term adherence. Recent evidence suggests that combining empowering education with exercise yields significant improvements in frailty among frail and pre-frail older adults (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). The inclusion of patient education is therefore intended not only to support short-term participation but also to promote lasting behavioural change. To ensure care continuity and sustained PA, patients are referred to the DAPAP at the end of the FRAGECO program. This transition supports long-term adherence, bridges the gap between hospital-based interventions and community care, and promotes durable lifestyle changes.\u003c/p\u003e \u003cp\u003eAnother key innovation is the assessment of the programmes\u0026rsquo;s implementation. This will allow the identification of barriers and facilitators to integrating personalized APA and patient education within oncogeriatric care. It will provide valuable insights into contextual, professional and organizational factors influencing feasibility, acceptability, and sustainability, information essential for scaling and optimizing similar interventions.\u003c/p\u003e \u003cp\u003eA foreseeable challenge lies in both patient recruitment and maintaining adherence after surgery, as postoperative fatigue, complications or treatment-related side effects may reduce participation. Previous studies have identified comorbidities, physical symptoms, functional limitations, anxiety, and unfamiliarity with APA as common barriers during the perioperative period (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe results of this study could support the implementation of APA and patient education within oncogeriatric units, and more widely in oncology, where such interventions remain insufficiently developed and may provide a scalable model for routine integration of PA in cancer care pathways.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003e6MWT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Six-minute walk test\u003c/p\u003e\n\u003cp\u003eAPA Adapted physical activity\u003c/p\u003e\n\u003cp\u003eAURA DAPAPs Auvergne Rhône-Alpes\u0026nbsp;Devices for Adapted Physical Activity Practice\u003c/p\u003e\n\u003cp\u003eCFIR Consolidated Framework for Implementation Research\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCIRS-G Cumulative Illness Rating Scale for Geriatrics\u003c/p\u003e\n\u003cp\u003eeAPAQ e-Adult Physical Activity Questionnaire\u003c/p\u003e\n\u003cp\u003eGDS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Geriatric Depression Scale\u003c/p\u003e\n\u003cp\u003eINCa\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;French National Cancer Institute\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMMSE\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Memory using the Mini-Mental State Examination\u003c/p\u003e\n\u003cp\u003ePA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Physical activity\u003c/p\u003e\n\u003cp\u003eRPE Rated perceived exertion\u003c/p\u003e\n\u003cp\u003eTUG\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Timed Up and Go\u003c/p\u003e\n\u003cp\u003eUCOGs Oncogeriatric coordination units\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u0026nbsp;\u003c/strong\u003eThe study protocol was approved by the Institutional Review Board\u0026nbsp;(n°\u0026nbsp;24.04790.000316#1, CPP Est III, France). Participants are provided with a study information sheet and are required to give their written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e: Not applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u0026nbsp;\u003c/strong\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interest:\u003c/strong\u003e None declared.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e The trial is sponsored by Saint-Etienne University Hospital.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions:\u0026nbsp;\u003c/strong\u003eEF, BA, DH, AFCS, and TC designed the study. EmF, AFCS, FT, FR, EF, DH, and AB implemented the protocol. EF conducted the adapted physical activity sessions. DH served as the principal investigator. EF wrote the manuscript, with DH and AB reviewing and revising it. All authors approved the final version.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u003c/strong\u003e The authors thank all the co-investigators and participating physicians of FRAGECO, as well as Thérence Dumont for his contribution to the development of the project.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003e\u0026Eacute;pid\u0026eacute;miologie des cancers chez les patients de 65 ans et plus - Oncog\u0026eacute;riatrie [Internet]. [cit\u0026eacute; 23 oct 2023]. Disponible sur: https://www.e-cancer.fr/Professionnels-de-sante/L-organisation-de-l-offre-de-soins/Oncogeriatrie/Epidemiologie\u003c/li\u003e\n\u003cli\u003eCancers de la vessie : les points cl\u0026eacute;s - Cancer de la vessie [Internet]. [cit\u0026eacute; 10 oct 2023]. 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Disponible sur: http://link.springer.com/10.1007/s40520-019-01124-7\u003c/li\u003e\n\u003cli\u003eArrieta H, Rezola-Pardo C, Gil SM, Virgala J, Iturburu M, Ant\u0026oacute;n I, et al. Effects of Multicomponent Exercise on Frailty in Long-Term Nursing Homes: A Randomized Controlled Trial. J Am Geriatr Soc. juin 2019;67(6):1145‑51. \u003c/li\u003e\n\u003cli\u003eFang J, Ren J, Wang J, Qiu X, Zhang S, Yuan S, et al. Combining motivational and exercise intervention components to reverse pre-frailty and promote self-efficacy among community-dwelling pre-frail older adults: a randomized controlled trial. BMC Geriatr. 30 oct 2024;24(1):896. \u003c/li\u003e\n\u003cli\u003eSun V, Raz DJ, Kim JY, Melstrom L, Hite S, Varatkar G, et al. Barriers and Facilitators of Adherence to a Perioperative Physical Activity Intervention for Older Adults with Cancer and their Family Caregivers. J Geriatr Oncol [Internet]. mars 2020 [cit\u0026eacute; 23 sept 2025];11(2):256‑62. Disponible sur: https://pmc.ncbi.nlm.nih.gov/articles/PMC6911031/\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"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":"bmc-geriatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bgtc","sideBox":"Learn more about [BMC Geriatrics](http://bmcgeriatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bgtc/default.aspx","title":"BMC Geriatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"frailty, older adult, physical activity, surgery, cancer, kidney, bladder","lastPublishedDoi":"10.21203/rs.3.rs-8558120/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8558120/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: Older adults with bladder or kidney cancer are particularly vulnerable to functional decline and postoperative complications that can exacerbate frailty. Conventional care models focus mainly on surgery and postoperative recovery, with limited continuity of support, resulting in suboptimal long-term functional outcomes.The aim is to evaluate the effectiveness of a personalized 6-month care pathway on reducing frailty in older adults undergoing surgery for bladder or kidney cancer, compared with standard care.\u003c/p\u003e\n\u003cp\u003eMethods: FRAGECO is a multicenter, controlled, randomized trial includes a personalized intervention combining two weekly 60-minute adapted physical activity sessions for one month before and one month after surgery, integrating moderate-intensity endurance, strength, and balance exercises. Optional patient education addresses physical activity, nutrition, treatments, and fatigue. Patients are then referred to local Devices for Adapted Physical Activity Practice (DAPAP) for 12 weeks to support long-term adherence.\u003c/p\u003e\n\u003cp\u003eThe primary outcome is frailty at 6 months, assessed using the six-minute walk test (6MWT). Secondary outcomes include: frailty, nutritional status, memory, quality of life, fatigue, depression, muscular strength and balance. A qualitative analysis will explore barriers, facilitators, and contextual factors influencing implementation.\u003c/p\u003e\n\u003cp\u003eDiscussion: The results of this study could be used to develop the management of older cancer patients in current practice in order to limit their post-operative frailty.\u003c/p\u003e\n\u003cp\u003eProtocol version n°2 09/04/2025\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTrial registration:ClinicalTrials.gov NCT07073703, registered on 10 July 2025, https://clinicaltrials.gov/study/NCT07073703\u003c/p\u003e","manuscriptTitle":"Effectiveness of a personalised 6-month programme on frailty in older patients treated for bladder or kidney cancer – FRAGECO program – Multicenter, controlled, randomized study protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-16 09:03:49","doi":"10.21203/rs.3.rs-8558120/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-01-18T15:18:05+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-01-17T09:37:07+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"231570296701653866589972205817280516650","date":"2026-01-17T08:53:55+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-01-12T13:42:59+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"70844079199562298803616991264279517875","date":"2026-01-12T13:31:24+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-01-12T12:53:21+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-10T04:13:44+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-10T04:13:42+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Geriatrics","date":"2026-01-09T07:24:07+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-geriatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bgtc","sideBox":"Learn more about [BMC Geriatrics](http://bmcgeriatr.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bgtc/default.aspx","title":"BMC Geriatrics","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"f2e59195-0030-4e97-a204-386dc5ada54d","owner":[],"postedDate":"January 16th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"in-revision","subjectAreas":[],"tags":[],"updatedAt":"2026-04-09T14:12:05+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-16 09:03:49","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8558120","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8558120","identity":"rs-8558120","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}