Clinical trial · Interventional
Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer.
Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer - FRAGECO - Multicenter, Controlled, Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bladder and kidney cancers are commonly diagnosed in older adults. Surgery remains the primary treatment modality for patients with kidney or bladder cancer. In older patients, common co-morbidities include fatigue, physical deconditioning characterized by reduced cardiorespiratory fitness and progressing sarcopenia, pain- whether disease- related or treatment-induced- and undernutrition. These factors increased the risk of post-operative complications and exacerbate patient frailty. The investigators propose a personalized 6-month program both pre- and post-surgery, including adapted physical activity sessions, therapeutic education workshops, and systematic referral to the department's DAPAP program.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder (Urothelial, Transitional Cell) Cancer | — | UNRESOLVED | — |
| Kidney (Renal Cell) Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APA | Procedure | — | UNRESOLVED |
| DAPAP | Procedure | — | UNRESOLVED |
| Therapeutic education workshops | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- The control group will consist of patients with bladder or kidney cancer receiving standard care, which includes a comprehensive assessment by an oncogeriatrician followed by surgery approximately 4 weeks later. Postoperatively, patients will be transferred to a rehabilitation center (SSR) for recovery, in line with standard clinical practice. As part of the study protocol, control group patients 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-will mirror those of the intervention group. They will include patients- completed questionnaires and physical assessments conducted by an adapted physical activity teacher.
- type
- EXPERIMENTAL
- label
- Interventional group
- description
- The interventional group will consist of bladder and kidney cancer patients who will follow a personalized 6-month care pathway in addition to standard care. This pathway includes: * 2 adapted physical activity (APA) sessions per week for 4 weeks prior to surgery * 2 APA sessions/ week for 4 weeks following surgery * Therapeutic education workshops tailored to individual needs, covering topics as physical activity, nutrition, treatments, fatigue, and relaxation * Referral to the department's DAPAP for a 12-week "bridge program", consisting of one APA session per week. The study will be conducted in the oncogeriatrics departments of Saint-Etienne University Hospital and Loire Private Hospital.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of bladder or kidney cancer * Surgical treatment * No severe cognitive impairment preventing understanding of the protocol * Affiliated or entitled to a social security scheme * Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study Exclusion Criteria: * Surgery already done * Significant co-morbidities that contraindicate physical activity: associated cardiac pathologies, respiratory pathologies, disabling joint pathologies, etc. * Deprived of liberty or under guardianship * Benefiting from a prehabilitation prescription with a private physiotherapist.
References
Publications (1)
- DERIVEDFayolle E, Baudot A, Chaneliere-Sauvant AF, Favier E, Rambaud F, Torche F, Celarier T, Hupin D. Effectiveness of a personalised 6-month programme on physical frailty in older patients treated for bladder or kidney cancer - FRAGECO program - multicenter, controlled, randomized study protocol. BMC Geriatr. 2026 Jun 12. doi: 10.1186/s12877-026-07821-z. Online ahead of print. PMID 42286520