Actively Recruiting
Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer FRAGECO Multicenter Controlled Randomized Study
Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2025-12-09
106
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bladder and kidney cancers are often diagnosed in older adults, and surgery is the main treatment for these patients. Older individuals frequently face challenges such as fatigue, reduced fitness, muscle loss, pain from disease or treatment, and poor nutrition, which increase the risk of complications and frailty after surgery. Researchers are evaluating a personalized 6-month program designed to reduce frailty in older patients undergoing surgery for bladder or kidney cancer. The study compares two groups: a control group receiving standard care, which includes assessment by an oncogeriatrician followed by surgery and rehabilitation, and an interventional group receiving standard care plus a customized program. This program involves two adapted physical activity sessions per week for four weeks before and after surgery, therapeutic education workshops addressing physical activity, nutrition, treatments, fatigue, and relaxation, and a referral to a 12-week bridge program with weekly physical activity sessions. Participants will be monitored through questionnaires and physical assessments at baseline, and at 1, 2, 3, and 6 months. Researchers will measure frailty, illness burden, physical activity levels, nutrition, memory, quality of life, fatigue, depression, muscle strength, and balance. The study includes safety follow-up and aims to evaluate patient frailty from day 1 to month 6 after surgery, with total participation lasting six months.
CONDITIONS
Brief Title
Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of bladder or kidney cancer
- Scheduled for surgical treatment
- No severe cognitive impairment preventing understanding of the protocol
- Affiliated or entitled to a social security scheme
- Provided informed consent to participate in the study
You will not qualify if you...
- Surgery already done
- Significant co-morbidities contraindicating physical activity such as cardiac, respiratory, or disabling joint conditions
- Deprived of liberty or under guardianship
- Currently receiving prehabilitation with a private physiotherapist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants in the interventional group attend 2 adapted physical activity (APA) sessions per week for 4 weeks before surgery.
2 sessions per week
Duration - 6 months
Participants undergo surgery followed by a personalized 6-month care pathway including 2 APA sessions per week for 4 weeks post-surgery, therapeutic education workshops tailored to individual needs, and a 12-week bridge program with one APA session per week.
2 APA sessions per week for 4 weeks post-surgery, therapeutic education workshops as scheduled, and 1 APA session per week for 12 weeks during the bridge program
Duration - 6 months
Participants complete follow-up assessments including questionnaires and physical assessments at baseline, 1, 2, 3, and 6 months.
Visits at baseline, 1, 2, 3, and 6 months
Trial Site Locations
Total: 2 locations
1
Chu Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
2
Hôpital privé de la Loire
Saint-Etienne, France, 42100
Not Yet Recruiting
Research Team
E
Evolène FAYOLLE, student
A
Amandine BAUDOT, Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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