Personalized 6-month program to reduce frailty around bladder or kidney cancer surgery
Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer - FRAGECO - Multicenter, Controlled, Randomized Study
This program will try personalized exercise, education workshops, and referral to a rehabilitation service before and after surgery to reduce frailty in older people having bladder or kidney cancer operations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 2 sites (Saint-Etienne and 1 other locations) |
| Trial ID | NCT07073703 on ClinicalTrials.gov |
What this trial studies
Older adults with bladder or kidney cancer who are scheduled for surgical treatment will be offered a tailored 6-month program delivered partly before and after surgery. The program combines adapted physical activity sessions, therapeutic education workshops, and systematic referral to the hospital's DAPAP rehabilitation service. Participation is limited to patients without severe cognitive impairment or contraindications to exercise, and who have not already had surgery or private prehabilitation. Outcomes will focus on changes in physical conditioning, frailty markers, postoperative complications, and nutritional status over the intervention period.
Who should consider this trial
Good fit: Ideal candidates are older adults diagnosed with bladder or kidney cancer who are planned for surgery, can follow exercise and educational sessions, have no major cardiac/respiratory or joint contraindications, and can provide informed consent.
Not a fit: Patients who have already undergone surgery, those with medical contraindications to physical activity, people under guardianship or deprived of liberty, or those already receiving private prehabilitation are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could reduce frailty and postoperative complications, improve physical fitness and nutrition, and speed recovery after bladder or kidney cancer surgery.
How similar studies have performed: Prehabilitation and exercise-based programs have shown benefit in reducing complications and improving fitness in older surgical cancer patients, though the exact combination of APA, education, and DAPAP referral in this format is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Saint-Etienne and 1 other locations
- Chu Saint-Etienne — Saint-Etienne, France (Recruiting)
- Hôpital privé de la Loire — Saint-Etienne, France (Not_yet_recruiting)
Study contacts
- Principal investigator: David HUPIN, MD — CHU de Saint Etienne
- Study coordinator: Evolène FAYOLLE, student
- Email: evolene.fayolle@chu-st-etienne.fr
- Phone: (0)4 77 12 78 35
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.