Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer - FRAGECO - Multicenter, Controlled, Randomized Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Saint-Etienne
RECRUITING
Saint-etienne
Hôpital privé de la Loire
NOT_YET_RECRUITING
Saint-etienne
Contact Information
Primary
Evolène FAYOLLE, student
evolene.fayolle@chu-st-etienne.fr
(0)4 77 12 78 35
Backup
Amandine BAUDOT, Project Manager
amandine.baudot@chu-st-etienne.fr
(0)4 77 82 94 50
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2028-03
Participants
Target number of participants: 106
Treatments
No_intervention: Control group
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.
Experimental: Interventional group
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.
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne

This content was sourced from clinicaltrials.gov