Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer.
FRAGECO
2 other identifiers
interventional
106
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2025
CompletedFirst Posted
Study publicly available on registry
July 18, 2025
CompletedStudy Start
First participant enrolled
December 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
December 9, 2025
December 1, 2025
1.7 years
July 10, 2025
December 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient frailty
Frailty will be measured using the walking distance (in metres) achieved during the 6-minute walk test (6MWT) 6 months after the patient's inclusion.
Day : 1 and Month : 6
Secondary Outcomes (11)
Cumulative Illness Rating Scale for Geriatrics (CIRS-G)
Months : 1, 2, 3 and 6
Fried's frailty phenotype (FP)
Months : 1, 2, 3 and 6
level of physical activity
Months : 1, 2, 3 and 6
level of sedentary lifestyle
Months : 1, 2, 3 and 6
Nutritional status
Months : 1, 2, 3 and 6
- +6 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONThe 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.
Interventional group
EXPERIMENTALThe 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.
Interventions
2 adapted physical activity (APA) sessions per week for 4 weeks before and after 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 session per week.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chu Saint-Etienne
Saint-Etienne, 42055, France
Hôpital privé de la Loire
Saint-Etienne, 42100, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David HUPIN, MD
CHU de Saint Etienne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2025
First Posted
July 18, 2025
Study Start
December 3, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
December 9, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share