Effectiveness of a Personalized 6-month Programme on Frailty in Older Patients Treated for Bladder or Kidney Cancer. (FRAGECO)

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Bladder (Urothelial, Transitional Cell) Cancer; Kidney (Renal Cell) Cancer

Treatments: Behavioral: Therapeutic education workshops; Procedure: DAPAP; Procedure: APA

Study type: Interventional

Funder types: Other

Identifiers

NCT07073703

24CH124

2024-A01991-46 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Control group

No Intervention 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.

Interventional group

Experimental 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.

Treatment:

Procedure: APA

Procedure: DAPAP

Behavioral: Therapeutic education workshops