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

NCT ID: NCT07073703

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-03

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bladder (Urothelial, Transitional Cell) Cancer Kidney (Renal Cell) Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

APA

Intervention Type PROCEDURE

2 adapted physical activity (APA) sessions per week for 4 weeks before and after surgery

Therapeutic education workshops

Intervention Type BEHAVIORAL

Therapeutic education workshops tailored to individual needs, covering topics as physical activity, nutrition, treatments, fatigue, and relaxation.

DAPAP

Intervention Type PROCEDURE

Referral to the department's DAPAP for a 12-week "bridge program", consisting of one session per week.

Interventions

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APA

2 adapted physical activity (APA) sessions per week for 4 weeks before and after surgery

Intervention Type PROCEDURE

Therapeutic education workshops

Therapeutic education workshops tailored to individual needs, covering topics as physical activity, nutrition, treatments, fatigue, and relaxation.

Intervention Type BEHAVIORAL

DAPAP

Referral to the department's DAPAP for a 12-week "bridge program", consisting of one session per week.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David HUPIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Hôpital privé de la Loire

Saint-Etienne, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Evolène FAYOLLE, student

Role: CONTACT

(0)4 77 12 78 35 ext. +33

Amandine BAUDOT, Project Manager

Role: CONTACT

(0)4 77 82 94 50 ext. +33

Facility Contacts

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David HUPIN, MD

Role: primary

(0)477828413 ext. +33

Emilie FAVIER, MD

Role: primary

(0)4 77 42 29 59 ext. +33

Other Identifiers

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2024-A01991-46

Identifier Type: OTHER

Identifier Source: secondary_id

24CH124

Identifier Type: -

Identifier Source: org_study_id

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