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Bladder (Urothelial, Transitional Cell) CancerFRAGECONCT07073703

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

A study testing APA, Therapeutic education workshops and DAPAP in people with Bladder (Urothelial, Transitional Cell) Cancer and Kidney (Renal Cell) Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
APA, Therapeutic education workshops and DAPAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
2 sitesFrance
Study dates
3 Dec 2025to Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Evolène FAYOLLE, student contact

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

evolene.fayolle@chu-st-etienne.fr

Amandine BAUDOT, Project Manager contact

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

amandine.baudot@chu-st-etienne.fr

France2 sites, 2 recruiting

  • Chu Saint-Etienne

    Saint-Etienne, 42055

    David HUPIN, MD, (0)477828413 ext. +33, david.hupin@chu-st-etienne.fr

    Anne-Françoise CHANELIERE, MD

    Recruiting

  • Hôpital privé de la Loire

    Saint-Etienne, 42100

    Emilie FAVIER, MD, (0)4 77 42 29 59 ext. +33, david.hupin@chu-st-etienne.fr

    Emilie FAVIER, MD

    Not yet recruiting

Other trials in France

About this study

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

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.

Being tested
APA, Therapeutic education workshops, DAPAP
Keywords
Exercise, Older people, Cancer, Bladder, Kidney, Frailty, Surgery
Medical subject headings
Neoplasms, Carcinoma, Renal Cell, Motor Activity, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APAProcedure or surgery

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

  • Therapeutic education workshopsBehavioural

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

  • DAPAPProcedure or surgery

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

Study groups in NCT07073703
Study groupRoleWhat they receive
Control groupNo 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 groupExperimentalThe 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.
Receives: Procedure: APA; Behavioral: Therapeutic education workshops; Procedure: DAPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day : 1 and Month : 6

Secondary outcomes (11)

  1. Cumulative Illness Rating Scale for Geriatrics (CIRS-G)

    The CIRS (Cumulative Illness Rating Scale) score provides a relevant comparison of the medical burden and treatment outcomes in geriatric patients with variable and complex pathologies.

    The score ranges from 0: no problem to 4: very serious problem.

    Measured: Months : 1, 2, 3 and 6

  2. Fried's frailty phenotype (FP)

    Frailty will be measured using Fried's frailty phenotype (FP), defined by exhaustion (EX), unexplained weight loss (WL), weakness (WK), sluggishness (SL) and low physical activity (LA). Three or more components define the frailty state, and one or two the pre-fragility state.

    Measured: Months : 1, 2, 3 and 6

  3. level of physical activity

    Objective measures of PA (in MET-hours/week) via accelerometry (Actigraph GT3x, Pensacola, Florida, USA) and subjective measurements of PA (in METhours/week) using the e-Adult Physical Activity Questionnaire (EA SNA-EPIS, Université Jean Monnet, Saint-Etienne, France).

    Measured: Months : 1, 2, 3 and 6

  4. level of sedentary lifestyle

    Objective measures of sedentary time (in h/d) via accelerometry (Actigraph GT3x, Pensacola, Florida, USA) and subjective measurements of sedentary behaviour (in hours/day) using the e-Adult Physical Activity Questionnaire (EA SNA-EPIS, Université Jean Monnet, Saint-Etienne, France).

    Measured: Months : 1, 2, 3 and 6

  5. Nutritional status

    With the Mini Nutritional Assessment (MNA) and albumin analysis in g/l, a level <35g/l: undernutrition, <30g/l: severe undernutrition.

    Measured: Months : 1, 2, 3 and 6

  6. Memory

    Mini-Mental State Examination (MMSE), which consists of 30 questions and is scored out of 30. The severity of memory impairment is considered mild if the score is above 20, moderate if the score is between 10 and 20, and severe if the score is below 10.

    Measured: Months : 1, 2, 3 and 6

  7. Healthy quality of life

    With the EORTC-QLC30 version 3. This 30-item questionnaire assesses 15 dimensions of quality of life (5 functional scales: physical, cognitive, social, emotional or psychological and limitations in daily activities; 1 global health/quality of life scale; 9 symptom scales: fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation and diarrhea, financial problems related to the disease).

    Measured: Months : 1, 2, 3 and 6

  8. Fatigue

    With the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F). The questionnaire consists of 13 questions, each of which corresponds to a Likert scale ranging from 0 to 4 (0 = not at all, 4 = very much). A score is obtained out of 52, with the higher the score, the less fatigued the patient is.

    Measured: Months : 1, 2, 3 and 6

  9. Depression

    Using the Mini Geriatric Depression Scale (GDS) to 4 questions. If the score is greater than 1: high probability of depression, if the score is 0: high probability of no depression.

    Measured: Months : 1, 2, 3 and 6

  10. Muscular strength

    Muscle strength (in kilogram) on the handgrip.

    Measured: Months : 1, 2, 3 and 6

  11. Balance

    Assessed using the time (in seconds) taken to complete the Timed Up and Go (TUG). A time ≥ 20 seconds is associated with a risk of falling.

    Measured: Months : 1, 2, 3 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2025
  2. Study start3 Dec 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07073703
Sponsor's protocol ID
24CH124
Other IDs
2024-A01991-46
Acronym
FRAGECO
Status last verified
Dec 2025
First submitted
10 Jul 2025
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fayolle E, Baudot A, Chaneliere-Sauvant AF, Favier E, Rambaud F, Torche F, Celarier T, Hupin D. Effectiveness of a personalised 6-month programme on physical frailty in older patients treated for bladder or kidney cancer - FRAGECO program - multicenter, controlled, randomized study protocol. BMC Geriatr. 2026 Jun 12. doi: 10.1186/s12877-026-07821-z. Online ahead of print.

    PubMed 42286520

Questions about this trial

What is this clinical trial studying?

A study testing APA, Therapeutic education workshops and DAPAP in people with Bladder (Urothelial, Transitional Cell) Cancer and Kidney (Renal Cell) Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Evolène FAYOLLE, student ((0)4 77 12 78 35 ext. +33, evolene.fayolle@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient frailty (time frame: Day : 1 and Month : 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07073703, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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