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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07073703
Acronym
FRAGECO
Enrollment
106
Registered
2025-07-18
Start date
2025-12-03
Completion date
2028-03-31
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Exercise, Older people, Cancer, Bladder, Kidney, Frailty, Surgery

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.

Interventions

PROCEDUREAPA

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

BEHAVIORALTherapeutic education workshops

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

PROCEDUREDAPAP

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient frailtyDay : 1 and Month : 6Frailty will be measured using the walking distance (in metres) achieved during the 6-minute walk test (6MWT) 6 months after the patient's inclusion.

Secondary

MeasureTime frameDescription
Fried's frailty phenotype (FP)Months : 1, 2, 3 and 6Frailty 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.
level of physical activityMonths : 1, 2, 3 and 6Objective 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).
level of sedentary lifestyleMonths : 1, 2, 3 and 6Objective 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).
Nutritional statusMonths : 1, 2, 3 and 6With the Mini Nutritional Assessment (MNA) and albumin analysis in g/l, a level \<35g/l: undernutrition, \<30g/l: severe undernutrition.
MemoryMonths : 1, 2, 3 and 6Mini-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.
Cumulative Illness Rating Scale for Geriatrics (CIRS-G)Months : 1, 2, 3 and 6The 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.
FatigueMonths : 1, 2, 3 and 6With 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.
DepressionMonths : 1, 2, 3 and 6Using 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.
Muscular strengthMonths : 1, 2, 3 and 6Muscle strength (in kilogram) on the handgrip.
BalanceMonths : 1, 2, 3 and 6Assessed 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.
Healthy quality of lifeMonths : 1, 2, 3 and 6With 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).

Countries

France

Contacts

Primary ContactEvolène FAYOLLE, student
evolene.fayolle@chu-st-etienne.fr(0)4 77 12 78 35
Backup ContactAmandine BAUDOT, Project Manager
amandine.baudot@chu-st-etienne.fr(0)4 77 82 94 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026