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NCT Number: NCT07073703

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

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.

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Key information

Conditions

Bladder (Urothelial, Transitional Cell) Cancer Adenocarcinoma Behavior Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Kidney (Renal Cell) Cancer Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne, Saint-Etienne, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APA

Procedure

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

Therapeutic education workshops

Behavioral

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

DAPAP

Procedure

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

Primary outcomes

  1. Patient frailty

    Time frame: Day : 1 and Month : 6

    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.

Secondary outcomes

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

    Time frame: Months : 1, 2, 3 and 6

    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.

  2. Fried's frailty phenotype (FP)

    Time frame: Months : 1, 2, 3 and 6

    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.

  3. level of physical activity

    Time frame: Months : 1, 2, 3 and 6

    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).

  4. level of sedentary lifestyle

    Time frame: Months : 1, 2, 3 and 6

    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).

  5. Nutritional status

    Time frame: Months : 1, 2, 3 and 6

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

  6. Memory

    Time frame: Months : 1, 2, 3 and 6

    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.

  7. Healthy quality of life

    Time frame: Months : 1, 2, 3 and 6

    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).

  8. Fatigue

    Time frame: Months : 1, 2, 3 and 6

    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.

  9. Depression

    Time frame: Months : 1, 2, 3 and 6

    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.

  10. Muscular strength

    Time frame: Months : 1, 2, 3 and 6

    Muscle strength (in kilogram) on the handgrip.

  11. Balance

    Time frame: Months : 1, 2, 3 and 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amandine BAUDOT, Project Manager

CONTACT

[email protected]

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

Evolène FAYOLLE, student

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: FRAGECO

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 18, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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