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Studies

Interventional Recruiting

NCT07073703 on ClinicalTrials.gov

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

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

  • Sponsor: Centre Hospitalier Universitaire de Saint-Etienne
  • Enrollment: 106 (Estimated)
  • Study start: 2025-12-03 (Actual)
  • Primary completion: 2027-09-01 (Estimated)
  • Study completion: 2028-03-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

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.

Conditions

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

Intervention / Treatment

  • Procedure: APA
  • Behavioral: Therapeutic education workshops
  • Procedure: DAPAP

Primary Outcome Measures

  • Patient frailty (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.

Countries

France

Locations and Investigators

  • Chu Saint-Etienne, Saint-Etienne, France (Recruiting)
    • David HUPIN, MD
    • Anne-Françoise CHANELIERE, MD (Principal Investigator)
    • Evolène FAYOLLE, Student
  • Hôpital privé de la Loire, Saint-Etienne, France (Not yet recruiting)
    • Emilie FAVIER, MD
    • Emilie FAVIER, MD (Principal Investigator)

Study Officials