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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • APA

    Procedure/Surgery

    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/Surgery

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

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Interventional groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
Day : 1 and Month : 6

Secondary outcomes

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.

Time frame
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.

Time frame
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).

Time frame
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).

Time frame
Months : 1, 2, 3 and 6

Other outcomes

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