Title Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients - ACTI-PAIR 2 Multicenter, Randomized Stepped-wedge Study

Centre Hospitalier Universitaire de Saint Etienne25 sites in 1 country850 target enrollmentApril 25, 2023

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Enrollment: 850
Locations: 25
Primary Endpoint: Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures the intensity of physical activity)
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Despite the recognized benefits of physical activity in tertiary prevention, 60-70% of prostate cancer patients are insufficiently active.

Yet 150 minutes of brisk walking per week (new WHO recommendations) is associated with a 29% reduction in cancer mortality and a 57% reduction in recurrence.

Increasing patients' adherence to regular physical activity appears to be a new challenge for personalized cancer care.

Personalized physical activity programmes (1) at home, (2) supported by health professionals, or (3) by peers have shown the effectiveness of regular physical activity.

However, these interventions last less than 6 months and do not allow for long-term sustainability of physical activity.

This study proposes to combine 3 interventions, which aim to initiate and maintain regular physical activity in prostate cancer patients:

1-The realization of a personalized and realistic physical activity project via physical activity support devices (sport health centers)
2-Coaching by a peer (a patient with the same disease who has reached the WHO recommendations for physical activity), who will provide motivational follow-up
3-Support by health professionals (attending physician) through the prescription of physical activity.

The feasibility of ACTI-PAIR program has been demonstrated, the investigators now wish to evaluate it effectiveness.

Registry

clinicaltrials.gov

Start Date

April 25, 2023

End Date

September 30, 2028

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years
•Diagnosed with prostate cancer for at least 1 year
•PA practice \< 150 minutes per week (considered inactive according to WHO)
•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

•For patients:
•Undergoing treatment (except hormone therapy)
•Significant comorbidities contraindicating the practice of physical activity: associated cardiac pathologies, respiratory pathologies, disabling joint pathologies
•Deprived of liberty or under guardianship

Outcomes

Primary Outcomes

Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures the intensity of physical activity)

Time Frame: Month: 12

via actimetry (Actigraph GT9x, Pensacola, Florida, USA) 12 months (+/- 1 month) after the patient's inclusion in the Acti-Pair program

Secondary Outcomes

Level of fatigue assessed by measuring heart rate variability (SDNN and RMSSD in ms)(Inclusion, 3, 6 and 12 months)
Measurement of muscle strength: biceps muscle strength (kg)(Inclusion, 3, 6 and 12 months)
Percentage of adherence to the intervention(12 months)
Measurement of physical capacity: walking distance (meters)(Inclusion, 3, 6 and 12 months)
Health-related quality of life(Inclusion, 3, 6 and 12 months)
Adoption of Acti-Pair program by physicians(through end of inclusion, an average of 30 months)
Subjective measurement of physical activity (in Metabolic equivalent of task-h/week) and sedentary time (h/d)(Inclusion, 3, 6 and 12 months)
Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures intensity of physical activity)(Inclusion, 3, 6 and 12 months)
Objective measure of physical inactivity (in h/d)(Inclusion, 3, 6 and 12 months)
Adoption of Acti-Pair program by Adapted Physical Activity (APA) professionals(through study completion, an average of 42 Months)
Assessment of the context:factors favoring and hindering implementation, achievement, adaptation and sustainability of the programme ; compliance with the programme ; social representations(Before and after the implementation of the intervention)
Cost per quality adjusted life year (QALY) gained through the intervention (quality adjusted life year)(12 months)
Level of fatigue(Inclusion, 3, 6 and 12 months)
Adoption of Acti-Pair program by peers(through end of inclusion, an average of 30 months)
Time dedicated by peers, Adapted Physical Activity (APA) professionals and health professionals to the Acti-Pair program(through study completion, an average of 42 Months)
Alliance between the patient and the peer(12 months)
Patients, peers and professionals satisfaction(12 months)
Motivation to engage in physical activity for patients and peers(Inclusion, 3, 6 and 12 months)
Cost per patient continuing physical activity at 12 months through the intervention(12 months)