Impact of a Physical Activity Intervention With Motivational Support From Peers for Prostate Cancer Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Acti-Pair program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acti-Pair program<br>Motivational support by the peer (a patient with the same pathology who meets the WHO recommendations for physical activity), who will provide motivational follow-up The implementation of a personalized and realistic physical activity project for the patient via the physical activity support systems (sport health centers) Support from health professionals (GP) via the prescription of physical activity and from adapted physical activity (APA) professionals | Behavioral: Acti-Pair program<br>* Motivational support by the peer (a patient with the same pathology who meets the WHO recommendations for physical activity), who will provide motivational follow-up The implementation of a personalized and realistic physical activity project for the patient via the physical activity support systems (sport health centers) Support from health professionals (GP) via the prescription of physical activity and from adapted physical activity (APA) professionals<br>|
| No Intervention: Usual care<br>The control group will be made up of patients followed up for prostate cancer and benefiting from usual care which consists of giving advice and recommendations for physical activity in consultation, aiming to make patients more active in their daily lives (=usual practice, physical activity to be carried out independently, at home). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures the intensity of physical activity) | via actimetry (Actigraph GT9x, Pensacola, Florida, USA) 12 months (+/- 1 month) after the patient's inclusion in the Acti-Pair program | Month: 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective measurement of physical activity (in MET-hr/week, Metabolic Equivalent of Task (MET), measures intensity of physical activity) | via actimetry (Actigraph GT9x, Pensacola, Florida, USA) (at 3 and 6 months). | Inclusion, 3, 6 and 12 months | 
| Objective measure of physical inactivity (in h/d) | via actimetry (Actigraph GT9x, Pensacola, Florida, USA) | Inclusion, 3, 6 and 12 months | 
| Subjective measurement of physical activity (in Metabolic equivalent of task-h/week) and sedentary time (h/d) | Via the e-Adult Physical Activity Questionnaire (e-APAQ, EA SNA-EPIS, University of Jean Monnet, Saint-Etienne, France) e-Adult Physical Activity Questionnaire (e-APAQ) assesses the 5 categories of physical activity (work, travel, daily life, leisure and sport) and daily life, leisure and sport). The minimum value is 1 and the maximum value is 300. More the physical activity score is high, more the patient is active. This questionnaire authenticates the periods of sedentarity (at work, during travel and daily life, leisure and sport). The minimum value is 1 and the maximum value is 24. More the sedentarity score is high, more the patient is sedentary. | Inclusion, 3, 6 and 12 months | 
| Measurement of physical capacity: walking distance (meters) | via the 6-minute walk test (6MWT). | Inclusion, 3, 6 and 12 months | 
| Measurement of muscle strength: biceps muscle strength (kg) | via the handgrip (JAMAR Hand Dynamometer, Nottingham, UK). | Inclusion, 3, 6 and 12 months | 
| Level of fatigue assessed by measuring heart rate variability (SDNN and RMSSD in ms) | via heart rate monitor connected to an actimeter (Actigraph GT3x, Pensacola, Florida, USA) for 24 hours | Inclusion, 3, 6 and 12 months | 
| Level of fatigue | via the FACIT-F questionnaire (Functional Assessment of Chronic Illness Therapy - Fatigue Scale). This questionnaire asseses fatigue and it impacts. The score range is 0 to 160. More the score is higher, more the fatigue is high. | Inclusion, 3, 6 and 12 months | 
| Health-related quality of life | via the EuroQol-5D questionnaire (EQ-5D-5L). The score range is -0.148 to 0.949. Mre the score is high, more the quality of life is good. | Inclusion, 3, 6 and 12 months | 
| Adoption of Acti-Pair program by physicians | Number of physicians including patients | through end of inclusion, an average of 30 months | 
| Adoption of Acti-Pair program by peers | Number of peers recruited | through end of inclusion, an average of 30 months | 
| Adoption of Acti-Pair program by Adapted Physical Activity (APA) professionals | Number of patients followed by APA professionals | through study completion, an average of 42 Months | 
| Time dedicated by peers, Adapted Physical Activity (APA) professionals and health professionals to the Acti-Pair program | Number of hours spend to follow-up patient specifically for the Acti-Pair program by peers, Adapted Physical Activity (APA) professionals and health 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 | Semi-structured interviews | Before and after the implementation of the intervention | 
| Percentage of adherence to the intervention | via the number of patients continuing the programme 12 months after initiation | 12 months | 
| Motivation to engage in physical activity for patients and peers | via the behavioural regulation in exercise questionnaire (BREQ-2). This questionnaire consists of 19 items includes 6 sub-scores of motivations : introjected regulation (3 items), external regulation (4 items), intrinsic regulation (4 items), integrated regulation, amotivation (4 items) and identified regulation (4 items) on a scale from 1 (Not at all true for me) to 5 (Absolutely true for me). | Inclusion, 3, 6 and 12 months | 
| Alliance between the patient and the peer | via the Working Alliance Inventory - short version (WAI-SR). This questionnaire measures three dimensions: bonding (development of a positive interpersonal attachment between the patient and the peer including mutual trust and respect), tasks (each partner's perception of the appropriateness and effectiveness of the care tasks, as well as tasks, as well as shared responsibility for their execution) and goals (understanding, validation and acceptance by both partners of the objectives of change in physical activity management). Patients rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The Goal, Task and Bond domains each have scores ranging from 5 to 20. Higher scores indicate a better therapeutic alliance. | 12 months | 
| Patients, peers and professionals satisfaction | Via a satisfaction questionnaire constructed for the Acti-Pair programme. The proposed responses are a likert scale ranging from Strongly Agree to Strongly Disagree. Each item will be described with a percentage of Likert scale for each response. More participants will fill out they have been strongly agree, more they will be satisfied.This questionnaire does not have a score. | 12 months | 
| Cost per quality adjusted life year (QALY) gained through the intervention (quality adjusted life year) | Quality of life data will be collected (e.g. quality of life using the EQ-5D-5L questionnaire, Appendix 3), transformed into utilities to calculate quality adjusted life year (QALY), and the number of patients continuing physical activity at 12 months. Cost data will be collected throughout the study, in each of the 8 departments involved. The analysis will be carried out from the payer's (health insurance) perspective. The time horizon will be that of the study (12 months), and therefore in accordance with French guidelines (HAS), no discount rate will be applied | 12 months | 
| Cost per patient continuing physical activity at 12 months through the intervention | The costs will include : - direct medical costs : health professionals consultations, peer-to-peer, patient sessions with APA professionals - indirect costs of implementing the intervention: training, facility rental operating costs, investment in small equipment | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, prostate cancer, interventional research