Physical Activity Experiment on Male Prostate Cancer Patients

Study Overview
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Brief Summary
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Prostate cancer is the most common cancer in France (56,841 cases in 2012). Although the benefits of physical activity (PA) in cancer patients are currently well established in the scientific literature, several studies have shown that this population is not sufficiently active. Strengthen patient adherence to prevention counseling by the physical activity (PA) is emerging as a new challenge for personalized treatment in oncology. In order to encourage the engagement and maintenance in a regular PA of cancer patients, first, their experiences of physical activity (PA) practice should be considered and their initial social representations of the practice considered. Secondarily, it is also important to identify health professionals who retain a key role in defining the framework, objectives and means of action to promote lifestyle changes towards a more active lifestyle. In addition, peer mentoring appears to offer promising perspectives for promoting adherence and long-term maintenance in physical activity (PA) of cancer patients.

Detailed Description
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The main objective of this project is to measure the adherence of prostate cancer patients to a physical activity program with a tracking of the motivation by a pair.

Official Title
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Physical Activity Experiment on Male Prostate Cancer Patients : Feasibility Multicenter Study of an Innovative Follow-up by Peers

Conditions
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Cancer Prostate

Intervention / Treatment
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* Diagnostic Test: interview
* Diagnostic Test: Adult Physical Activity Questionnaire (APAQ)
* Device: Activity actigraph
* Other: Peer training
* Other: Physical Activity Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patient in step1, 2 and 3: Major patient followed for prostate cancer: located or locally advanced, metastatic and / or resistant to castration and chemotherapy. Cancer diagnosed at least 1 year ago Patient affiliated or beneficiary to social security Signed informed consent. In more, step 2 = Patient with Physical Activity for at least 1 year Exclusion Criteria: For step 1= In the course of cancer treatment (excluding hormonal therapy) For step 2= Patient in sedentary lifestyle For step 3= In the course of cancer treatment (excluding hormonal therapy) Cardiac or respiratory conditions contraindicating physical activity

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is composed of 3 dependent steps.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: STEP 1: Patient with prostate cancer<br>First, patients with prostate cancer will be included during step 1. They will have an interview. | Diagnostic Test: interview<br>* The goal is to evaluate the needs, the constraints and representations of patients on the practice of physical activity.<br>|
| Other: STEP 2: Patient with prostate cancer and a physical activity<br>Secondly, patient with prostate cancer and a physical activity will be included during step 2. They are called peer. They will have a questionnaire Adult Physical Activity Questionnaire (APAQ), an activity actigraph and a peer training. The peer will help patients to realize the Physical Activity Program during step 3. | Diagnostic Test: Adult Physical Activity Questionnaire (APAQ)<br>* The goal of this questionnaire is to evaluate the sedentary lifestyle of patients.<br>Device: Activity actigraph<br>* An activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients.<br>Other: Peer training<br>* The goal of the peer training will organize once a week for 3 weeks for a patient. After this training, they will have : Skills in physical activity advice Knowledge of functional signs (symptoms) Knowledge to examine heart rate and perceived effort rate<br>|
| Other: STEP 3: Physical Activity Program<br>Finally, patients with prostate cancer (different from step 1) and who agrees to participate at the Physical Activity Program will be included during step 3. They will have an activity actigraph and a questionnaire Adult Physical Activity Questionnaire (APAQ) at inclusion and 3 months later. They will receive the Physical Activity Program. | Diagnostic Test: Adult Physical Activity Questionnaire (APAQ)<br>* The goal of this questionnaire is to evaluate the sedentary lifestyle of patients.<br>Device: Activity actigraph<br>* An activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients.<br>Other: Physical Activity Program<br>* During the Physical Activity Program, patients will be supervised by peers and a clubs and sports associations labeled sport-health by Olympic and Sports Committee of the Loire Department. The peer will coach the patient once a week minimum for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity sessions performed | Analysis of the proportion (%) of Physical Activity sessions performed after 3 months of intervention. | At month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity via activity actigraph | Assessment of physical activity via activity actigraph | At month 3 | 
| sedentary lifestyle via activity actigraph | Assessment of sedentary lifestyle via activity actigraph | At month 3 | 
| Patient's activation | Measure patient's activation via questionnaire Patient Activation Measure (PAM). | At month 3 | 
| brakes blocking intervention | Identification of brakes blocking intervention via interviews and Adult Physical Activity Questionnaire (APAQ). APAQ measures the sleeping time (h/night), sedentary time (h/week) and physical activity time (h/day) | At month 3 | 
| levers favoring intervention | Identification of levers favoring intervention via interviews and Adult Physical Activity Questionnaire (APAQ). APAQ measures the sleeping time (h/night), sedentary time (h/week) and physical activity time (h/day) | At month 3 | 
| Peers mobilized | Number of peers mobilized | At month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Physical activity, Activity actigraph, Peer, Program, Sports medicine