Physical Activity Experiment on Male Prostate Cancer Patients (ACTI_PAIR)

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer Prostate
• Intervention / Treatment: Diagnostic test: interview; Diagnostic test: Adult Physical Activity Questionnaire (APAQ); Device: Activity actigraph; Other: Peer training; Other: Physical Activity Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David HUPIN, MD; Phone Number: +33 (0)477127985; Email: david.hupin@chu-st-etienne.fr
• Study Contact Backup: Name: Amandine BAUDOT, CRA; Phone Number: +33 (0)477120285; Email: amandine.baudot@chu-st-etienne.fr

Study Locations

• France
  • Saint-Priest-en-Jarez, France
    • ICLN - département de radiothérapie
  • Saint-Priest-en-Jarez, France
    • ICLN - Oncologie médicale
  • Saint-Étienne, France
    • Chu Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: STEP 1: Patient with prostate cancer; First, patients with prostate cancer will be included during step 1. They will have an interview.	Diagnostic test: interview; The goal is to evaluate the needs, the constraints and representations of patients on the practice of physical activity.
OTHER: STEP 2: Patient with prostate cancer and a physical activity; 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); The goal of this questionnaire is to evaluate the sedentary lifestyle of patients.; Device: Activity actigraph; An activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients.; Other: Peer training; 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
OTHER: STEP 3: Physical Activity Program; 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); The goal of this questionnaire is to evaluate the sedentary lifestyle of patients.; Device: Activity actigraph; An activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients.; Other: Physical Activity Program; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: National Cancer Institute, France

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 2, 2018
• Primary Completion (ACTUAL): September 14, 2021
• Study Completion (ACTUAL): September 14, 2021

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (ACTUAL): March 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Prostate cancer; Physical activity; Peer; Program; Activity actigraph; Sports medicine
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 18CH034; 2018-A00710-55 (OTHER: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No