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Physical Activity Experiment on Male Prostate Cancer Patients (ACTI_PAIR)

Primary Purpose

Cancer Prostate

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
interview
Adult Physical Activity Questionnaire (APAQ)
Activity actigraph
Peer training
Physical Activity Program
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Prostate focused on measuring Prostate cancer, Physical activity, Activity actigraph, Peer, Program, Sports medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • ICLN - département de radiothérapie
  • ICLN - Oncologie médicale
  • CHU Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

STEP 1: Patient with prostate cancer

STEP 2: Patient with prostate cancer and a physical activity

STEP 3: Physical Activity Program

Arm Description

First, patients with prostate cancer will be included during step 1. They will have an interview.

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.

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.

Outcomes

Primary Outcome Measures

Physical Activity sessions performed
Analysis of the proportion (%) of Physical Activity sessions performed after 3 months of intervention.

Secondary Outcome Measures

physical activity via activity actigraph
Assessment of physical activity via activity actigraph
sedentary lifestyle via activity actigraph
Assessment of sedentary lifestyle via activity actigraph
Patient's activation
Measure patient's activation via questionnaire Patient Activation Measure (PAM).
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)
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)
Peers mobilized
Number of peers mobilized

Full Information

First Posted
October 22, 2018
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
National Cancer Institute, France
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1. Study Identification

Unique Protocol Identification Number
NCT03866785
Brief Title
Physical Activity Experiment on Male Prostate Cancer Patients
Acronym
ACTI_PAIR
Official Title
Physical Activity Experiment on Male Prostate Cancer Patients : Feasibility Multicenter Study of an Innovative Follow-up by Peers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
September 14, 2021 (Actual)
Study Completion Date
September 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
National Cancer Institute, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Prostate
Keywords
Prostate cancer, Physical activity, Activity actigraph, Peer, Program, Sports medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is composed of 3 dependent steps.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STEP 1: Patient with prostate cancer
Arm Type
Other
Arm Description
First, patients with prostate cancer will be included during step 1. They will have an interview.
Arm Title
STEP 2: Patient with prostate cancer and a physical activity
Arm Type
Other
Arm Description
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.
Arm Title
STEP 3: Physical Activity Program
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
interview
Intervention Description
The goal is to evaluate the needs, the constraints and representations of patients on the practice of physical activity.
Intervention Type
Diagnostic Test
Intervention Name(s)
Adult Physical Activity Questionnaire (APAQ)
Intervention Description
The goal of this questionnaire is to evaluate the sedentary lifestyle of patients.
Intervention Type
Device
Intervention Name(s)
Activity actigraph
Intervention Description
An activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients.
Intervention Type
Other
Intervention Name(s)
Peer training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Physical Activity Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Activity sessions performed
Description
Analysis of the proportion (%) of Physical Activity sessions performed after 3 months of intervention.
Time Frame
At month 3
Secondary Outcome Measure Information:
Title
physical activity via activity actigraph
Description
Assessment of physical activity via activity actigraph
Time Frame
At month 3
Title
sedentary lifestyle via activity actigraph
Description
Assessment of sedentary lifestyle via activity actigraph
Time Frame
At month 3
Title
Patient's activation
Description
Measure patient's activation via questionnaire Patient Activation Measure (PAM).
Time Frame
At month 3
Title
brakes blocking intervention
Description
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)
Time Frame
At month 3
Title
levers favoring intervention
Description
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)
Time Frame
At month 3
Title
Peers mobilized
Description
Number of peers mobilized
Time Frame
At month 3

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David HUPIN, MD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICLN - département de radiothérapie
City
Saint-Priest-en-Jarez
Country
France
Facility Name
ICLN - Oncologie médicale
City
Saint-Priest-en-Jarez
Country
France
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Activity Experiment on Male Prostate Cancer Patients

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