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Physical Activity Experiment on Male Prostate Cancer Patients (ACTI_PAIR)

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ClinicalTrials.gov Identifier: NCT03866785
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Cancer Prostate Diagnostic Test: interview Diagnostic Test: Adult Physical Activity Questionnaire (APAQ) Device: Activity actigraph Other: Peer training Other: Physical Activity Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is composed of 3 dependent steps.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Physical Activity Experiment on Male Prostate Cancer Patients : Feasibility Multicenter Study of an Innovative Follow-up by Peers
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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.





Primary Outcome Measures :
  1. Physical Activity sessions performed [ Time Frame: At month 3 ]
    Analysis of the proportion (%) of Physical Activity sessions performed after 3 months of intervention.


Secondary Outcome Measures :
  1. physical activity via activity actigraph [ Time Frame: At month 3 ]
    Assessment of physical activity via activity actigraph

  2. sedentary lifestyle via activity actigraph [ Time Frame: At month 3 ]
    Assessment of sedentary lifestyle via activity actigraph

  3. brakes blocking intervention [ Time Frame: At month 3 ]
    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)

  4. levers favoring intervention [ Time Frame: At month 3 ]
    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)

  5. Peers mobilized [ Time Frame: At month 3 ]
    Number of peers mobilized



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  • Patient who was included in step 1
  • Contraindication to the practice of sport

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866785


Contacts
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Contact: David HUPIN, MD (0)477127985 ext +33 David.Hupin@chu-st-etienne.fr
Contact: Arnauld GARCIN, CRA (0)477120286 ext +33 Arnauld.Garcin@chu-st-etienne.fr

Locations
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France
ICLN - département de radiothérapie Not yet recruiting
Saint-Priest-en-Jarez, France
Principal Investigator: Julien LANGRAND-ESCURE, MD         
Sub-Investigator: Grégoire PIGNE, MD         
Sub-Investigator: Alexis VALLARD, MD         
ICLN - Oncologie médicale Not yet recruiting
Saint-Priest-en-Jarez, France
Principal Investigator: Cécile VASSAL, MD         
Sub-Investigator: Mathieu ORIOL, MD         
Sub-Investigator: Aline GUILLOT, MD         
Sub-Investigator: Benoîte MERY, MD         
CHU Saint-Etienne Recruiting
Saint-Étienne, France
Principal Investigator: David HUPIN, MD         
Sub-Investigator: Nicolas MOTTET, PhD         
Sub-Investigator: Hocine HABCHI, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
National Cancer Institute, France
Investigators
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Principal Investigator: David HUPIN, MD CHU Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03866785     History of Changes
Other Study ID Numbers: 18CH034
2018-A00710-55 ( Other Identifier: ANSM )
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Prostate cancer
Physical activity
Activity actigraph
Peer
Program
Sports medicine

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases