Physical Activity Experiment on Male Prostate Cancer Patients

Cancer Prostate Clinical Trial

— ACTI_PAIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03866785
• Other study ID #: 18CH034
• Secondary ID: 2018-A00710-55
• Status: Completed
• Phase: N/A
• Start date: August 2, 2018
• Est. completion date: September 14, 2021

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Prostate
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• interview
The goal is to evaluate the needs, the constraints and representations of patients on the practice of physical activity.
• 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
• 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.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne
France	ICLN - département de radiothérapie	Saint-Priest-en-Jarez
France	ICLN - Oncologie médicale	Saint-Priest-en-Jarez

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity sessions performed	Analysis of the proportion (%) of Physical Activity sessions performed after 3 months of intervention.	At month 3
Secondary	physical activity via activity actigraph	Assessment of physical activity via activity actigraph	At month 3
Secondary	sedentary lifestyle via activity actigraph	Assessment of sedentary lifestyle via activity actigraph	At month 3
Secondary	Patient's activation	Measure patient's activation via questionnaire Patient Activation Measure (PAM).	At month 3
Secondary	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
Secondary	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
Secondary	Peers mobilized	Number of peers mobilized	At month 3