Physical Activity Experiment on Male Prostate Cancer Patients
ACTI_PAIR
2 other identifiers
interventional
66
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2018
CompletedFirst Submitted
Initial submission to the registry
October 22, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2021
CompletedFebruary 8, 2023
February 1, 2023
3.1 years
October 22, 2018
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical Activity sessions performed
Analysis of the proportion (%) of Physical Activity sessions performed after 3 months of intervention.
At month 3
Secondary Outcomes (6)
physical activity via activity actigraph
At month 3
sedentary lifestyle via activity actigraph
At month 3
Patient's activation
At month 3
brakes blocking intervention
At month 3
levers favoring intervention
At month 3
- +1 more secondary outcomes
Study Arms (3)
STEP 1: Patient with prostate cancer
OTHERFirst, patients with prostate cancer will be included during step 1. They will have an interview.
STEP 2: Patient with prostate cancer and a physical activity
OTHERSecondly, 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.
STEP 3: Physical Activity Program
OTHERFinally, 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.
Interventions
The goal is to evaluate the needs, the constraints and representations of patients on the practice of physical activity.
The goal of this questionnaire is to evaluate the sedentary lifestyle of patients.
An activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients.
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
CHU Saint-Etienne
Saint-Etienne, France
ICLN - département de radiothérapie
Saint-Priest-en-Jarez, France
ICLN - Oncologie médicale
Saint-Priest-en-Jarez, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David HUPIN, MD
CHU SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2018
First Posted
March 7, 2019
Study Start
August 2, 2018
Primary Completion
September 14, 2021
Study Completion
September 14, 2021
Last Updated
February 8, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share