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NCT Number: NCT03866785

Physical Activity Experiment on Male Prostate Cancer Patients

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.

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Key information

Conditions

Cancer Prostate Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne, Saint-Etienne, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interview

Diagnostic Test

The goal is to evaluate the needs, the constraints and representations of patients on the practice of physical activity.

Adult Physical Activity Questionnaire (APAQ)

Diagnostic Test

The goal of this questionnaire is to evaluate the sedentary lifestyle of patients.

activity actigraph

Device

An activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients.

Peer Training

Other

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

Other

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 outcomes

  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 outcomes

  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. Patient's activation

    Time frame: At month 3

    Measure patient's activation via questionnaire Patient Activation Measure (PAM).

  4. 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)

  5. 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)

  6. Peers mobilized

    Time frame: At month 3

    Number of peers mobilized

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • National Cancer Institute, France

Registry information

Official study title

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

Acronym: ACTI_PAIR

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 7, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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