PERTINENCE: Psycho-social Determinant for Sport Practised During Cancer

Sponsor
Centre Hospitalier Régional Metz-Thionville (Other)
Overall Status
Suspended
CT.gov ID
NCT03919149
Collaborator
(none)
693
3
59.8
231
3.9

Study Details

Study Description

Brief Summary

The litterature has demonstrates that physical activity can play an important role in decreasing patient mortality rates and increasing its well-being at all time of cancer. Despite this evidence, there is a weak adhesion in patients. It is therefore appropriate to look and see which may explain the high prevalence of physical inactivity in patients with cancer. The main objective of this study will be to recognize psychological and social factors which could explain the commitment or not to a physical activity in cancer patients. Besides the physical limitations related to the cancer and its treatment, socio-economic and psycho-social factors can often play an extremely important role in engagement or maintenance of sporting activity.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Different individual factors have been identified as playing an important role in physical activity (PA) practice. For example, sex, age, education level, socio-professional category, ethnicity, overweight seemed to impact PA level in general population and among cancer patient.

    Beyond the disease's effect, as well as its treatment, the socio-ecological approach has identified five group of factors associated to PA practice: individual factors, interpersonal factors, environmental factors, political factors and global factors.

    The aim of this mixed methods study is to identify the variables of the socioecological model facilitating PA practice, as well as PA level and preferences at different time during cancer (at diagnose, during treatment, after treatment).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    693 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Psychological and Social Determinants of Physical Activity Practice From Diagnose to Survival Among French Cancer Patients
    Actual Study Start Date :
    Oct 9, 2019
    Anticipated Primary Completion Date :
    Oct 8, 2022
    Anticipated Study Completion Date :
    Oct 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Physical activity [Day 1]

      The Questionnaire include four main section: medical, socio-economic variables, personality traits situational variables and physical activity. Sociological variables will encompass age, gender, education, and socio-professional category, and professional activity, marital and socio-economic status, place of living. Life habits and PA practice before diagnose will help to look at inter-determinants relationships. Medical data will also be collected from patient perspective. Situational variables will encompass passion, basic need satisfaction in sport, state-hope, self-determined motivation for PA, anxiety and depression. PA and sedentary behaviors will be measured using self-reported Global Physical Activity questionnaire. This questionnaire will measure the frequency, intensity, duration, as well as context of PA practice.

    Secondary Outcome Measures

    1. Physical activity at 6 months [Month 6]

      The Questionnaire six months after the inclusion

    2. Physical activity at 12 months [Month 12]

      The Questionnaire one year after the inclusion

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Major patient

    • With an histollogically confirmed non-metastatic (breast, prostate or colorectal) cancer diagnosis

    • To be addressed to an oncologist before the beginning of any treatment

    • Informed and having agreed to participate in the study

    • Operated patient without adjuvant therapy

    Exclusion Criteria:
    • Presence of threatening bone lesion

    • physical, cognitive or linguistics incapacity to fulfil the questionnaire

    • With a life expectancy of less than 6 months

    • Pregnant woman

    • Under legal protection or deprived of liberty

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHR Metz Thionville Metz France
    2 Institut de Cancérologie de Lorraine Nancy France
    3 CHR Metz Thionville Thionville France

    Sponsors and Collaborators

    • Centre Hospitalier Régional Metz-Thionville

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Régional Metz-Thionville
    ClinicalTrials.gov Identifier:
    NCT03919149
    Other Study ID Numbers:
    • 2018-08Obs-CHRMT
    First Posted:
    Apr 18, 2019
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 10, 2021