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Psycho-social Determinant for Sport Practised During Cancer (PERTINENCE)

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ClinicalTrials.gov Identifier: NCT03919149
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

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
Physical Activity Cancer

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).


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Study Type : Observational
Estimated 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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Physical activity [ Time Frame: 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 [ Time Frame: Month 6 ]
    The Questionnaire six months after the inclusion

  2. Physical activity at 12 months [ Time Frame: Month 12 ]
    The Questionnaire one year after the inclusion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with an histollogically confirmed non-metastatic breast, prostate or colorectal cancer diagnosis, who had no started any treatment.
Criteria

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

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): NCT03919149


Contacts
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Contact: Raffaele Longo, MD 387553554 ext 0033 r.longo@chr-metz-thionville.fr

Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville

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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT03919149     History of Changes
Other Study ID Numbers: 2018-08Obs-CHRMT
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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