- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03919149
Psycho-social Determinant for Sport Practised During Cancer (PERTINENCE)
Psychological and Social Determinants of Physical Activity Practice From Diagnose to Survival Among French Cancer Patients
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Didier Peiffert, Pr
- Phone Number: 0033 383598413
- Email: d.peiffert@nancy.unicancer.fr
Study Locations
-
-
-
Metz, France
- Recruiting
- CHR Metz Thionville
-
Contact:
- Raffaele LONGO, MD
-
Nancy, France
- Recruiting
- Institut de Cancérologie de Lorraine
-
Contact:
- Didier Peiffert, Pr
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Thionville, France
- Recruiting
- CHR Metz Thionville
-
Contact:
- Nidal AL-AUKLA, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity at 6 months
Time Frame: Month 6
|
The Questionnaire six months after the inclusion
|
Month 6
|
Physical activity at 12 months
Time Frame: Month 12
|
The Questionnaire one year after the inclusion
|
Month 12
|
Collaborators and Investigators
Investigators
- Study Chair: Tarquino Cyril, Pr, Centre Pierre Janet, Université de Lorraine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-08Obs-CHRMT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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