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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03919149
Other study ID # 2018-08Obs-CHRMT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 9, 2019
Est. completion date December 2024

Study information

Verified date August 2023
Source Institut de Cancérologie de Lorraine
Contact Didier Peiffert, Pr
Phone 383598413
Email d.peiffert@nancy.unicancer.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 693
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHR Metz Thionville Metz
France Institut de Cancérologie de Lorraine Nancy
France CHR Metz Thionville Thionville

Sponsors (1)

Lead Sponsor Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity 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 Physical activity at 6 months The Questionnaire six months after the inclusion Month 6
Secondary Physical activity at 12 months The Questionnaire one year after the inclusion Month 12
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