- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02867475
REduction of Physical Inactivity Facing the CAncer (RESCA)
Physical Activity in Patients With Cancer: Epidemiological Study of Patients' Beliefs and Promotional Messages Efficiency
Study 1:
The investigator hypothesizes that the level of knowledge about the benefits of physical activity, physical activity level and physical fatigue level observed in cancer patients, would influence their beliefs about physical activity and their intention to engage in AP.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study 2:
Because of a recent research, it is shown that a narrative message from a peer generates an identification, a sense of self-efficacy and intention to practice in sedentary patients with breast cancer.
The investigator hypothesize that a promotional message about physical activity, issued by a self-determined peer (intrinsic motivation), compared to a non-self-determined peer (extrinsic motivation), generate higher scores of positive beliefs about physical activity and intention to engage in a physical activity program for sedentary patients.
These promotional messages will be delivered through two videos, one featuring the self-determined pair, the other featuring the non-self-determined pair.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nice, France, 06189
- Centre Antoine Lacassagne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- PS 0-3
- Patients with breast cancer undergoing chemotherapy treatment
- neoadjuvant, adjuvant, metastatic, any histological type, any stage breast cancer
- Sedentary Patients (physical activity score of Dijon less than or equal to 20)
Exclusion Criteria:
- Patients with PS greater than 3
- Patients with cognitive disorders not allowing them to understand the questionnaires and study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Study 2 IM
Intrinsic Motivation
|
Physical activity promotion message delivered by a self-determined peer [PAD] (intrinsic motivation)
|
|
Other: Study 2 EM
Extrinsic Motivation
|
Physical activity promotion message delivered by a non-self-determined peer [PNAD] (extrinsic motivation)
|
|
No Intervention: Study 1
Psychometric measures: "Cancer Beliefs and Exercise Scale (CaBES)"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CaBES
Time Frame: 1 day
|
psychometric measures: Cancer Beliefs and Exercise Scale Questionnaire
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multidimensional Fatigue Inventory
Time Frame: 1 day
|
Fatigue level determination
|
1 day
|
|
Dijon's Score
Time Frame: 1 day
|
Physical activity level determination
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Véronique MARI, md, Centre Antoine Lacassagne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013/03 RESCA
- 2013-A01015-40 (Other Identifier: ANSM ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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