- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04675814
Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA) (APA)
Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA) at Institut de Cancerologie de l'Ouest (ICO)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment.
A 12-week Adapted Physical Activity program (APA) is proposed to patients included in the study with an assessment of fatigue, quality of life, level of physical activity and kinesiophobia (fear of movement) at the beginning of the study.
A second assessment of fatigue and quality of life will be done during the 6-week management.
At the end of the program, a final evaluation of fatigue, quality of life and kinesiophobia will be done.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Angers, France, 49055
- Institut de cancerologie de l'ouest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Oncological care at the ICO
- All types of cancer
- Regardless of the type of treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy)
- Age > 18 years old
- Follow the APA program at the ICO
- Subject informed of the study
Exclusion Criteria:
- Contraindication to the practice of sport
- APA Program outside the ICO
- Subject opposing the use of his data
- Minor or adult patient under guardianship or curatorship
- Pregnant woman
- Altered general condition
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program.
Time Frame: 12 weeks
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Describe the evolution of the quality of life of patients being treated for their cancer pathology at the ICO site in Angers, and participating in the 12-week adapted physical activity program at ICO. Quality of life is measured with the FACIT-F Fatigue and Quality of Life Questionnaire. The questionnaire is structured into five sections, each containing between 6 and 13 items. In total, it includes 40 items, each scored from 0 to 4: 0 - Not at all
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe Attendance at the APA Program.
Time Frame: 12 weeks
|
The number of sessions is planned by the APA coach at the beginning of the APA program.
The number of performed sessions is measured.
|
12 weeks
|
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Measure the Evolution of Kinesiophobia (Fear of Movement).
Time Frame: 12 weeks
|
Kinesiophobia is measured with the TAMPA Scale for Kinesiophobia (TSK-CF). This scale assesses the kinesiophobia index presented by the patient at the time of the assessment. The higher the score, the greater the level of kinesiophobia. Total score range: 17 to 68. Higher scores indicate greater fear of movement. A score ≥ 40 is considered significant kinesiophobia. |
12 weeks
|
|
Measure Physical Activity at the Initiation of the APA Program.
Time Frame: Week 0
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The level of physical activity (PA) is assessed using the GPAQ questionnaire. The questionnaire consists of 16 items. Physical activity is expressed in MET-minutes per week (Metabolic Equivalent of Task), calculated from reported activity. Based on the score, three profiles are defined: High
|
Week 0
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Sophie ABADIE-LACOURTOISIE, MD, Institut de cancerologie de l'ouest
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICO-2020-05
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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