Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA)

Completed

• Conditions: Sports Physical Therapy

• Registration Number: NCT04675814
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief Summary

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.

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 Timeline

• Study Start: 2020-09-14
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Primary Completion: 2021-03-14
• Study Completion: 2021-03-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. Oncological care at the ICO
2. All types of cancer
3. Regardless of the type of treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy)
4. Age > 18 years old
5. Follow the APA program at the ICO
6. Subject informed of the study

Exclusion Criteria

1. Contraindication to the practice of sport
2. APA Program outside the ICO
3. Subject opposing the use of his data
4. Minor or adult patient under guardianship or curatorship
5. Pregnant woman
6. Altered general condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quality of life of patients participating in the 12-week adapted physical activity program.	12 weeks	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 the ICO.; Quality of life is measured with the FACIT-F Fatigue and Quality of Life Questionnaire. This is a 13-question questionnaire in which the patient ranks on a Likert-type scale ranging from 1 to 5 (1 = completely, 5 = not at all). By adding up the answers, a score out of 65 is obtained: the higher the score, the less tired the patient is.

Secondary Outcome Measures

Name	Time	Method
Describe attendance at the APA program.	12 weeks	The number of sessions is planned by the APA coach at the beginning of the APA program. The number of missing sessions will be measured.
Measure the evolution of Kinesiophobia (fear of movement).	12 weeks	Kinesiophobia is measured with the TAMPA questionnaire. This tool assesses the kinesiophobia index presented by the patient at the time of the assessment. The higher the score, the greater the level of kinesiophobia. A score of 40/68 is considered significant kinesiophobia.
Measure physical activity at the initiation of the APA program.	12 weeks	The level of physical activity is evaluated by the GPAQ questionnaire. This questionnaire will assess the level of physical activity in work activities, modes of travel and leisure activities. It also evaluates sedentary behaviour. It includes 16 questions. The score obtained gives 3 profiles: insufficient activity level, level in line with recommendations and high level. It also provides MET (metabolic equivalent) results corresponding to the subject's energy expenditure during physical activities.

Trial Locations

Locations (1)

Institu de Cancérologie de L'Ouest; 🇫🇷 Angers, France