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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted Physical Activity (APA) | Other | Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy). The APA program duration is : 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Describe Attendance at the APA Program. | 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 |
| Measure the Evolution of Kinesiophobia (Fear of Movement). |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects participating in the ICO's APA program during the enrolment period regardless of the type of cancer and the type of treatment in progress (chemotherapy, radiotherapy, hormone therapy, immunotherapy) who accept to participate to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Sophie ABADIE-LACOURTOISIE, MD | Institut de Cancérologie de l'Ouest | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de L'Ouest | Angers | 49055 | France |
All screened patients have been included
Study start date first signed consent: 14 SEP 2020 Date of first patient inclusion: 14 SEP 2020 End of trial date (last visit of last patient): 14 MAR 2021
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapted Physical Activity (APA) | Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Cancer patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapted Physical Activity (APA) | Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Life of Patients Participating in the 12-week Adapted Physical Activity Program. | 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
| Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
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This is a non-interventional (observational) category 3 study. No adverse events (AEs), serious adverse events (SAEs) or all-cause mortality were collected.
"0" Total Number of Participants at Risk in adverse events, serious adverse events and all-cause mortality sections means that these events were not collected or assessed as part of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adapted Physical Activity (APA) | Adults participating in the APA program at ICO during the first semester of 2020, regardless of cancer type and ongoing treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr ABADIE-LACOURTOISIE Sophie | Institut de Cancérologie de l'Ouest | +33 2 41 35 27 00 | Sophie.Abadie-Lacourtoisie@ico.unicancer.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2020 | Dec 10, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000092442 | Kinesiophobia |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
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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. | 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 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Describe Attendance at the APA Program. | The number of sessions is planned by the APA coach at the beginning of the APA program. The number of performed sessions is measured. | Posted | Mean | Standard Deviation | Number of APA sessions | 12 weeks |
|
|
|
| Secondary | Measure the Evolution of Kinesiophobia (Fear of Movement). | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks |
|
|
|
| Secondary | Measure Physical Activity at the Initiation of the APA Program. | 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
| Posted | Count of Participants | Participants | Week 0 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|