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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01857-42 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Nice | OTHER |
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A single-center, randomized (1:1) open-label, prospective, stratified study with two parallel arms, designed to evaluate adherence to the adapted physical activity (APA) program for patients participating in an APA program and to compare changes in fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APA | Experimental | participating to an APA program |
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| control arm | No Intervention | no APA program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APA program | Other | patient will benefit of an activity monitored by a wtach and an APA program during 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| adherence to the adapted physical activity (APA) program by the percentage of patients who completed 75% of the weekly sessions of the APA program with a heart rate (HR) between 40 and 60% of their reserve HR for 20-40 minutes. | Assessing adherence to the adapted physical activity (APA) program for patients participating in an APA program | 3 months |
| evolution of fatigue in patients who are participating in an APA program by the difference in Multidimensional Fatigue Inventory (MFI-20) questionnaire scores (20 items) between the first and last visit at 3 months. | Compare the evolution of fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program. Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0;100] | Compare changes in patients' quality of life following the APA program versus standard follow-up. QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ludovic EVESQUE, Doctor | Contact | +33 492 03 16 22 | ludovic.evesque@nice.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Nice | 06100 | France |
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| 3 months |
| evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100] | Compare changes in patients' quality of life following the APA program versus standard follow-up. QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level. | 6 months |
| evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100] | Compare changes in patients' quality of life following the APA program versus standard follow-up. QLQ-C30 contains 30 items that assess 15 dimensions of quality of life: 5 functional dimensions (physical functioning, role, cognitive, emotional, and social), one dimension of overall quality of life/health, and 8 symptom dimensions (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea) as well as a dimension corresponding to the level of financial difficulties. A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). These scores are standardized from 0 to 100 so that a high score reflects a high level of overall quality of life/health, a high functional level, and a high symptomatic level. | 12 months |
| Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126] | Compare the motivation for physical activity among patients following the APA program compared to standard follow-up. The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). | 3 months |
| Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126] | Compare the motivation for physical activity among patients following the APA program compared to standard follow-up. The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). | 6 months |
| Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126] | Compare the motivation for physical activity among patients following the APA program compared to standard follow-up. The EMAPS questionnaire comprise six motivational concepts highlighted by self-determination theory (intrinsic, integrated, identified, introjected, and external motivation). A score is calculated for each dimension, reflecting the patient's level on the corresponding quality of life scale (dimension). | 12 months |
| Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 6 months, in patients who followed the APA program versus standard follow-up | Compare the difference in MFI-20 fatigue scores between the first visit and the visits at 6 months. Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue. | 6 months |
| Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 12 months, in patients who followed the APA program versus standard follow-up | Compare the difference in MFI-20 fatigue scores between the first visit and the visits at 12 months. Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue. | 12 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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