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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01075-42 | Other Identifier | ID RCB |
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| Name | Class |
|---|---|
| Cancéropôle Lyon Auvergne Rhône-Alpes | OTHER |
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CANDY is a single-center, prospective study designed to observe the evolution of clinical and motivational constructs during the APA program KHEOPS program, already offered to patients at the Centre Léon Bérard (CLB).
The main aim of the CANDY study is to observe the evolution of psychological constructs derived from M-PAC during a 13-week KHEOPS APA program in women undergoing treatment for breast cancer.
Secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHEOPS participants during breast cancer treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHEOPS program | Behavioral | the KHEOPS program is an physical activity intervention, offered to patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| score for each construct of multiprocess action control model (M-PAC) |
Constructs of M-PAC :
| Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), one friday per month (Friday week 1 to Friday week 22), post-intervention + 1 month (Week 26) |
| Measure | Description | Time Frame |
|---|---|---|
| acceptability | participation rate (>70%) and dropout rate (<20%) | Post-intervention (week 22) |
| completion rate of bi-weekly online questionnaires during the intervention | (>80%) |
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Inclusion Criteria
Exclusion Criteria:
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Patients with breast cancer, with a current treatment, followed at CLB
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmen Dupuis, PhD | Contact | 0469856218 | carmen.dupuisl@lyon.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Olivia Perol, PhD | Département Prévention Cancer Environnement, Centre Léon Bérard | Study Director |
| Béatrice Fervers, Pr | Département Prévention Cancer Environnement, Centre Léon Bérard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| each monday (Monday week 1 to monday week 22), one friday per month (Friday week 1 to friday week 22) |
| cancer-related psychological symptoms during and after the program | - depressive symptoms, by Patient Health Questionnaire | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - anxiety symptoms, by Generalized Anxiety Disorder | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - perceived pain, by Brief Pain Inventory | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - perceived fatigue, by Multidimensional Fatigue Inventory Short Form or Daily Fatigue Cancer Scale | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - sense of self-efficacy, by Perceived Capacity over Physical Activity questionnaire | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - sense of self-efficacy related to coping with barriers, by Coping self-efficacy Scale | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - affective and instrumental attitudes, by Attitude toward PA - affective attitude and instrumental attitude | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - habit, by Self-Report Behavioral Automaticity Index | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - identity, by Athletic Identity Measurement Scale | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - planification, by self-reported planning for PA Scale | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| cancer-related psychological symptoms during and after the program | - therapeutic alliance questionnaire, by Therapeutic alliance questionnaire | Inclusion (Day 0), each monday (Monday week 1 to Monday week 22), each friday (Friday week 1 to Friday week 22), post-intervention (week 22), post-intervention + 1 month (Week 26) |
| Johan Caudroit, PhD | Université Lyon1 | Study Director |
| D017437 |
| Skin and Connective Tissue Diseases |