Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01648-35 | Registry Identifier | ID-RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment.
The experimental arm "APAD": tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment
The experimental program will include:
The control arm: standard of care
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapted Physical Activity and Dietetique | Experimental | tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APAD | Other | 8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week. 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of cancer-related fatigue | The primary assessment criterion is subjective fatigue measured using the 'General Fatigue' subscale of the Multidimensional Fatigue Inventory (MFI-20) questionnaire. | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilles Romieu | Institut du Cancer de Montpellier - Val d'Aurelle | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Sainte Catherine | Avignon | 84918 | France | |||
| Centre Oscar Lambret |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C005941 | 3-acetylpyridine adenine dinucleotide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Lille |
| 59020 |
| France |
| Centre Léon Bérard | Lyon | 69373 | France |
| CH Ambroise Paré | Marseille | 13003 | France |
| CH Montélimar | Montélimar | 26216 | France |
| ICM | Montpellier | 34298 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| Institut de Cancéologie de l'Ouest | Saint-Herblain | 44805 | France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |