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| Name | Class |
|---|---|
| Claude Bernard University | OTHER |
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About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The physical, biological, psychological and clinical benefits of physical activity (PA) during treatment in patients with localized breast cancer have been widely demonstrated. Numerous studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of PA in patients with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA intervention | Experimental | The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA intervention | Other | The program is individualized according to age, fitness level, place of residence, access to adapted specific training group or associations, PA preferences and wishes of each participant. Patients are informed of the recommendations in terms of PA, and the target of 150min per week in order to maintain health benefits. Patients are asked to walk at least 30 minutes per day and increase their activities into daily routine. Several individual strategies are established with the patients to attain their objectives and increase their daily life PA. Withings® PA trackers have been used to provide an incentive effect to increase PA, to measure the number of steps per day and make people think about their PA. Patients wore a Withings Go® wristband PA tracker throughout the whole study and had in real time a feedback on their number of steps per day. A 7 mL blood sample is collected at baseline (D1) and at the end of the 6-month study (M6) for the biological study. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving the physical activity program recommendations | 150 min per week of moderate PA assessed by the IPAQ | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of oxidative stress | 7mL blood sample is collected at baseline and at the end of the study | 6 months |
| Investigate the effects of a PA intervention on fitness level | IPAQ in MET-min per week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Lyon | 69008 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34326920 | Derived | Delrieu L, Touillaud M, Perol O, Morelle M, Martin A, Friedenreich CM, Mury P, Dufresne A, Bachelot T, Heudel PE, Fervers B, Tredan O, Pialoux V. Impact of Physical Activity on Oxidative Stress Markers in Patients with Metastatic Breast Cancer. Oxid Med Cell Longev. 2021 Jul 16;2021:6694594. doi: 10.1155/2021/6694594. eCollection 2021. | |
| 32012082 |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| 6 months |
| Investigate the effects of a PA intervention on fitness level | 6-min walk test in meters | 6 months |
| Investigate the effects of a PA intervention on fitness level | VO2 peak in ml per kg per minute | 6 months |
| Investigate the effects of a PA intervention on fitness level | strength test in kilograms | 6 months |
| Investigate the effects of a PA intervention on quality of life | EORTC QLQ-C30 | 6 months |
| Investigate the effects of a PA intervention on quality of life | BR-23 | 6 months |
| Investigate the effects of a PA intervention on fatigue | PIPER scale | 6 months |
| Investigate the effects of a PA intervention on social deprivation | EPICES score | 6 months |
| Investigate the barriers and facilitators of adherence to a PA program | Specific questionnaire | 6 months |
| Investigate the effects of a PA intervention on changes in anthropometrics | BMI in kilograms per m² | 6 months |
| Investigate the effects of a PA intervention on changes in anthropometrics | waist circumference in centimeters | 6 months |
| Investigate the effects of a PA intervention on changes in anthropometrics | Weight in kilograms | 6 months |
| Investigate the effects of a PA intervention on changes in anthropometrics | Hip circumference in centimeters | 6 months |
| Delrieu L, Pialoux V, Perol O, Morelle M, Martin A, Friedenreich C, Febvey-Combes O, Perol D, Belladame E, Clemencon M, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Touillaud M, Tredan O, Fervers B. Feasibility and Health Benefits of an Individualized Physical Activity Intervention in Women With Metastatic Breast Cancer: Intervention Study. JMIR Mhealth Uhealth. 2020 Jan 28;8(1):e12306. doi: 10.2196/12306. |
| 31571315 | Derived | Delrieu L, Vallance JK, Morelle M, Fervers B, Pialoux V, Friedenreich C, Dufresne A, Bachelot T, Heudel PE, Tredan O, Perol O, Touillaud M. Physical activity preferences before and after participation in a 6-month physical activity intervention among women with metastatic breast cancer. Eur J Cancer Care (Engl). 2020 Jan;29(1):e13169. doi: 10.1111/ecc.13169. Epub 2019 Sep 30. |
| 30166274 | Derived | Delrieu L, Perol O, Fervers B, Friedenreich C, Vallance J, Febvey-Combes O, Perol D, Canada B, Roitmann E, Dufresne A, Bachelot T, Heudel PE, Tredan O, Touillaud M, Pialoux V. A Personalized Physical Activity Program With Activity Trackers and a Mobile Phone App for Patients With Metastatic Breast Cancer: Protocol for a Single-Arm Feasibility Trial. JMIR Res Protoc. 2018 Aug 30;7(8):e10487. doi: 10.2196/10487. |