Metastatic Breastcancer
Conditions
Keywords
Physical activity
Brief summary
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.
Interventions
OTHERPA intervention
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.
Sponsors
Claude Bernard University
Centre Leon Berard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* aged 18 to 78 years old, * newly diagnosed with a metastatic breast cancer (i.e. within the last 3 months) * treated in the CLB by chemotherapy, and/or radiotherapy and/or hormonotherapy and/or targeted therapy. * ECOG Performance status \<2, * being French-speaking * able to complete questionnaires and follow instructions in French * valid health insurance affiliation. * medical certificate of no contraindications to exercise physical activity
Exclusion criteria
* untreated brain metastases * uncontrolled cardiac disease, * contraindications to PA, * unable to be followed for medical, social, familial, geographical or psychological reasons over the study duration, * deprivation of liberty by court or administrative decision * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving the physical activity program recommendations | 6 months | 150 min per week of moderate PA assessed by the IPAQ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigate the effects of a PA intervention on fitness level | 6 months | IPAQ in MET-min per week |
| Investigate the effects of a PA intervention on quality of life | 6 months | EORTC QLQ-C30 |
| Investigate the effects of a PA intervention on fatigue | 6 months | PIPER scale |
| Variation of oxidative stress | 6 months | 7mL blood sample is collected at baseline and at the end of the study |
| Investigate the barriers and facilitators of adherence to a PA program | 6 months | Specific questionnaire |
| Investigate the effects of a PA intervention on changes in anthropometrics | 6 months | BMI in kilograms per m² |
| Investigate the effects of a PA intervention on social deprivation | 6 months | EPICES score |
Countries
France
Outcome results
None listed