- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03148886
Advanced Breast Cancer and Lifestyle Exercise Study (ABLE)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Lyon, France, 69008
- Centre Léon Berard
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PA intervention
The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients achieving the physical activity program recommendations
Time Frame: 6 months
|
150 min per week of moderate PA assessed by the IPAQ
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of oxidative stress
Time Frame: 6 months
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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
Time Frame: 6 months
|
IPAQ in MET-min per week
|
6 months
|
Investigate the effects of a PA intervention on fitness level
Time Frame: 6 months
|
6-min walk test in meters
|
6 months
|
Investigate the effects of a PA intervention on fitness level
Time Frame: 6 months
|
VO2 peak in ml per kg per minute
|
6 months
|
Investigate the effects of a PA intervention on fitness level
Time Frame: 6 months
|
strength test in kilograms
|
6 months
|
Investigate the effects of a PA intervention on quality of life
Time Frame: 6 months
|
EORTC QLQ-C30
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6 months
|
Investigate the effects of a PA intervention on quality of life
Time Frame: 6 months
|
BR-23
|
6 months
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Investigate the effects of a PA intervention on fatigue
Time Frame: 6 months
|
PIPER scale
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6 months
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Investigate the effects of a PA intervention on social deprivation
Time Frame: 6 months
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EPICES score
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6 months
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Investigate the barriers and facilitators of adherence to a PA program
Time Frame: 6 months
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Specific questionnaire
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6 months
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Investigate the effects of a PA intervention on changes in anthropometrics
Time Frame: 6 months
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BMI in kilograms per m²
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6 months
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Investigate the effects of a PA intervention on changes in anthropometrics
Time Frame: 6 months
|
waist circumference in centimeters
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6 months
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Investigate the effects of a PA intervention on changes in anthropometrics
Time Frame: 6 months
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Weight in kilograms
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6 months
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Investigate the effects of a PA intervention on changes in anthropometrics
Time Frame: 6 months
|
Hip circumference in centimeters
|
6 months
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABLE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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