Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2016-10-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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PA intervention
The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities.
PA 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.
Interventions
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PA 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
78 Years
FEMALE
No
Sponsors
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Claude Bernard University
OTHER
Centre Leon Berard
OTHER
Responsible Party
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Locations
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Centre Léon Bérard
Lyon, , France
Countries
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References
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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.
Other Identifiers
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ABLE
Identifier Type: -
Identifier Source: org_study_id
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