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Advanced Breast Cancer and Lifestyle Exercise Study (ABLE)

Primary Purpose

Metastatic Breastcancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PA intervention
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Breastcancer focused on measuring Physical activity

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Léon Bérard

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PA intervention

Arm Description

The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities.

Outcomes

Primary Outcome Measures

Proportion of patients achieving the physical activity program recommendations
150 min per week of moderate PA assessed by the IPAQ

Secondary Outcome Measures

Variation of oxidative stress
7mL blood sample is collected at baseline and at the end of the study
Investigate the effects of a PA intervention on fitness level
IPAQ in MET-min per week
Investigate the effects of a PA intervention on fitness level
6-min walk test in meters
Investigate the effects of a PA intervention on fitness level
VO2 peak in ml per kg per minute
Investigate the effects of a PA intervention on fitness level
strength test in kilograms
Investigate the effects of a PA intervention on quality of life
EORTC QLQ-C30
Investigate the effects of a PA intervention on quality of life
BR-23
Investigate the effects of a PA intervention on fatigue
PIPER scale
Investigate the effects of a PA intervention on social deprivation
EPICES score
Investigate the barriers and facilitators of adherence to a PA program
Specific questionnaire
Investigate the effects of a PA intervention on changes in anthropometrics
BMI in kilograms per m²
Investigate the effects of a PA intervention on changes in anthropometrics
waist circumference in centimeters
Investigate the effects of a PA intervention on changes in anthropometrics
Weight in kilograms
Investigate the effects of a PA intervention on changes in anthropometrics
Hip circumference in centimeters

Full Information

First Posted
May 5, 2017
Last Updated
July 17, 2018
Sponsor
Centre Leon Berard
Collaborators
Claude Bernard University
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1. Study Identification

Unique Protocol Identification Number
NCT03148886
Brief Title
Advanced Breast Cancer and Lifestyle Exercise Study
Acronym
ABLE
Official Title
Advanced Breast Cancer and Lifestyle Exercise Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
Claude Bernard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breastcancer
Keywords
Physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PA intervention
Arm Type
Experimental
Arm Description
The intervention consisted in a home-based adapted PA program defined at the inclusion, according to patient's capacities.
Intervention Type
Other
Intervention Name(s)
PA intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients achieving the physical activity program recommendations
Description
150 min per week of moderate PA assessed by the IPAQ
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Variation of oxidative stress
Description
7mL blood sample is collected at baseline and at the end of the study
Time Frame
6 months
Title
Investigate the effects of a PA intervention on fitness level
Description
IPAQ in MET-min per week
Time Frame
6 months
Title
Investigate the effects of a PA intervention on fitness level
Description
6-min walk test in meters
Time Frame
6 months
Title
Investigate the effects of a PA intervention on fitness level
Description
VO2 peak in ml per kg per minute
Time Frame
6 months
Title
Investigate the effects of a PA intervention on fitness level
Description
strength test in kilograms
Time Frame
6 months
Title
Investigate the effects of a PA intervention on quality of life
Description
EORTC QLQ-C30
Time Frame
6 months
Title
Investigate the effects of a PA intervention on quality of life
Description
BR-23
Time Frame
6 months
Title
Investigate the effects of a PA intervention on fatigue
Description
PIPER scale
Time Frame
6 months
Title
Investigate the effects of a PA intervention on social deprivation
Description
EPICES score
Time Frame
6 months
Title
Investigate the barriers and facilitators of adherence to a PA program
Description
Specific questionnaire
Time Frame
6 months
Title
Investigate the effects of a PA intervention on changes in anthropometrics
Description
BMI in kilograms per m²
Time Frame
6 months
Title
Investigate the effects of a PA intervention on changes in anthropometrics
Description
waist circumference in centimeters
Time Frame
6 months
Title
Investigate the effects of a PA intervention on changes in anthropometrics
Description
Weight in kilograms
Time Frame
6 months
Title
Investigate the effects of a PA intervention on changes in anthropometrics
Description
Hip circumference in centimeters
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34326920
Citation
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.
Results Reference
derived
PubMed Identifier
32012082
Citation
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.
Results Reference
derived
PubMed Identifier
31571315
Citation
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.
Results Reference
derived
PubMed Identifier
30166274
Citation
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.
Results Reference
derived

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Advanced Breast Cancer and Lifestyle Exercise Study

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