Advanced Breast Cancer and Lifestyle Exercise Study (ABLE)

July 17, 2018 updated by: Centre Leon Berard
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lyon, France, 69008
        • Centre Léon Berard

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of oxidative stress
Time Frame: 6 months
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
6 months
Investigate the effects of a PA intervention on quality of life
Time Frame: 6 months
BR-23
6 months
Investigate the effects of a PA intervention on fatigue
Time Frame: 6 months
PIPER scale
6 months
Investigate the effects of a PA intervention on social deprivation
Time Frame: 6 months
EPICES score
6 months
Investigate the barriers and facilitators of adherence to a PA program
Time Frame: 6 months
Specific questionnaire
6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Time Frame: 6 months
BMI in kilograms per m²
6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Time Frame: 6 months
waist circumference in centimeters
6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Time Frame: 6 months
Weight in kilograms
6 months
Investigate the effects of a PA intervention on changes in anthropometrics
Time Frame: 6 months
Hip circumference in centimeters
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

May 5, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • ABLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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