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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Oct 2016

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

October 1, 2016

Completed

7 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed

Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

May 5, 2017

Last Update Submit

July 17, 2018

Conditions

Metastatic Breastcancer

Keywords

Physical activity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (14)

Variation of oxidative stress
6 months
Investigate the effects of a PA intervention on fitness level
6 months
Investigate the effects of a PA intervention on fitness level
6 months
Investigate the effects of a PA intervention on fitness level
6 months
Investigate the effects of a PA intervention on fitness level
6 months
+9 more secondary outcomes

Study Arms (1)

PA intervention

EXPERIMENTAL

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

Other: PA intervention

Interventions

PA interventionOTHER

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.

PA intervention

Eligibility Criteria

Age18 Years - 78 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Centre Leon Berardlead
Claude Bernard Universitycollaborator

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

Location

Related Publications (4)

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.
PMID: 34326920DERIVED
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.
PMID: 32012082DERIVED
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.
PMID: 31571315DERIVED
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.
PMID: 30166274DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SUPPORTIVE CARE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 11, 2017

Study Start

October 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing: Will not share

Locations

FR(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (1)

PA intervention

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Data Sharing

Locations