Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer (MBSR)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endurance exercise training
Mindfulness-based-stress-reduction
Both interventions together
Vo2max measurements
Telomerase activity on a blood sample
Quality of life (questionnaires)
Cerebral IRMf
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Exercise capacity, Mindfulness, Quality of life
Eligibility Criteria
Inclusion Criteria:
- Breast cancer
- Having completed the chemotherapy period
- Undergoing radiotherapy and/or hormono therapy
Exclusion Criteria:
- Regular physical activity higher than 4 hours per week.
- Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training )
Sites / Locations
- Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Control patients with no intervention
Endurance training program (8 weeks) group
MBSR group (mindfulness-based-stress-reduction)
Endurance training program combined with MBSR sessions
Arm Description
group without intervention
only physical training group
only mental training group (8 weeks)
Endurance training program combined with MBSR sessions, during 8 weeks (mindfulness-based-stress-reduction)
Outcomes
Primary Outcome Measures
Evolution of V02 max between inclusion and 8 weeks
effect of physical training associated with mental work on physical abilities of patients
Secondary Outcome Measures
Full Information
NCT ID
NCT02900326
First Posted
June 16, 2015
Last Updated
May 17, 2022
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02900326
Brief Title
Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer
Acronym
MBSR
Official Title
Effect of a Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help to Improve Exercise Capacity and Quality of Life in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2015 (Actual)
Primary Completion Date
May 12, 2015 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Integrative approaches to promote wellness and reduce the distress associated with cancer are considered as essential components of cancer care. In case, exercise training has been shown to produce many positive physiological and psychological benefits. Mindfulness-based stress reduction program shows similar beneficial effects, and especially in emotional distress management. The aim of the study is to examine the cumulative effect of an 8 week-exercise-training program combined with an MBSR program on cardio-respiratory fitness and quality of life in women with breast cancer. These effects are thought to be mediated in part through changes in underlying brain processes, that investigators will be put in light. Through telomerase activity, oxidative stress, mitochondrial respiration and blood cytokine level measurements, investigators could expect to better understand the effect of these combined training in breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Exercise capacity, Mindfulness, Quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control patients with no intervention
Arm Type
Placebo Comparator
Arm Description
group without intervention
Arm Title
Endurance training program (8 weeks) group
Arm Type
Experimental
Arm Description
only physical training group
Arm Title
MBSR group (mindfulness-based-stress-reduction)
Arm Type
Experimental
Arm Description
only mental training group (8 weeks)
Arm Title
Endurance training program combined with MBSR sessions
Arm Type
Experimental
Arm Description
Endurance training program combined with MBSR sessions, during 8 weeks (mindfulness-based-stress-reduction)
Intervention Type
Other
Intervention Name(s)
Endurance exercise training
Intervention Description
In each group, there will be a comparison of aerobic capacity, quality of life (with questionnaires), functional cerebral measurements (fRMI), and telomerase activity between before and after the 8 weeks program
Intervention Type
Other
Intervention Name(s)
Mindfulness-based-stress-reduction
Intervention Type
Other
Intervention Name(s)
Both interventions together
Intervention Type
Other
Intervention Name(s)
Vo2max measurements
Intervention Type
Genetic
Intervention Name(s)
Telomerase activity on a blood sample
Intervention Type
Other
Intervention Name(s)
Quality of life (questionnaires)
Intervention Type
Other
Intervention Name(s)
Cerebral IRMf
Primary Outcome Measure Information:
Title
Evolution of V02 max between inclusion and 8 weeks
Description
effect of physical training associated with mental work on physical abilities of patients
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Breast cancer
Having completed the chemotherapy period
Undergoing radiotherapy and/or hormono therapy
Exclusion Criteria:
Regular physical activity higher than 4 hours per week.
Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LONSDORFER Evelyne
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire
City
Strasbourg
ZIP/Postal Code
67091
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer
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