Mindfulness-based Stress Reduction (MBSR) Program Combined With Endurance Exercise Training: a Help in Treatment for Breast Cancer

NCT02900326 | Completed

• 1 other identifier: 5970
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Exercise capacity; Mindfulness; Quality of life

Outcome Measures

Primary Outcomes (1)

• Evolution of V02 max between inclusion and 8 weeks

  effect of physical training associated with mental work on physical abilities of patients

  8 weeks

Study Arms (4)

Control patients with no intervention

PLACEBO COMPARATOR

group without intervention

Other: Vo2max measurements; Genetic: Telomerase activity on a blood sample; Other: Quality of life (questionnaires); Other: Cerebral IRMf

Endurance training program (8 weeks) group

EXPERIMENTAL

only physical training group

Other: Endurance exercise training; Other: Vo2max measurements; Genetic: Telomerase activity on a blood sample; Other: Quality of life (questionnaires); Other: Cerebral IRMf

MBSR group (mindfulness-based-stress-reduction)

EXPERIMENTAL

only mental training group (8 weeks)

Other: Mindfulness-based-stress-reduction

Endurance training program combined with MBSR sessions

EXPERIMENTAL

Endurance training program combined with MBSR sessions, during 8 weeks (mindfulness-based-stress-reduction)

Other: Both interventions together

Interventions

Endurance exercise training OTHER

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

Endurance training program (8 weeks) group

Mindfulness-based-stress-reduction OTHER

MBSR group (mindfulness-based-stress-reduction)

Both interventions together OTHER

Endurance training program combined with MBSR sessions

Vo2max measurements OTHER

Control patients with no intervention; Endurance training program (8 weeks) group

Quality of life (questionnaires) OTHER

Control patients with no intervention; Endurance training program (8 weeks) group

Cerebral IRMf OTHER

Control patients with no intervention; Endurance training program (8 weeks) group

Telomerase activity on a blood sample GENETIC

Control patients with no intervention; Endurance training program (8 weeks) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer
• Having completed the chemotherapy period
• Undergoing radiotherapy and/or hormono therapy

You may not qualify if:

• Regular physical activity higher than 4 hours per week.
• Any disease cardiac, respiratory, neurological or articular disease, which counteract the muscular training )

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Physiologie et EFR/ EA 3072 mitochondrie, stress oxydant et protection musculaire

Strasbourg, 67091, France

Location

Related Publications (1)

• Sibeoni J, Manolios E, Mathe J, Feka V, Vinez MM, Lonsdorfer-Wolf E, Bloch JG, Bayle F, Meunier JP, Revah-Levy A, Verneuil L. The experience of a program combining two complementary therapies for women with breast cancer: An IPSE qualitative study. PLoS One. 2023 Aug 17;18(8):e0285617. doi: 10.1371/journal.pone.0285617. eCollection 2023.

  PMID: 37590246 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mindfulness; Quality of Life; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• LONSDORFER Evelyne

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: September 14, 2016
• Study Start: May 12, 2015
• Primary Completion: May 12, 2015
• Study Completion: March 30, 2021
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)