Open Access Highly Accessed Study protocol

Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer

Elisabeth Kenne Sarenmalm123*, Lena B Mårtensson4, Stig B Holmberg5, Bengt A Andersson6, Anders Odén7 and Ingrid Bergh4

Author Affiliations

1 Research and Development Centre, Skaraborg Hospital, Skövde, Sweden

2 Institute of Health and Caring Sciences, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden

3 Palliative Research Centre, Ersta Sköndal University College and Ersta Hospital, Stockholm, Sweden

4 School of Life Sciences, University of Skövde, Skövde, Sweden

5 Department of Surgery, SU/Sahlgrenska University Hospital, Gothenburg, Sweden

6 Microbiology and Immunology, Göteborg University, Göteborg, Sweden

7 Department of Mathematical Sciences, Chalmers University of Technology, Gothenburg, Sweden

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BMC Complementary and Alternative Medicine 2013, 13:248  doi:10.1186/1472-6882-13-248

Published: 2 October 2013

Abstract

Background

The stress of a breast cancer diagnosis and its treatment can produce a variety of psychosocial sequelae including impaired immune responses. Mindfulness Based Stress Reduction (MBSR) is a structured complementary program that incorporates meditation, yoga and mind-body exercises. Despite promising empirical evidence for the efficacy of MBSR, there is a need for randomized controlled trials (RCT). There is also a need for RCTs investigating the efficacy of psychosocial interventions on mood disorder and immune response in women with breast cancer. Therefore, the overall aim is to determine the efficacy of a Mindfulness Based Stress Reduction (MBSR) intervention on well-being and immune response in women with breast cancer.

Methods and design

In this RCT, patients diagnosed with breast cancer, will consecutively be recruited to participate. Participants will be randomized into one of three groups: MBSR Intervention I (weekly group sessions + self-instructing program), MBSR Intervention II (self-instructing program), and Controls (non-MBSR). Data will be collected before start of intervention, and 3, 6, and 12 months and thereafter yearly up to 5 years. This study may contribute to evidence-based knowledge concerning the efficacy of MBSR to support patient empowerment to regain health in breast cancer disease.

Discussion

The present study may contribute to evidence-based knowledge concerning the efficacy of mindfulness training to support patient empowerment to regain health in a breast cancer disease. If MBSR is effective for symptom relief and quality of life, the method will have significant clinical relevance that may generate standard of care for patients with breast cancer.

Trial registration

ClinicalTrials.gov: NCT01591915

Keywords:
Breast cancer; Mindfulness based stress reduction; Randomized controlled trials; Well-being