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Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer
Research and Development Centre, Skaraborg Hospital, Skövde, Sweden / Institute of Health and Caring Sciences, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden / Palliative Research Centre, Ersta Sköndal University College and Ersta Hospital, Stockholm, Sweden.ORCID iD: 0000-0001-9559-0952
University of Skövde, School of Life Sciences.ORCID iD: 0000-0002-0079-3966
Department of Surgery, SU/Sahlgrenska University Hospital, Gothenburg, Sweden.
Microbiology and Immunology, Göteborg University, Göteborg, Sweden.
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2013 (English)In: BMC Complementary and Alternative Medicine, ISSN 1472-6882, Vol. 13, 248Article in journal (Refereed) Published
Abstract [en]

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. © 2013 Kenne Sarenmalm et al.; licensee BioMed Central Ltd.

Place, publisher, year, edition, pages
BioMed Central, 2013. Vol. 13, 248
Keyword [en]
Breast cancer, Mindfulness based stress reduction, Randomized controlled trials, Well-being, anxiety, article, controlled study, coping behavior, depression, empowerment, female, health, health care quality, health program, human, immune response, knowledge, longitudinal study, mood disorder, quality of life, randomized controlled trial, stress, study design, training, wellbeing
National Category
Clinical Medicine
Research subject
Medical sciences
URN: urn:nbn:se:his:diva-8713DOI: 10.1186/1472-6882-13-248ISI: 000325801100003PubMedID: 24088535ScopusID: 2-s2.0-84884770463OAI: oai:DiVA.org:his-8713DiVA: diva2:683157
Available from: 2014-01-02 Created: 2014-01-02 Last updated: 2015-08-13Bibliographically approved

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Kenne Sarenmalm, ElisabethMårtensson, Lena B.Bergh, Ingrid
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