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BMC Complementary Medicine and Therapies

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Open Access 01-12-2013 | Study protocol

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

Authors: Elisabeth Kenne Sarenmalm, Lena B Mårtensson, Stig B Holmberg, Bengt A Andersson, Anders Odén, Ingrid Bergh

Published in: BMC Complementary Medicine and Therapies | Issue 1/2013

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

Available only for authorised users

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The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6882/13/248/prepub

Title: Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer
Authors: Elisabeth Kenne Sarenmalm
Lena B Mårtensson
Stig B Holmberg
Bengt A Andersson
Anders Odén
Ingrid Bergh
Publication date: 01-12-2013
Publisher: BioMed Central
Published in: BMC Complementary Medicine and Therapies / Issue 1/2013
Electronic ISSN: 2662-7671
DOI: https://doi.org/10.1186/1472-6882-13-248

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods and design

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods and design

Discussion

Trial registration

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