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

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.

Authors+Show Affiliations

Research and Development Centre, Skaraborg Hospital, Skövde, Sweden. elisabeth.kenne.sarenmalm@vgregion.se.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

24088535

Citation

Kenne Sarenmalm, Elisabeth, et al. "Mindfulness Based Stress Reduction Study Design of a Longitudinal Randomized Controlled Complementary Intervention in Women With Breast Cancer." BMC Complementary and Alternative Medicine, vol. 13, 2013, p. 248.
Kenne Sarenmalm E, Mårtensson LB, Holmberg SB, et al. Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer. BMC Complement Altern Med. 2013;13:248.
Kenne Sarenmalm, E., Mårtensson, L. B., Holmberg, S. B., Andersson, B. A., Odén, A., & Bergh, I. (2013). Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer. BMC Complementary and Alternative Medicine, 13, p. 248. doi:10.1186/1472-6882-13-248.
Kenne Sarenmalm E, et al. Mindfulness Based Stress Reduction Study Design of a Longitudinal Randomized Controlled Complementary Intervention in Women With Breast Cancer. BMC Complement Altern Med. 2013 Oct 2;13:248. PubMed PMID: 24088535.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer. AU - Kenne Sarenmalm,Elisabeth, AU - Mårtensson,Lena B, AU - Holmberg,Stig B, AU - Andersson,Bengt A, AU - Odén,Anders, AU - Bergh,Ingrid, Y1 - 2013/10/02/ PY - 2013/06/16/received PY - 2013/09/10/accepted PY - 2013/10/4/entrez PY - 2013/10/4/pubmed PY - 2014/8/8/medline SP - 248 EP - 248 JF - BMC complementary and alternative medicine JO - BMC Complement Altern Med VL - 13 N2 - 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. SN - 1472-6882 UR - https://www.unboundmedicine.com/medline/citation/24088535/Mindfulness_based_stress_reduction_study_design_of_a_longitudinal_randomized_controlled_complementary_intervention_in_women_with_breast_cancer_ L2 - https://bmccomplementalternmed.biomedcentral.com/articles/10.1186/1472-6882-13-248 DB - PRIME DP - Unbound Medicine ER -