The effectiveness of mindfulness-based stress reduction MBSR for survivors of breast cancer: study protocol for a randomized controlled trialReport as inadecuate




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Trials

, 17:209

First Online: 22 April 2016Received: 01 December 2015Accepted: 08 April 2016DOI: 10.1186-s13063-016-1335-z

Cite this article as: Huang, J. & Shi, L. Trials 2016 17: 209. doi:10.1186-s13063-016-1335-z

Abstract

BackgroundAfter treatment completion, breast cancer BC survivors frequently experience residual symptoms of pain, fatigue, high levels of psychological stress, anxiety, depression, fear of recurrence, and metastasis. Post-treatment stress, in particular, can adversely affect health-related quality of life, which, in turn, induces onset or recurrence of chronic diseases. Effective interventions that target these psychological symptoms and their physiological consequences are needed, especially for economically disadvantaged patients. However, in China, few evidence-based intervention strategies have been established among BC survivors. This study will formally adapt, develop, and evaluate an intensive mindfulness-based stress reduction MBSR intervention protocol to improve mental health, quality of life, and compliance with medication among Chinese BC survivors.

MethodsA randomized, waitlist-controlled clinical trial will be conducted. Based on our power calculation, 418 BC survivors will be recruited from 10 low-income communities in Shanghai. All subjects will be randomly assigned either to the MBSR program or to a waitlisted usual care regimen that will offer the MBSR program after the completion of the other trial arm after 6 months follow-up. Our 8-week MBSR intervention program will provide systematic training to promote stress reduction by self-regulating arousal to stress. Assessments will be made at baseline, 4 weeks in the middle of the first MBSR intervention, 8 weeks at the end of the first MBSR intervention, 6 months, and 12 months, and will include measures of psychological symptoms depression, anxiety, and perceived stress, quality of life, and medication adherence. The expected outcome will be the improvement in psychological symptoms, quality of life, and medication compliance in the MBSR intervention group.

DiscussionThis study will help develop an affordable, self-care psychological intervention protocol to help Chinese BC survivors improve their quality of life, and could be helpful in further developing affordable disease management plans for patients of other chronic diseases.

Trial registrationChiCTR-IOR-14005390 10-27-2014

KeywordsMindfulness-based stress reduction Breast cancer survivor Quality of life Compliance AbbreviationsMBSRMindfulness-based stress reduction, an intervention to reduce the stress by mindfulness

BCBreast cancer

QOLQuality of life

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Author: Jiayan Huang - Lu Shi

Source: https://link.springer.com/



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