The effectiveness of mindfulness-based stress reduction (MBSR) for survivors of breast cancer: study protocol for a randomized controlled trial
Jiayan Huang, Lu Shi
Trials April 22, 2016 DOI: 10.1186/s13063-016-1335-z (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized waitlist-controlled clinical trial Peer reviewed |
|---|---|
| Sample size | 418 |
| Population | Breast cancer survivors from 10 low-income communities in Shanghai |
| Intervention | Mindfulness-based stress reduction (MBSR) |
| Duration | 8-week intervention, 12-month follow-up |
| Topics | Meditation |
| Key findings | The trial protocol aims to evaluate whether an 8-week MBSR program improves psychological symptoms, quality of life, and medication adherence in Chinese breast cancer survivors. No results are reported, as the study is ongoing. |
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)
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 7
- Mindfulness-Based Stress Reduction on breast cancer symptoms: systematic review and meta-analysis Einstein 2018
- STRESS REDUCTION INTERVENTION FOR PREVENTIVE MEDICINE STUDENTS IN VIETNAM’S LIMITED RESOURCES SETTING STRESS REDUCTION INTERVENTION FOR PREVENTIVE MEDICINE STUDENTS IN VIETNAM’S LIMITED RESOURCES SETTING Archives of the Balkan Medical Union July 5, 2023
- The effect of mindfulness-based stress reduction on chemotherapy-related physical and psychological distress in colorectal cancer patients: a retrospective cohort study. Future oncology June 1, 2026
- Generative Artificial Intelligence (AI) to Uncover Insights From Breast Cancer Patients' Perceptions to Mindfulness-Based Stress Reduction (MBSR) Interventions. Holistic Nursing Practice August 13, 2025
- The efficacy of mindfulness-based stress reduction vs. standard or usual care in patients with breast cancer: a systematic review and meta-analysis of randomized controlled trials. Translational cancer research November 2022
and 2 more in the library
Cites 14
- Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Journal of Consulting and Clinical Psychology 2000
- Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders American Journal of Psychiatry July 1, 1992
- Teaching self-care to caregivers: Effects of mindfulness-based stress reduction on the mental health of therapists in training. Training and Education in Professional Psychology May 1, 2007
- Mindfulness-Based Stress Reduction in Relation to Quality of Life, Mood, Symptoms of Stress, and Immune Parameters in Breast and Prostate Cancer Outpatients Psychosomatic Medicine July 1, 2003
- Monitoring mindfulness practice quality: An important consideration in mindfulness practice Psychotherapy Research October 9, 2012
and 9 more in the library