Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial.
Study Goal
The researchers aimed to examine the feasibility and initial efficacy of a Mindful Yoga program compared to a social support condition for managing disease-related symptoms like pain and fatigue in women with metastatic breast cancer.
Results Summary
The study assessed feasibility through attendance rates and evaluated efficacy outcomes including pain, fatigue, sleep quality, psychological distress, mindfulness, and functional capacity at post-intervention and follow-up points, but specific results were not detailed in the abstract.
Population
Women aged ≥18 with metastatic breast cancer.
Effective Dosage
120-minute sessions weekly for 8 weeks.
Duration
8 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
Mindful Yoga program | increase | psychological and functional health | early stage breast cancer patients and survivors | - | demonstrated a positive impact | #1 |
Mindful Yoga program | neutral | disease-related symptoms such as pain and fatigue | women with metastatic breast cancer (MBC) | - | examines the feasibility and initial efficacy | #2 |
Mindful Yoga program | neutral | yoga as an intervention for women with advanced cancer | women with advanced cancer | - | will provide important information regarding | #3 |
Mindful Yoga program | neutral | psychological and functional effects | MBC patients | - | preliminary data on the psychological and functional effects | #4 |
BACKGROUND: Women with metastatic breast cancer (MBC) have average life expectancies of about 2 years, and report high levels of disease-related symptoms including pain, fatigue, sleep disturbance, psychological distress, and functional impairment. There is growing recognition of the limitations of medical approaches to managing such symptoms. Yoga is a mind-body discipline that has demonstrated a positive impact on psychological and functional health in early stage breast cancer patients and survivors, but has not been rigorously studied in advanced cancer samples. METHODS: This randomized controlled trial examines the feasibility and initial efficacy of a Mindful Yoga program, compared with a social support condition that controls for attention, on measures of disease-related symptoms such as pain and fatigue. The study will be completed by December 2017. Sixty-five women with MBC age ≥ 18 are being identified and randomized with a 2:1 allocation to Mindful Yoga or a support group control intervention. The 120-min intervention sessions take place weekly for 8 weeks. The study is conducted at an urban tertiary care academic medical center located in Durham, North Carolina. The primary feasibility outcome is attendance at intervention sessions. Efficacy outcomes include pain, fatigue, sleep quality, psychological distress, mindfulness and functional capacity at post-intervention, 3-month follow-up, and 6-month follow-up. DISCUSSION: In this article, we present the challenges of designing a randomized controlled trial with long-term follow-up among women with MBC. These challenges include ensuring adequate recruitment including of minorities, limiting and controlling for selection bias, tailoring of the yoga intervention to address special needs, and maximizing adherence and retention. This project will provide important information regarding yoga as an intervention for women with advanced cancer, including preliminary data on the psychological and functional effects of yoga for MBC patients. This investigation will also establish rigorous methods for future research into yoga as an intervention for this population. TRIAL REGISTRATION: ClinicalTrials.gov identifer: NCT01927081 , registered August 16, 2013.