Mindful Yoga for women with metastatic breast cancer: Design of a randomized controlled trial

James Carson, Kimberly M. Carson, Maren K. Olsen, Linda Sanders, Laura S. Porter

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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

Original languageEnglish (US)
Article number153
JournalBMC Complementary and Alternative Medicine
Volume17
Issue number1
DOIs
StatePublished - Mar 13 2017

Fingerprint

Yoga
Randomized Controlled Trials
Breast Neoplasms
Psychology
Fatigue
Pain
Sleep
Mindfulness
Selection Bias
Self-Help Groups
Social Conditions
Tertiary Healthcare
Life Expectancy
Social Support
Survivors
Neoplasms
Health

Keywords

  • Breast cancer
  • Cancer pain
  • Mindfulness
  • Research design
  • Yoga

ASJC Scopus subject areas

  • Complementary and alternative medicine

Cite this

Mindful Yoga for women with metastatic breast cancer : Design of a randomized controlled trial. / Carson, James; Carson, Kimberly M.; Olsen, Maren K.; Sanders, Linda; Porter, Laura S.

In: BMC Complementary and Alternative Medicine, Vol. 17, No. 1, 153, 13.03.2017.

Research output: Contribution to journalArticle

Carson, James ; Carson, Kimberly M. ; Olsen, Maren K. ; Sanders, Linda ; Porter, Laura S. / Mindful Yoga for women with metastatic breast cancer : Design of a randomized controlled trial. In: BMC Complementary and Alternative Medicine. 2017 ; Vol. 17, No. 1.
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