title: Mindful Yoga for women with metastatic breast cancer: design of a randomized controlled trial.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifer: NCT01927081 , registered August 16, 2013.
authors.affiliation: Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR, 97239, USA. carsonja@ohsu.edu.
authors.forename: James W
authors.initials: JW
authors.lastname: Carson
authors.affiliation: Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., Portland, OR, 97239, USA.
authors.forename: Kimberly M
authors.initials: KM
authors.lastname: Carson
authors.affiliation: Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, 27705, USA.
authors.forename: Maren K
authors.initials: MK
authors.lastname: Olsen
authors.affiliation: Department of Medicine, Duke University Medical Center, Box 2628, Durham, NC, 27710, USA.
authors.forename: Linda
authors.initials: L
authors.lastname: Sanders
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Box 90399, Durham, NC, 27708, USA.
authors.forename: Laura S
authors.initials: LS
authors.lastname: Porter
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000150:complications* / Q000473:pathology / Q000523:psychology / Q000628:therapy; D005221:Fatigue / Q000209:etiology / Q000628:therapy*; D005260:Female; D006801:Humans; D019122:Meditation; D064866:Mindfulness; D009362:Neoplasm Metastasis; D010146:Pain / Q000209:etiology; D059408:Pain Management; D011788:Quality of Life; D012107:Research Design; D015013:Yoga; D055815:Young Adult
keywords: Breast cancer; Cancer pain; Mindfulness; Research design; Yoga