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

Abstract

BackgroundWomen 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.MethodsThis 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.DiscussionIn 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 registrationClinicalTrials.gov identifer: NCT01927081, registered August 16, 2013

Greater mindfulness associated with lower pain, fatigue, and psychological distress in women with metastatic breast cancer

“…16 We hypothesized that higher mindfulness across the facets would be associated with lower levels of symptoms. 16 We hypothesized that higher mindfulness across the facets would be associated with lower levels of symptoms.…”

“…The aim of the current study was to examine the strength and direction of baseline associations between mindfulness facets and patient-reported symptoms including pain, fatigue, psychological distress, and sleep disturbance in a sample of women with MBC who participated in a randomized controlled trial of a Mindful Yoga intervention. 16 We hypothesized that higher mindfulness across the facets would be associated with lower levels of symptoms. Consistent with previous literature, we hypothesized that the nonreactivity, nonjudging, and acting with awareness facets would demonstrate the strongest associations with symptoms and that the observing facet would show weaker associations.…”

Percepção De Pacientes Sobre a Prática De Yoga Em Unidade De Internação Psiquiátrica Em Hospital Geral

“…Estudos apontam interesses crescentes em desenvolver as práticas mentais e corporais como o yoga como coadjuvantes em diversas ações terapêuticas, bem como melhoras significativas na vitalidade dos praticantes, tornando-se efetiva na redução dos níveis de ansiedade e na melhoria da qualidade de vida. Outros estudos avaliaram o benefício do yoga nos distúrbios de sono e também no alívio dos sintomas depressivos, encontrando resultados que sugerem a remissão desses sintomas ao mesmo tempo em que outros não foram conclusivos no desaparecimento desses sintomas (11)(12)(13)(14) .…”

Effects of yoga in managing fatigue in breast cancer patients: A randomized controlled trial

“…However, there is a paucity of studies showing effects of yogic intervention in reducing fatigue in advanced breast cancer patients. [ 33 34 ]…”