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

ABSTRACT: 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.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.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.ClinicalTrials.gov identifer: NCT01927081 , registered August 16, 2013.

SUBMITTER: Carson JW

PROVIDER: S-EPMC5348886 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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

Carson James W JW Carson Kimberly M KM Olsen Maren K MK Sanders Linda L Porter Laura S LS

BMC complementary and alternative medicine 20170313 1

<h4>Background</h4>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 ...[more]

PMID: 28288595

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Project description:Yoga is a popular mind-body therapy that has demonstrated beneficial effects on psychological, behavioral, and functional outcomes. However, few studies have investigated effects on inflammatory processes. This study tested the hypothesis that an Iyengar yoga intervention specifically designed for fatigued breast cancer survivors would lead to decreases in inflammation-related gene expression and circulating markers of proinflammatory cytokine activity.Breast cancer survivors with persistent cancer-related fatigue were randomized to a 12-week Iyengar yoga intervention (n=16) or a 12-week health education control condition (n=15). Blood samples were collected at baseline, post-intervention, and at a 3-month follow-up for genome-wide transcriptional profiling and bioinformatic analyses. Plasma inflammatory markers and salivary cortisol were also assessed.In promoter-based bioinformatics analyses, the yoga group showed reduced activity of the pro-inflammatory transcription factor nuclear factor kappa B (NF-?B), increased activity of the anti-inflammatory glucocorticoid receptor, and reduced activity of cAMP response element-binding protein (CREB) family transcription factors relative to controls (all ps<.05). There was also a significant intervention effect on the soluble tumor necrosis factor receptor type II (sTNF-RII), a marker of TNF activity; plasma levels of sTNF-RII remained stable in the yoga group, whereas levels of this marker increased in the health education group (p=.028). A similar, non-significant trend was observed for the interleukin 1 receptor antagonist (p=.16). No significant changes in C reactive protein (CRP), interleukin 6 (IL-6), or diurnal cortisol measures were observed.A 12-week restorative Iyengar yoga intervention reduced inflammation-related gene expression in breast cancer survivors with persistent fatigue. These findings suggest that a targeted yoga program may have beneficial effects on inflammatory activity in this patient population, with potential relevance for behavioral and physical health.

Project description:Osteoarthritis (OA) is a common problem in older women that is associated with pain and disabilities. Although yoga is recommended as an exercise intervention to manage arthritis, there is limited evidence documenting its effectiveness, with little known about its long term benefits. This study's aims were to assess the feasibility and potential efficacy of a Hatha yoga exercise program in managing OA-related symptoms in older women with knee OA.Eligible participants (N=36; mean age 72 years) were randomly assigned to 8-week yoga program involving group and home-based sessions or wait-list control. The yoga intervention program was developed by a group of yoga experts (N=5). The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score that measures knee OA pain, stiffness, and function at 8 weeks. The secondary outcomes, physical function of the lower extremities, body mass index (BMI), quality of sleep (QOS), and quality of life (QOL), were measured using weight, height, the short physical performance battery (SPPB), the Pittsburgh Sleep Quality Index (PSQI), the Cantril Self-Anchoring Ladder, and the SF12v2 Health Survey. Data were collected at baseline, 4 weeks and 8 weeks, and 20 weeks.The recruitment target was met, with study retention at 95%. Based on ANCOVAs, participants in the treatment group exhibited significantly greater improvement in WOMAC pain (adjusted means [SE]) (8.3 [.67], 5.8 [.67]; p=.01), stiffness (4.7 [.28], 3.4 [.28]; p=.002) and SPPB (repeated chair stands) (2.0 [.23], 2.8 [.23]; p=.03) at 8 weeks. Significant treatment and time effects were seen in WOMAC pain (7.0 [.46], 5.4 [.54]; p=.03), function (24.5 [1.8], 19.9 [1.6]; p=.01) and total scores (35.4 [2.3], 28.6 [2.1]; p=.01) from 4 to 20 weeks. Sleep disturbance was improved but the PSQI total score declined significantly at 20 weeks. Changes in BMI and QOL were not significant. No yoga related adverse events were observed.A weekly yoga program with home practice is feasible, acceptable, and safe for older women with knee OA, and shows therapeutic benefits.ClinicalTrials.gov: NCT01832155.

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

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

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