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Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors.

ABSTRACT: PURPOSE:Cancer-related fatigue (CRF) is a disruptive symptom for many survivors. Despite promising evidence for efficacy of mindfulness-based stress reduction (MBSR) in reducing CRF, no trials comparing it to an active comparator for fatigued survivors have been published. The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms. METHODS:Breast (n = 60) and colorectal (n = 11) cancer survivors (stage 0-III) with clinically significant CRF after completing chemotherapy and/or radiation therapy an average of 28 months prior to enrollment were randomized to MBSR or psychoeducation/support groups (PES). MBSR focused on mindfulness training; PES focused on CRF self-management. Outcomes included CRF interference (primary), CRF severity and global improvement, vitality, depression, anxiety, sleep disturbance, and pain. Outcomes were assessed at baseline (T1), post-intervention (T2), and 6-month follow-up (T3) using intent-to-treat analysis. RESULTS:Between-group differences in CRF interference were not significant at any time point; however, there was a trend favoring MBSR (d = -0.46, p = 0.073) at T2. MBSR participants reported significantly greater improvement in vitality (d = 0.53, p = 0.003) and were more likely to report CRF as moderately to completely improved compared to the PES group (?2 (1) = 4.1765, p = 0.041) at T2. MBSR participants also reported significantly greater reductions in pain at T2 (d = 0.53, p = 0.014). In addition, both MBSR and PES produced moderate-to-large and significant within-group improvements in all fatigue outcomes, depression, anxiety, and sleep at T2 and T3 compared to T1. CONCLUSION:MBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01724333.

SUBMITTER: Johns SA

PROVIDER: S-EPMC5221754 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors.

Johns Shelley A SA Brown Linda F LF Beck-Coon Kathleen K Talib Tasneem L TL Monahan Patrick O PO Giesler R Brian RB Tong Yan Y Wilhelm Laura L Carpenter Janet S JS Von Ah Diane D Wagner Christina D CD de Groot Mary M Schmidt Karen K Monceski Diane D Danh Marie M Alyea Jennifer M JM Miller Kathy D KD Kroenke Kurt K

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20160517 10

<h4>Purpose</h4>Cancer-related fatigue (CRF) is a disruptive symptom for many survivors. Despite promising evidence for efficacy of mindfulness-based stress reduction (MBSR) in reducing CRF, no trials comparing it to an active comparator for fatigued survivors have been published. The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms.<h4>Methods</h4>Breast (n = 60) and colorectal (n = 11) cancer survivors (stage 0-III) with clinically significant CRF af ...[more]

PMID: 27189614

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Project description:ObjectiveCancer-related fatigue (CRF) is one of the most common, persistent, and disabling symptoms associated with cancer and its treatment. Evidence-based treatments that are acceptable to patients are critically needed. This study examined the efficacy of mindfulness-based stress reduction (MBSR) for CRF and related symptoms.MethodA sample of 35 cancer survivors with clinically significant CRF was randomly assigned to a 7-week MBSR-based intervention or wait-list control group. The intervention group received training in mindfulness meditation, yoga, and self-regulatory responses to stress. Fatigue interference (primary outcome) and a variety of secondary outcomes (e.g., fatigue severity, vitality, disability, depression, anxiety, and sleep disturbance) were assessed at baseline, post-intervention, and 1-month follow-up. Bonferroni correction was employed to account for multiple comparisons. Controls received the intervention after the 1-month follow-up. Participants in both groups were followed for 6 months after completing their respective MBSR courses to assess maintenance of effects.ResultsCompared to controls, the MBSR group reported large post-intervention reductions as assessed by effect sizes (d) in the primary outcome, fatigue interference (d = -1.43, p < 0.001), along with fatigue severity (d = -1.55, p < 0.001), vitality (d = 1.29, p < 0.001), depression (d = -1.30, p < 0.001), and sleep disturbance (d = -0.74, p = 0.001). Results were maintained or strengthened at 1-month follow-up, the point at which significant improvements in disability (d = -1.22, p < 0.002) and anxiety (d = -0.98, p = 0.002) occurred. Improvements in all outcomes were maintained 6 months after completing the course. MBSR adherence was high, with 90% attendance across groups and high rates of participant-reported home practice of mindfulness.ConclusionsMindfulness-based stress reduction is a promising treatment for CRF and associated symptoms.

Project description:BackgroundStroke is one of the leading causes of disability in China and worldwide, affecting the health and well-being of both stroke survivors and their family caregivers (i.e. stroke dyads). Dyadic interventions targeting both as active participants can be beneficial for the dyads' health and well-being. Psychoeducation is a potentially acceptable approach to developing participants' knowledge about their disease management to promote their recovery. This study aims to explore the feasibility, acceptability, and preliminary effects of a family-focused dyadic psychoeducational intervention for stroke dyads.MethodsThis study was a single-blinded, parallel-group randomised controlled trial. Totally, a convenience sample of 40 stroke dyads was recruited. The intervention included three in-hospital face-to-face education sessions and four weekly post-discharge follow-up telephone counselling sessions. Feasibility was assessed by the rates of recruitment, attritions, and adherence to the intervention. Acceptability was evaluated via semi-structured qualitative interviews. Preliminary intervention effects were evaluated on primary (survivors' functioning and caregivers' burden) and secondary (caregivers' competence and dyads' coping, depressive and anxiety symptoms, family functioning, and dyadic relationship) outcomes.ResultsIntervention feasibility was established with satisfactory recruitment (76.9%), attrition (10%), and intervention completion (75%) rates. Qualitative interviews suggested that the intervention was acceptable and useful to stroke dyads. The intervention effects on survivors' functioning were significant in the memory and thinking (F = 8.39, p = 0.022, η = 0.18) and mobility (F = 5.37, p = 0.026, η = 0.12) domains, but not significant on their overall functioning (F = 2.39, p = 0.131). Caregiver burden in the intervention group was significantly greater reduced at post-test than the control group, with a large effect size (F = 7.55, p = 0.013, η = 0.28). For secondary outcomes, this intervention suggested a significant effect on caregivers' competence (F = 5.20, p = 0.034, η = 0.22), but non-significant effects on other outcomes.ConclusionsThe family-focused dyadic psychoeducation programme was feasible and acceptable for stroke dyads and showed preliminary effects for stroke dyads. These findings support a larger-scale controlled trial to further examine its intervention effects over a longer-term follow-up.Trial registrationThis study was retrospectively registered as a randomised controlled trial in the ISRCTN Registry. Registration Date: October 10, 2022.Registration numberISRCTN18158500.

Project description:Pre-symptomatic frontotemporal dementia (FTD) mutation carriers and first-degree family members that are 50% at-risk for FTD may experience symptoms of anxiety and depression as a result of the ambiguity of when or if symptoms of the disease will manifest. We conducted a pilot study to investigate the use of an online mindfulness-based stress reduction (MBSR) course to reduce symptoms of anxiety and depression in presymptomatic frontotemporal dementia (FTD) mutation carriers and individuals 50% at-risk. Seven known mutation carriers and six individuals 50% at-risk completed a standardized 8-week MBSR course, and filled out pre- and post and two-month follow-up questionnaires. The primary outcome measure was the Hospital Anxiety and Depression Scale (HADS). Measures of psychological distress (SCL-90-R), coping style (UCL), quality of life (SF-36) and mindfulness skills (FFMQ) were administered as secondary outcome. Group effects were analyzed with repeated measures ANOVA or Friedman's test, and the individual reliability change index (RCI) was calculated per participant for each outcome measure. Semi-quantitative data included an evaluation and process measure post-intervention. Significant decline was found on the HADS-A post-intervention and after 2 months (p = 0.01), with 54% and 62% of participants demonstrating a clinically significant RCI, respectively. On the HADS-D, significant decline was found 2 months post-intervention (p = 0.04), which was driven by 23% of participants whom had a clinically significant RCI. Additional changes were found between baseline and post-intervention on the seeking distraction and reassuring thoughts subscales of the UCL, the depression and interpersonal sensitivity subscales of the SCL, the observe subscale of the FFMQ, and on physical role limitations of the SF-36 (all p < 0.05). The process evaluation form indicated that the course was found beneficial by participants, and that they applied it in a wide range of everyday situations. This exploratory pilot study indicates the feasibility of MBSR in reducing anxiety and depression in presymptomatic FTD mutation carriers and 50% at-risk individuals. A randomized controlled trial is necessary to replicate these results.

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.

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Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors.

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Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors.

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