Feasibility of a meditation intervention for stroke survivors and informal caregivers: a randomized controlled trial.

BACKGROUND: Depressive symptoms are a significant psychological complication of stroke, impacting both survivors and informal caregivers of survivors. Randomized controlled trials are needed to determine optimal non-pharmacological strategies to prevent or ameliorate depressive symptoms in stroke survivors and their informal caregivers. METHODS: A prospective, randomized, parallel-group, single-center, feasibility study. Participants were assigned to a 4-week meditation intervention or expressive writing control group. The intervention comprised four facilitator-led group meditation sessions, one session per week and building upon prior session(s). Descriptive statistics were used to examine the proportion of eligible individuals who enrolled, retention and adherence rates, and the proportion of questionnaires completed. Data were collected at baseline, immediately after the 4-week intervention period, and 4 and 8 weeks after the intervention period. Secondary analysis tested for changes in symptoms of depression (Center for Epidemiologic Studies-Depression [CES-D]), anxiety [State-Trait Anxiety Inventory for Adults (STAI)], and pain (Brief Pain Inventory-Short Form) in the intervention group via paired t tests. Linear mixed models were used to compare longitudinal changes in the measures between the groups. Intervention and trial design acceptability were preliminary explored. RESULTS: Seventy-one (77%) individuals enrolled and 26 (37%) completed the study (baseline and 8-week post-intervention visits completed). Forty-two (66%) participants completed baseline and immediate post-intervention visits. Mean questionnaire completion rate was 95%. The median meditation group session attendance rate for the intervention group was 75.0%, and the mean attendance rate was 55%. Non-significant reductions in CES-D scores were found. Paired t tests for stroke survivors indicated a significant reduction from baseline through week 8 in BPI-sf severity scores (p = 0.0270). Repeated measures analysis with linear mixed models for informal caregivers indicated a significant reduction in in STAI-Trait scores (F [3,16.2] = 3.28, p = 0.0479) and paired t test showed a significant reduction from baseline to week 4 in STAI-Trait scores (mean = - 9.1250, 95% CI [- 16.8060 to 1.4440], p = 0.0262). No between-group differences were found. CONCLUSIONS: Future trials will require strategies to optimize retention and adherence before definitive efficacy testing of the meditation intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03239132. Registration date: 03/08/2017.

Self-administered Meditation Application Intervention for Cancer Patients With Psychosocial Distress: A Pilot Study.

BACKGROUND: We explored the use of a novel smart phone-based application (APP) for delivery and monitoring of meditation to treat mood symptoms experienced by cancer patients. METHODS: We assessed the feasibility of using a meditation delivery and tracking APP over 2-weeks and its impact on cancer patients' self-reported anxiety and depression. Outpatients reporting depression and/or anxiety were recruited and randomized to the APP or waitlist control group. Assessments included an expectancy scale, exit survey, mood rating before and after each meditation, and the Edmonton Symptom Assessment Scale (ESAS-FS), Hospital Anxiety and Depression Scale (HADS), and Pittsburgh Sleep Quality Index (PSQI) at baseline and after 2-weeks. The primary aim was to assess feasibility; secondary aims included satisfaction with the APP, association between meditation frequency and length with self-reported symptoms, and change in symptom measures (symptoms, anxiety, depression, and sleep). RESULTS: Our study included 35 participants (17 meditation group; 18 controls) who were primarily female (94%) with breast cancer (60%). The 61% enrollment rate and 71% adherence rate met pre-specified feasibility criteria. Most meditation group participants described the APP as "Useful" to "Very Useful" and would "Probably" or "Definitely" recommend its use. Mixed model analysis revealed a statistically significant association between meditation length (5, 10, or 15 minutes) and change in anxiety, with 15-minute sessions associated with greater reductions in anxiety. In the exit survey, more meditation group vs. control group participants reported improved focus, mood, and sleep. Study groups differed significantly by ESAS fatigue score change; the meditation group decreased a median of 1.5 pts (IQR 2.5) and the control group increased a median of 0.5 points (IQR 2). The meditation group, but not the control group, experienced statistically significant improvement in ESAS fatigue, depression, anxiety, appetite, and physical, psychological, and global distress. Change in PSQI and HADS anxiety and depression scores did not reveal any statistically significant between-group differences. CONCLUSIONS: This pilot study demonstrated the feasibility and acceptability of a meditation APP for cancer patients. Meditation APP users reported improvement in several measures of symptom distress. Future studies should explore ways to enhance the APP's usability and clinical benefit.

Sleep moderates the effects of Tibetan yoga for women with breast cancer undergoing chemotherapy.

This study examined self-reported and actigraphy-assessed sleep and depression as moderators of the effect of a Tibetan yoga intervention on sleep and depression among women undergoing chemotherapy for breast cancer. This is a secondary analysis of an RCT examining a 4-session Tibetan yoga program (TYP; n = 74) versus stretching program (STP; n = 68) or usual care (UC; n = 85) on self-reported sleep (Pittsburgh Sleep Quality Index (PSQI), actigraphy-assessed sleep efficiency (SE)) and depression (Centers for Epidemiological Studies Depression Scale; CES-D) for women undergoing chemotherapy for breast cancer. Data were collected at baseline and 1-week and 3-month post-intervention. Baseline PSQI, actigraphy-SE, and CES-D were examined as moderators of the effect of group on PSQI, actigraphy-SE, and CES-D 1 week and 3 months after treatment. There was a significant baseline actigraphy-SE × group effect on PSQI at 1 week (p < .001) and 3 months (p = .002) and on CES-D at 3 months (p = .049). Specifically, the negative association of baseline actigraphy-SE with subsequent PSQI and CES-D was buffered for women in the TYP and, to a lesser extent in STP, compared to those in the UC. Baseline PSQI and CES-D were not significant moderators of the effect of group on any outcome. Behaviorally assessed sleep may be a more robust indicator of which patients are most appropriate for a yoga intervention than self-reported sleep quality. Women with poor sleep efficiency may derive the greatest benefit in terms of sleep quality and mood from a yoga intervention.

A randomized trial of nurse-administered behavioral interventions to manage anticipatory nausea and vomiting in chemotherapy.

PURPOSE: Chemotherapy side effects diminish quality of life and can lead to treatment delay. Nausea and vomiting can occur prior to chemotherapy because of classical conditioning. We studied the effects of 20-minute behavioral interventions, administered by oncology nurses, of higher intensity (mindfulness relaxation-MR) or lower intensity (relaxing music-RM), on anticipatory nausea and vomiting (ANV). PATIENTS AND METHODS: Patients undergoing chemotherapy for solid tumors were randomized to MR (N = 160), RM (N = 159), or standard care SC (N = 155). Subjects were mostly female (91.8%) and white (86.1%) with breast cancer (85%). Most patients had early stage disease (Stage I: 26%; II: 52.9%; III: 19%; IV: 0.1%). Anticipatory nausea and vomiting were assessed at the midpoint and end of the chemotherapy course using the Morrow Assessment of Nausea and Emesis (MANE). RESULTS: Compared to SC, there was reduced anticipatory nausea at the midpoint of chemotherapy in those receiving MR (OR 0.44, 95% CI 0.20-0.93) and RM (OR 0.40, 95% CI 0.20-0.93), controlling for age, sex, cancer stage, and emetogenic level of chemotherapy. There was no difference between treatment groups in anticipatory nausea at the end of chemotherapy or in anticipatory vomiting and postchemotherapy nausea and vomiting at either time point. CONCLUSION: A brief nurse-delivered behavioral intervention can reduce midpoint ANV associated with chemotherapy.

Feasibility and acceptability of a faith-based mind-body intervention among African American adults.

Physical activity reduces cancer risk, yet African American adults remain insufficiently active, contributing to cancer health disparities. Harmony & Health (HH) was developed as a culturally adapted mind-body intervention to promote physical activity, psychosocial well-being, and quality of life among a church-based sample of overweight/obese, insufficiently active African American adults. Men and women were recruited to the study through an existing church partnership. Eligible participants (N = 50) were randomized to a movement-based mind-body intervention (n = 26) or waitlist control (n = 24). Participants in the intervention attended 16 mind-body sessions over 8 weeks and completed a physical assessment, questionnaires on moderate-to-vigorous physical activity (MVPA) and psychosocial factors, and accelerometry at baseline (T1), post-intervention (T2), and 6 week follow-up (T3). Eighty percent of participants (94% women, M age = 49.7 ± 9.4 years, M body mass index = 32.8 ± 5.2 kg/m2) completed the study, and 61.5% of intervention participants attended ≥10 mind-body sessions. Participants self-reported doing 78.8 ± 102.9 (median = 40.7, range: 0-470.7) min/day of MVPA and did 27.1 ± 20.7 (median = 22.0, range: 0-100.5) min/day of accelerometer-measured MVPA at baseline. Trends suggest that mind-body participants self-reported greater improvements in physical activity and psychosocial well-being from baseline to post-intervention than waitlist control participants. HH is feasible and acceptable among African American adults. Trends suggest that the mind-body intervention led to improvements in physical activity and psychosocial outcomes. This study extends the literature on the use of mind-body practices to promote physical and psychological health and reduce cancer disparities in African American adults.

Efficacy of combining home-based transcranial direct current stimulation with mindfulness-based meditation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study.

Transcranial direct current stimulation (tDCS) has been shown to be effective for reducing pain, and a growing body of literature shows the potential analgesic effects of mindfulness-based meditation (MBM). However, few studies have investigated the potential benefits associated with combining tDCS and MBM in older adults with knee osteoarthritis (OA). Therefore, the aim of this study was to examine the feasibility and preliminary efficacy of home-based tDCS paired with MBM in older adults with knee OA. Thirty participants 50-85 years old with symptomatic knee OA were randomly assigned to receive 10 daily sessions of home-based 2 mA tDCS paired with active MBM for 20 min (n = 15) or sham tDCS paired with sham MBM (n = 15). We measured clinical pain and OA symptoms via a Numeric Rating Scale and the Western Ontario and McMaster Universities Osteoarthritis Index. Pressure pain sensitivity and conditioned pain modulation were measured using quantitative sensory testing. Participant satisfaction and side effects were assessed via a questionnaire. Active tDCS paired with active MBM significantly reduced scores on the Numeric Rating Scale and Western Ontario and McMaster Universities Osteoarthritis Index and increased pressure pain thresholds and conditioned pain modulation. Participants tolerated tDCS paired with MBM well without serious adverse effects and were satisfied with the treatment. Our findings demonstrate promising clinical efficacy of home-based tDCS paired with MBM for older adults with knee OA.

Mind-Body Interventions, Psychological Stressors, and Quality of Life in Stroke Survivors.

Background and Purpose- Psychological stressors, including poststroke depression, poststroke anxiety, and posttraumatic stress disorder, are highly prevalent in stroke survivors. These symptoms exact a significant toll on stroke survivors. Clinical and research efforts in stroke recovery focus on motor disability, speech and language deficits, and cognitive dysfunction while largely neglecting psychological stressors. Evidence suggests mind-body interventions in other chronic illness populations decrease symptoms of depression, regulate immune responses, and promote resilience, yet similar studies are lacking in stroke populations. This review aims to synthesize evidence of the effects of mind-body interventions on psychological stressors, quality of life, and biological outcomes for stroke survivors. Methods- A systematic search of PubMed, PsycINFO, and CINAHL was conducted from database inception to November 2017. Results- Eight studies were included in the review, with a total of 292 participants. Mind-body interventions included yoga or tai chi. Of the 5 included randomized controlled trials, most were pilot or feasibility studies with small sample sizes. Psychological stressors, including poststroke depression and anxiety, along with the quality of life, improved over time, but statistically significant between-group differences were largely absent. The 3 included studies with a qualitative design reported themes reflecting improvement in psychological stressors and quality of life. No included studies reported biological outcomes. Conclusions- Studies of mind-body interventions suggest a possible benefit on psychological stressors and quality of life; however, rigorously designed, sufficiently powered randomized controlled trials with mixed-methods design are warranted to delineate specific treatment effects of these interventions. Studies with both biological and psychological stressors as outcomes would provide evidence about interaction effects of these factors on stroke-survivor responses to mind-body interventions.

A Randomized Controlled Trial of Brief Mindfulness Meditation for Women Undergoing Stereotactic Breast Biopsy.

PURPOSE: Stereotactic breast biopsy (SBB) is a common, anxiety-producing procedure. Nonpharmacologic methods to manage acute anxiety are needed. METHODS: In this single-blind trial, women were recruited before SBB and randomized in a 2:2:1 ratio to a single session of guided mindfulness-based meditation (GM; n = 30), focused breathing (FB; n = 30), or standard care (SC; n = 16). Anxiety and pain were assessed at baseline after a 10-min prebiopsy group-specific activity (GM, FB, or SC), every 4 min during SBB, and after biopsy. Electroencephalographic activity in the medial prefrontal cortex, insula, anterior cingulate cortex, and precuneus was collected throughout the study. RESULTS: Women in the GM group reported a steeper reduction in anxiety than women in the FB and SC groups (P < .001 for all, Cohen's d > 0.4 for all). There were no group differences in pain ratings during the biopsy. Women in the GM group experienced increased beta activity during biopsy in the insula (P = .006, Cohen's d = 1.4) and anterior cingulate cortex (P = .019, Cohen's d = 1.0) compared with women in the SC group, and there was a trend toward the same effect compared with women in the FB group (P < .10 for both). Women in the GM and FB groups experienced a nonsignificant decrease in delta activity in the precuneus during biopsy compared with those in the SC group (P < .40 for both, Cohen's d > 0.6 for both), which was associated with a steeper reduction in anxiety during the biopsy (r = 0.51, P < .01). CONCLUSIONS: Brief, guided meditation may provide effective anxiety relief during an acute medical procedure and affect neuronal activity in regions associated with attention, self-awareness, and emotion regulation.

Group Yoga Effects on Cancer Patient and Caregiver Symptom Distress: Assessment of Self-reported Symptoms at a Comprehensive Cancer Center.

BACKGROUND: Complementary and integrative health approaches such as yoga provide support for psychosocial health. We explored the effects of group-based yoga classes offered through an integrative medicine center at a comprehensive cancer center. METHODS: Patients and caregivers had access to two yoga group classes: a lower intensity (YLow) or higher intensity (YHigh) class. Participants completed the Edmonton Symptom Assessment System (ESAS; scale 0-10, 10 most severe) immediately before and after the class. ESAS subscales analyzed included global (GDS; score 0-90), physical (PHS; 0-60), and psychological distress (PSS; 0-20). Data were analyzed examining pre-yoga and post-yoga symptom scores using paired t-tests and between types of classes using ANOVAs. RESULTS: From July 18, 2016, to August 8, 2017, 282 unique participants (205 patients, 77 caregivers; 85% female; ages 20-79 years) attended one or more yoga groups (mean 2.3). For all participants, we observed clinically significant reduction/improvement in GDS, PHS, and PSS scores and in symptoms (ESAS decrease ≥1; means) of anxiety, fatigue, well-being, depression, appetite, drowsiness, and sleep. Clinically significant improvement for both patients and caregivers was observed for anxiety, depression, fatigue, well-being, and all ESAS subscales. Comparing yoga groups, YLow contributed to greater improvement in sleep versus YHigh (-1.33 vs -0.50, P = .054). Improvement in fatigue for YLow was the greatest mean change (YLow -2.12). CONCLUSION: A single yoga group class resulted in clinically meaningful improvement of multiple self-reported symptoms. Further research is needed to better understand how yoga class content, intensity, and duration can affect outcomes.

A Pragmatic Evaluation of Symptom Distress After Group Meditation for Cancer Patients and Caregivers: A Preliminary Report.

CONTEXT: Complementary health approaches such as meditation may help improve cancer patient and caregiver symptoms, yet little research has examined the clinical application of these programs. OBJECTIVES: We explored the effects of a meditation group class, offered as part of an integrative medicine clinic at a comprehensive cancer center, on patient and caregiver self-reported symptoms. METHODS: Participants (patients and caregivers) of any three meditation group classes offered-Power of Breath (PB), Sacred Sounds (SS), and Movement & Breath (MB)-were asked to complete the Edmonton Symptom Assessment Scale (ESAS; scale 0-10, 10 most severe) before and after participation. ESAS individual items and subscales were analyzed; distress subscales included global (global distress score 0-90), physical (physical distress score 0-60), and psychological (psychological distress score, 0-20). Data were analyzed examining premeditation/postmeditation scores using paired t-tests and between types of meditation using analyses of variance. RESULTS: One hundred forty-two unique participants (76 patients and 66 caregivers) attended one or more meditation groups (mean 1.84) from May to December 2015 (265 total attendance: PB n = 92; SS n = 87; MB n = 86). For all participants, we observed clinically significant reduction/improvement in global distress scores (-5.17, SD 8; P < 0.0001) and in individual symptoms (ESAS decrease ≥ 1; means) of well-being (-1.36 SD 1.7; P < 0.0001), fatigue (-1.34 SD 1.9; P < 0.0001), anxiety (-1.26 SD 1.6; P < 0.001), and shortness of breath (-1.2 SD 2; P = 0.001). Comparing class length (60 vs. 90 minutes), class content (PB vs. SS vs. MB), and participants (caregivers vs. patients), there were no statistically significant differences in symptom score reduction. CONCLUSION: A single meditation group class offered as part of clinical care resulted in relief of multiple self-reported symptoms in both patients and caregivers.

Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy.

BACKGROUND: The current randomized trial examined the effects of a Tibetan yoga program (TYP) versus a stretching program (STP) and usual care (UC) on sleep and fatigue in women with breast cancer who were undergoing chemotherapy. METHODS: Women with stage (American Joint Committee on Cancer (AJCC) TNM) I to III breast cancer who were undergoing chemotherapy were randomized to TYP (74 women), STP (68 women), or UC (85 women). Participants in the TYP and STP groups participated in 4 sessions during chemotherapy, followed by 3 booster sessions over the subsequent 6 months, and were encouraged to practice at home. Self-report measures of sleep disturbances (Pittsburgh Sleep Quality Index), fatigue (Brief Fatigue Inventory), and actigraphy were collected at baseline; 1 week after treatment; and at 3, 6, and 12 months. RESULTS: There were no group differences noted in total sleep disturbances or fatigue levels over time. However, patients in the TYP group reported fewer daily disturbances 1 week after treatment compared with those in the STP (difference, -0.43; 95% confidence interval [95% CI], -0.82 to -0.04 [P = .03]) and UC (difference, -0.41; 95% CI, -0.77 to -0.05 [P = .02]) groups. Group differences at the other time points were maintained for TYP versus STP. Actigraphy data revealed greater minutes awake after sleep onset for patients in the STP group 1 week after treatment versus those in the TYP (difference, 15.36; 95% CI, 7.25-23.48 [P = .0003]) and UC (difference, 14.48; 95% CI, 7.09-21.87 [P = .0002]) groups. Patients in the TYP group who practiced at least 2 times a week during follow-up reported better Pittsburgh Sleep Quality Index and actigraphy outcomes at 3 months and 6 months after treatment compared with those who did not and better outcomes compared with those in the UC group. CONCLUSIONS: Participating in TYP during chemotherapy resulted in modest short-term benefits in sleep quality, with long-term benefits emerging over time for those who practiced TYP at least 2 times a week. Cancer 2018;124:36-45. © 2017 American Cancer Society.

Inpatient Acupuncture at a Major Cancer Center.

BACKGROUND: Use of complementary and integrative therapies is increasing among cancer patients, but data regarding the impact treatments such as acupuncture have in an inpatient oncology setting are limited. METHODS: Patients who received acupuncture in an inpatient hospital environment between December 2014 and December 2015 were asked to complete a modified Edmonton Symptom Assessment Scale (ESAS; 0-10 scale) before and after each visit. Pre- and post-treatment scores were examined for each symptom using paired t tests. RESULTS: A total of 172 inpatients were treated with acupuncture in their hospital beds (257 visits). Thirty percent (n = 51) received at least one additional follow-up treatment (mean visits/patient = 1.5). Completion rate of the modified ESAS after acupuncture was 42%. The most common reasons for not completing the post-treatment ESAS were "patient too drowsy" or "patient fell asleep" (72%). For patients who reported a baseline symptom score ≥1, the greatest improvements (mean change ± SD) after acupuncture on the initial visit were found for pain (-1.8 ± 2.2; n = 69; P < .0001), nausea (-1.2 ± 1.9; n = 30; P < .001), anxiety (-0.8 ± 1.8; n = 36; P = .01), drowsiness (-0.6 ± 1.8; n = 57; P = .02), and fatigue (-0.4 ± 1.1; n = 67; P = .008). For patients who received at least one follow-up visit, significant improvement from baseline was found for sleep disturbance (-2.5 ± 4.4; n = 17; P = .03), anxiety (-2.4 ± 1.7; n = 9; P = .002), pain (-2.3 ± 2.7; n = 20; P = .001), and drowsiness (-2.0 ± 2.6; n = 16; P = .008). CONCLUSIONS: Patients who received inpatient acupuncture at a major cancer center experienced significant improvement after treatment for pain, sleep disturbance, anxiety, drowsiness, nausea, and fatigue.

Pilot Testing of a Brief Couple-Based Mind-Body Intervention for Patients With Metastatic Non-Small Cell Lung Cancer and Their Partners.

CONTEXT: Given the generally incurable nature of metastatic lung cancer, patients and their spouses/partners are at risk for psychological and spiritual distress. To address this concern, we developed a couple-based mind-body (CBMB) intervention. OBJECTIVES: This formative research aimed at examining the intervention's acceptability and initial efficacy in patients with metastatic lung cancer undergoing treatment and their spouses. METHODS: Intervention content evaluation sessions and an ensuing single-arm trial were conducted. To evaluate intervention content, participants performed intervention exercises and then participated in semistructured interviews and completed written evaluations. In the single-arm trial, four intervention sessions were delivered over two weeks, focusing on cultivating mindfulness, interpersonal connection, gratitude, and purpose. Newly recruited couples completed measures of depressive symptoms, cancer distress, spiritual well-being, and sleep disturbances before and after the intervention. RESULTS: Content evaluations by seven dyads of patients and their partners revealed high acceptability ratings for the CBMB intervention (e.g., all participants would recommend the intervention). Consent and adherence rates (54% and 67%, respectively) were acceptable in the single-arm trial. All patients (n = 7 dyads; 67% male; mean age, 55 years) and partners (33% male; mean age, 59 years) rated the intervention as useful. Paired t-test analyses revealed large effect sizes for reduced sleep disturbances (d = 1.83) and medium effect sizes for cancer-specific distress (d = 0.61) for patients and large effect sizes for depressive symptoms (d = 0.90) for partners. CONCLUSION: Based on these results, the CBMB intervention appears to be acceptable and subjectively useful. In addition, we observed preliminary evidence of quality of life gains in both patients and their partners.

Review of yoga therapy during cancer treatment.

PURPOSE: Reviews of yoga research that distinguish results of trials conducted during (versus after) cancer treatment are needed to guide future research and clinical practice. We therefore conducted a review of non-randomized studies and randomized controlled trials of yoga interventions for children and adults undergoing treatment for any cancer type. METHODS: Studies were identified via research databases and reference lists. Inclusion criteria were the following: (1) children or adults undergoing cancer treatment, (2) intervention stated as yoga or component of yoga, and (3) publication in English in peer-reviewed journals through October 2015. Exclusion criteria were the following: (1) samples receiving hormone therapy only, (2) interventions involving meditation only, and (3) yoga delivered within broader cancer recovery or mindfulness-based stress reduction programs. RESULTS: Results of non-randomized (adult n = 8, pediatric n = 4) and randomized controlled trials (adult n = 13, pediatric n = 0) conducted during cancer treatment are summarized separately by age group. Findings most consistently support improvement in psychological outcomes (e.g., depression, distress, anxiety). Several studies also found that yoga enhanced quality of life, though further investigation is needed to clarify domain-specific efficacy (e.g., physical, social, cancer-specific). Regarding physical and biomedical outcomes, evidence increasingly suggests that yoga ameliorates sleep and fatigue; additional research is needed to advance preliminary findings for other treatment sequelae and stress/immunity biomarkers. CONCLUSIONS: Among adults undergoing cancer treatment, evidence supports recommending yoga for improving psychological outcomes, with potential for also improving physical symptoms. Evidence is insufficient to evaluate the efficacy of yoga in pediatric oncology. We describe suggestions for strengthening yoga research methodology to inform clinical practice guidelines.

A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience.

BACKGROUND: Although epidemiological research demonstrates that there is an association between lifestyle factors and risk of breast cancer recurrence, progression of disease, and mortality, no comprehensive lifestyle change clinical trials have been conducted to determine if changing multiple risk factors leads to changes in biobehavioral processes and clinical outcomes in women with breast cancer. This article describes the design, feasibility, adherence to the intervention and data collection, and patient experience of a comprehensive lifestyle change clinical trial (CompLife). METHODS: CompLife is a randomized, controlled trial of a multiple-behavior intervention focusing on diet, exercise, and mind-body practice along with behavioral counseling to support change. The initial exposure to the intervention takes place during the 4 to 6 weeks of radiotherapy (XRT) for women with stage III breast cancer and then across the subsequent 12 months. The intervention group will have 42 hours of in-person lifestyle counseling during XRT (7-10 hours a week) followed by up to 30 hours of counseling via video connection for the subsequent 12 months (weekly sessions for 6 months and then monthly for 6 months). The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) patient-reported outcomes; (4) dietary patterns/fitness levels, anthropometrics, and body composition; and (5) economic outcomes. Qualitative data of the patient experience in the trial is collected from exit interviews, concluding remarks, direct email correspondences, and web postings from patients. RESULTS: Fifty-five patients have been recruited and randomized to the trial to date. Accrual of eligible patients is high (72%) and dropout rates extremely low (5%). Attendance to the in-person sessions is high (95% attending greater than 80% of sessions) as well as to the 30 hours of video counseling (88% attending more than 70% of sessions). Adherence to components of the behavior change intervention is high and compliance with the intensive amount of data collection is exceptional. Qualitative data collected from the participants reveals testimonials supporting the importance of the comprehensive nature of intervention, especially the mind-body/mindfulness component and social support, and meaningful lifestyle transformations. CONCLUSION: Conducting a comprehensive, multicomponent, lifestyle change clinical trial for women with breast was feasible and collection of biobehavioral outcomes successful. Adherence to behavior change was high and patient experience was overwhelmingly positive.

Examining Mediators and Moderators of Yoga for Women With Breast Cancer Undergoing Radiotherapy.

Hypothesis This study examines moderators and mediators of a yoga intervention targeting quality-of-life (QOL) outcomes in women with breast cancer receiving radiotherapy.Methods Women undergoing 6 weeks of radiotherapy were randomized to a yoga (YG; n = 53) or stretching (ST; n = 56) intervention or a waitlist control group (WL; n = 54). Depressive symptoms and sleep disturbances were measured at baseline. Mediator (posttraumatic stress symptoms, benefit finding, and cortisol slope) and outcome (36-item Short Form [SF]-36 mental and physical component scales [MCS and PCS]) variables were assessed at baseline, end-of-treatment, and 1-, 3-, and 6-months posttreatment. Results Baseline depressive symptoms (P = .03) and sleep disturbances (P < .01) moderated the Group × Time effect on MCS, but not PCS. Women with high baseline depressive symptoms in YG reported marginally higher 3-month MCS than their counterparts in WL (P = .11). Women with high baseline sleep disturbances in YG reported higher 3-months MCS than their counterparts in WL (P < .01) and higher 6-month MCS than their counterparts in ST (P = .01). YG led to greater benefit finding than ST and WL across the follow-up (P = .01). Three-month benefit finding partially mediated the effect of YG on 6-month PCS. Posttraumatic stress symptoms and cortisol slope did not mediate treatment effect on QOL. Conclusion Yoga may provide the greatest mental-health-related QOL benefits for those experiencing pre-radiotherapy sleep disturbance and depressive symptoms. Yoga may improve physical-health-related QOL by increasing ability to find benefit in the cancer experience.

Vivekananda Yoga Program for Patients With Advanced Lung Cancer and Their Family Caregivers.

BACKGROUND: The primary purpose of this study was to establish the feasibility of a couple-based Vivekananda Yoga (VKC) intervention in lung cancer patients and caregivers. Secondly, we examined preliminary efficacy regarding quality of life (QOL) outcomes. METHOD: In this single-arm feasibility trial, patients with lung cancer undergoing radiotherapy and their caregivers participated in a 15-session VKC program that focused on the interconnectedness of the dyad. We assessed pre-and post-intervention levels of fatigue, sleep disturbances, psychological distress, overall QOL, spirituality, and relational closeness. We tracked feasibility data, and participants completed program evaluations. RESULTS: We approached 28 eligible dyads of which 15 (53%) consented and 9 (60%) completed the intervention. Patients (mean age = 73 years, 63% female, all stage III) and caregivers (mean age = 62 years, 38% female, 63% spouses) completed a mean of 10 sessions and 95.5% of them rated the program as very useful. Paired t tests revealed a significant increase in patients' mental health (d = 0.84; P = .04) and a significant decrease in caregivers' sleep disturbances (d = 1.44; P = .02). Although not statistically significant, for patients, effect sizes for change scores were medium for benefit finding and small for distress (d = 0.65 and 0.37, respectively). For caregivers, medium effects were found for improvement in physical functioning (d = 0.50). CONCLUSION: This novel supportive care program appears to be safe, feasible, acceptable, and subjectively useful for lung cancer patients and their caregivers and lends support for further study.

Mind-body practices in cancer care.

Being diagnosed with a life-threatening disease such as cancer and undergoing treatment can cause unwanted distress and interferes with quality of life. Uncontrolled stress can have a negative effect on a number of biological systems and processes leading to negative health outcomes. While some distress is normal, it is not benign and must be addressed, as failure to do so may compromise health and QOL outcomes. We present the evidence for the role of stress in cancer biology and mechanisms demonstrating how distress is associated with worse clinical outcomes. The National Comprehensive Cancer Network states that all patients be screened with the single-item distress thermometer and to also indicate the source of distress and to get appropriate referral. In addition to the many conventional approaches for managing distress from the fields of psychology and psychiatry, many patients are seeking strategies to manage their distress that are outside conventional medicine such as mind-body techniques. Mind-body techniques such as meditation, yoga, tai chi, and qigong have been found to lower distress and lead to improvements in different aspects of quality of life. It is essential that the standard of care in oncology include distress screening and the delivery of different techniques to help patients manage the psychosocial challenges of diagnosis and treatment of cancer.

Randomized, controlled trial of yoga in women with breast cancer undergoing radiotherapy.

PURPOSE: Previous research incorporating yoga (YG) into radiotherapy (XRT) for women with breast cancer finds improved quality of life (QOL). However, shortcomings in this research limit the findings. PATIENTS AND METHODS: Patients with stages 0 to III breast cancer were recruited before starting XRT and were randomly assigned to YG (n = 53) or stretching (ST; n = 56) three times a week for 6 weeks during XRT or waitlist (WL; n = 54) control. Self-report measures of QOL (Medical Outcomes Study 36-item short-form survey; primary outcomes), fatigue, depression, and sleep quality, and five saliva samples per day for 3 consecutive days were collected at baseline, end of treatment, and 1, 3, and 6 months later. RESULTS: The YG group had significantly greater increases in physical component scale scores compared with the WL group at 1 and 3 months after XRT (P = .01 and P = .01). At 1, 3, and 6 months, the YG group had greater increases in physical functioning compared with both ST and WL groups (P < .05), with ST and WL differences at only 3 months (P < .02). The group differences were similar for general health reports. By the end of XRT, the YG and ST groups also had a reduction in fatigue (P < .05). There were no group differences for mental health and sleep quality. Cortisol slope was steepest for the YG group compared with the ST and WL groups at the end (P = .023 and P = .008) and 1 month after XRT (P = .05 and P = .04). CONCLUSION: YG improved QOL and physiological changes associated with XRT beyond the benefits of simple ST exercises, and these benefits appear to have long-term durability.