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.

Systematic review of acupuncture to control hot flashes in cancer patients.

Hot flashes (HFs) are a common side effect of cancer treatment. The purpose of this systematic review was to evaluate evidence related to the use of acupuncture for HFs in cancer patients. EMBASE, MEDLINE, Cochrane (all databases), PubMed, the Cumulative Index to Nursing and Allied Health Literature, and Scopus were searched from their inception through December 2014. Included studies had to be randomized controlled trials with a usual-care and/or placebo comparison group that investigated acupuncture to treat HFs in cancer patients. No language limits were applied. The risk of bias (ROB) was rated as low, high, or unclear according to Cochrane criteria. Both within-group and between-group changes were evaluated. Four hundred two items were identified, and 192 duplicates were omitted; this left 210 publications to be screened. Eight studies met the inclusion criteria, and all involved women with breast cancer. All studies showed significant within-group improvement from the baseline for true acupuncture (TA). One study showed significant improvement in favor of TA over sham acupuncture (SA; P < .001), 1 study found in favor of TA over SA for nighttime HFs only (P = .03), and 1 study found in favor of TA over SA or untreated controls (P < .01 and P < .001, respectively). Between-group (TA vs SA) effect size (ES) estimates for daytime and nighttime HFs were calculated (ES range, 0.04-0.9) whenever possible. No studies were rated with a low ROB. In conclusion, the current level of evidence is insufficient to either support or refute the benefits of acupuncture for the management of HFs in cancer patients. Future studies should provide within-group and between-group ES estimates in addition to P values.

Acupuncture for symptom management in cancer care: an update.

In a previous systematic review of the worldwide literature of randomized controlled trials (RCTs) involving needle insertion into acupuncture points for symptom management in cancer patients, we identified only one high-quality RCT that was deemed to have a low risk of bias. Medline, Embase, CINAHL, Cochrane (all databases), Scopus, and PubMed were searched from inception through December 2011 with no language limits applied. A total of 41 RCTs met all inclusion criteria and were rated. In the current review, we examined 18 trials published since our last report. The purpose of this update was to emphasize important recent findings and discuss how concerns such as blinding, separating non-specific placebo effects from specific needling effects, determining biologic mechanisms and dosing parameters, evaluating determinants of response such as expectation, controlling for sources of bias, and the lack of standardization in treatment and study methods may affect the interpretation of study results.

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.

Acupuncture for treatment of uncontrolled pain in cancer patients: a pragmatic pilot study.

PURPOSE: Pain control is an ongoing challenge in the oncology setting. Prior to implementing a large randomized trial at our institution, we investigated the feasibility, safety, and initial efficacy of acupuncture for uncontrolled pain among cancer patients. HYPOTHESES: Our hypotheses were that the acupuncture treatments provided would be ( : ) feasible, ( : ) safe, and ( : ) a beneficial adjunct to pain management. STUDY DESIGN: This was a single arm, nonrandomized pragmatic pilot study. METHODS: Participants experiencing pain ≥4 on a 0 to 10 numeric rating scale received a maximum of 10 treatments on an individualized basis. Recruitment, attrition, compliance, and adverse events (AEs) were assessed. Pain (Brief Pain Inventory-Short Form), quality of life (MD Anderson Symptom Inventory [MDASI]), and patient satisfaction were assessed at baseline and at the end of treatment. RESULTS: Of 115 patients screened, 52 (45%) were eligible and agreed to participate. Eleven (21%) were lost to follow-up, leaving 41 who completed all study procedures. No AEs were reported. Mean pain SEVERIT: was 6.0 ± 1.3 at baseline and 3.8 ± 2.0 at follow-up ( : < .0001). Pain INTERFERENC: was 6.2 ± 2.3 at baseline and 4.3 ± 2.8 at follow-up ( : < .0011). On the MDASI, the mean symptom SEVERIT: was 4.6 ± 1.8 at baseline and 3.2 ± 1.9 at follow-up ( : < .0001), and mean symptom INTERFERENC: was 5.8 ± 2.4 at baseline and 4.1 ± 2.9 at follow-up ( : < .002). Prescribed pain medications decreased across the course of the study. Patient satisfaction was high: 87% reported that their expectations were met "very well" or "extremely well"; 90% said they were likely to participate again; 95% said they were likely to recommend acupuncture to others; and 90% reported they found the service to be "useful" or "very useful." CONCLUSIONS: Acupuncture was feasible, safe, and a helpful treatment adjunct for cancer patients experiencing uncontrolled pain in this study. Randomized placebo-controlled trials are needed to confirm these results.

Systematic review of acupuncture in cancer care: a synthesis of the evidence.

PURPOSE: Many cancer centers offer acupuncture services. To date, a comprehensive systematic review of acupuncture in cancer care has not been conducted. The purpose of this review was to evaluate the efficacy of acupuncture for symptom management in patients with cancer. METHODS: Medline, Embase, CINAHL, Cochrane (all databases), Scopus, and PubMed were searched from inception through December 2011 for prospective randomized clinical trials (RCT) evaluating acupuncture for symptom management in cancer care. Only studies involving needle insertion into acupuncture points were included. No language limitations were applied. Studies were assessed for risk of bias (ROB) according to Cochrane criteria. Outcomes by symptom were designated as positive, negative, or unclear. RESULTS: A total of 2,151 publications were screened. Of those, 41 RCTs involving eight symptoms (pain, nausea, hot flashes, fatigue, radiation-induced xerostomia, prolonged postoperative ileus, anxiety/mood disorders, and sleep disturbance) met all inclusion criteria. One positive trial of acupuncture for chemotherapy-induced nausea and vomiting had low ROB. Of the remaining studies, eight had unclear ROB (four positive, three negative, and one with unclear outcomes). Thirty-three studies had high ROB (19 positive, 11 negative, and three with both positive and negative outcomes depending on the symptom). CONCLUSION: Acupuncture is an appropriate adjunctive treatment for chemotherapy-induced nausea/vomiting, but additional studies are needed. For other symptoms, efficacy remains undetermined owing to high ROB among studies. Future research should focus on standardizing comparison groups and treatment methods, be at least single-blinded, assess biologic mechanisms, have adequate statistical power, and involve multiple acupuncturists.