Work Productivity Among Younger Breast Cancer Survivors: The Impact of Behavioral Interventions for Depression.

OBJECTIVES: The Pathways to Wellness randomized controlled trial found that 2 behavioral interventions, mindfulness awareness practices and survivorship education, reduced depressive symptoms in younger breast cancer survivors (BCSs) compared with wait-list control. This secondary analysis examines whether the interventions led to reduced loss of work productivity among younger BCSs and whether such reductions were mediated by reductions in depressive symptoms. METHODS: The Work Productivity and Activity Impairment scale was used to measure work productivity loss at 4 assessment time points. Correlates of productivity loss at enrollment were examined using multivariable linear regression. Differences in change over time in productivity loss between each intervention group and control were assessed using linear mixed models. Reduced depressive symptoms were tested as a mediator of reduced productivity loss. RESULTS: Of 247 trial participants, 199 were employed and included in the analyses. At enrollment, higher productivity loss was associated with chemotherapy receipt (P = .003), younger age (P = .021), more severe cognitive problems (P = .002), higher musculoskeletal pain severity (P = .002), more depressive symptoms (P = .016), and higher fatigue severity (P = .033). The mindfulness intervention led to significantly less productivity loss compared with control at all 3 postintervention assessment points (all P < .05), with about 54% of the effect mediated by reduction in depressive symptoms. Survivorship education was not associated with reduced loss of productivity. CONCLUSIONS: These findings suggest that addressing depressive symptoms through behavioral interventions, such as mindfulness, may mitigate impacts on work productivity in younger BCSs.

Dyadic versus individual delivery of a yoga program for family caregivers of glioma patients undergoing radiotherapy: Results of a 3-arm randomized controlled trial.

BACKGROUND: Despite their significant distress, supportive care interventions for caregivers of glioma patients are generally lacking. And, whether caregivers are more likely to benefit from interventions targeting patient-caregiver dyads or caregivers individually is unknown. This pilot randomized controlled trial compared the feasibility and preliminary efficacy of a dyadic yoga (DY) versus an individual caregiver yoga (CY) intervention as a supportive care strategy for family caregivers. METHODS: Patient-caregiver dyads were randomized to a DY, CY or usual care (UC) arm. DY and CY interventions were delivered over 15 sessions. Caregivers completed assessments of their depressive symptoms, quality of life (QOL), and caregiving reactions at baseline, 6 weeks, and 12 weeks, and a subset completed qualitative interviews at 12 weeks. RESULTS: With a consent rate of 63%, 67 dyads were randomized. Attendance in the DY was higher than in the CY group (session means, DY = 12.23, CY = 9.00; p = 0.06). Caregivers (79% female; 78% non-Hispanic White; mean age, 53 years) reported significantly more subjective benefit in the CY arm than in the DY arm (d = 2.1; p < .01), which was consistent with the qualitative assessment. There were medium effect sizes for improved mental QOL (d = 0.46) and financial burden (d = 0.53) in favor of the CY over the UC group. Caregivers in the CY group reported more caregiving esteem (d = 0.56) and less health decline (d = 0.60) than those in the DY group. CONCLUSION: Individual rather than dyadic delivery may be a superior supportive care approach for this vulnerable caregiver population. A larger, adequately powered efficacy trial is warranted.

Evaluation of the Efficacy of a Smoking Cessation Intervention for Cervical Cancer Survivors and Women With High-Grade Cervical Dysplasia: Protocol for a Randomized Controlled Trial.

BACKGROUND: The prevalence of smoking among cervical cancer survivors is strikingly high, yet no smoking cessation interventions to date have specifically targeted this population. This paper describes the study design, methods, and data analysis plans for a randomized clinical trial designed to evaluate the efficacy of a theoretically and empirically based Motivation And Problem Solving (MAPS) approach for promoting and facilitating smoking cessation among cervical cancer survivors. MAPS is a comprehensive, dynamic, and holistic intervention that incorporates empirically supported cognitive behavioral and social cognitive theory-based treatment strategies within an overarching motivational framework. MAPS is designed to be appropriate for all smokers regardless of their motivation to change and views motivation as dynamically fluctuating from moment to moment throughout the behavior change process. OBJECTIVE: This 2-group randomized controlled trial compares the efficacy of standard treatment to MAPS in facilitating smoking cessation among women with a history of high-grade cervical dysplasia or cervical cancer. METHODS: Participants (N=202) are current smokers with a history of high-grade cervical dysplasia or cervical cancer recruited nationally and randomly assigned to one of two treatment conditions: (1) standard treatment (ST) or (2) MAPS. ST consists of repeated letters referring participants to their state's tobacco cessation quitline, standard self-help materials, and free nicotine replacement therapy when ready to quit. MAPS has all ST components along with 6 proactive telephone counseling sessions delivered over 12 months. The primary outcome is abstinence from tobacco at 18 months. Secondary outcomes include abstinence over time across all assessment points, abstinence at other individual assessment time points, quit attempts, cigarettes per day, and use of state quitlines. Hypothesized treatment mechanisms and cost-effectiveness will also be evaluated. RESULTS: This study was approved by the institutional review boards at the University of Texas MD Anderson Cancer Center, the University of Oklahoma Health Sciences Center, and Moffitt Cancer Center. Participant enrollment concluded at Moffitt Cancer Center in January 2020, and follow-up data collection was completed in July 2021. Data analysis is ongoing. CONCLUSIONS: This study will yield crucial information regarding the efficacy and cost-effectiveness of a MAPS approach for smoking cessation tailored to the specific needs of women with a history of high-grade cervical dysplasia or cervical cancer. Findings indicating that MAPS has substantially greater efficacy than existing evidence-based tobacco cessation treatments would have tremendous public health significance. TRIAL REGISTRATION: ClinicalTrials.gov NCT02157610; https://clinicaltrials.gov/ct2/show/NCT02157610. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34502.

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.

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.

Use of Chinese medicine among survivors of nasopharyngeal carcinoma in Taiwan: a population-based study.

UNLABELLED: Hypotheses. The authors hypothesized that the use of alternative medicine, in the form of Chinese medicine (CM), among patients in the continuing care phase of nasopharyngeal carcinoma (NPC) in Taiwan is higher than the use in a matched control group of noncancer individuals. STUDY DESIGN: This was a case-control study. METHODS: Using a population-based claim database, the authors identified 181 long-term survivors of NPC and 905 matched controls. They obtained information on CM use and associated cost as outcome measures. Descriptive analysis and regression models were applied to examine the association between NPC and the outcome measures. RESULTS: The unadjusted CM initiation (34% vs 32%; P = .54), intensity of use (2.15 vs 1.73 visits; P = .37), and cost (US$79 vs US$58; P = .16) were higher for patients in the NPC group than for those in the control group. Regression analyses suggested that the NPC group had significantly more CM visits (1.01; 95% confidence interval = 0.07-1.96), and more than 50% of these visits were related to cancer. CONCLUSION: The authors confirmed their hypotheses that the use of CM in the continuing care phase by patients with NPC in Taiwan was higher than the use in their matched, noncancer counterparts. These findings suggest that current clinical surveillance strategies for NPC might not meet patients' physical and emotional needs.

Information technology facilitates cost-effectiveness analysis in developing countries: an observational study of breast cancer chemotherapy in Taiwan.

Health information technology offers a powerful tool to monitor the performance of a healthcare system. Advances in computer technology and capacity combined with lower start-up costs will allow developing countries to achieve greater impact when they initiate electronic health information systems. We focused on the integrated health information system that was established in Taiwan in conjunction with the launch of the National Health Insurance (NHI) programme. We used data from that health information system to conduct a cost-effectiveness analysis of chemotherapy use among breast cancer patients. We then used this analysis to discuss what policy makers can learn from this type of analysis. We identified a cohort of patients in the NHI Research Database who had been diagnosed with breast cancer in 2001 and had received chemotherapy following surgical removal of the tumour. We followed these patients for 3 years and conducted a cost-effectiveness analysis from the payer's perspective. Using the net benefit regression approach, we compared the cost effectiveness of the two most commonly prescribed first-line chemotherapy regimens for the treatment of breast cancer in 2001 in Taiwan. The dependent variable of the regression model was the individual-level net benefit, and the independent variables included a binary variable indicating the choice of chemotherapy regimen, the patients' age, co-morbidity, type of surgery, geographic region and type of treatment facility. We employed both frequentist and Bayesian approaches in our net benefit regression analyses. In the Bayesian analysis, we applied non-informative priors to all parameters in the base-case analyses. We then explored the use of informative priors in the sensitivity analysis, using cost-effectiveness data published in the literature to form the prior distributions for the relevant parameters. Over 60% of surgically treated breast cancer patients received either CMF (cyclophosphamide, methotrexate, fluorouracil) or CEF (cyclophosphamide, epirubicin, fluorouracil). A comparison of patient characteristics indicated that patients in the CEF group tended to be younger (47.8 vs 49.1 years; p = 0.016), and were significantly more likely to have undergone a mastectomy (84% vs 76%; p < 0.001) and to have been treated in a teaching hospital (26% vs 13%; p < 0.001). We also observed significant variations in geographic region of the location of facilities between treatment groups. On average, CEF was not cost effective in the treatment of patients with breast cancer in Taiwan, although analyses stratified by geographic region suggested a wide variation across regions. At a societal willingness to pay (WTP) of new Taiwanese dollar ($NT)1 500 000 ($US80 000), the probability that CEF was more cost effective than CMF was 0.0%, 0.0%, 0.0% and 3.9% for the Taipei metropolitan area, and the north, middle and the combined south and east region, respectively; the probability became 0.6%, 0.0%, 1.3% and 54.5%, respectively, at a WTP of $NT5 000 000 ($US270 000). After co-variate adjustments, the probabilities were 0.0%, 0.0%, 0.0% and 0.8%, respectively at a WTP of $NT1 500 000, and were 0.0%, 0.0%, 1.4% and 34.7% at $NT5 000 000. Sensitivity analyses showed that CEF potentially could have been more cost effective than CMF within a reasonable range of societal WTP (i.e. $NT1 000 000-3 000 000 or $US55 000-160 000) had the optimal dosage level for CEF been established for breast cancer patients in Taiwan. A population-based, fully integrated electronic health information system provides useful data to assess the cost effectiveness of competing treatments and interventions in current practice. This research may potentially inform policy makers of modifications that can be instituted to improve the cost effectiveness of a new therapy. However, findings from this study need to be interpreted with caution because the study provided information only on the short-term cost effectiveness (i.e. 3 years) of CEF compared with CMF. It is possible that a future analysis will reach a different conclusion when more years of follow-up data become available.