Feasibility and Preliminary Efficacy of Implementing a Group-Mediated Cognitive Behavioral Resistance Exercise Intervention in Head and Neck Cancer Patients Undergoing Chemoradiation Treatment

Head and neck cancer (HNCa) patients report some of the lowest quality of life (QOL) compared to other cancer populations, due to the clinically meaningful deficits in muscle mass, called cancer cachexia, and physical function that are associated with the established standard of care, which includes Chemoradiation therapy (CRT). PURPOSE: Determine the feasibility and preliminary efficacy of implementing a group-mediated cognitive behavioral (GMCB) resistance exercise (RE) intervention in HNCa patients undergoing CRT. METHODS: The HNCaRE study was a single-arm, pilot trial designed to evaluate the safety, feasibility, and preliminary efficacy of implementing a GMCB personalized RE intervention in nine HNCa patients undergoing CRT. Assessment of all functional, anthropometric, and patient-reported outcomes were obtained at baseline, 3-months, and 6-month follow-up visits. RESULTS: Findings from the initial cohort of the HNCaRE pilot trial (n=9) suggest that the GMCB RE intervention was a feasible, safe, and well-tolerated intervention for HNCa patients undergoing CRT. The Cohen’s d effect sizes were calculated by taking the mean difference and diving by the pooled standard deviation to determine the magnitude. Percent change was determined by calculating the mean difference from baseline at each assessment and dividing by the baseline value. Evaluation of the effect sizes and percent change indicate the RE intervention attenuated the deleterious effects that have been observed upon muscle mass (d=-0.74), physical function (d=0.28), and QOL (d=-0.65) previously among HNCa patients undergoing CRT. Patients who demonstrated the greatest adherence to the intervention sessions yielded the most favorable changes in these outcomes. CONCLUSION: Findings from the HNCaRE pilot trial provide evidence of the feasibility, safety, and preliminary efficacy of implementing a GMBC-based RE intervention among HNCa patients undergoing CRT. The RE intervention shows promise for countering the well-established deleterious effects upon body composition, physical function, and QOL accompanying CRT

Design and methods of a translational, community-based, lifestyle weight management pilot intervention trial in breast cancer survivors with overweight or obesity

Background: Breast cancer survivors (BCS) with overweight or obesity are at heightened risk of cancer recurrence, cardiometabolic disease, and compromised quality of life. Given the prevalence of significant weight gain during and following breast cancer treatment, there is growing recognition of the need to develop efficacious, widely-accessible, weight management programs for BCS. Unfortunately, access to evidence-based weight management resources for BCS remains limited and little is known of the optimal theoretical basis, program components, and mode of delivery for community-based interventions. The primary aim of the Healthy New Albany Breast Cancer (HNABC) pilot trial was to determine the safety, feasibility, and preliminary efficacy of delivering a translational, evidence-based, and theory-driven lifestyle weight management intervention to BCS with overweight or obesity in the community setting. Methods: HNABC was a single-arm, pilot trial evaluating a 24-week, multi-component intervention leveraging exercise, dietary modification, and group-mediated cognitive behavioral (GMCB) counseling components designed to facilitate lifestyle behavior change and promote sustained independent adherence. Assessments of various objectively-determined and patient-reported outcomes and theory-derived determinants of behavioral adoption and maintenance were obtained at baseline, 3- and 6-month follow-up. Measures of trial feasibility were calculated prospectively throughout the study. Conclusion: Findings from the HNABC pilot trial will provide evidence demonstrating the feasibility and preliminary efficacy of a multi-component, community-based, GMCB lifestyle weight management intervention for BCS. Results will inform the design of a future, large-scale, randomized controlled efficacy trial. If successful, this approach could offer a widely accessible, community-based intervention model for weight management programs in BCS

Effect of a Telephone-Based Lifestyle Intervention on Weight, Body Composition, and Metabolic Biomarkers in Rural Ohio: Results from a Randomized Pilot Study

Rural residents experience higher rates of obesity, obesity-related chronic diseases, and poorer lifestyle. Promoting physical activity and healthy eating are critical for rural residents; however, lack of resources and access barriers limit the feasibility of in-person lifestyle interventions. There is a need to design and deliver remotely accessible lifestyle interventions in this population. This pilot study examined the effect of a telephone-based lifestyle intervention on weight, body composition, lipids, and inflammatory biomarkers among rural Ohio residents. Rural Ohio adults with overweight/obesity (n = 40) were 2:1 randomized to a 15-week telephone-based lifestyle intervention (n = 27) or control group (n = 13). The lifestyle intervention group received weekly telephone counseling sessions emphasizing healthy eating and increasing physical activity. The control group received educational brochures describing physical activity and dietary recommendations. Weight, body composition, fasting blood lipids, and inflammatory biomarkers were objectively measured at baseline and 15 weeks at local community centers (trial registration#: NCT05040152 at ClinicalTrial.gov). Linear mixed models were used to examine change over time by group. Participants were mostly female, with an average age of 49 years. Over the 15-week trial, the lifestyle intervention showed superior improvements in total cholesterol (∆ = −18.7 ± 7.8 mg/dL, p = 0.02) and LDL (∆ = −17.1 ± 8.1 mg/dL, p = 0.04) vs. control, whereas no significant between-group differences in weight, body composition, or inflammation were observed. Our findings suggest that a 15-week telephone-based lifestyle intervention may offer metabolic benefits that reduce disease risk in rural adults with obesity. Future large-scale studies are needed to determine the efficacy of remotely accessible lifestyle interventions in rural populations, with the goal of reducing obesity-related disparities