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

Social Cognitive Outcomes are Associated With Improvements in Mobility Performance Following Lifestyle Intervention in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy

Objective To compare the effects of an exercise and dietary intervention with those of standard-of-care management upon change in lift and carry performance and mobility-related self-efficacy beliefs and explore associations in prostate cancer patients undergoing androgen deprivation therapy. Methods 32 prostate cancer patients (M age = 66.2 years; SD = 7.8) undergoing androgen deprivation therapy were randomly assigned to a 3-month exercise and dietary lifestyle intervention (n = 16) or standard-of-care management (n = 16). Outcome assessments were obtained at baseline, 2- and 3-month follow-up. Results The lifestyle intervention resulted in significantly greater improvements in lift and carry performance (p = 0.01) at 2 Months (d = 1.01; p \u3c 0.01) and 3 Months (d = 0.95; p \u3c 0.01) and superior improvements in mobility-related self-efficacy at 2 Months (d = 0.38) and 3 Months (d = 0.58) relative to standard-of-care. Mobility-related self-efficacy (r = -.66; p = 0.006) and satisfaction with function (r = -.63; p = 0.01) were significantly correlated with lift and carry performance at 3 Months. Conclusions The exercise and dietary lifestyle intervention yielded superior improvements in lift and carry performance and mobility-related self-efficacy relative to standard-of-care and key social cognitive outcomes were associated with more favorable mobility performance

Effects of a group-mediated cognitive behavioral lifestyle intervention on select social cognitive outcomes in prostate cancer patients undergoing androgen deprivation therapy

Objective. To compare the effects of a group-mediated cognitive behavioral (GMCB) exercise and dietary (EX+D) intervention with those of standard-of-care (SC) treatment on select social cognitive outcomes in prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Methods. In the single-blind, 2-arm, randomized controlled Individualized Diet and Exercise Adherence–Pilot (IDEA-P) trial, 32 PCa patients (mean age = 66.2 years; SD = 7.8) undergoing ADT were randomly assigned to a 12-week EX+D intervention (n = 16) or SC treatment (n = 16). The exercise component of the personalized EX+D intervention integrated a combination of supervised resistance and aerobic exercise performed twice per week. The dietary component involved counseling and education to modify dietary intake and composition. Blinded assessments of social cognitive outcomes were obtained at baseline and 2-month and 3-month follow-up. Results. Intent-to-treat analysis of covariance demonstrated that the EX+D intervention resulted in significantly greater improvements in scheduling (P \u3c .05), coping (P \u3c .01), and exercise self-efficacy (P \u3c .05), and satisfaction with function (P \u3c .01) at 3 months relative to SC. Results of partial correlation analysis also demonstrated that select social cognitive outcomes were significantly correlated with primary trial outcomes of mobility performance and exercise participation (P \u3c .05) at 3-month follow-up. Conclusions: The GMCB lifestyle intervention yielded more favorable improvements in relevant social cognitive outcomes relative to SC among PCa patients undergoing ADT. Additionally, more favorable social cognitive outcomes were associated with superior mobility performance and exercise participation following the independent maintenance phase of the EX+D intervention

Mediators of physical activity outcomes in a peer-led intervention for breast cancer survivors

OBJECTIVES: Physical activity (PA) adoption can reduce treatment-related sequelae of breast cancer. Peer-led PA interventions are a promising and relatively inexpensive approach to scaling up interventions. The current study seeks to identify mediators of PA change amongst cancer survivors enrolled in a peer-led behavior change intervention. The study team partnered with the American Cancer Society\u27s Reach to Recovery program (RTR) whose volunteers\u27 provided information and support to breast cancer survivors. METHODS: Participants were 76 survivors (mean age 55.6 years, 1.1 years since diagnosis) who were randomized to PA Plus RTR (12-week PA telephone counseling delivered by RTR volunteers) or contact control. Data was collected on PA (self-reported and objectively measured) and potential mediators (self-efficacy, exercise decisional balance [ratio of the pros/advantages to the cons/disadvantages] and social support) at baseline and 12 weeks. Using a multiple mediation approach with bootstrapped standard errors, we examined mediators of the intervention effect on PA outcomes. RESULTS: Compared to control, PA Plus RTR participants had higher mean self-efficacy, lower decisional balance cons and social support at 12 weeks controlling for baseline. Higher mean self-efficacy was associated with greater minutes of self-reported PA, whereas higher decisional balance pros was associated with higher objectively measured PA at 12 weeks. There were significant indirect effects of self-efficacy on self-reported PA and decisional balance on objectively measured PA. CONCLUSIONS: PA Plus RTR increased self-reported and objectively measured PA by changing theoretical constructs hypothesized to be associated with behavior change. Peers delivering a PA intervention should focus on increasing survivors\u27 self-efficacy for exercise especially in challenging circumstances such as being on vacation, and also help to overcome disadvantages of exercise such as taking time away from family

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