Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP): Protocol for a Feasibility and Exploratory Efficacy Study in Men on Androgen Deprivation Therapy (Preprint)

BACKGROUND Androgen deprivation therapy (ADT) for prostate cancer is associated with adverse cardiometabolic effects such as reduced libido, hot flashes, metabolic syndrome, diabetes, myocardial infarction, and stroke. This reduces quality of life and potentially increases mortality. Several large clinical trials have demonstrated improvements in cardiometabolic risk with comprehensive multimodality lifestyle modification. However, there is a lack of data for such interventions in men on ADT for prostate cancer, and existing studies have used non-standardized interventions or lacked data on metabolic risk factors. OBJECTIVE The Comprehensive Lifestyle Improvement Project for Prostate Cancer (CLIPP) is designed to address these gaps by using an intervention modeled on the Diabetes Prevention Program, a standardized multicomponent intervention with demonstrated effectiveness in reducing cardiometabolic risk factors that has been successfully adapted for multiple disease types including breast cancer. METHODS A single-arm unblinded clinical trial will be conducted to determine the feasibility of conducting a 24-week comprehensive lifestyle modification intervention that targets weight loss and increased physical activity modeled on the Diabetes Prevention Program in 30 men on ADT for prostate cancer. Secondary aims are to determine the effect of the intervention on cardiometabolic markers and quality of life. The tertiary aim is to determine the effect of the intervention on markers of inflammation and angiogenesis, important mechanisms for prostate cancer progression. Participants will be recruited from the University of Arizona Cancer Center and the surrounding community. The intervention will be delivered weekly in person and over the phone for 16 weeks. For Weeks 16-24, participants receive weekly phone calls from the study health coach to motivate them to continue their lifestyle modification. Questionnaire and biological data are collected at baseline, 12 weeks, and 24 weeks. Body composition using dual-energy x-ray absorptiometry scans will be performed at baseline and end of study. RESULTS Based on a sample size of 30, the two-sided 95% confidence interval will not be wider than 0.373 standard deviations for the adherence rate and will not be wider than 0.374 for the retention rate. In addition, the study will have a power of 80% to detect a change of 0.47 standard deviations from baseline for each of the markers investigated in the secondary and tertiary aims assuming a within-subject correlation of 0.20 at a significance level of 5%. The recruitment period is from October 2018 to April 2019. CONCLUSIONS The aim of CLIPP is to determine the feasibility of conducting a Diabetes Prevention Program–style comprehensive lifestyle modification intervention in men with ADT for prostate cancer and its effects on cardiometabolic adverse effects, quality of life, as well as markers of inflammation and angiogenesis. Results will inform the development of future clinical trials in this population. INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12579

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Impact of Lifestyle Intervention and Metformin on Health-Related Quality of Life: the Diabetes Prevention Program Randomized Trial

Journal of General Internal Medicine ◽

10.1007/s11606-012-2122-5 ◽

2012 ◽

Vol 27 (12) ◽

pp. 1594-1601 ◽

Cited By ~ 52

Author(s):

Hermes Florez ◽

◽

Qing Pan ◽

Ronald T. Ackermann ◽

David G. Marrero ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Trial ◽

Lifestyle Intervention ◽

Prevention Program ◽

Diabetes Prevention ◽

Diabetes Prevention Program ◽

Health Related Quality ◽

Related Quality ◽

Health Related

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Theoretical Mediators of Diabetes Risk and Quality of Life Following a Diabetes Prevention Program for Latino Youth With Obesity

American Journal of Health Promotion ◽

10.1177/08901171211012951 ◽

2021 ◽

pp. 089011712110129

Author(s):

Erica G. Soltero ◽

Stephanie L. Ayers ◽

Marvyn A. Avalos ◽

Armando Peña ◽

Allison N. Williams ◽

...

Keyword(s):

Quality Of Life ◽

Social Support ◽

Health Behaviors ◽

Self Efficacy ◽

Diabetes Prevention ◽

Latino Youth ◽

Diabetes Prevention Program ◽

Family Social Support

Purpose: This study tested self-efficacy and social support for activity and dietary changes as mediators of changes in type 2 diabetes related outcomes following a lifestyle intervention among Latino youth. Setting and Intervention: Latino adolescents (14-16 years) with obesity (BMI% = 98.1 ± 1.4) were randomized to a 3-month intervention (n = 67) that fostered self-efficacy and social support through weekly, family-centered sessions or a comparison condition (n = 69). Measures: Primary outcomes included insulin sensitivity and weight specific quality of life. Mediators included self-efficacy, friend, and family social support for health behaviors. Data was collected at baseline, 3-months, 6-months, and 12-months. Analysis: Sequential path analysis was used to examine mediators as mechanisms by which the intervention influenced primary outcomes. Results: The intervention had a direct effect on family (β = 0.33, P < .01) and friend social support (β = 0.22, P < .001) immediately following the intervention (3-months). Increased family social support mediated the intervention’s effect on self-efficacy at 6-months (β = 0.09, P < .01). However, social support and self-efficacy did not mediate long-term changes in primary outcomes ( P > .05) at 12-months. Conclusions: Family social support may improve self-efficacy for health behaviors in high-risk Latino youth, highlighting the important role of family diabetes prevention. Fostering family social support is a critical intervention target and more research is needed to understand family-level factors that have the potential to lead to long-term metabolic and psychosocial outcome in vulnerable youth.

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Health Behavior Change Following Stroke: Recommendations for Adapting the Diabetes Prevention Program–Group Lifestyle Balance Program

American Journal of Lifestyle Medicine ◽

10.1177/1559827619897252 ◽

2020 ◽

pp. 155982761989725

Author(s):

Ryan R. Bailey ◽

Jennifer L. Stevenson ◽

Simon Driver ◽

Evan McShan

Keyword(s):

Focus Groups ◽

Prevention Program ◽

Diabetes Prevention ◽

Lifestyle Modification ◽

Recurrent Stroke ◽

Diabetes Prevention Program ◽

Health Behavior Change ◽

Community Dwelling ◽

Dietary Recommendations ◽

Care Partners

Objective. History of stroke increases risk for recurrent stroke, which is a significant issue faced by survivors. The Diabetes Prevention Program–Group Lifestyle Balance (DPP-GLB) program is an effective lifestyle modification intervention for ameliorating cardiovascular risk factors but has not been adapted to account for common stroke-related deficits. The purpose of this study was to determine appropriate adaptations to the DPP-GLB for adults with stroke. Design and Methods. In this phenomenological qualitative study, a total of 15 community-dwelling adults with stroke and 10 care-partners participated in 4 focus groups to review DPP-GLB curriculum materials and provide recommendations for adaptation. Focus groups were recorded and transcribed. Inductive content analysis was used to identify key themes. Results. Three themes were identified. First, physical, cognitive, sensory, and psychosocial stroke-related deficits could affect DPP-GLB participation. Second, existing DPP-GLB characteristics could facilitate participation by adults with stroke. Third, stroke-specific adaptations were recommended, including modified session content and format, adapted physical activity and dietary recommendations, and inclusion of care-partners. Conclusion. Current DPP-GLB content and structure may be insufficient to meet the unique needs of adults with stroke. The suggested adaptations should be incorporated into a stroke-specific curriculum and tested for preliminary efficacy for reducing recurrent stroke risk.

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Sex Differences in Diabetes Risk and the Effect of Intensive Lifestyle Modification in the Diabetes Prevention Program

Diabetes Care ◽

10.2337/dc07-2390 ◽

2008 ◽

Vol 31 (7) ◽

pp. 1416-1421 ◽

Cited By ~ 72

Author(s):

L. Perreault ◽

Y. Ma ◽

S. Dagogo-Jack ◽

E. Horton ◽

D. Marrero ◽

...

Keyword(s):

Sex Differences ◽

Prevention Program ◽

Diabetes Prevention ◽

Lifestyle Modification ◽

Diabetes Prevention Program ◽

Diabetes Risk

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Effects of Exercise on Treatment-Related Adverse Effects for Patients With Prostate Cancer Receiving Androgen-Deprivation Therapy: A Systematic Review

Journal of Clinical Oncology ◽

10.1200/jco.2013.49.5523 ◽

2014 ◽

Vol 32 (4) ◽

pp. 335-346 ◽

Cited By ~ 141

Author(s):

Jason R. Gardner ◽

Patricia M. Livingston ◽

Steve F. Fraser

Keyword(s):

Quality Of Life ◽

Prostate Cancer ◽

Systematic Review ◽

Adverse Effects ◽

Androgen Deprivation Therapy ◽

Bone Health ◽

Cardiometabolic Risk ◽

Androgen Deprivation ◽

Cochrane Library

Purpose Androgen-deprivation therapy is a commonly used treatment for men with prostate cancer; however, the adverse effects can be detrimental to patient health and quality of life. Exercise has been proposed as a strategy for ameliorating a range of these treatment-related adverse effects. We conducted a systematic review of the literature regarding the effects of exercise on treatment-related adverse effects in men receiving androgen-deprivation therapy for prostate cancer. Methods An online electronic search of the Cochrane Library, EMBASE, MEDLINE, CINAHL, SPORTDiscus, and Health Source databases was performed to identify relevant peer-reviewed articles published between January 1980 and June 2013. Eligible study designs included randomized controlled trials as well as uncontrolled trials with pre- and postintervention data. Information was extracted regarding participant and exercise intervention characteristics as well as the effects of exercise on bone health, body composition, physical performance, cardiometabolic risk, fatigue, and quality of life. Results Ten studies were included, with exercise interventions involving aerobic and/or resistance training. Exercise training demonstrated benefits in muscular strength, cardiorespiratory fitness, functional task performance, lean body mass, and fatigue, with inconsistent effects observed for adiposity. The impact of exercise on bone health, cardiometabolic risk markers, and quality of life are currently unclear. Conclusion Among patients with prostate cancer treated with androgen-deprivation therapy, appropriately prescribed exercise is safe and may ameliorate a range of treatment-induced adverse effects. Ongoing research of high methodologic quality is required to consolidate and expand on current knowledge and to allow the development of specific evidence-based exercise prescription recommendations.

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