This is a competitive revision application to a RCT evaluating the effects of a group-based linguistically translated and culturally adapted cognitive-behavioral stress and self-management (C-CBSM) intervention on symptom burden and health related quality of life (HRQoL) in Hispanic men treated for localized prostate cancer (PC). Hispanic PC survivors report lower physical and social functioning, poorer emotional well-being and greater sexual and urinary dysfunction relative to non-Hispanics, even after accounting for SES and disease severity well-beyond post-treatment. In the funded RO1, our Primary Aim is to determine the incremental efficacy of C-CBSM, relative to standard CBSM, for reducing symptom burden and improving HRQoL among 230 Hispanic PC survivors. Our Secondary Aims evaluate whether participation in C-CBSM is associated with greater improvements in the intervention targets (e.g., improved stress management, reduced psychological distress & interpersonal disruption), and improvements in physiologic adaptation (i.e., glucocorticoid receptor sensitivity & inflammatory gene expression). This is a 2x4 randomized design with condition (C-CSBM vs. CBSM) as the between groups factor, and time (baseline [T1] & post-intervention [T2], 6-[T3], and 12-mos. [T4] post baseline assessments) as the within groups factor. The goals of this revision are as follows: Goal 1: to integrate selected SOBC mechanistic variables from the self-regulation, interpersonal and social processes, and stress reactivity domains into the CBSM trial among 120 of our participants (60 per experimental condition, evenly divided across the Northwestern and Miami sites); Goal 2: recruit their spouses/partners who will also complete the selected SOBC measures, along with measures of dyadic adjustment and HRQoL; Goal 3: add ?real time? EMA-based assessments of social connectivity, positive/negative mood, stress management skills and physiological arousal (SNS & HPAC activation) in PC participants through mHealth technology, and relate EMA measures to SOBC targets, neuroimmune regulation (i.e., glucocorticoid receptor sensitivity & inflammatory gene expression), symptom burden and HRQoL. The Overarching Goal is to evaluate how CBSM targets (e.g., anxiety reduction and cognitive reappraisal skills, coping, emotional expression, communication skills, social support, etc.), operate through SOBC measures and influence dyadic adjustment, physiology, symptom burden and HRQoL. Supplemental activities will take place across T1-T3 (pre-intervention to the 6-month follow-up). Supplemental SOBC measures will be administered to patients and spouses/partners at T1, T2 and T3. EMA data will be collected from PC survivors at 5 time-points from T1-T3 (pre-CBSM, final week of CBSM, & every two months between T2-T3).
Our aims will evaluate whether C-CBSM, relative to CBSM has a greater impact on SOBC measures, and the association between SOBC measures and our primary and secondary outcomes (patients only), EMA-based SNS and HPAC activity (patients only), and dyadic adjustment and HRQOL in patients & spouse/partners.
Cognitive behavioral stress management (CBSM) is effective in reducing symptom burden and improving health-related quality of life (HRQoL) in prostate cancer (PC) survivors but limited work has targeted racial/ethnic minority patients, comprehensively assessed intra- and inter-personal mechanisms (e.g., self- and emotional-regulation) in patients and spouses/partners, or collected ?real time? data that maps onto psychological and physiological adjustment. This revised study will address these shortcomings by assessing how CBSM's impact on primary study outcomes of symptom burden and HRQoL operate through Science of Behavioral Change (SOBC) measures in the self-regulation, interpersonal/ social processes and stress domains, and by using ?real time? ecological momentary assessments of social connectivity, positive/negative mood, stress management skills and physiological arousal (SNS & HPAC activation) through mHealth technologies. Further, this revision considers the experience of both patients and their spouses/partners, by conducting spousal/partner assessments in the context to psychological, dyadic and physiological adjustment, SOBC measures, symptom burden and HRQoL in Hispanic PC survivors.
| Penedo, Frank J; Antoni, Michael H; Moreno, Patricia I et al. (2018) Study design and protocol for a culturally adapted cognitive behavioral stress and self-management intervention for localized prostate cancer: The Encuentros de Salud study. Contemp Clin Trials 71:173-180 |
