This 5-year study evaluates the effects of a 10-week 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). About 80% PC cases are diagnosed as early disease and have a 5- and 10-year survival rate of almost 100% and 99%, respectively. Most patients receive active treatment (~70%) leading to prolonged treatment-related side effects and dysfunction persisting well beyond primary treatment. Survival is offset by chronic side effects such as sexual and urinary dysfunction, pain and fatigue that can lead to poor psychosocial functioning, impaired intimacy and social functioning, and masculinity concerns. Hispanic PC survivors report lower physical and social functioning, poorer emotional well-being and greater sexual and urinary dysfunction, even after accounting for SES and disease severity. This sequela can lead to elevated glucocorticoid release and inflammatory cytokines that have a direct effect on these symptoms and can interfere with physiological pathways necessary for recovery of sexual and urinary functioning. We have shown that CBSM reduces symptom burden and improves HRQOL in bilingual Hispanic PC survivors. In a pilot we showed that a linguistic translation of CBSM with attention to sociocultural processes improved symptom burden and HRQOL in Spanish monolingual PC survivors. We have also shown that CBSM is associated with reduced glucocorticoid resistance and inflammatory gene expression pathways in breast cancer survivors. We propose to (a) deliver a culturally adapted C-CBSM intervention in Spanish that places greater emphasis on salient sociocultural determinants of symptom burden and HRQOL in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo), (b) incorporate a neuroimmune model of symptom regulation and management, and (c) test the efficacy of C-CBSM, relative to standard non-culturally adapted CBSM, in two diverse Hispanic communities (Chicago & Miami). We will test our aims in 260 Hispanic men post-treatment for localized PC with elevated symptom burden in a 2 x 4 randomized design with condition (C- CSBM vs. CBSM) as the between groups factors, and time (baseline, post-intervention & 6- and 12-months post baseline) as the within groups factor. Our Primary Aim is to determine whether randomization to C- CBSM, relative to standard CBSM, is associated with reduced symptom burden and improved HRQOL. Our Secondary Aims evaluate whether C-CBSM leads to greater improvements in the intervention targets (e.g., stress management, psychological distress & interpersonal disruption), and physiologic adaptation (i.e., glucocorticoid receptor sensitivity & inflammatory gene expression). We will also evaluate psychosocial and physiological mechanisms as mediators of C-CBSM's effects on our primary outcomes. We will explore moderators (e.g., SES, Hispanic origin) of C-CBSM's effect and C-CBSM's effects on cardiometabolic health.
Although highly efficacious, active treatment (e.g., surgery & radiation; ~70% of cases) for localized prostate cancer (PC) can lead to significant symptom burden (i.e., sexual & urinary dysfunction) and compromises in multiple facets of health related quality of life (HRQoL). Hispanic PC survivors are at a physical and psychosocial disadvantage, yet evidence based treatments (EBTs) such as cognitive behavioral stress management (CBSM) that have proven effective in reducing symptom burden and improving HRQoL in cancer survivors have rarely targeted Hispanics or delivered culturally adapted CBSM in diverse Hispanics in Spanish in the context of a randomized behavioral clinical trial with an adequate sample size and long-term follow-up. This study will fill several critical gaps in our knowledge on the incremental efficacy of culturally adapted EBTs, relative to standard linguistic translations, on improving symptom burden and HRQoL in Hispanic men with localized PC, and map sociocultural, psychosocial and molecular mechanisms involved in the efficacy of CBSM, and therefore help guide targeted treatments for this critically understudied population and other Spanish speaking cancer 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|