||7R01CA206456-04 Interpret this number
||University Of Miami Coral Gables
||Culturally Adapted Cognitive Behavioral Stress and Self-Management (CCBSM)
Project Summary: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.
Study design and protocol for a culturally adapted cognitive behavioral stress and self-management intervention for localized prostate cancer: The Encuentros de Salud study.
, Antoni M.H.
, Moreno P.I.
, Traeger L.
, Perdomo D.
, Dahn J.
, Miller G.E.
, Cole S.
, Orjuela J.
, Pizarro E.
, et al.
Contemporary Clinical Trials, 2018 Aug; 71, p. 173-180.