Michael H. Antoni, PhD - US grants

This is a 5-year project to test the experimental effects of a 10-week group cognitive behavioral stress management (CBSM) intervention on distress and adherence to HIV combination antiretroviral therapy (CART) in 210 gay and bisexual men with symptomatic HIV infections (including those with and without Acquired Immunodeficiency Syndrome, AIDS). We will test the effects of CBSM on a set of theoretically-determined variables which are proposed to mediate its psychosocial effects. Furthermore, this project will consider the role of hypothesized moderators (e.g., ethnicity) in our analyses. We will also evaluate the effects of CBSM on health status by measuring changes in HIV viral load. This study is a 2 X 4 randomized experimental design with experimental condition (Standard Care + CBSM versus Standard Care Control) as the between-group factor and time point (pre-treatment, post-treatment, 6-month and 12-month follow-up) as the within-group factor. In several previously published papers on asymptomatic HIV+ gay men, we demonstrated that CBSM buffered the psychological and immune impact of an HIV-seropositive diagnosis, decreased social isolation, and improved adaptive coping strategies. Subsequently, we published a series of papers showing that CBSM in symptomatic pre-AIDS gay men increased psychological adjustment and improved immunologic surveillance of herpes viruses. These effects were found in part to be mediated by changes in cognitive appraisals, improved coping strategies and improved perceptions of social support. In the presently proposed project, we propose to evaluate the effectiveness of CBSM in HIV+ gay men with symptomatic disease who are on CART. We intend to specifically focus on (a) whether this intervention can reduce distress and depressive symptoms; (b) whether CBSM increase medication adherence using MEMs, pill counts, pharmacy records and self-reports as indicators, and (c) whether these behavioral changes, in turn, predict HIV viral load. We shall also attempt to specify the mediators and moderators of these behavioral and psychological effects as well as viral load to address issues of mechanism of action and generalizability, respectively. As secondary aims related to harm induction, we will examine the effects of CBSM on negative health behaviors such as substance use and unsafe sexual behaviors over time. Finally, the proposed project extends our prior studies to examine the generality of the effects of a CBSM intervention in subsamples of Black, Hispanic, and non-Hispanic White gay and bisexual men with symptomatic infection (Centers for Disease Control Stages B and C including AIDS).

The key mission of the Psychosocial Assessment Core is to generate a comprehensive set of information about the psychosocial and behavioral changes that occur as a result of the interventions proposed for this Chronic Fatigue Syndrome (CFS) Research Center. This Core is responsible for conducting a basic phone screen to rule out individuals who do not meet essential criteria, scheduling screening visits for prospective recruits, conducting face-to-face psychiatric screening interviews, administering psychosocial questionnaires at each time point in each of the Center's studies, ensuring participants' comfort and minimizing participant burden, and coordinating participant compensations. The administration of these measures by a central core is reasonable given that (a) all of these measures will be utilized in each project of this Center, and (b) administration of measures by Core personnel would provide the constancy of assessment conditions and blinding of participants' group assignment needed in order to conduct unbiased Center-wide comparisons. At the same time such a blinded procedure may allow participants to respond to certain questions (e.g., concerning health behaviors) honestly without fear of offending study personnel with whom they may have bonded (e.g., intervention group leaders) over the course of the study. The Psychosocial Assessment Core personnel will work with the other Cores to assure the appropriate placement of specific participants into the different projects and to ensure completion of assessments at each time point for all of the projects.

Cognitive Behavioral Stress Management (CBSM) can change stressor appraisals and build coping resources; modulate the output of sympathetic nervous system, Hypothalamic Pituitary Adrenal, and Hypothalamic Pituitary Gonadal hormones; and help normalize immunologic status in different HIV+ populations. Recent work suggests that these psychosocial and physiologic changes may influence quality of life and possibly disease course. The proposed 5-year project will directly address these issues in 200 HIV-infected women who are co-infected with Human Papillomavirus (HPV), the putative etiologic virus in cervical carcinoma. We will (a) evaluate the effects of CBSM intervention on quality of life (negative affect, positive growth, fatigue and physical functioning, sexuality) and physical health changes (biopsy-determined squamous fatigue and physical functioning, sexuality) and physical health changes (biopsy-determined squamous intraepithelial lesions [SIL] and opportunistic infections [E.G. herpesvirus outbreaks]; and (b) examine the hypothesized psycho-biological mediators (psychosocial endocrine, and immunologic changes) of intervention effects observed. We will address the psychosocial (quality of life indicators, intervention process measures), virologic (HPV type), immunologic status (natural killer cell cytotoxicity and lymphocyte phenotypes for T-helper-inducer cells [CD3+CD4+, T-suppressor-cytotoxic cells [CD3+CD8+] and natural killer cells [CD3-CD56+]) and health status (SIL incidence and severity, herpes simplex virus) in HIV+HPV+ women at study entry (T1) and then randomize women to either a 10-week CBSM intervention or a one-day CBSM seminar. We will re-assess psychosocial, immunologic and physical health variables after the intervention period (T2) and again at a 6-month (T3) and 12-month (T4) follow-up. We will examine 5 hypothesized CBSM process variables as mediators of its effects on Quality of Life including Cognitive Appraisals, Coping Self-Efficacy, Emotional Processing, Social Support and Physiologic Arousal (using 24- hour urinary catecholamines and cortisol). We will examine 3 hypothesized mediators of physical health changes during the 12-month follow-up including Health Behaviors (medication adherence, health care utilization, smoking, unprotected ex, and substance use). Immunologic Status (NKCC, CD3+CD4+, CD3+CD8+, CD3-CD56+), and Reproductive Hormones (DHEA-S, testosterone, estradiol).

This application is for a 5-year Center for Psycho-Oncology Research (CPOR) grant to conduct behavioral, psychological, social, and biomedical research on the interrelationships among cognition, emotion, biological processes, and physical health in patients with different forms of cancer including breast cancer, prostate cancer and AIDS-related cervical neoplasia. The Center will systematically evaluate the efficacy group-based Cognitive Behavioral Stress Management (CBSM) intervention in Projects 1, 2 and 3., and a pharmacological hormonal treatment in Project 4, for improving quality of life and physical health in patients with different types of cancer or carcinogenic processes associated with reproductive health or hormonal functioning. These include women with breast cancer, older men with prostate cancer, and women at high risk for cervical cancer due to co-infection with Human Immunodeficiency Virus (HIV+) AND Human Papillomavirus (HPV+). Our prior work has shown that CBSM intervention can improve mood, change cognitions and build coping resources; that it modulates the output of sympathetic nervous system (SNS), Hypothalamic Pituitary Adrenal (HPA), and Hypothalamic Pituitary Gonadal (HPG) hormones; and that it helps normalize immunologic status in different populations. The Center will directly address these issues through four (4) randomized clinical trials as follows. Project 1 will (a) evaluate the effects of CBSM intervention on psychological distress, quality of life and biopsy- determined level of cervical cellular atypia; and (b) examine the putative psycho-biological mediators (psychosocial, endocrine, and immunologic changes) on intervention effects observed. Project 2 will (a) investigate the effects of CBSM intervention and quality of life and disease status (change in CA15-3) antigen levels) in women with early-mid stage breast, and (b) examine the putative psycho-biological mediators of intervention effects observed. Project 3 will (a) investigate the effects of CBSM in combination with Viagra (sildenafil citrate) on quality of life and physical health in older men with prostate cancer, and (b) examine the putative psycho-biological mediators of intervention effects observed. Project 4 will (a) evaluate the effects of estrogen therapy (chronic low-dose oral 17- beta estradiotherapy) on mood and quality of life, and physical health in patients with metastatic prostate cancer, and (b) examine the putative psycho-biological mediators of intervention effects observed. The Center will also support and conduct pilot studies of interventions in men and women with other cancers, and will also develop and test other forms of intervention as well as Spanish translations of CBSM for Spanish- speaking Breast and Prostate cancer patients.

The proposed 5-year study examines the effects of a cognitive behavioral stress management (CBSM) intervention (including relaxation training and cognitive restructuring) on physical health status and illness burden in 150 (after attrition) patients diagnosed with Chronic Fatigue Syndrome (CFS). The study tests the efficacy of a conceptual model which holds that the interaction of psychological factors (distress and depression associated with either CFS related symptoms or other stressful life events) and immunologic dysfunction (elevations in cytokines such as tumor necrosis factor [TNF]-alpha and the macrophage activation marker, neopterin) contribute to: (a) the exacerbation of physical symptoms associated with CFS (e.g., fatigue, joint pain, fever) and subsequent increases in illness burden (operationalized as disruptions in daily activities due to fatigue and related physical symptoms); and (b) further dysfunction in the immune system (e.g., impaired lymphocyte proliferative responses to phytohemagglutinin [PHA] and natural killer cell cytotoxicity [NKCC]). The proposed revised study tests this model experimentally by first evaluating the effects of a 10 week group CBSM intervention upon the primary health outcome variables: physical health status (CFS symptoms), fatigue severity, CFS-related illness burden and functional quality of life. Secondly, this study examines the role of two sets of hypothesized mediator variables: (l) reductions in psychological distress and depression levels; and (2) immune system modulation (less impaired NKCC and PHA responsivity, lowered TNF-alpha peptides and TNF-type II receptors in serum, reduced neopterin levels, reduced numbers of lymphocyte subsets expressing activation markers). To bring about these effects the intervention is hypothesized to directly modulate a set of psychosocial intervention targets that we hypothesize will influence the mediator variables. These intervention targets include reductions in distorted cognitive appraisals, greater use of active and engaging coping strategies, increased coping self-efficacy and increased perceptions of social support provisions. This is a randomized experiment with a 12-week CBSM (plus education and standard care) condition vs. an Education plus standard care (ED/SC) control condition, At the end of the 12-week CBSM intervention, the experimental group will continue on a standard of care regimen and will be monitored for their adherence to the techniques learned in the CBSM intervention and for intercurrent medical treatment. At the end of the 12-week ED/SC period the control group will be subsequently monitored as they continue on their standard of care. We will follow subjects at 6 and 12 months post-CBSM to assess treatment carryover and to correlate prospectively pre-post CBSM changes in mediator and health outcome variables measured at these follow-up points.

People treated for cancer confront much adversity, but there are also reports that the experience changes many people's lives for the better. At present, little is known about whether such positive changes can be enhanced by psychosocial interventions or what factors might mediate or moderate the process. Even less is known about whether growth experiences might relate to beneficial physiological changes that could reduce the risk of later disease recurrence. With prior funding we examined cross-sectionally 223 early-stage breast cancer patients and found widespread evidence of perceived positive contributions from having been diagnosed with cancer. Positive contributions in this sample related to lower levels of emotional, social, and sexual disruption. We also tested a 10-week Cognitive Behavioral Stress Management (CBSM) program in a second sample of early-stage breast cancer patients (n = 132, final followups continuing). This intervention proved to induce a sense of positive contribution above the levels that arose spontaneously in the control group. The increase remains in place 9 months after the intervention (i.e., 1 year post-diagnosis). This enhancement of positive contributions in the therapy group mediated lower levels of subsequent distress. We have also conducted pilot work in this sample to develop an immunologic assessment battery, with measures that characterize cellular immune functions and related cell-signalling cytokines. In the proposed work we will evaluate CBSM among White, Hispanic (both English- and Spanish-speaking), and Black women who are newly diagnosed with and treated for early/middle stage breast cancer (Stages I-III). The proposed project will further examine impact of positive contributions (as well as distress), by examining the effects of CBSM in a variety of life spheres at 3 months and 9 months after the intervention. The intervention is hypothesized to improve psychosocial adjustment and foster a sense of positive growth, foster a more rapid return to pre-diagnosis quality of life, indexed by levels of positive and negative mood, fatigue symptoms and sleep quality, and disturbances in social and psychosexual functioning. We also will examine how changes in these spheres are paralleled by changes in aspects of immune functioning relevant for future risk of disease recurrence, including lymphocyte subpopulations; lymphoproliferative responses to anti- CD3; interleukin-2 (IL-2) and interferon-gamma (IFN-y) production during lymphoproliferative challenge; and recombinant (r)IL-2- and rIFN-y-stimulated natural killer cell cytotoxicity to K562 targets, and three breastcancer lines, MB453 SKBR3, and MCF-7.

stress management; cognitive behavior therapy; human therapy evaluation; prostate neoplasms; group therapy; quality of life; functional ability; social support network; anxiety; coping; psychological aspect of cancer; arousal; psychological adaptation; health behavior; depression; psychological stressor; patient oriented research; behavioral /social science research tag; human subject; male; clinical research;

stress management; cognitive behavior therapy; human therapy evaluation; AIDS; HIV infections; bisexual; quality of life; social support network; caucasian American; African American; emotions; health; psychoneuroimmunology; longitudinal human study; psychological adaptation; health behavior; homosexuals; cognition; male; Hispanic Americans; racial /ethnic difference; virus load; patient oriented research; human subject; behavioral /social science research tag; clinical research;

[unreadable] DESCRIPTION (provided by applicant): This is a 4-year study that uses a 10-week telephone based cognitive behavioral stress management intervention (T-CBSM) to illuminate neuroimmune mechanisms underlying the effects of stress and stress management on physical health status and immune regulation in individuals with chronic fatigue syndrome (CFS) relative to participants receiving a health promotion telephone (T-HP) intervention. CFS is characterized by physical symptoms which bring about severe limitations in lifestyle behaviors and vocational activities. Associated symptoms include debilitating fatigue, low grade fever, lymph node pain and tenderness, cognitive difficulties, and mood changes. There is growing evidence that CFS patients may also show abnormalities in HPA axis functioning and on several indices of immune functioning. Chronic stress is also associated with a flattened diurnal secretion pattern for cortisol. An inability to maintain regulation in the HPA axis may contribute to the pathophysiology of CFS via diminished control of pro-inflammatory cytokines and associated physical symptoms related to chronic immune activation and inflammation. Given the debilitating nature of CFS, we propose to deliver the T-CBSM intervention through a telecommunications system (i.e. Telecare) designed to enhance access to formal and informal care for a population that may have difficulty accessing traditional psychotherapeutic settings. In our prior work with individuals with CFS, we have shown that individuals in a structured group CBSM intervention report significantly improved quality of life, perceived stress, fatigue, memory, muscle pain, and post-exertional malaise compared to individuals in the control condition. The Telecare system has been successful in delivering a supportive intervention for older caregivers of dementia patients. This study is novel in expanding our prior work to individuals with CFS who have reported difficulty participating in structured groups due to physical burden. The study design is a 2 X 3 randomized experimental design with group (T-CBSM, n=60 vs. T-HP, n=60) as the between-group factor, and time (Pre-intervention, Post-intervention and 6 month follow-up) as the within-group factor. Our primary objective is to evaluate the extent to which a T-CBSM intervention Aimed at building skills in anxiety reduction, distress tolerance, stressor appraisals, and adaptive coping strategies may improve physical health status and immune regulation in CFS by modulating neuroimmune interactions. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): This is a 5-year study to evaluate the effect of a 10-week patient-partner telephone- based cognitive behavioral stress management (CBSM) intervention on chronic fatigue syndrome (CFS) symptoms in 150 patients diagnosed with CFS. Because many patients with CFS are unable to attend intervention sessions in clinical settings due to unpredictable periods of debilitating fatigue and limited mobility, we created a form of CBSM intervention that is delivered at the participant's home through a telecommunications system (i.e., Telephone-based CBSM, T-CBSM). A unique aspect of T-CBSM is that it uses the telephone to convene groups of individuals in their homes-thus it retains some of the supportive elements of a group-based intervention. We have observed that over a 5-month period this patient-focused T-CBSM intervention is associated with decreases in CDC-based CFS symptoms and decreases in the pro- inflammatory cytokines, interleukin-1b (IL-1b) and tumor necrosis factor-a (TNF-a) and increases in the anti-inflammatory cytokine, IL-13. Greater decreases in pro- inflammatory cytokines were associated with greater increases in the negative pitch of the AM-PM slope of salivary cortisol and greater decreases in CFS symptoms. This supported our neuroimmune model as an explanation for the effects of T-CBSM on CFS symptoms. We also conducted subgroup analyses comparing partnered and unpartnered CFS patients and found that the effects of the intervention were much larger in the partnered group. We have designed a study to follow up on these findings by testing a newly designed partner-patient dual focus videotelephone-delivered CBSM intervention (PP-T-CBSM) that allows the partner to learn stress management techniques with the patient in a group setting and to then practice together a set of stress management techniques such as relaxation and cognitive, behavioral and interpersonal skills training. We will compare changes in CFS symptoms, neuroimmune indicators, and psychosocial (patient and partner) functioning in participants assigned to PP-T-CBSM vs an attention time-matched telephone-based health information (T-HI) control condition in a 2 X 3 randomized experimental design with group (PP-T-CBSM, n=75 vs. T-HI, n=75) as the between-group factor, and time (Pre-intervention, 5- and 9- month follow-up) as the within-group factor. PUBLIC HEALTH RELEVANCE: Because chronic fatigue syndrome (CFS) is a debilitating condition, that has no cure, and which represents an economic burden for society due to high rates of unemployment due to disability and repeated utilization of healthcare resources it is critical that interventions target long-term management by addressing the multi-level factors that maintain the symptoms of this disorder. The results of this study have major significance since they might offer an intervention that is efficacious in managing CFS symptoms through a theory-based comprehensive stress management approach, and one that will reach a broader population of CFS patients who would not otherwise be able to benefit from these empirically supported techniques. The proposed study is innovative in being the first randomized trial to test the effects of a patient-partner Video- Telephone-delivered psychosocial intervention (PP-T-CBSM) for CFS patients while examining a neuroimmune mechanism (hypothalamic-pituitary-adrenal [HPA] axis-cytokine regulation) to explain the effects of this intervention on CFS symptoms.

DESCRIPTION (provided by applicant): Despite the fact that prostate cancer (PCa) continues to be the second leading cause of cancer-related death among Hispanic (H) and African American (AA) men, participation of these ethnic minorities in quality of life (QoL) outcome research is often minimal with Hs being significantly underrepresented. Ethnic minority men with PCa have less educational and financial resources at diagnosis, more indicators of disease burden (e.g., more advanced disease, higher prostate specific antigen [PSA]), and reduced QoL and survival following treatment even after controlling for sociodemographic and disease variables. Furthermore, PCa mortality rates among AAs are twice as high as in non-Hispanic white (NHW) men. Although limited by small samples, available studies indicate that there are differential outcomes by ethnicity with minority men consistently reporting lower QoL (e.g., reduced physical functioning and more disease-specific decrements such as urinary/bowel and sexual dysfunction), lower treatment satisfaction and poorer recovery after treatment;however, the mechanisms by which ethnicity may impact QoL remain to be explored. These prior studies are also lacking in a multidimensional conceptualization of ethnicity, as well as a theoretical framework that links ethnicity to health outcomes. This revised application consists of a 5-year prospective observational study designed to assess the effect of ethnic group membership on general and disease- specific QoL outcomes and disease status (i.e., PSA) in men diagnosed and treated for PCa. We will recruit 690 ethnically diverse men (230 NHW;230 H;230 AA) at diagnosis for PCa and conduct psychosocial and physical health assessments at baseline (pre-treatment), at 3-months post-treatment, and every 6 months over a 24-month post-treatment follow-up period. Our Specific Aims are to determine over a 24-month follow-up: (Aim 1) whether the relationship between ethnic group membership and (a) general (i.e., physical and mental health functioning) and disease-specific quality of life (QoL), and (b) disease status (i.e., PSA) is explained by PCa knowledge and attitudes, psychosocial resources (i.e., optimism, social support, coping and family environment), adherence to treatment and access to health care over a two-year follow-up period in men treated for PCa;(Aim 2) whether specific components of ethnicity (i.e., cultural values [e.g., familism, religiosity, cancer fatalism], ethnic identity, acculturation, minority status &SES) are associated with PCa knowledge and attitudes, psychosocial resources, access to health care &adherence to treatment over a two-year follow-up period in men treated for PCa;and (Aim 3) whether the relationship between specific components of ethnic group membership, and QoL and disease status are explained by PCa knowledge and attitudes, psychosocial resources, access to health care &adherence to treatment over a two-year follow-up period in men treated for PCa. To investigate if there are ethnic differences in baseline scores and the trajectory of change in QoL over time and the potential determinants of these differences (e.g., components of ethnicity, psychosocial resources), latent growth curve modeling in the framework of structural equation modeling will be performed. We will also test the relationships among components of ethnic group membership, postulated mediators of QoL and disease status, and their joint effects, while incorporating relevant socio-demographic and medical factors in the hypothesized models.

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.

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.