Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer

This 5-year study evaluates the effects of a 10-week technology-based and delivered cognitive-behavioral stress management intervention (T-CBSM) on symptom burden in men with advanced prostate cancer (APC) undergoing hormonal therapy (HT), or HT with prior radiotherapy (RT) and/or radical prostatectomy (RP). APC is chronic and debilitating with survival rates about 32% and even lower rates for ethnic minorities. Most (70%) men diagnosed with APC receive HT to control progression. HT is associated with side effects including depression, fatigue, hot flashes, and sexual and urinary dysfunction, while RT and RP also lead to fatigue, irritation, urinary dysfunction, etc. Symptoms combined with challenges of living with advanced disease (e.g., unpredictable disease course) significantly deteriorate health-related quality of life (HRQOL). Yet, there is limited information on how psychosocial factors impact symptom burden, or on the efficacy of psychosocial interventions in reducing symptom burden and improving HRQOL. Furthermore, psychosocial modulation of endocrine and immune function is associated with symptoms and HRQOL in cancer patients, including those with advanced disease. Stress-related disruption in diurnal cortisol can promote inflammation that can exacerbate symptoms (e.g., fatigue, depression, pain). In the investigaros' pilot work, the investigators observed that audio-based T-CBSM improves social and physical functioning, and decreases symptom burden in APC. Moreover, targets of T-CBSM (e.g., coping skills) explain reductions in symptoms, whereas decreases in inflammatory cytokines (e.g., IL-1, IL-6) and enhanced cortisol regulation are associated with decreases in symptoms such as depression, pain, urinary dysfunction and fatigue. The investigators propose to deliver an enhanced T-CBSM intervention to (a) capitalize on new technology using a video-conferencing for hard-to-reach and ethnically diverse patients, (b) incorporate a neuroimmune model of symptom regulation and management, and (c) test the efficacy of Web-CBSM in a multi-ethnic sample of 200 men living with APC. Men will be randomized to a T-CBSM group intervention or a health promotion group (T-HP) control condition. The investigators' primary aims are to determine the extent to which randomization to T-CBSM relative to T-HP is associated with: (Aim 1) improved symptom burden management and HRQOL, (Aim 2) reduced distress and interpersonal disruption, and improved stress management skills, and (Aim 3) improved neuroimmune regulation (i.e., normalized diurnal cortisol \& decreases in inflammatory cytokines). The investigators will also test (Aim 4) a set of hypothesized pathways (e.g., T-CBSM driven changes in distress, stress management skills, neuroimmune regulation, etc.) that explain the association between group assignment and the primary outcomes of symptom burden and HRQOL. This is a 2x3 randomized experimental design with condition (T-CBSM vs. T-HP) as the between groups factor and time (baseline \[T1\], 6-mos. post-baseline \[T2\], \& 12-mos. post-baseline \[T3\]) as the within groups factor. Experimental Design. This is a randomized experimental trial designed to evaluate the effects of a 10-week technology-based group cognitive-behavioral stress management intervention vs. a health promotion group-based attention matched control condition. Primary outcomes are symptom burden (e.g., urinary function, fatigue, pain) and HRQOL (e.g., general, physical \& social functioning). Participants. Participants will be 200 ethnically diverse men ages 50 or older, with stage III or IV prostate cancer (i.e., APC) who are on hormonal treatment (HT; androgen ablation, androgen deprivation, chemical castration) with or without radiotherapy (RT). Participants must also have undergone HT within the past 12 months.