Tele-based Psychosocial Intervention for Symptom Management &HRQOL in Men Living with Advanced Prostate Cancer This 5-year evaluates the effects of a 10-week group-based videophone delivered cognitive-behavioral stress management intervention (Tele-CBSM) on symptom burden in men with advanced prostate cancer (APC) at initial diagnosis undergoing hormonal therapy (HT), or HT with prior radiotherapy (RT). 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 and men with regionally advanced APC also undergo RT. HT is associated with side effects including depression, fatigue, hot flashes, and sexual and urinary dysfunction, while RT also leads 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 our pilot work we observed that audio-based Tele-CBSM improves social and physical functioning, and decreases symptom burden in APC. Moreover, targets of Tele-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. We propose to deliver an enhanced Tele-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 Tele-CBSM in a multi-ethnic sample of 200 men living with APC undergoing HT or HT with prior RT. Men will be randomized to a Tele-CBSM group intervention or a health promotion group (Tele-HP) control condition. Our primary aims are to determine the extent to which randomization to Tele-CBSM relative to Tele-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). We will also test (Aim 4) a set of hypothesized pathways (e.g., Tele- CBSM driven changes in distress, stress management skills, neuroimmune regulation, etc.) that explain the association between group assignment and our primary outcomes of symptom burden and HRQOL. This is a 2x3 randomized experimental design with condition (Tele-CBSM vs. Tele-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.
Hormonal therapy (HT) for advanced prostate cancer (APC) is the most commonly available treatment and is characterized by emotionally and physically compromising treatment-related side effects including fatigue, depression, hot flashes, pain, sexual/urinary dysfunction, etc. thus presenting a significant burden to APC patients and their families. This study will provide information for the management of APC and reduction of symptom burden by testing a videophone-delivered group-based intervention (Tele-CBSM) targeting APC symptoms using a comprehensive stress management approach that will reach a broad hard to reach and ethnically diverse population. Delineating pathways (e.g., stress management skills, neuroimmune regulation) that explain the effects of Tele-CBSM on symptom burden will provide a better understanding of mechanisms that link psychosocial and physiological processes to symptom management that is evidence- based and can guide psychosocial treatments in a critically understudied subgroup of PC patients.
