Symptom burden profiles in men with advanced prostate cancer undergoing androgen deprivation therapy.

To identify symptom burden profiles among men with advanced prostate cancer undergoing androgen-deprivation therapy and examine their association with baseline sociodemographic and medical characteristics and psychosocial outcomes over time. Latent profile analysis was employed to identify distinct groups based on the Expanded Prostate Index Composite and the McGill Pain Questionnaire at baseline. Psychosocial outcomes were assessed at baseline, 6- and 12-month follow-ups. Three profiles emerged: "high symptom burden," "high sexual bother," and "low symptom burden." Men with "high symptom burden" were younger and exhibited higher baseline levels of depression, stress, cancer-specific distress, and anxiety than men in the other two groups. However, men with "high symptom burden" also demonstrated improvement in these psychosocial outcomes over time. Men with advanced prostate cancer who experience multiple co-occurring symptoms demonstrate worse psychosocial adjustment. Patients with substantial symptom burden, and specifically young men, may benefit from prompt referral to supportive care services.

Effects of web-based cognitive behavioral stress management and health promotion interventions on neuroendocrine and inflammatory markers in men with advanced prostate cancer: A randomized controlled trial.

Cognitive behavioral stress management (CBSM) improves quality of life and mitigates stress biology in patients with early-stage cancer, including men with localized prostate cancer. However, treatments for advanced prostate cancer like androgen deprivation therapy (ADT) can lead to significant symptom burden that may be further exacerbated by stress-induced inflammation and cortisol dysregulation. The aim of this study was to examine the effects of CBSM (versus an active health promotion control) on circulating inflammatory markers and cortisol in men with advanced prostate cancer. METHODS: Men with stage III or IV prostate cancer (N = 192) who had undergone ADT within the last year were randomized to CBSM or health promotion. Both interventions were 10 weeks, group-based, and delivered online. Venous blood was drawn at baseline, 6 months, and 12 months to measure circulating levels of CRP, IL-6, IL-8, IL-10, and TNF-α. Saliva samples were collected at awakening, 30 min after awakening, evening, and night for two consecutive days at baseline, 6-months, and 12-months to measure diurnal cortisol slopes. RESULTS: Mixed modeling analyses demonstrated that changes in inflammatory markers and cortisol did not differ by intervention. Men in both CBSM and health promotion showed decreases in IL-10, IL-8, and TNF-α from baseline to 6 months (ß = -3.85--5.04, p's = 0.004-<0.001). However, these markers generally demonstrated a rebound increase from 6 to 12 months (ß = 1.91-4.06, p's = 0.06-<0.001). Men in health promotion also demonstrated a flatter diurnal cortisol slope versus men in CBSM at 6 months (ß = -2.27, p = .023), but not at 12 months. There were no intervention effects on CRP, IL-6, or overall cortisol output. CONCLUSIONS: Contrary to hypotheses, CBSM did not lead to changes in the circulating inflammatory markers and cortisol relative to health promotion. CBSM may be associated with healthy diurnal cortisol rhythm because of its focus on cognitive behavioral approaches to stress management. More research is needed to understand the impact of CBSM and health promotion on biomarkers among men with advanced prostate cancer.

Technology-Based Psychosocial Intervention to Improve Quality of Life and Reduce Symptom Burden in Men with Advanced Prostate Cancer: Results from a Randomized Controlled Trial.

BACKGROUND: Men with advanced prostate cancer (APC) face multiple challenges including poor prognosis, poor health-related quality of life (HRQOL), and elevated symptom burden. This study sought to establish the efficacy of a tablet-delivered, group-based psychosocial intervention for improving HRQOL and reducing symptom burden in men with APC. We hypothesized that men randomized to cognitive-behavioral stress management (CBSM) would report improved HRQOL and reduced symptom burden relative to men randomized to an active control health promotion (HP) condition. Condition effects on intervention targets and moderators of these effects were explored. METHODS: Men with APC (N = 192) were randomized (1:1) to 10-week tablet-delivered CBSM or HP, and followed for 1 year. Multilevel modeling was used to evaluate condition effects over time. RESULTS: Changes in HRQOL and symptom burden did not differ between groups. Men in both groups improved across several intervention targets; men in the CBSM condition reported greater increases in self-reported ability to relax, and both conditions showed improvements in cancer-related anxiety, cancer-related distress, and feelings of cohesiveness with other patients over time. Moderating factors included baseline interpersonal disruption, fatigue, and sexual functioning. CONCLUSIONS: Tablet-delivered CBSM and HP were well received by men with APC. The hypothesized effects of CBSM on HRQOL and symptom burden were not supported, though improvements in intervention targets were observed across conditions. Participants reported high-baseline HRQOL relative to cancer and general population norms, possibly limiting intervention effects. The identified moderating factors should be considered in the development and implementation of interventions targeting HRQOL and symptom burden. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03149185.

Feasibility, acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for racially diverse men with advanced prostate cancer.

BACKGROUND: The utility of psychosocial interventions in reducing symptom burden and improving health-related quality of life (HRQOL) for men with localized prostate cancer has been demonstrated. However, studies have yet to demonstrate the efficacy of interventions in advanced prostate cancer (APC). This study examined the feasibility, acceptability, and preliminary efficacy of a technology-assisted, 10-week, group-based psychosocial intervention for diverse men with APC. METHODS: The participants were 74 men (mean age, 68.84 years; non-Hispanic white, 57%; black, 40.5%) who were randomized to a cognitive-behavioral stress management (CBSM) treatment or health promotion (HP) attention-control condition. The participants were assessed at the baseline, weekly throughout the 10-week program, and 6 months after the baseline. Outcomes were assessed with the Patient-Reported Outcomes Measurement Information System along with established measures of HRQOL, CBSM intervention targets (eg, relaxation skills), and patient-reported acceptability. RESULTS: Feasibility was demonstrated through good retention rates (>85%) and acceptable average attendance rates (>70%), and acceptability was demonstrated through very favorable weekly session evaluations (mean score, 4/5) and exit surveys (mean score, 3.6/4). Men randomized to the CBSM condition reported significant reductions (P < .05) in depressive symptoms and improvements in relaxation self-efficacy (P < .05) at the 6-month follow-up. CBSM participants reported trends for improvement in distress and functional well-being (P < .08) in comparison with those in the HP condition. Effect sizes ranged from medium (0.54) to large (1.87) and, in some instances, were clinically meaningful. CONCLUSIONS: Technology-based CBSM interventions among diverse men with APC may be feasible, acceptable, and efficacious.

Integrating PROMIS® computerized adaptive tests into a web-based intervention for prostate cancer.

OBJECTIVE: This study outlined the implementation and feasibility of delivering PROMIS® computer adaptive tests (CATs) using a web-based method to evaluate the impact of a technological adaptation of Cognitive-Behavioral Stress Management (CBSM) on the psychosocial functioning of men with advanced prostate cancer (APC) undergoing hormone therapy. METHOD: Patients were randomized to a CBSM group intervention (n = 95) or a health promotion (HP) attention-matched control condition (n = 97). Participants attended all sessions via video conference using tablets, and completed PROMIS® computer adaptive tests (CATs) assessing anxiety, depression, fatigue, pain interference, and physical function weekly during the 10-week intervention. RESULTS: Assessment completion rates >50% at week 1 and week 10 demonstrated moderate feasibility of repeatedly administering PROMIS® CATs using a web-based method. Multilevel modeling demonstrated no significant group-by-time interactions from week 1 to week 10 for any of the assessed PROMIS® domains adjusting for sociodemographic and medical covariates. However, simple effects demonstrated decreases in PROMIS® anxiety scores from week 1 to 10 for both groups. Results also demonstrated significant relationships of medical variables to psychosocial functioning across time points. CONCLUSIONS: Results highlight the feasibility and benefits of utilizing PROMIS® CATs to repeatedly assess psychosocial functioning using a web-based method and indicate that web-based interventions may be effective for decreasing psychosocial distress and adverse symptoms among men with APC undergoing hormone therapy. (PsycINFO Database Record (c) 2019 APA, all rights reserved).