Frank J Penedo1, Rina S Fox2, Laura B Oswald2, Patricia I Moreno2, Cody L Boland3, Ryne Estabrook2, Heather L McGinty4, David C Mohr5, Mark J Begale6, Jason R Dahn7, Sarah C Flury8, Kent T Perry8, Shilajit D Kundu8, Betina Yanez2. 1. Departments of Psychology and Medicine, University of Miami, 5665 Ponce de Leon Boulevard, Flipse Building, 5th Floor, Coral Gables, FL, 33146, USA. frank.penedo@miami.edu. 2. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 3. Departments of Psychology and Medicine, University of Miami, 5665 Ponce de Leon Boulevard, Flipse Building, 5th Floor, Coral Gables, FL, 33146, USA. 4. Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA. 5. Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. 6. Vibrent Health, Fairfax, VA, USA. 7. Mental Health and Behavioral Sciences Service, Miami Veterans Affairs Healthcare System, Miami, FL, USA. 8. Department of Urology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Abstract
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.
RCT Entities:
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.
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