At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer
In Brief
A clinical study evaluating Technology based cognitive behavioral stress management and Technology based health promotion group-based attention matched control condition for Prostate Cancer. Completed, enrolled 224 participants across 2 sites.
Detailed Summary
The purpose of this study is to examine the effects of various factors such as emotions, stress, stress management techniques (for example relaxation and coping techniques), and health information on quality of life, distress, depression, coping, and physical health in men diagnosed with advanced prostate cancer. The investigators also evaluate the effectiveness of a 10-week group-based internet delivered psychosocial intervention. Primary outcomes are symptom burden (e.g., urinary function, fatigue, pain) and HRQOL (e.g., general, physical \& social functioning). Participation in this study includes three face-to-face assessments: baseline (at the beginning of the research study), 6-month follow-up, and 12-month follow-up. The 6- and 12-month follow-up interviews are conducted after the participant has completed the 10-week group intervention. Participants are randomized into either an intervention group (targets stress management skills - relaxation, coping) or a control group (health information and health promotion strategies - benefits of proper nutrition and treatment compliance). Both groups meet for 10 consecutive weeks through an internet video conferencing platform. At the baseline, 6- and 12-month follow-ups, the investigators collect blood and saliva samples. The blood samples go through a three-day process in which the investigators extract and store serum, plasma, and cells for further analysis and gather proliferation data. The investigators use the saliva to measure the cortisol diurnal rhythm.
Study Details
Timeline
Interventions
Intervention is delivered through Telecare (web based technology) in a group for 60-90 minutes/session. During each session, participants are taught/discuss a new anxiety/arousal reduction technique and focus on stress management. Efficacy of available treatments, disease course, symptom burden, communication with intimate partner and/or family members and health care provider, impact of stress on physical and mental health and symptoms, and management of APC and HT symptoms are used for educational purposes and as catalysts for discussing TCBSM techniques. We allow participants to describe psychosocial stressors with an emphasis on symptoms and disruption, HRQOL and their coping responses for in-session role-plays. Participants are able to access the system at any time to retrieve relaxation and stress management didactics, and contact community resources and other participants in their group.
Sessions include content from relevant NCI, ACS and other resources developed to address the needs of advanced cancer populations into each topic session. All sessions address APC-specific issues. While men receiving treatment for APC remain interested in general health issues and as they become increasingly aware of the end-of-life issues raised by facing advanced disease, they seem to be interested in making life changes in areas in which they do exercise control (e.g., nutrition), and as such have been integrated into the T-HP modules in addition to general recommendations from sources such as American Heart Association, the NIA and the ACS. T-HP participants are scheduled for weekly group-based health information and promotion sessions (60-90 mins.), which are delivered via our videophones by our T-HP facilitators.