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

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.

Sex

Male

Minimum age

50 Years

Inclusion Criteria:

* ≥ 50 years of age
* Fluent in spoken English (6th grade level required to complete assessments and participate in groups)
* Diagnosis of Stage III or IV (T3/N1/ M0-T4/N3/M1) prostate cancer
* Received HT, or HT and RT treatment within the past year or is currently receiving HT, or HT and RT
* Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review
* Willingness to be randomized and followed for 12 months

Exclusion Criteria:

* Received treatment for a type of cancer other than prostate or skin cancer within the past 5 years or is currently receiving treatment for a cancer other than prostate or skin
* Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis), as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review
* Active alcohol abuse or dependence OR inpatient treatment for alcohol abuse within the last 6 months may be exclusionary, per P.I. discretion
* Active substance abuse or dependence OR inpatient treatment for substance abuse within the last 6 months may be exclusionary, per P.I. discretion
* Acute or chronic immune system medical conditions, medications or other conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Sjogren's disease, SLE, Hepatitis C, or any immunosuppressive treatment requiring conditions)
* Life expectancy \<12 months.

• DERIVEDBenzo RM, Moreno PI, Fox RS, Silvera CA, Walsh EA, Yanez B, Balise RR, Oswald LB, Penedo FJ. Comorbidity burden and health-related quality of life in men with advanced prostate cancer. Support Care Cancer. 2023 Jul 28;31(8):496. doi: 10.1007/s00520-023-07962-6. PMID 37501020
• DERIVEDWalsh EA, Boland CL, Popok PJ, Pedreira PB, Fox RS, Moreno PI, Yanez B, Penedo FJ. Marital status and perceived stress in men with advanced prostate cancer: A randomized-controlled trial of cognitive behavioral stress management. J Psychosom Res. 2023 Apr;167:111198. doi: 10.1016/j.jpsychores.2023.111198. Epub 2023 Feb 16. PMID 36812663
• DERIVEDWalsh EA, Pedreira PB, Moreno PI, Popok PJ, Fox RS, Yanez B, Antoni MH, Penedo FJ. Pain, cancer-related distress, and physical and functional well-being among men with advanced prostate cancer. Support Care Cancer. 2022 Dec 14;31(1):28. doi: 10.1007/s00520-022-07453-0. PMID 36515785
• DERIVEDPenedo FJ, Fox RS, Oswald LB, Moreno PI, Boland CL, Estabrook R, McGinty HL, Mohr DC, Begale MJ, Dahn JR, Flury SC, Perry KT, Kundu SD, Yanez B. 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. Int J Behav Med. 2020 Oct;27(5):490-505. doi: 10.1007/s12529-019-09839-7. PMID 31898309
• DERIVEDFox RS, Moreno PI, Yanez B, Estabrook R, Thomas J, Bouchard LC, McGinty HL, Mohr DC, Begale MJ, Flury SC, Perry KT, Kundu SD, Penedo FJ. Integrating PROMIS(R) computerized adaptive tests into a web-based intervention for prostate cancer. Health Psychol. 2019 May;38(5):403-409. doi: 10.1037/hea0000672. PMID 31045423