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

NCT03149185 | Completed DMC

• 1 other identifier: STU00064136
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; advanced prostate cancer; technology based

Outcome Measures

Primary Outcomes (2)

• Change in symptom burden from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control).

  Symptom burden will be measured with the Expanded PC Index Composite (EPIC)

  baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)

• Change in HRQOL from baseline (T1) to 6- and 12-month follow-up assessments (T2 & T3) relative to participants in T-HP (control).

  SF-12, a short form version of the commonly used SF-36, a health survey designed to assess multiple dimensions of HRQOL

  baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)

Other Outcomes (4)

• Distress & Positive/Negative Affect

  baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)

• Interpersonal Disruption

  baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)

• Stress Management Skills

  baseline (T1), 6-months post-baseline (T2), and 12-months post-baseline (T3)

Study Arms (2)

T-CBSM

ACTIVE COMPARATOR

Technology based cognitive behavioral stress management.

Behavioral: Technology based cognitive behavioral stress management

T-HP

ACTIVE COMPARATOR

Technology based health promotion (control condition)

Behavioral: Technology based health promotion group-based attention matched control condition

Interventions

Technology based cognitive behavioral stress management BEHAVIORAL

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.

Also known as: T-CBSM

T-CBSM

Technology based health promotion group-based attention matched control condition BEHAVIORAL

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.

Also known as: T-HP

T-HP

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Jesse Brown VA Medical Center

Chicago, Illinois, United States

Location

Rush University Medical Center

Chicago, Illinois, United States

Location

Related Publications (5)

• Benzo 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 DERIVED

• Walsh 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 DERIVED

• Walsh 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 DERIVED

• Penedo 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 DERIVED

• Fox 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 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized experimental trial designed to evaluate the effects of a 10-week technology-based group cognitive-behavioral stress management intervention (T-CBSM) vs. a health promotion (T-HP) group-based attention matched control condition. This is a 2 x 3 design with group assignment (T-CBSM vs. T-HP) as the between group factor, and time (baseline \[T1\], 6-months post-T1 \[T2\], and 12-months post T1 \[T3\]) as the within-group factor.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 11, 2017
• Study Start: May 25, 2012
• Primary Completion: April 22, 2018
• Study Completion: April 22, 2018
• Last Updated: November 22, 2023

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)