Clinical trial NCT05486754: Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer
Official title: Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: group therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 260
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test a stress management program for men with early-stage prostate cancer.


Eligibility criteria: Inclusion criteria:

* Men who had undergone either a radical prostatectomy or radiation therapy (i.e., external beam or seed implant) for stage I or II prostate cancer in the preceding 18-months
* 50 years of age or older
* Ability to speak, read, and write in English
* Having a ninth grade reading level or greater
* Being free of cognitive impairment that would interfere with the study
* No active psychiatric symptoms in the previous three months.

Exclusion criteria:

* Previous history of non-skin cancer
* Have received adjuvant treatment, including hormone treatment, for prostate cancer

Primary outcomes:
measure: Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire
timeFrame: Baseline, up to 18 months
measure: Change in post-traumatic event perceptions as measured by the Benefit Finding Scale questionnaire
timeFrame: Baseline, up to 18 months
measure: Change in optimism as measured by the Life Orientation Test - Revised questionnaire
timeFrame: Baseline, up to 18 months
measure: Change in immune cell count
timeFrame: Baseline, up to 18 months
measure: Change in immune cell percentage
timeFrame: Baseline, up to 18 months
measure: Change in natural killer cell percentage
timeFrame: Baseline, up to 18 months
measure: Change in natural killer cell count
timeFrame: Baseline, up to 18 months
measure: Change in natural killer cell cytotoxicity as captured by activity percentage
timeFrame: Baseline, up to 18 months
measure: Change in ratio of natural killer cell cytotoxicity as captured by Lytic Index
timeFrame: Baseline, up to 18 months
measure: Change in count of natural killer cell cytotoxicity as captured by Kinetic Lytic Index
timeFrame: Baseline, up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Michael H Antoni, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penedo FJ, Molton I, Dahn JR, Shen BJ, Kinsinger D, Traeger L, Siegel S, Schneiderman N, Antoni M. A randomized clinical trial of group-based cognitive-behavioral stress management in localized prostate cancer: development of stress management skills improves quality of life and benefit finding. Ann Behav Med. 2006 Jun;31(3):261-70. doi: 10.1207/s15324796abm3103_8.
citation: Traeger L, Penedo FJ, Benedict C, Dahn JR, Lechner SC, Schneiderman N, Antoni MH. Identifying how and for whom cognitive-behavioral stress management improves emotional well-being among recent prostate cancer survivors. Psychooncology. 2013 Feb;22(2):250-9. doi: 10.1002/pon.2074. Epub 2011 Sep 19.
citation: Molton IR, Siegel SD, Penedo FJ, Dahn JR, Kinsinger D, Traeger LN, Carver CS, Shen BJ, Kumar M, Schneiderman N, Antoni MH. Promoting recovery of sexual functioning after radical prostatectomy with group-based stress management: the role of interpersonal sensitivity. J Psychosom Res. 2008 May;64(5):527-36. doi: 10.1016/j.jpsychores.2008.01.004.
citation: Walsh EA, Antoni MH, Popok PJ, Moreno PI, Penedo FJ. Effects of a randomized-controlled trial of cognitive behavioral stress management: Psychosocial adaptation and immune status in men with early-stage prostate cancer. Gen Hosp Psychiatry. 2022 Nov-Dec;79:128-134. doi: 10.1016/j.genhosppsych.2022.10.012. Epub 2022 Oct 27.