Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

NCT05486754 | Completed

• 2 other identifiers: 199902881P50CA084944
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress

Keywords

group therapy

Outcome Measures

Primary Outcomes (10)

• Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire

  The Measure of Current Status questionnaire is a 23-item questionnaire each scored on a range of 0-4. The total score ranges from 0-92 with the higher score corresponding to greater perceived abilities.

  Baseline, up to 18 months

• Change in post-traumatic event perceptions as measured by the Benefit Finding Scale questionnaire

  The Benefit Finding Scale questionnaire is a 17-item measure capturing perception of a traumatic event (e.g., cancer diagnosis for participants) with each item scored on a scale of 1 to 5. The total score ranges from 17-85 with the higher score corresponding to greater perceived benefit.

  Baseline, up to 18 months

• Change in optimism as measured by the Life Orientation Test - Revised questionnaire

  The Life Orientation Test - Revised questionnaire measures participant's optimism. The total score ranges from 0-24 with the higher score corresponding to greater levels of optimism.

  Baseline, up to 18 months

• Change in immune cell count

  Immune cell count (including T-cell (Cluster of Differentiation (CD) 3+) and T-helper cells (CD 3+ CD 4+) will be evaluated from blood samples. Both values will be evaluated in count per cubic millimeter.

  Baseline, up to 18 months

• Change in immune cell percentage

  Immune cell percentage (including T-cell (Cluster of Differentiation (CD) 3+) and T-helper cells (CD 3+ CD 4+) will be evaluated from blood samples. Both values evaluated in count per cubic millimeter over total cell count per cubic millimeter.

  Baseline, up to 18 months

• Change in natural killer cell percentage

  Natural killer cell (CD56+CD3-) percentage is evaluated from blood samples. Values are evaluated in count per cubic millimeter over total cell count per cubic millimeter.

  Baseline, up to 18 months

• Change in natural killer cell count

  Natural killer cell (CD56+CD3-) count is evaluated from blood samples. Values are evaluated in count per cubic millimeter.

  Baseline, up to 18 months

• Change in natural killer cell cytotoxicity as captured by activity percentage

  Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples. Cells are stimulated through exposure to a reactive cell line and the percentage of cells active are counted and divided by total cells present per cubic millimeter.

  Baseline, up to 18 months

• Change in ratio of natural killer cell cytotoxicity as captured by Lytic Index

  Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples. Cells are stimulated through exposure to a reactive cell line and quantified as the ratio of responsive to unresponsive cells required to kill 10% of the target cell line.

  Baseline, up to 18 months

• Change in count of natural killer cell cytotoxicity as captured by Kinetic Lytic Index

  Natural killer cell (CD56+CD3-) cytotoxicity is evaluated from blood samples. Cells are stimulated through exposure to a reactive cell line and incubated for four hours total. Kinetic lytic index is quantified as the count of targeted cells killed during incubation. An average count of these cells will be calculated.

  Baseline, up to 18 months

Study Arms (2)

Cognitive behavioral stress management group

EXPERIMENTAL

Participants received the cognitive behavioral stress management intervention for 10 weeks.

Behavioral: Cognitive behavioral stress management

Health promotion group

ACTIVE COMPARATOR

Participants received the health promotion group for one day.

Behavioral: Psychoeducational Control

Interventions

Cognitive behavioral stress management BEHAVIORAL

Participants will receive in-person weekly stress management group sessions (3-8 participants) for two hours per week for ten weeks total. Each session will consist of a half hour of relaxation training and one and a half hours of stress management skill training, including coping effectiveness training, anger management, assertiveness training, and stress awareness.

Cognitive behavioral stress management group

Psychoeducational Control BEHAVIORAL

Participants will receive one four-hour seminar in-person groups (3-8 participants) of educational information related to prostate cancer and abbreviated psychological information provided in cognitive behavioral stress management.

Health promotion group

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (4)

• 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.

  PMID: 16700640 RESULT

• 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.

  PMID: 21932396 RESULT

• 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.

  PMID: 18440406 RESULT

• 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.

  PMID: 36375341 DERIVED

Study Officials

• Michael H Antoni, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: June 22, 1999
• Primary Completion: August 3, 2006
• Study Completion: August 3, 2006
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)