Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

August 2, 2022 updated by: Michael H. Antoni, University of Miami
The purpose of this study is to test a stress management program for men with early-stage prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive behavioral stress management group
Participants received the cognitive behavioral stress management intervention for 10 weeks.
Behavioral: Cognitive behavioral stress management
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.
Active Comparator: Health promotion group
Participants received the health promotion group for one day.
Behavioral: Psychoeducational Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire
Time Frame: Baseline, up to 18 months
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
Time Frame: Baseline, up to 18 months
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
Time Frame: Baseline, up to 18 months
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
Time Frame: Baseline, up to 18 months
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
Time Frame: Baseline, up to 18 months
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
Time Frame: Baseline, up to 18 months
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
Time Frame: Baseline, up to 18 months
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
Time Frame: Baseline, up to 18 months
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
Time Frame: Baseline, up to 18 months
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
Time Frame: Baseline, up to 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Michael H Antoni, Ph.D., University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 1999

Primary Completion (Actual)

August 3, 2006

Study Completion (Actual)

August 3, 2006

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19990288
  • 1P50CA084944 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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