Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

Not Applicable

Completed

• Conditions: Stress
• Interventions: Behavioral: Psychoeducational Control; Behavioral: Cognitive behavioral stress management

• Registration Number: NCT05486754
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-06-22
• Primary Completion: 2006-08-03
• Study Completion: 2006-08-03
• Status Verified: 2022-08
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health promotion group	Psychoeducational Control	Participants received the health promotion group for one day.
Cognitive behavioral stress management group	Cognitive behavioral stress management	Participants received the cognitive behavioral stress management intervention for 10 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire	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.
Change in immune cell percentage	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.
Change in ratio of natural killer cell cytotoxicity as captured by Lytic Index	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.
Change in post-traumatic event perceptions as measured by the Benefit Finding Scale questionnaire	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.
Change in optimism as measured by the Life Orientation Test - Revised questionnaire	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.
Change in count of natural killer cell cytotoxicity as captured by Kinetic Lytic Index	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.
Change in immune cell count	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.
Change in natural killer cell percentage	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.
Change in natural killer cell count	Baseline, up to 18 months	Natural killer cell (CD56+CD3-) count is evaluated from blood samples. Values are evaluated in count per cubic millimeter.
Change in natural killer cell cytotoxicity as captured by activity percentage	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States