Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

Stress Clinical Trial

Official title:

Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05486754
• Other study ID #: 19990288
• Secondary ID: 1P50CA084944
• Status: Completed
• Phase: N/A
• Start date: June 22, 1999
• Est. completion date: August 3, 2006

Study information

• Verified date: August 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 3, 2006
• Est. primary completion date: August 3, 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 s — View 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 impr — View 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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