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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05486754
Other study ID # 19990288
Secondary ID 1P50CA084944
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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