Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

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

Official Title
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Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

Conditions
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Stress

Intervention / Treatment
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* Behavioral: Cognitive behavioral stress management
* Behavioral: Psychoeducational Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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group therapy