The purpose of this study is to test a stress management program for men with early-stage prostate cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
260
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.
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.
University of Miami
Miami, Florida, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, up to 18 months