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Completed

NCT Number: NCT05486754

Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

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

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Key information

Conditions

Stress

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Stress Management

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire

    Time frame: 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.

  2. Change in post-traumatic event perceptions as measured by the Benefit Finding Scale questionnaire

    Time frame: 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.

  3. Change in optimism as measured by the Life Orientation Test - Revised questionnaire

    Time frame: 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.

  4. Change in immune cell count

    Time frame: 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.

  5. Change in immune cell percentage

    Time frame: 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.

  6. Change in natural killer cell percentage

    Time frame: 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.

  7. Change in natural killer cell count

    Time frame: Baseline, up to 18 months

    Natural killer cell (CD56+CD3-) count is evaluated from blood samples. Values are evaluated in count per cubic millimeter.

  8. Change in natural killer cell cytotoxicity as captured by activity percentage

    Time frame: 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.

  9. Change in ratio of natural killer cell cytotoxicity as captured by Lytic Index

    Time frame: 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.

  10. Change in count of natural killer cell cytotoxicity as captured by Kinetic Lytic Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
1999
Primary completion
2006
Study completion
2006
First posted
Aug 4, 2022
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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