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Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

Primary Purpose

Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral stress management
Psychoeducational Control
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring group therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive behavioral stress management group

Health promotion group

Arm Description

Participants received the cognitive behavioral stress management intervention for 10 weeks.

Participants received the health promotion group for one day.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2022
Last Updated
August 2, 2022
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05486754
Brief Title
Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer
Official Title
Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 1999 (Actual)
Primary Completion Date
August 3, 2006 (Actual)
Study Completion Date
August 3, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress
Keywords
group therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral stress management group
Arm Type
Experimental
Arm Description
Participants received the cognitive behavioral stress management intervention for 10 weeks.
Arm Title
Health promotion group
Arm Type
Active Comparator
Arm Description
Participants received the health promotion group for one day.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral stress management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Control
Intervention Description
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 Outcome Measure Information:
Title
Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire
Description
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
Title
Change in post-traumatic event perceptions as measured by the Benefit Finding Scale questionnaire
Description
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
Title
Change in optimism as measured by the Life Orientation Test - Revised questionnaire
Description
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
Title
Change in immune cell count
Description
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
Title
Change in immune cell percentage
Description
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
Title
Change in natural killer cell percentage
Description
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.
Time Frame
Baseline, up to 18 months
Title
Change in natural killer cell count
Description
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
Title
Change in natural killer cell cytotoxicity as captured by activity percentage
Description
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
Title
Change in ratio of natural killer cell cytotoxicity as captured by Lytic Index
Description
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
Title
Change in count of natural killer cell cytotoxicity as captured by Kinetic Lytic Index
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Antoni, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16700640
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 improves quality of life and benefit finding. Ann Behav Med. 2006 Jun;31(3):261-70. doi: 10.1207/s15324796abm3103_8.
Results Reference
result
PubMed Identifier
21932396
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):250-9. doi: 10.1002/pon.2074. Epub 2011 Sep 19.
Results Reference
result
PubMed Identifier
18440406
Citation
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 sensitivity. J Psychosom Res. 2008 May;64(5):527-36. doi: 10.1016/j.jpsychores.2008.01.004.
Results Reference
result
PubMed Identifier
36375341
Citation
Walsh EA, Antoni MH, Popok PJ, Moreno PI, Penedo FJ. Effects of a randomized-controlled trial of cognitive behavioral stress management: Psychosocial adaptation and immune status in men with early-stage prostate cancer. Gen Hosp Psychiatry. 2022 Nov-Dec;79:128-134. doi: 10.1016/j.genhosppsych.2022.10.012. Epub 2022 Oct 27.
Results Reference
derived

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Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

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