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StressNCT05486754

Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer

A study testing Cognitive behavioral stress management in people with Stress, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Stress
What is being tested?
Cognitive behavioral stress management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteUnited States
Study dates
22 Jun 1999to 3 Aug 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Previous history of non-skin cancer
  • Have received adjuvant treatment, including hormone treatment, for prostate cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

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

Conditions
Stress
Being tested
Cognitive behavioral stress management, Psychoeducational Control
Keywords
group therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive behavioral stress managementBehavioural

    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 ControlBehavioural

    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.

Study groups in NCT05486754
Study groupRoleWhat they receive
Cognitive behavioral stress management groupExperimentalParticipants received the cognitive behavioral stress management intervention for 10 weeks.
Receives: Behavioral: Cognitive behavioral stress management
Health promotion groupActive comparatorParticipants received the health promotion group for one day.
Receives: Behavioral: Psychoeducational Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, up to 18 months

  2. 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.

    Measured: Baseline, up to 18 months

  3. 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.

    Measured: Baseline, up to 18 months

  4. 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.

    Measured: Baseline, up to 18 months

  5. 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.

    Measured: Baseline, up to 18 months

  6. 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.

    Measured: Baseline, up to 18 months

  7. 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.

    Measured: Baseline, up to 18 months

  8. 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.

    Measured: Baseline, up to 18 months

  9. 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.

    Measured: Baseline, up to 18 months

  10. 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.

    Measured: Baseline, up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2022
  2. Study start22 Jun 1999
  3. Primary completion3 Aug 2006
  4. Study completion3 Aug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05486754
Sponsor's protocol ID
19990288
Other IDs
1P50CA084944
Status last verified
Aug 2022
First submitted
2 Aug 2022
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16700640

  • 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.

    PubMed 21932396

  • 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.

    PubMed 18440406

  • 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.

    PubMed 36375341

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive behavioral stress management in people with Stress, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire (time frame: Baseline, up to 18 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05486754, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.

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