Cognitive Behavioral Stress Management (CBSM) & Prostate Cancer
2. august 2022 opdateret af: Michael H. Antoni, University of Miami
The purpose of this study is to test a stress management program for men with early-stage prostate cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
260
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Cognitive behavioral stress management group
Participants received the cognitive behavioral stress management intervention for 10 weeks.
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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.
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Aktiv komparator: Health promotion group
Participants received the health promotion group for one day.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Perceived Stress Management Abilities as measured by the Measure of Current Status Questionnaire
Tidsramme: 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.
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Baseline, up to 18 months
|
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Change in post-traumatic event perceptions as measured by the Benefit Finding Scale questionnaire
Tidsramme: Baseline, up to 18 months
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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.
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Baseline, up to 18 months
|
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Change in optimism as measured by the Life Orientation Test - Revised questionnaire
Tidsramme: 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.
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Baseline, up to 18 months
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Change in immune cell count
Tidsramme: Baseline, up to 18 months
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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.
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Baseline, up to 18 months
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Change in immune cell percentage
Tidsramme: 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.
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Baseline, up to 18 months
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Change in natural killer cell percentage
Tidsramme: Baseline, up to 18 months
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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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Baseline, up to 18 months
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Change in natural killer cell count
Tidsramme: Baseline, up to 18 months
|
Natural killer cell (CD56+CD3-) count is evaluated from blood samples.
Values are evaluated in count per cubic millimeter.
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Baseline, up to 18 months
|
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Change in natural killer cell cytotoxicity as captured by activity percentage
Tidsramme: 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.
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Baseline, up to 18 months
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Change in ratio of natural killer cell cytotoxicity as captured by Lytic Index
Tidsramme: 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.
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Baseline, up to 18 months
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Change in count of natural killer cell cytotoxicity as captured by Kinetic Lytic Index
Tidsramme: 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.
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Baseline, up to 18 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Michael H Antoni, Ph.D., University of Miami
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. juni 1999
Primær færdiggørelse (Faktiske)
3. august 2006
Studieafslutning (Faktiske)
3. august 2006
Datoer for studieregistrering
Først indsendt
2. august 2022
Først indsendt, der opfyldte QC-kriterier
2. august 2022
Først opslået (Faktiske)
4. august 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. august 2022
Sidst verificeret
1. august 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 19990288
- 1P50CA084944 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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