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ClinicalTrials.gov Identifier: NCT03344757
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : December 22, 2020
Sponsor:
Collaborators:
Northwestern University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Frank Penedo, University of Miami

Brief Summary:
The purpose of this study is to look at the effects of a 10-week stress management in-person group program. The program will study emotions, stress, and stress management techniques (such as relaxation and coping techniques) on quality of life, distress, depression, and physical health in Spanish- speaking, Hispanic/Latino men diagnosed with Prostate Cancer (PC).

Condition or disease Intervention/treatment Phase
Prostate Neoplasm Genital Neoplasms, Male Urogenital Neoplasms Neoplasm, Prostate Genital Diseases, Male Prostatic Diseases Behavioral: Cultural CBSM Behavioral: Standard CBSM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: C-CBSM
Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
Behavioral: Cultural CBSM
The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).

Active Comparator: CBSM
Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
Behavioral: Standard CBSM
The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.




Primary Outcome Measures :
  1. Change in symptom burden as measure by EPIC-S. [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    Symptom Burden will be measured using the Expanded Prostate Cancer Index Composite (EPIC) - Short Form Summary (EPIC-S). The EPIC-S is a 6-item questionnaire with a total score ranging from 6 - 29 with the lower score indicating greater symptom burden.

  2. Change in HRQoL as measured by the FACT questionnaire. [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    HRQoL will be measured using Functional Assessment of Cancer Therapy - Prostate (FACT-P) including 4 domains of the FACT-General (FACT-G). The questionnaire has 39 items, with the total score ranging from 0-156. Higher scores indicate better function.

  3. Change in symptom burden as measure by EPIC-UIN. [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    Symptom Burden will be measured using the EPIC-Short Form Urinary Domain (EPIC-UIN). The EPIC-UIN is a 5-item questionnaire with a total score ranging from 9-43 with the higher score indicating greater symptom burden.

  4. Change in HRQoL as measured by the PROMIS Fatigue questionnaire [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    HRQoL will be measured using Patient-Reported Outcome Measurement Information System (PROMIS) short form for Fatigue Questionnaire. The total score ranges from 95-475 with the higher score indicating increased fatigue.

  5. Change in HRQoL as measured by the PROMIS Pain questionnaire [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    HRQoL will be measured using PROMIS short form for Pain Questionnaire. The items are item banks and the scoring via a computer adaptive testes (CAT) which use item response theory (IRT) to calculate a score that is transformed to a T score. Items are administered in an iterative approach where subsequent items are calibrated on prior ones. Once standard error reaches 2 or less, the CAT stops administering items. The higher the score the greater pain symptom.


Secondary Outcome Measures :
  1. Change in stress management skills as measured by MOCS-A [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    Stress management skills will be measured using the Measure of Current Status Part A (MOCS-A) Questionnaire. MOCS-A is a 13-item questionnaire with a total score ranging from 0 - 52 with the higher score indicating greater stress management skills.

  2. Change in prostate cancer-specific psychological distress as measured by MAX-PC - Section I-II [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC sections I-II is a 14-item questionnaire with a total score ranging from 0-42 with the higher score indicating increased distress.

  3. Change in prostate cancer-specific psychological distress as measured by MAX-PC - Section III [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    Psychological distress will be measured using the Memorial Anxiety Scale for Prostate Cancer Patients (MAX-PC) Questionnaire. The MAX-PC section III is a 4-item questionnaire with a total score ranging from 0-12 with the lower score indicating increased distress.

  4. Change in psychosocial distress as measured by the PROMIS Depression questionnaire [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    PROMIS-Depression is a 28-item questionnaire with a total score ranging from 28-140 with the higher score indicating increased symptoms of depression.

  5. Change in psychosocial distress as measured by the PROMIS Anxiety questionnaire [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    PROMIS-Anxiety is a 29-item questionnaire with a total score ranging from 29-145 with the higher score indicating increased symptoms of anxiety.

  6. Change in interpersonal function as measured the SIP questionnaire [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    Sickness Impact Profile (SIP) is a 20-item questionnaire responded with a yes or no. The total number of yes responses will be scored as 1 point with the total score ranging from 0-20 with the higher score indicating poor interpersonal function.

  7. Change in the activation of leukocyte glucocorticoid receptors expression [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    Leukocyte glucocorticoid receptor expression will be evaluated via blood serum

  8. Change in the inflammatory gene expression [ Time Frame: Baseline to Month 3, Baseline to Month 6, Baseline to Month 12 ]
    Inflammatory gene expression will be evaluated via blood serum.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥ 18 years of age;
  2. Hispanic/Latino self-identification;
  3. Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);
  4. Primary diagnosis of localized Prostate Cancer (T1-T3, N0, M0);
  5. Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) within minimum of 4 months and maximum of 72-months;
  6. Some patients with prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) may be enrolled, per P.I. discretion, based on a case-by-case review;
  7. Willingness to be randomized and followed for approximately12 months.

Exclusion Criteria:

  1. History of non-skin cancer within the last 5 years.
  2. Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months, as these conditions can interfere with adequate participation in our experimental conditions may be exclusionary, per P.I. discretion, based on a case-by-case review;
  3. Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review;
  4. Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; and
  5. Acute or chronic immune system medical conditions, medications or conditions that impact immune and endocrine function (e.g., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review.
  6. Individuals scoring >3 on the SPMSQ will be excluded or per PI discretion based on a case by case review.

    .


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03344757


Contacts
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Contact: Dolores M Perdomo, Ph.D. 305-431-2574 dperdomo@med.miami.edu
Contact: Madeline Krause 305-243-3329 madeline@miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Dolores M Perdomo, PhD, LCSW    305-355-9057    dperdomo@med.miami.edu   
Principal Investigator: Frank Penedo, PhD         
United States, Illinois
Northwestern University Completed
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
University of Miami
Northwestern University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Frank Penedo, Ph.D. University of Miami
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Responsible Party: Frank Penedo, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03344757    
Other Study ID Numbers: 20170656
STU00203197 ( Other Identifier: Northwestern ID )
1R01CA206456-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frank Penedo, University of Miami:
prostate cancer
localized prostate cancer
spanish
latino
hispanic
stress management
Additional relevant MeSH terms:
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Neoplasms
Prostatic Neoplasms
Urogenital Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Neoplasms by Site