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Health Gatherings - For Your Health After Cancer

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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

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date December 22, 2020
Actual Study Start Date  ICMJE October 5, 2017
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Change in symptom burden from baseline relative to participants in CBSM (control). [ Time Frame: Baseline [T1], 3-mos. [T2], 6-mos. [T3] & 12-mos. [T4] follow-up assessments ]
    Symptom burden will be measured with the Expanded PC Index Composite (EPIC), sexual and urinary sub scales
  • Change in HRQoL from baseline relative to participants in CBSM (control). [ Time Frame: Baseline [T1], 3-mos. [T2], 6-mos. [T3] & 12-mos. [T4] follow-up assessments ]
    HRQoL will be measured using FACT-P including 4 domains of the FACT-G and PROMIS measures.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Change in stress management skills relative to CBSM (control) [ Time Frame: Baseline [T1], 3-mos. [T2], 6-mos. [T3] & 12-mos. [T4] follow-up assessments ]
    Stress management will be measured using the MOCS-A
  • Change in prostate cancer-specific psychological distress relative to CBSM (control) [ Time Frame: Baseline [T1], 3-mos. [T2], 6-mos. [T3] & 12-mos. [T4] follow-up assessments ]
    Psychological distress will be measured using the MAX-PC (sub scales: PC anxiety, PSA testing anxiety and fear of recurrence).
  • Change in interpersonal disruption relative to CBSM (control) [ Time Frame: Baseline [T1], 3-mos. [T2], 6-mos. [T3] & 12-mos. [T4] follow-up assessments ]
    Interpersonal disruption will be measured using the social interaction subscale of the Sickness Impact Profile (SIP).
  • Change in the activation of leukocyte glucocorticoid receptors relative to participants in CBSM (control). [ Time Frame: Baseline [T1], 3-mos. [T2], 6-mos. [T3] & 12-mos. [T4] follow-up assessments ]
    Level of greater expression of differentially expressed genes for glucocorticoid receptor sensitivity showing >/= 1.5 fold difference in experimental arms
  • Change in inflammatory gene expression relative to participants in CBSM (control). [ Time Frame: Baseline [T1], 3-mos. [T2], 6-mos. [T3] & 12-mos. [T4] follow-up assessments ]
    Level of lower expression of differentially expressed inflammatory genes showing >/= 1.5 fold difference in experimental arms
  • Change in symptom burden in a mediated test relative to participants in CBSM [ Time Frame: Baseline [T1], 3-mos. [T2], 6-mos. [T3] & 12-mos. [T4] follow-up assessments ]
    Measure of greater activation of glucocorticoid receptor and lower activation of inflammatory gene pathways
  • Change in HRQoL in a mediated test relative to participants in CBSM (control).(control) [ Time Frame: Baseline [T1], 3-mos. [T2], 6-mos. [T3] & 12-mos. [T4] follow-up assessments ]
    Measure of greater activation of glucocorticoid receptor and lower activation of inflammatory gene pathways
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Gatherings - For Your Health After Cancer
Official Title  ICMJE Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Prostate Neoplasm
  • Genital Neoplasms, Male
  • Urogenital Neoplasms
  • Neoplasm, Prostate
  • Genital Diseases, Male
  • Prostatic Diseases
Intervention  ICMJE
  • 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).
  • 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.
Study Arms  ICMJE
  • Experimental: C-CBSM
    Participants randomized to this arm will receive 10 weekly group-based C-CBSM intervention.
    Intervention: Behavioral: Cultural CBSM
  • Active Comparator: CBSM
    Participants randomized to this arm will receive 10 weekly group-based standard CBSM intervention.
    Intervention: Behavioral: Standard CBSM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    .

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dolores M Perdomo, Ph.D. 305-431-2574 dperdomo@med.miami.edu
Contact: Madeline Krause 305-243-3329 madeline@miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03344757
Other Study ID Numbers  ICMJE 20170656
STU00203197 ( Other Identifier: Northwestern ID )
1R01CA206456-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Frank Penedo, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE
  • Northwestern University
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Frank Penedo, Ph.D. University of Miami
PRS Account University of Miami
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP