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Health Gatherings - For Your Health After Cancer (C-CBSM)

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ClinicalTrials.gov Identifier: NCT03344757
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Frank Penedo, Northwestern University

Brief Summary:
This 5-year study evaluates the effects of a 10-week group-based linguistically translated and culturally adapted cognitive-behavioral stress and self-management (C-CBSM) intervention on symptom burden and health related quality of life (HRQoL) in Hispanic men treated for localized prostate cancer (PC). About 80% PC cases are diagnosed as early disease and have a 5- and 10-year survival rate of almost 100% and 99%, respectively. Most patients receive active treatment (~70%) leading to prolonged treatment-related side effects and dysfunction persisting well beyond primary treatment. Survival is offset by chronic side effects such as sexual and urinary dysfunction, pain and fatigue that can lead to poor psychosocial functioning, impaired intimacy and social functioning, and masculinity concerns. Hispanic PC survivors report lower physical and social functioning, poorer emotional well-being and greater sexual and urinary dysfunction, even after accounting for SES and disease severity. This sequela can lead to elevated glucocorticoid release and inflammatory cytokines that have a direct effect on these symptoms and can interfere with physiological pathways necessary for recovery of sexual and urinary functioning. The investigators have shown that CBSM reduces symptom burden and improves HRQoL in bilingual Hispanic PC survivors. In a pilot study conducted by the investigators, it was shown that a linguistic translation of CBSM with attention to sociocultural processes improved symptom burden and HRQoL in Spanish monolingual PC survivors. The investigators have also shown that CBSM is associated with reduced glucocorticoid resistance and inflammatory gene expression pathways in breast cancer survivors. The investigators propose to (a) deliver a culturally adapted C-CBSM intervention in Spanish that places greater emphasis on salient sociocultural determinants of symptom burden and HRQoL in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo), (b) incorporate a neuroimmune model of symptom regulation and management, and (c) test the efficacy of C-CBSM, relative to standard non-culturally adapted CBSM, in two diverse Hispanic communities (Chicago & Miami). The investigators will test the aims in 260 Hispanic men post-treatment for localized PC with elevated symptom burden in a 2 x 4 randomized design with condition (C-CSBM vs. CBSM) as the between groups factors, and time (baseline, 3 months post-intervention & 6- and 12-months post intervention) as the within groups factor.

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

Detailed Description:

Available evidence suggests that culturally adapted psychological interventions and treatments are valuable and needed. Integrating sociocultural components into EBTs can help achieve desired outcomes in specific populations. In conditions such as asthma, diabetes, and HIV/AIDS culturally adapted EBTs have proven to be effective, and in depression, culturally adapted CBT programs show superior effects relative to standard treatment. However, there are very few culturally adapted EBTs for cancer survivors. In Hispanic BC survivors, linguistically translated and community-engaged stress management and peer-support interventions have shown feasibility and some preliminary efficacy. In Hispanic BC survivors, physical activity interventions delivered in a culturally sensitive manner reduce distress, while adapted psychoeducational interventions decrease depressive symptoms. Although promising, available studies have multiple conceptual and methodological limitations, and the vast majority only have involved a linguistic translation. A linguistic translation is limited in that language does not fully address cultural patterns, behaviors, frames of reference/world view, belief systems and other factors, does not imply cultural competence and therefore limits the potential of therapeutic gains. In fact, in cultural competent care, by definition, a cultural adaptation involves "adaptation of interventions to meet culturally unique needs". Consequently, there are significant gaps in understanding the efficacy of culturally adapted treatments: (a) cultural adaptation has generally involved a linguistic translation, or racial/ethnic pairing of interventionist, with no or very limited attention to cultural and social norms; (b) rarely have studies addressed how culture impacts provision and acquisition of EBT skills; (c) the vast majority of culturally adapted treatments have been paired against usual care, wait-list or other inert conditions thus limiting our knowledge on whether the cultural adaptation or the standard EBT mechanisms impacted observed outcomes; and (d) the utility and incremental efficacy of adapted interventions, relative to standard EBTs, remains unknown.

Among cancer survivors, psychosocial processes (e.g., stress, anxiety, isolation) coupled with ongoing monitoring and symptom burden can promote dysregulation of neuroendocrine (e.g., cortisol) and immune (e.g., pro-inflammatory response) mechanisms, psychological and physical symptoms (e.g., pain, fatigue) and disease activity. For example, low social support, repressive coping and anxiety are associated with disruptions in diurnal cortisol output and reduced glucocorticoid receptor sensitivity. , Cancer-related stress is also associated with cortisol dysregulation, and stress-modulated alterations in cortisol are related to disruption in immune function and cancer progression. BC patients with altered cortisol patterns show greater inflammatory cytokine responses. Stress-related disruptions in glucocorticoid sensitivity promote a shift from a Th1, to a Th2 pro-inflammatory response that can promote or exacerbate symptom burden and negatively impact HRQoL. Although limited to BC survivors, stress management interventions that improve psychosocial adjustment impact physiological mechanisms (e.g., cortisol, inflammatory markers) with salutary effects on physical symptoms (e.g., fatigue, pain), HRQoL and disease activity. Very limited work has assessed these patterns in PC survivors.


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 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: C-CBSM
Culturally adapted cognitive behavioral stress management
Behavioral: Cultural CBT
During each session, participants are taught a new anxiety/arousal reduction technique and focus on stress management. Efficacy of available treatments, disease course, symptom burden, communication with intimate partner and/or family members and health care provider, impact of stress on physical and mental health and symptoms are used for educational purposes and as catalysts for discussing CBSM techniques. The delivery of the culturally adapted C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and HRQoL in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).The investigators allow participants to describe psychosocial stressors with an emphasis on symptoms and disruption, HRQOL and their coping responses with role-plays. Participants are able to access the system at any time to retrieve relaxation and stress management didactics, and contact community resources and other participants in their group.

Active Comparator: CBSM
Standard cognitive behavioral stress management
Behavioral: Standard CBT
During each session, participants are taught/discuss a new anxiety/arousal reduction technique and focus on stress management. Efficacy of available treatments, disease course, symptom burden, communication with intimate partner and/or family members and health care provider, impact of stress on physical and mental health and symptoms are used for educational purposes and as catalysts for discussing CBSM techniques. The investigators allow participants to describe psychosocial stressors with an emphasis on symptoms and disruption, HRQOL and their coping responses for in-session role-plays. Participants are able to access the system at any time to retrieve relaxation and stress management didactic, and contact community resources and other participants in their group.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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).

  3. 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).

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

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

Inclusion Criteria:

  • ≥ 18 years of age;
  • Hispanic/Latino self-identification;
  • Spanish speakers (including bilinguals who express interest in a Spanish-based psychosocial intervention);
  • Primary diagnosis of localized prostate cancer (T1-T3, N0, M0);
  • Surgical or radiation treatment (e.g., external beam, brachytherapy, proton) approximately 4- to 24-mos. prior to taking part in this study;
  • Moderate or severe erectile and/or urinary dysfunction (score of 0-45 on the Expanded Prostate Cancer Index Composite [EPIC]-Short Form Sexual Summary [EPIC-S], and/or a score of 0-69 on the EPIC-Short Form urinary domain [EPIC-UIN] for individual's who received surgical treatment. A score of 0-80 on the Expanded Prostate Cancer Index Composite [EPIC]-Short Form Sexual Summary [EPIC-S], and/or a score of 0-80 on the EPIC-Short Form urinary domain [EPIC-UIN] for individual's who received radiation treatment);
  • 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;
  • Willingness to be randomized and followed for approximately 12 months.

Exclusion Criteria:

  • History of non-skin cancer;
  • 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;
  • Active alcohol dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review;
  • Active substance dependence within the past six months may be exclusionary, per P.I. discretion, based on a case-by-case review; and
  • Acute or chronic immune system medical conditions, medications or conditions that impact immune and endocrine function (e.g., CFS, Lupus, Hepatitis C, or immunosuppressive treatment requiring conditions).
  • Individuals scoring > 3 on the SPMSQ will be excluded.

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
Contact: Victoria Morken 312-503-5197 victoria.morken@northwestern.edu
Contact: Edgar Pizarro, MPH 312-503-3943 edgar.pizarro@northwestern.edu

Locations
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   
Sub-Investigator: Michael H Antoni, PhD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Edgar Pizarro, MPH    312-503-3943    edgar.pizarro@northwestern.edu   
Principal Investigator: Frank J Penedo, PhD         
Sponsors and Collaborators
Northwestern University

Responsible Party: Frank Penedo, Roswell Park Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03344757     History of Changes
Other Study ID Numbers: STU00203197
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Frank Penedo, Northwestern University:
prostate cancer
localized prostate cancer
spanish
latino
hispanic
stress management

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Urogenital Neoplasms
Prostatic Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site