ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

September 27, 2017
November 17, 2017
April 17, 2018
October 5, 2017
September 2021   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT03344757 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Health Gatherings - For Your Health After Cancer
Culturally Adapted Cognitive Behavioral Stress and Self-Management (C-CBSM) Intervention for Prostate Cancer
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
  • Prostate Neoplasm
  • Genital Neoplasms, Male
  • Urogenital Neoplasms
  • Neoplasm, Prostate
  • Genital Diseases, Male
  • Prostatic Diseases
  • 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.
  • 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.
  • Experimental: C-CBSM
    Culturally adapted cognitive behavioral stress management
    Intervention: Behavioral: Cultural CBT
  • Active Comparator: CBSM
    Standard cognitive behavioral stress management
    Intervention: Behavioral: Standard CBT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
Same as current
September 2022
September 2021   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years and older   (Adult, Older Adult)
No
Contact: Victoria Morken 312-503-5197 victoria.morken@northwestern.edu
Contact: Edgar Pizarro, MPH 312-503-3943 edgar.pizarro@northwestern.edu
United States
 
 
NCT03344757
STU00203197
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Frank Penedo, Northwestern University
Northwestern University
Not Provided
Not Provided
Northwestern University
April 2018

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