Health Gatherings - For Your Health After Cancer
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).
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) within minimum of 4 months and maximum of 72-months;
- 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 approximately12 months.
Exclusion Criteria
- History of non-skin cancer within the last 2 years.
- 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., Chronic Fatigue Syndrome (CFS), Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions), per PI discretion based on a case by case review.
- Individuals scoring >3 on the SPMSQ will be excluded or per PI discretion based on a case by case review. .
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03344757.
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.1 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. These sequelae 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. We have shown that CBSM reduces symptom burden and
improves HRQoL in bilingual Hispanic PC survivors. In a pilot we showed that a linguistic
translation of CBSM with attention to sociocultural processes improved symptom burden and
HRQoL in Spanish monolingual PC survivors. We have also shown that CBSM is associated
with reduced glucocorticoid resistance and inflammatory gene expression pathways in
circulating leukocytes among breast cancer survivors. We 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). We will test our aims in 200 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, post-intervention &
6- and 12-months post intervention) as the within groups factor.
Our Primary Aim is to determine whether randomization to C-CBSM, relative to standard
CBSM, is associated with reduced symptom burden and improved HRQoL. Our Secondary Aims
evaluate whether C-CBSM leads to greater improvements in the intervention targets (e.g.,
stress management, psychological distress & interpersonal disruption), and physiologic
adaptation (i.e., glucocorticoid receptor sensitivity & inflammatory gene expression). We
will also evaluate psychosocial and physiological mechanisms as mediators of C-CBSM's
effects on our primary outcomes. We also explore several moderators (e.g., SES,
acculturation, treatment, Hispanic origin) of CCBSM's effect on primary outcomes and the
effects of C-CBSM on cardiometabolic health (e.g., lipids, fasting glucose) via reduced
inflammation.
Primary Aim:
Aim 1: Determine whether participation in C-CBSM is associated with significantly greater
reductions in symptom burden and improvements in HRQoL relative to participation in CBSM.
Secondary Aims:
Aim 2: Determine whether participation in C-CBSM is associated with significantly greater
improvements in intervention targets (i.e., improved stress management, and reduced
psychological distress and interpersonal disruption) relative to participation in the
CBSM condition.
Exploratory Aims:
Aim 3: Explore whether participation in C-CBSM is associated with significantly greater
activation of leukocyte glucocorticoid receptor and less inflammatory gene expression
profiles relative to CBSM.
Aim 4: Explore whether C-CBSM related improvements in symptom burden and HRQoL are
mediated by improvements in intervention targets and gene expression profiles.
Aim 5: Explore moderators of C-CBSM (e.g., SES, treatment type, acculturation, Hispanic
ancestry) and CCBSM's effects on cardiometabolic markers via reduced inflammation.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
- Primary ID20170656
- Secondary IDsNCI-2019-02448, 1R01CA206456-01A1, STU00203197
- ClinicalTrials.gov IDNCT03344757