Health Gatherings - For Your Health After Cancer

Conditions:Prostate Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:October 5, 2017
End Date:September 2022
Contact:Dolores M Perdomo, Ph.D.

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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-CBSM vs. CBSM) as the between groups factors, and
time (baseline (BL), 3 months post-BL & 6-month BL and 12-months post BL) 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.

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 48-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

- 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.
We found this trial at
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Frank Penedo, PhD
Phone: 305-355-9057
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Greg Miller, PhD
Phone: 312-503-5422
Chicago, IL
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