Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2019-10-11
2024-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cognitive Behavioral Stress Management (CBSM) - PC Survivor
Participant receives standard cognitive behavioral stress management from the Parent study NCT03344757.
No interventions assigned to this group
CBSM - PC Survivor Partner
The survivor partner does not receive any intervention.
No interventions assigned to this group
Cultural CBSM (C-CBSM) - PC Survivor
Participant receives culturally adapted cognitive behavioral stress management from the Parent study NCT03344757.
No interventions assigned to this group
Cultural CBSM (C-CBSM) - PC Survivor Partner
The survivor partner does not receive any intervention.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. ≥18 years of age
2. Hispanic/Latino self- identification
3. Spanish speakers (including bilinguals who agree to participate in a Spanish intervention)
4. primary diagnosis of localized PC (T1-T3, N0, M0)
5. surgical or radiation treatment in the past 4-months
6. no history of non-skin cancer for the past 2 years
7. no psychiatric treatment or overt signs of severe psychopathology (e.g., psychosis, substance dependence)
8. owning a smartphone device with an Android or iPhone Operating System (iOS), which is necessary to collect the proposed Ecological Momentary Assessment (EMA) data or a valid email address.
(I) willingness to wear the E4 wristband at 5 time points, over the course of 4 days (J) has a spouse/partner that is willing to participate or is willing to participate in the study alone
Spouses/Partners:
1. female or male ≥18 years of age
2. have no history of inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis, substance dep., dementia)
3. willingness to be assessed and followed for 6 months
4. no life-threatening illness with a life expectancy \< 12 months
5. identifies as a spouse/partner and is willing to participate in the study.
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Miami
OTHER
Responsible Party
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Frank Penedo
Professor
Principal Investigators
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Frank Penedo, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Other Identifiers
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20190613
Identifier Type: -
Identifier Source: org_study_id
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