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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03993054
Other study ID # 20200127
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 9, 2023
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source University of Miami
Contact Sara St. George, Ph.D.
Phone 305-243-0726
Email s.stgeorge@miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a one year study to develop and test a culturally-tailored, web-based cognitive behavioral stress management (CBSM) intervention for Latino sexual minority men living with both HIV and cancer. Sexual minority Latino men living with HIV and cancer experience a variety of health disparities related to their diagnoses, including higher distress. The project will be a pilot randomized trial, comparing culturally-tailored CBSM to standard CBSM for dually-diagnosed participants. The project will use a community-based participatory research approach, and the investigators have included (and will continue to include) LGBT-serving community partners in all phases of the research from study design to implementation and dissemination of findings. The proposed study will aid in attenuating health disparities among Latino sexual minority men living with HIV and cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Have been diagnosed with at least one form of non-metastatic solid tumor cancer, 2. Are = 30 days post active primary treatment (i.e. surgery, radiation, and/or chemotherapy*) for their cancer. (Note: Adjuvant therapies, such as hormone therapy for prostate cancer, etc. are not considered exclusionary), 3. Self-identify as a sexual minority man, 4. have been diagnosed with HIV, 5. Have reliable access to a computer/device with internet accessibility, and 6. Are fluent English. Exclusion Criteria: 1. Have had one of the following exclusionary cancer types: Leukemia (or other cancers of the blood), Non-melanoma skin cancer only (not in combination with another type listed in the inclusion criteria above), Brain cancer, Eye cancer, a form of pediatric cancer (if the pediatric cancer is the only cancer diagnosis the patient has had), 2. Have a history of advanced (metastatic) cancer of any type or are currently undergoing primary treatment for their cancer, 3. Have had inpatient treatment for severe mental illness in the past 12 months, or have overt signs of psychopathology (i.e. psychosis) and/or suicidality at the time of screening, 4. Are experiencing active alcohol dependence, or have had inpatient treatment for alcohol abuse within the past 12 months, 5. Are experiencing active substance dependence, or have had inpatient treatment for substance abuse within the past 12 months, and/or 6. Have any other medical conditions resulting in a predicted life expectancy <12 months.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive behavioral stress management
The SmartManage CBSM intervention includes content that is of clinical relevance to sexual minority men dually diagnosed with HIV and cancer. Intervention content includes: co-management of HIV and cancer, strategies for self-advocacy, partnering with the health system and health providers, intimacy and disclosure concerns regarding both conditions, and contextual stressors (e.g., racial/ethnic minority status), stigmatization, assertiveness and communication skills, and self-efficacy in care coordination. Participants receive weekly 1.5 hour interactive group sessions online that focus on stress and self-management skill-building, and also receive access to didactic information regarding intervention content via the intervention website. Intervention length is 4 weeks.
Culturally-tailored cognitive behavioral stress management
This intervention will be a version of SmartManage that is culturally-tailored for Latino populations.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary General Stress Perceived Stress Scale; items summed to create total score; total score range: 0-56; higher scores indicate worse outcome 4 weeks
Primary Disease-Related Distress Impact of Events Scale-Revised; items summed to create total score; total score range: 0-88; higher scores indicate worse outcome 4 weeks
Primary Health Related Quality of Life Functional Assessment of Cancer Therapy-General and Medical Outcomes Study-HIV Survey 4 weeks
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