Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer

Not Applicable

Recruiting

• Conditions: Cancer; HIV/AIDS
• Interventions: Behavioral: Cognitive behavioral stress management; Behavioral: Culturally-tailored cognitive behavioral stress management

• Registration Number: NCT03993054
• Lead Sponsor: University of Miami

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Study Start: 2023-01-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard CBSM	Cognitive behavioral stress management	Participants will receive standard web-based cognitive behavioral stress management (CBSM) over 4 weeks.
Culturally-tailored CBSM	Culturally-tailored cognitive behavioral stress management	Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 4 weeks.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States