N/A
N=16
Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer
HIV/AIDS · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03993054 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in General Stress — -1.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Culturally-tailored cognitive behavioral stress management (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in General Stress |
-1.8 | — |
| PRIMARY Change in Disease-Related Distress |
-3.2; -5.0; -1.9; -10.2 | — |
| PRIMARY Change in Health-Related Quality of Life (FACT-G) |
-1.5; 0.2; 3.5; 0.4; 2.7 | — |
| PRIMARY Change in Health-Related Quality of Life (MOS-HIV) |
-1; -0.2; -0.2; 0.6; 0.7; -2.5 | — |
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 use a single-group pre-post design. 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.
Eligibility Criteria
Inclusion Criteria
- Have been diagnosed with at least one form of non-metastatic solid tumor cancer,
- 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),
- Self-identify as a sexual minority man,
- have been diagnosed with HIV,
- Have reliable access to a computer/device with internet accessibility, and
- Are fluent English.
Exclusion Criteria
- 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),
- Have a history of advanced (metastatic) cancer of any type or are currently undergoing primary treatment for their cancer,
- 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,
- Are experiencing active alcohol dependence, or have had inpatient treatment for alcohol abuse within the past 12 months,
- Are experiencing active substance dependence, or have had inpatient treatment for substance abuse within the past 12 months, and/or
- Have any other medical conditions resulting in a predicted life expectancy <12 months.
Data sourced from ClinicalTrials.gov (NCT03993054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.