Clinical trial NCT03993054: Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer
Official title: Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-06-20
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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:

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.

Primary outcomes:
measure: Change in General Stress
timeFrame: 10 weeks
measure: Change in Disease-Related Distress
timeFrame: 10 weeks
measure: Change in Health-Related Quality of Life (FACT-G)
timeFrame: 10 weeks
measure: Change in Health-Related Quality of Life (MOS-HIV)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sara St. George, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: