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

Not Applicable

Completed

Conditions: Cancer
HIV/AIDS

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 16

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in General Stress	10 weeks	The Perceived Stress Scale (PSS) consists of 10 items, which are summed to create a total score ranging from 0 to 40. Higher scores indicate greater levels of perceived stress. The outcome was analyzed as the change from baseline.
Change in Disease-Related Distress	10 weeks	The Impact of Events Scale-Revised (IES-R) measures the psychological impact of traumatic events. It consists of three subscales: intrusion (eight items), avoidance (eight items), and hyperarousal (six items). Each subscale score is calculated by summing the items within that subscale. The maximum possible score for intrusion and avoidance is 32 each, while hyperarousal has a maximum score of 24. The scores from these subscales are summed to create a total score, which ranges from 0 to 88. Higher scores indicate a greater negative impact of the traumatic event. The outcome was analyzed as the change from baseline.
Change in Health-Related Quality of Life (FACT-G)	10 weeks	The Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire was used to assess quality of life. It comprises four sub-scales: physical well-being (7 items, score range 0-28), social/family well-being (7 items, score range 0-28), emotional well-being (6 items, score range 0-24), and functional well-being (7 items, score range 0-28). The overall score is calculated by summing the scores of these four sub-scales, resulting in a total possible score range of 0-108. Higher scores on the FACT-G indicate a better quality of life. The outcome was analyzed as the change from baseline.
Change in Health-Related Quality of Life (MOS-HIV)	10 weeks	The Medical Outcomes Study HIV Survey (MOS-HIV) assesses 10 health dimensions (i.e., health perceptions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy, health distress, and quality of life). Subscales are scored on a 0-100 scale, with a higher score indicating better health. The outcome was analyzed as the change from baseline.