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

Cancer Clinical Trial

— C-SmartManage  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03993054
• Other study ID #: 20200127
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Cancer
• HIV Infections
• HIV/AIDS

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