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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; HIV/AIDS
• Intervention / Treatment: Behavioral: Cognitive behavioral stress management; Behavioral: Culturally-tailored cognitive behavioral stress management

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara St. George, Ph.D.; Phone Number: 305-243-0726; Email: s.stgeorge@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Sara St.George, Ph.D.; Phone Number: 305-243-0726; Email: s.stgeorge@miami.edu
      • Principal Investigator: Sara St.George, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard CBSM; Participants will receive standard web-based cognitive behavioral stress management (CBSM) over 4 weeks.	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.; Other Names: SmartManage
Experimental: Culturally-tailored CBSM; Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 4 weeks.	Behavioral: Culturally-tailored cognitive behavioral stress management; This intervention will be a version of SmartManage that is culturally-tailored for Latino populations.; Other Names: C-SmartManage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Stress	Perceived Stress Scale; items summed to create total score; total score range: 0-56; higher scores indicate worse outcome	4 weeks
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
Health Related Quality of Life	Functional Assessment of Cancer Therapy-General and Medical Outcomes Study-HIV Survey	4 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Sara St. George, Ph.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Urogenital Diseases; Genital Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 20200127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No