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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03993054
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
Sara StGeorge, University of Miami

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Cancer Behavioral: Cognitive behavioral stress management Behavioral: Culturally-tailored cognitive behavioral stress management Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer
Actual Study Start Date : January 9, 2023
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: C-SmartManage


Outcome Measures
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Primary Outcome Measures :
  1. General Stress [ Time Frame: 4 weeks ]
    Perceived Stress Scale; items summed to create total score; total score range: 0-56; higher scores indicate worse outcome

  2. Disease-Related Distress [ Time Frame: 4 weeks ]
    Impact of Events Scale-Revised; items summed to create total score; total score range: 0-88; higher scores indicate worse outcome

  3. Health Related Quality of Life [ Time Frame: 4 weeks ]
    Functional Assessment of Cancer Therapy-General and Medical Outcomes Study-HIV Survey


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender males
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993054


Contacts
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Contact: Sara St. George, Ph.D. 305-243-0726 s.stgeorge@miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Sara St.George, Ph.D.    305-243-0726    s.stgeorge@miami.edu   
Principal Investigator: Sara St.George, Ph.D.         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Sara St. George, Ph.D. University of Miami
More Information
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Responsible Party: Sara StGeorge, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03993054    
Other Study ID Numbers: 20200127
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
 Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases