Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified November 2019 by Julia Seay, University of Miami

Sponsor
University of Miami


Information provided by (Responsible Party)
Julia Seay, University of Miami

ClinicalTrials.gov Identifier
NCT03993054

First received: June 19, 2019
Last updated: November 5, 2019
Last Verified: November 2019
History of Changes
Purpose

Purpose

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 Intervention
HIV/AIDS
Cancer

Behavioral : Cognitive behavioral stress management
Behavioral : Culturally-tailored cognitive behavioral stress management

Study Type: Interventional
Study Design: 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

Further study details as provided by Julia Seay, University of Miami:

Primary Outcome Measures

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

Estimated Enrollment: 50
Anticipated Study Start Date: February 1, 2020
Estimated Study Completion Date: January 1, 2021
Estimated Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Detailed Description:

Over a one year period, the investigators will conduct a two-group pilot trial of web-based CBSM among 50 Latino sexual minority men living with HIV and cancer. Potentially eligible participants will be recruited via UM health clinics, our community partners, LGBT-focused community events, and LGBT-focused social media. Study eligibility will be confirmed using a brief study screener. Those who are eligible and interested in participating will ideally be consented during recruitment. Directly following informed consent, participants will complete an intake questionnaire, which will be informed by the Behavioral Model for Vulnerable Populations. Following recruitment, informed consent, and the intake questionnaire, participants will be randomized to one of two study groups. Participants randomized to Group 1 will receive standard CBSM and participants randomized to Group 2 will CBSM that is culturally-tailored for Latino men specifically. The primary outcomes will be general stress, disease-related distress, and health-related quality of life. Additionally, the investigators will collecting detailed information on intervention implementation, feasibility, and acceptability to inform a future large R01 trial of culturally-tailored CBSM within the target population.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03993054

Sponsors and Collaborators

University of Miami
More Information

More Information


Responsible Party: Julia Seay, Research Assistant Professor, University of Miami  
ClinicalTrials.gov Identifier: NCT03993054   History of Changes  
Other Study ID Numbers: 20190603  
Study First Received: June 19, 2019  
Last Updated: November 5, 2019  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

ClinicalTrials.gov processed this data on December 13, 2019
This information is provided by ClinicalTrials.gov.