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

May 20, 2025 updated by: Sara StGeorge, University of Miami
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Culturally-tailored CBSM
Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 10 weeks.
Behavioral: Culturally-tailored 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 10 weeks. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in General Stress
Time Frame: 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.
10 weeks
Change in Disease-Related Distress
Time Frame: 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.
10 weeks
Change in Health-Related Quality of Life (FACT-G)
Time Frame: 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.
10 weeks
Change in Health-Related Quality of Life (MOS-HIV)
Time Frame: 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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sara St. George, Ph.D., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20200127
  • U54MD002266 (U.S. NIH Grant/Contract)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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