search
Back to results

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

Primary Purpose

HIV/AIDS, Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral stress management
Culturally-tailored cognitive behavioral stress management
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard CBSM

Culturally-tailored CBSM

Arm Description

Participants will receive standard web-based cognitive behavioral stress management (CBSM) over 4 weeks.

Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 4 weeks.

Outcomes

Primary Outcome Measures

General Stress
Perceived Stress Scale; items summed to create total score; total score range: 0-56; higher scores indicate worse outcome
Disease-Related Distress
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
Functional Assessment of Cancer Therapy-General and Medical Outcomes Study-HIV Survey

Secondary Outcome Measures

Full Information

First Posted
June 19, 2019
Last Updated
January 10, 2023
Sponsor
University of Miami
search

1. Study Identification

Unique Protocol Identification Number
NCT03993054
Brief Title
Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer
Acronym
C-SmartManage
Official Title
Web-Based Cognitive Behavioral Stress Management for Latino Sexual Minority Men Living With HIV and Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard CBSM
Arm Type
Active Comparator
Arm Description
Participants will receive standard web-based cognitive behavioral stress management (CBSM) over 4 weeks.
Arm Title
Culturally-tailored CBSM
Arm Type
Experimental
Arm Description
Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral stress management
Other Intervention Name(s)
SmartManage
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Culturally-tailored cognitive behavioral stress management
Other Intervention Name(s)
C-SmartManage
Intervention Description
This intervention will be a version of SmartManage that is culturally-tailored for Latino populations.
Primary Outcome Measure Information:
Title
General Stress
Description
Perceived Stress Scale; items summed to create total score; total score range: 0-56; higher scores indicate worse outcome
Time Frame
4 weeks
Title
Disease-Related Distress
Description
Impact of Events Scale-Revised; items summed to create total score; total score range: 0-88; higher scores indicate worse outcome
Time Frame
4 weeks
Title
Health Related Quality of Life
Description
Functional Assessment of Cancer Therapy-General and Medical Outcomes Study-HIV Survey
Time Frame
4 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Cisgender males
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have been diagnosed with at least one form of non-metastatic solid tumor cancer, 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), Self-identify as a sexual minority man, have been diagnosed with HIV, Have reliable access to a computer/device with internet accessibility, and Are fluent English. Exclusion Criteria: 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), Have a history of advanced (metastatic) cancer of any type or are currently undergoing primary treatment for their cancer, 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, Are experiencing active alcohol dependence, or have had inpatient treatment for alcohol abuse within the past 12 months, Are experiencing active substance dependence, or have had inpatient treatment for substance abuse within the past 12 months, and/or Have any other medical conditions resulting in a predicted life expectancy <12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara St. George, Ph.D.
Phone
305-243-0726
Email
s.stgeorge@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara St. George, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara St.George, Ph.D.
Phone
305-243-0726
Email
s.stgeorge@miami.edu
First Name & Middle Initial & Last Name & Degree
Sara St.George, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs