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Clinical Trials/NCT04544917
NCT04544917
Completed
Not Applicable

Development of an eHealth-based Cognitive Behavioral Stress and Self-Management Intervention to Reduce Symptom Burden in HIV+ Gay and Bisexual Men Who Have Sex With Men (MSM) Treated for Non-Metastatic Cancer

University of Miami1 site in 1 country50 target enrollmentFebruary 15, 2021
ConditionsCancerHivStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Miami
Enrollment
50
Locations
1
Primary Endpoint
Proportion of eligible SMM that agree to participate
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

The purpose of this study is to design and refine a web-based platform developed for managing symptom burden in men who have sex who are HIV+ cancer survivors.

Registry
clinicaltrials.gov
Start Date
February 15, 2021
End Date
September 3, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Frank Penedo

Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Age: 18 years or older
  • Fluent in English
  • Have evidence of at least one form of non-metastatic solid tumor cancer or blood cancer
  • Be at least 30 days post active primary cancer treatment
  • Self identify as a sexual minority cisgender man
  • Self-report having been diagnosed with HIV
  • Have reliable access to a computer/device with internet accessibility

Exclusion Criteria

  • Have had one of the following exclusionary cancer types: Non-melanoma skin cancer, brain cancer, eye cancer, history of some form of pediatric cancer (if that is participant's only cancer diagnosis)
  • History of advanced (metastatic) cancer of any type
  • Inpatient treatment for severe mental illness in the past 12 months and/or suicidality of moderate or greater risk
  • Appears actively intoxicated or otherwise unable to provide full informed consent
  • Have any other medical condition resulting in predicted live expectancy of less than 12 months

Outcomes

Primary Outcomes

Proportion of eligible SMM that agree to participate

Time Frame: Up to one year

Feasibility of the intervention will be reported as the proportion of eligible sexual minority men (SMM) who agree to participate versus decline

Secondary Outcomes

  • USE Questionnaire Scores(Week 10)

Study Sites (1)

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