Cancer Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 15, 2024 |
Est. primary completion date | September 15, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age: 18 years or older 2. Fluent in English 3. Have evidence of at least one form of non-metastatic solid tumor cancer or blood cancer 4. Be at least 30 days post active primary cancer treatment 5. Self identify as a sexual minority cisgender man 6. Self-report having been diagnosed with HIV 7. Have reliable access to a computer/device with internet accessibility Exclusion Criteria: 1. 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) 2. History of advanced (metastatic) cancer of any type 3. Inpatient treatment for severe mental illness in the past 12 months and/or suicidality of moderate or greater risk 4. Appears actively intoxicated or otherwise unable to provide full informed consent 5. Have any other medical condition resulting in predicted live expectancy of less than 12 months |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | American Cancer Society, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of eligible SMM that agree to participate | Feasibility of the intervention will be reported as the proportion of eligible sexual minority men (SMM) who agree to participate versus decline | Up to one year | |
Secondary | USE Questionnaire Scores | Acceptability of the intervention will be reported as Usefulness, Satisfaction and Ease of Use (USE) Questionnaire Scores. USE is a 30-item questionnaire with a total score ranging from 30-240 with the higher score indicating greater acceptability of the intervention. | Week 10 |
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