Cancer, Hiv, Stress
Conditions
Keywords
Symptom burden, Cognitive behavioral stress management, Intervention development
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.
Interventions
BEHAVIORALSmartManage for HIV+ cancer survivors
Ten weekly therapist delivered group sessions delivered via web conference. Sessions focus on cognitive behavioral stress management, psychoeducation, and management strategies for dual diagnosis of HIV and cancer. Participants will have access to the SmartManage web platform which has all intervention material, resources, and exercises.
BEHAVIORALEducational Control
Participants in the control condition will view ten videos over ten weeks, consisting of informational and educational material relevant to cancer and HIV.
Sponsors
American Cancer Society, Inc.
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible SMM that agree to participate | 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
| Measure | Time frame | Description |
|---|---|---|
| USE Questionnaire Scores | Week 10 | 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. |
Countries
United States
Outcome results
None listed