SmartManage Stress Management for HIV+ Cancer Survivors

Not Applicable

Recruiting

• Conditions: Stress; Hiv; Cancer
• Interventions: Behavioral: SmartManage for HIV+ cancer survivors; Behavioral: Educational Control

• Registration Number: NCT04544917
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-10
• Study Start: 2021-02-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2024-09-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SmartManage Group	SmartManage for HIV+ cancer survivors	Participants in this group will receive ten 90-minute weekly therapist delivered SmartManage group sessions via video conference. Participants will have access to the SmartManage web platform, which will also guide the live intervention sessions.
Educational Control Group	Educational Control	Participants in this group will view ten weekly control content video recorded sessions.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States