SmartManage Stress Management for HIV+ Cancer Survivors

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04544917
• Other study ID #: 20190762
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: December 15, 2024

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Marc J Puccinelli, Ph.D.
• Phone: 3052433508
• Email: mpuccinelli[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cancer
• Hiv
• Stress

Intervention

Behavioral:
• SmartManage 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.
• Educational Control
Participants in the control condition will view ten videos over ten weeks, consisting of informational and educational material relevant to cancer and HIV.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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