SmartManage Stress Management for HIV+ Cancer Survivors

August 11, 2025 updated by: Frank Penedo, University of Miami

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SmartManage Group
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.
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.
Active Comparator: Educational Control Group
Participants in this group will view ten weekly control content video recorded sessions.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
USE Questionnaire Scores
Time Frame: 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.
Week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Frank J Penedo, Ph.D., University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

September 3, 2024

Study Completion (Actual)

September 3, 2024

Study Registration Dates

First Submitted

September 3, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 13, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20190762

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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