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SmartManage Stress Management for HIV+ Cancer Survivors

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT04544917
Collaborator
American Cancer Society, Inc. (Other)
50
Enrollment
1
Location
2
Arms
21.9
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SmartManage for HIV+ cancer survivors
  • Behavioral: Educational Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 15, 2021
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 33136

Sponsors and Collaborators

  • University of Miami
  • American Cancer Society, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Frank Penedo, Professor, University of Miami
ClinicalTrials.gov Identifier:
NCT04544917
Other Study ID Numbers:
  • 20190762
First Posted:
Sep 10, 2020
Last Update Posted:
May 25, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Frank Penedo, Professor, University of Miami
Symptom burden
Cognitive behavioral stress management
Intervention development

Study Results

No Results Posted as of May 25, 2022