SmartManage Stress Management for HIV+ Cancer Survivors

NCT ID: NCT04544917

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2024-09-03

Brief Summary

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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

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Conditions

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Cancer Hiv Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SmartManage for HIV+ cancer survivors

Intervention Type BEHAVIORAL

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 Group

Participants in this group will view ten weekly control content video recorded sessions.

Group Type ACTIVE_COMPARATOR

Educational Control

Intervention Type BEHAVIORAL

Participants in the control condition will view ten videos over ten weeks, consisting of informational and educational material relevant to cancer and HIV.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Frank Penedo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frank J Penedo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20190762

Identifier Type: -

Identifier Source: org_study_id

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