CancerNCT04544917
SmartManage Stress Management for HIV+ Cancer Survivors
A study testing SmartManage for HIV+ cancer survivors in people with Cancer and Hiv, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- What is being tested?
- SmartManage for HIV+ cancer survivors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Fluent in English
- Have evidence of at least one form of non-metastatic solid tumor cancer or blood cancer
- Be at least 30 days post active primary cancer treatment
- Self identify as a sexual minority cisgender man
- Self-report having been diagnosed with HIV
- Have reliable access to a computer/device with internet accessibility
Who cannot join
- 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)
- History of advanced (metastatic) cancer of any type
- Inpatient treatment for severe mental illness in the past 12 months and/or suicidality of moderate or greater risk
- Appears actively intoxicated or otherwise unable to provide full informed consent
- Have any other medical condition resulting in predicted live expectancy of less than 12 months
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- SmartManage for HIV+ cancer survivors, Educational Control
- Keywords
- Symptom burden, Cognitive behavioral stress management, Intervention development
- Medical subject headings
- Neoplasms, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartManage for HIV+ cancer survivorsBehavioural
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 ControlBehavioural
Participants in the control condition will view ten videos over ten weeks, consisting of informational and educational material relevant to cancer and HIV.
| Study group | Role | What they receive |
|---|---|---|
| SmartManage Group | Experimental | 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. Receives: Behavioral: SmartManage for HIV+ cancer survivors |
| Educational Control Group | Active comparator | Participants in this group will view ten weekly control content video recorded sessions. Receives: Behavioral: Educational Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to one year
Secondary outcomes (1)
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.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start15 Feb 2021
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Frank Penedo, University of Miami
- Investigators
- Frank J Penedo, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544917
- Sponsor's protocol ID
- 20190762
- Status last verified
- Aug 2025
- First submitted
- 3 Sep 2020
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04544917
- Acronym / sponsor ID
- 20190762
- Keywords
- Symptom burden, Cognitive behavioral stress management, Intervention development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmartManage Group | Experimental | Behavioral: SmartManage for HIV+ cancer survivorsParticipants 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 | Active comparator | Behavioral: Educational ControlParticipants in this group will view ten weekly control content video recorded sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18 years or older
- Fluent in English
- Have evidence of at least one form of non-metastatic solid tumor cancer or blood cancer
- Be at least 30 days post active primary cancer treatment
- Self identify as a sexual minority cisgender man
Key exclusion criteria (5 listed)
- 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)
- History of advanced (metastatic) cancer of any type
- Inpatient treatment for severe mental illness in the past 12 months and/or suicidality of moderate or greater risk
- Appears actively intoxicated or otherwise unable to provide full informed consent
- Have any other medical condition resulting in predicted live expectancy of less than 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartManage for HIV+ cancer survivorsTen 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. | Behavioural | SmartManage Group |
| Educational ControlParticipants in the control condition will view ten videos over ten weeks, consisting of informational and educational material relevant to cancer and HIV. | Behavioural | Educational Control Group |
Primary outcome
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
1 secondary outcome
USE Questionnaire Scores
Time frame: Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank J Penedo, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartManage for HIV+ cancer survivors in people with Cancer and Hiv, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible SMM that agree to participate (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.