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Stress Management Website for HIV+ Cancer Survivors
N/A
Recruiting
Led By Frank J Penedo, Ph.D.
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self identify as a sexual minority cisgender man
Be at least 30 days post active primary cancer treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one year
Awards & highlights
Study Summary
This trial is testing a new website that will help HIV+ cancer survivors manage their symptoms.
Who is the study for?
This trial is for English-speaking, adult men who have sex with men, are HIV+ cancer survivors at least 30 days post primary cancer treatment for non-metastatic solid tumor or blood cancers. Participants must have internet access and not be in severe mental health treatment or at high suicide risk.Check my eligibility
What is being tested?
The study is testing a web-based platform called SmartManage designed to help manage symptoms of stress in HIV+ cancer survivors. It will be compared against standard educational materials to see which is more effective.See study design
What are the potential side effects?
Since the interventions involve psychological support and education, there may not be direct physical side effects; however, participants might experience emotional discomfort when discussing personal health issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a cisgender man and identify as part of a sexual minority.
Select...
It has been over 30 days since my last cancer treatment.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with HIV.
Select...
I have been diagnosed with a type of cancer that has not spread to distant parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of eligible SMM that agree to participate
Secondary outcome measures
USE Questionnaire Scores
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SmartManage GroupExperimental Treatment1 Intervention
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 II: Educational Control GroupActive Control1 Intervention
Participants in this group will view ten weekly control content video recorded sessions.
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Who is running the clinical trial?
University of MiamiLead Sponsor
897 Previous Clinical Trials
409,209 Total Patients Enrolled
American Cancer Society, Inc.OTHER
224 Previous Clinical Trials
110,407 Total Patients Enrolled
Frank J Penedo, Ph.D.Principal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not under the influence of substances that impair my judgment.I am a cisgender man and identify as part of a sexual minority.I have had non-melanoma skin, brain, eye cancer, or a pediatric cancer only.It has been over 30 days since my last cancer treatment.My doctor expects I have more than 12 months to live.I have been hospitalized for severe mental illness or had moderate to high suicide risk in the past year.I am 18 years old or older.I have been diagnosed with HIV.I have had advanced cancer that spread to other parts.I have been diagnosed with a type of cancer that has not spread to distant parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: SmartManage Group
- Group 2: Educational Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available spots in this experiment for participants?
"Affirmative. According to information on clinicaltrials.gov, this medical trial is enlisting new participants as of now. Initially posted on February 15th 2021 and last modified May 23rd 2022, the experiment necessitates 50 volunteers from one location."
Answered by AI
How many people have thus far opted to participate in this experiment?
"Confirmed. Clinicaltrials.gov data implies that this research program is currently recruiting participants; the study was first advertised on February 15th 2021, and last modified on May 23rd 2022. This clinical trial requires 50 patients to be recruited from 1 site."
Answered by AI
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