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Behavioral Intervention
Cognitive Behavioral Stress Management for HIV/AIDS and Cancer (C-SmartManage Trial)
N/A
Recruiting
Led By Sara St. George, 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
Have been diagnosed with HIV
Have been diagnosed with at least one form of non-metastatic solid tumor cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
C-SmartManage Trial Summary
This trial will compare a culturally-tailored stress management intervention to a standard one, to see if it's more effective for Latino sexual minority men living with both HIV and cancer. The study will use a community-based participatory research approach.
Who is the study for?
This trial is for Latino sexual minority men over the age of 18, living with HIV and non-metastatic solid tumor cancer, who are past their primary cancer treatment. Participants must have internet access and be fluent in English. Those with a life expectancy under 12 months, active severe mental illness or substance dependence, or certain types of cancers (like leukemia or brain cancer) cannot join.Check my eligibility
What is being tested?
The study tests a web-based cognitive behavioral stress management program tailored for Latino sexual minority men with HIV and cancer. It compares this specialized version to a standard one over one year to see if it better reduces health disparities related to distress from their diagnoses.See study design
What are the potential side effects?
Since the intervention involves stress management techniques without medication, side effects may include emotional discomfort or increased personal awareness during therapy sessions but no physical side effects like those seen with drugs.
C-SmartManage Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with HIV.
Select...
I have been diagnosed with a non-spreading solid tumor cancer.
C-SmartManage Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-Related Distress
General Stress
Health Related Quality of Life
C-SmartManage Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Culturally-tailored CBSMExperimental Treatment1 Intervention
Participants will receive web-based CBSM that is culturally-tailored for Latino men specifically over 4 weeks.
Group II: Standard CBSMActive Control1 Intervention
Participants will receive standard web-based cognitive behavioral stress management (CBSM) over 4 weeks.
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Who is running the clinical trial?
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,632 Total Patients Enrolled
Sara St. George, Ph.D.Principal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had leukemia, non-melanoma skin cancer, brain cancer, eye cancer, or a pediatric cancer as my only cancer diagnosis.I have or am being treated for advanced cancer.I have been diagnosed with HIV.My doctor expects I have less than 12 months to live due to my health conditions.It's been over 30 days since my last main cancer treatment.I identify as a sexual minority man.I have been diagnosed with a non-spreading solid tumor cancer.I have been hospitalized for severe mental illness or shown signs of psychosis or suicidality in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Culturally-tailored CBSM
- Group 2: Standard CBSM
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.
Is this investigation currently recruiting participants?
"Affirmative. The information available on clinicaltrials.gov indicates that this medical trial is currently enrolling patients; it was first published on July 1st 2022 and the most recent update occurred on August 2nd 2022. This study seeks to recruit 50 participants at a single site."
Answered by AI
How many individuals have volunteered for this research project?
"Yes, the information posted on clinicaltrials.gov indicated that this trial is still seeking participants. It was initially published on July 1st 2022 and has since been updated on August 2nd 2022. The research requires 50 enrollees from one location."
Answered by AI
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