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Behavioral Intervention
Video-Conference Stress Management for Breast Cancer (VSMART Trial)
Phase 4
Waitlist Available
Led By Michael H Antoni, 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
Women age 50 and older diagnosed with stage 0-III breast cancer
No diagnosis of major psychiatric condition or mental disorder (i.e. schizophrenia, psychosis, and/or bipolar disorder) or active (in the past 12 months) Major Depressive Disorder (MDD), panic disorder, Post Traumatic Stress Disorder (PTSD) diagnosis or history of suicide thoughts, attempts or plans
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (t0) to 6 months (t1).
Awards & highlights
VSMART Trial Summary
This trial will test if a new home-based stress management intervention can improve health outcomes in older women being treated for breast cancer.
Who is the study for?
This trial is for women over 50 with early-stage breast cancer (stage 0-III) who are experiencing distress but do not have major psychiatric conditions, cognitive impairment, a history of other cancers (except non-melanoma skin cancer), substance dependency, or immune system-affecting medical conditions. Participants must have a life expectancy over one year and be able to read English at a 6th-grade level.Check my eligibility
What is being tested?
The study is examining the effectiveness of remote group stress management training (R-CBSM) in improving health outcomes and response to the influenza vaccine in older women receiving treatment for breast cancer. The goal is to see if this home-based intervention can also improve psychological well-being and immune function.See study design
What are the potential side effects?
While specific side effects are not detailed for R-CBSM, it's generally considered low-risk involving relaxation techniques. The influenza vaccine may cause temporary soreness at the injection site, mild fever, muscle aches or fatigue.
VSMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 50 with stage 0-III breast cancer.
Select...
I have not been diagnosed with a major psychiatric condition or had active depression, panic disorder, PTSD, or suicidal thoughts in the past year.
Select...
I have not had treatment before surgery to shrink my tumor.
Select...
I am not taking any medications that directly modify my immune system.
Select...
I do not have HIV or any autoimmune diseases.
VSMART Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (t0) to 6 months (t1).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (t0) to 6 months (t1).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemagglutination inhibition assay (HAI) - Fold response to IV
Percent of cases that achieve a clinical vaccine response of greater than or equal to 4 fold titer increase.
Secondary outcome measures
Change in Affective Status
Change in Affective Status markers
Change in Circulating Cytokine levels
+4 moreVSMART Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: R-CBSMExperimental Treatment2 Interventions
10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.
Group II: Wait List Condition (WLC)Active Control2 Interventions
Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza vaccine
2014
Completed Phase 4
~5650
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,612 Total Patients Enrolled
Florida Department of HealthOTHER_GOV
28 Previous Clinical Trials
12,883 Total Patients Enrolled
Michael H Antoni, Ph.DPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a high score on a distress scale or report feeling at least moderately distressed when asked about your distress level.I am a woman over 50 with stage 0-III breast cancer.I have not been diagnosed with a major psychiatric condition or had active depression, panic disorder, PTSD, or suicidal thoughts in the past year.You are expected to live for more than 12 months.You must have good memory and thinking skills, and score less than 31 on a test called the Telephone Interview for Cognitive Status.I have not had treatment before surgery to shrink my tumor.I have never had cancer, except for non-melanoma skin cancer.I am not taking any medications that directly modify my immune system.I do not have HIV or any autoimmune diseases.
Research Study Groups:
This trial has the following groups:- Group 1: R-CBSM
- Group 2: Wait List Condition (WLC)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has the Food and Drug Administration given approval to R-CBSM?
"There is adequate evidence to suggest that R-CBSM is safe, and thus it earned a score of 3."
Answered by AI
What is the ultimate goal of this research endeavor?
"The primary aim of this clinical trial, which will be monitored post-vaccine for approximately 28 days, is to assess the percent of cases that experience a 4 fold titer increase following vaccination. The secondary goals are to ascertain changes in immune status through switched B cells percentage, shifts in affective state via Impact of Event Score Intrusion (IES-I), Affect Balance Scale (ABS) negative and positive affect measures as well as Center for Epidemiologic Studies Depression (CES-D) scores; lastly, alterations associated with flu vaccine response based on inflammatory cytokines change score against HAI response also need to be examined"
Answered by AI
How many participants is this research endeavor welcoming?
"Affirmative. According to information posted on clinicaltrials.gov, this medical investigation is actively recruiting participants since its initial posting on July 21st 2016 with the most recent update occurring on May 6th 2022. A total of 120 patients are being sought from a single site for enrollment in the study."
Answered by AI
Are any new participants being accepted into this research project?
"Indeed, clinicaltrials.gov reports that this medical trial is actively recruiting. It was first published on July 21st 2016 and the most recent update occured May 6th 2022. The investigators aim to enrol 120 individuals across 1 location."
Answered by AI
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