R-CBSM for Stress

Phase-Based Progress Estimates
Flipse Building, Coral Gables, FLStressR-CBSM - Behavioral
What conditions do you have?

Study 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.

Eligible Conditions
  • Stress

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Baseline (T0) to 6 months (T1).

28 days post vaccine
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.
Baseline (T0) to 28-day post IV (T3)
Influenza virus vaccine
Magnitude of Inflammatory changes associated with Flu Vaccine response
Baseline (T0) to 28-day post IV (T3).
Change in Affective Status markers
Month 6
Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG)
Month 6
Change in Circulating Cytokine levels
Month 12
Change in Affective Status

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Wait List Condition (WLC)
1 of 2
1 of 2

Active Control

Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: R-CBSM · No Placebo Group · Phase 4

R-CBSMExperimental Group · 2 Interventions: R-CBSM, Influenza vaccine · Intervention Types: Behavioral, Biological
Wait List Condition (WLC)ActiveComparator Group · 2 Interventions: R-CBSM, Influenza vaccine · Intervention Types: Behavioral, Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza vaccine
Completed Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (t0) to 6 months (t1).

Who is running the clinical trial?

Florida Department of HealthOTHER_GOV
24 Previous Clinical Trials
12,221 Total Patients Enrolled
University of MiamiLead Sponsor
806 Previous Clinical Trials
386,996 Total Patients Enrolled
Michael H Antoni, Ph.DPrincipal InvestigatorUniversity of Miami

Eligibility Criteria

Age 18+ · Female Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for more than a year.
You have to feel moderate to extreme levels of distress related to your cancer diagnosis. This will be determined by answering a question or completing a screening test.
You do not have a history of severe mental health conditions like schizophrenia, psychosis, bipolar disorder, or major depression within the last year. You have not had suicidal thoughts, attempts or plans.
You haven't been dependent on drugs or alcohol in the last year.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.