VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer) (VSMART)

Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients

The proposed study tests the effects of a novel remotely-delivered group cognitive behavioral stress management (R-CBSM) intervention on improving health and quality of life in older women undergoing breast cancer (BCa) treatment. This study tests if delivered home-based group CBSM (R-CBSM) improves response to influenza vaccine (IV) in parallel with improved psychological adaptation, inflammation and other immune functioning indicators in older women treated for BCa.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress
• Intervention / Treatment: Behavioral: R-CBSM; Biological: Influenza vaccine

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dolores M Perdomo, Ph.D.; Phone Number: 305-355-9057; Email: dperdomo@med.miami.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33124
      • Flipse Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Must meet the criterion of a score of >14 on the Impact of Event Scale-Intrusion scale (IES-I48) for cancer-specific distress or self-report at least moderate distress (score of 4 or greater) on a screening question, "How would you rate your distress level, over the past week, on a scale of 0 to 10, with 0 meaning no distress and 10 being extreme distress"
2. No prior history of cancer (with the exception of non-melanoma skin cancer)
3. Life expectancy of > 12 months.
4. 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.
5. No substance dependency in the past 12 months.
6. No acute or chronic co-morbid medical condition with known effects on the immune system (e.g., HIV infection, autoimmune diseases)
7. No prior neo-adjuvant therapy
8. No current medications that act as direct immunomodulators (e.g., Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interferons)
9. No significant cognitive impairment, must score <31 on the Telephone Interview for Cognitive Status (TICS)49.
10. At least a 6th grade reading level in English and be available for follow-up
11. Women age 50 and older diagnosed with stage 0-III breast cancer.

Exclusion Criteria:

• Does not meet all Inclusion Criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R-CBSM; 10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.	Behavioral: R-CBSM; 10 weekly educational modules via an electronic tablet. A participant workbook is also provided that contains a summary of the rationale for each module, outline of each technique, and homework exercises.; Biological: Influenza vaccine; Standard of care Influenza vaccine for that given year.
Active Comparator: Wait List Condition (WLC); Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.	Behavioral: R-CBSM; 10 weekly educational modules via an electronic tablet. A participant workbook is also provided that contains a summary of the rationale for each module, outline of each technique, and homework exercises.; Biological: Influenza vaccine; Standard of care Influenza vaccine for that given year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemagglutination inhibition assay (HAI) - Fold response to IV	As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine	28 days post vaccine
Percent of cases that achieve a clinical vaccine response of greater than or equal to 4 fold titer increase.	Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum.	28 days post vaccine

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Affective Status	Affective Status is comprised of the Impact of Event Score Intrusion (IES-I), Affect Balance Scale (ABS) negative affect, positive affect and Center for Epidemiologic Studies Depression (CES-D) that comprise a latent construct	Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4).
Change in Circulating Cytokine levels	Serum from blood samples will be evaluated for cytokine indices for Interleukin (IL) 1, IL-6 and Tumor Necrosis Factor (TNF-Alpha).	Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3)
Change in Affective Status markers	Affective status change as measured by a Latent variable that compares the effects of the 2 groups.	Baseline (T0) to 28-day post IV (T3).
Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG)	Level of AID activity in B cells	Baseline (T0) to 6 months (T1).
Change in Immune Status measured by Switched B-cells (swB)	Percentage of B-cells indicator.	Baseline (T0) to 28-day post IV (T3).
Magnitude of Immune changes associated with Flu Vaccine response	Measured by a change score in sw B-Cell and AID response with change HAI response	Baseline (T0) to 28-day post IV (T3)
Magnitude of Inflammatory changes associated with Flu Vaccine response	Measured by a change score in inflammatory cytokines with change in HAI response	Baseline (T0) to 28-day post IV (T3)

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Florida Department of Health
• Investigators: Principal Investigator: Michael H Antoni, Ph.D, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2016
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Flu Vaccine
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20160525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No