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

NCT03955991 | Completed Phase 4 DMC

• 1 other identifier: 20160525
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress

Keywords

Breast Cancer; Flu Vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in Affective Status

  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

  Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3)

• Change in Affective Status markers

  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)

  Baseline (T0) to 6 months (T1).

• Change in Immune Status measured by Switched B-cells (swB)

  Baseline (T0) to 28-day post IV (T3).

Study Arms (2)

R-CBSM

EXPERIMENTAL

10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.

Behavioral: R-CBSM; Biological: Influenza vaccine

Wait List Condition (WLC)

ACTIVE COMPARATOR

Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.

Behavioral: R-CBSM; Biological: Influenza vaccine

Interventions

R-CBSM BEHAVIORAL

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.

R-CBSM; Wait List Condition (WLC)

Influenza vaccine BIOLOGICAL

Standard of care Influenza vaccine for that given year.

R-CBSM; Wait List Condition (WLC)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"
• No prior history of cancer (with the exception of non-melanoma skin cancer)
• Life expectancy of \> 12 months.
• 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.
• No substance dependency in the past 12 months.
• No acute or chronic co-morbid medical condition with known effects on the immune system (e.g., HIV infection, autoimmune diseases)
• No prior neo-adjuvant therapy
• No current medications that act as direct immunomodulators (e.g., Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interferons)
• No significant cognitive impairment, must score \<31 on the Telephone Interview for Cognitive Status (TICS)49.
• At least a 6th grade reading level in English and be available for follow-up
• Women age 50 and older diagnosed with stage 0-III breast cancer.

Sponsors & Collaborators

• University of Miami: lead
• Florida Department of Health: collaborator

Study Sites (1)

Flipse Building

Coral Gables, Florida, 33124, United States

Location

Related Publications (1)

• Saez-Clarke E, Walsh EA, Lovan P, Plotke R, Ream M, Popok P, Perdomo D, Blomberg B, Antoni MH. Distress tolerance and perceived cancer-related cognitive impairment in nonmetastatic breast cancer. Health Psychol. 2025 Feb;44(2):166-170. doi: 10.1037/hea0001417. Epub 2024 Sep 23.

  PMID: 39311813 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Michael H Antoni, Ph.D

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 20, 2019
• Study Start: July 21, 2016
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 26, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)