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Completed

NCT Number: NCT03955991

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

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.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Flipse Building

Coral Gables, Florida, 33124, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Does not meet all Inclusion Criteria.

Treatment and study plan

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.

influenza vaccine

Biological

Standard of care Influenza vaccine for that given year.

Primary outcomes

  1. Hemagglutination inhibition assay (HAI) - Fold response to IV

    Time frame: 28 days post vaccine

    As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine

  2. Percent of cases that achieve a clinical vaccine response of greater than or equal to 4 fold titer increase.

    Time frame: 28 days post vaccine

    Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum.

Secondary outcomes

  1. Change in Affective Status

    Time frame: Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4).

    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

  2. Change in Circulating Cytokine levels

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

    Serum from blood samples will be evaluated for cytokine indices for Interleukin

    (IL) 1, IL-6 and Tumor Necrosis Factor (TNF-Alpha).

  3. Change in Affective Status markers

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

    Affective status change as measured by a Latent variable that compares the effects of the 2 groups.

  4. Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG)

    Time frame: Baseline (T0) to 6 months (T1).

    Level of AID activity in B cells

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

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

    Percentage of B-cells indicator.

  6. Magnitude of Immune changes associated with Flu Vaccine response

    Time frame: Baseline (T0) to 28-day post IV (T3)

    Measured by a change score in sw B-Cell and AID response with change HAI response

  7. Magnitude of Inflammatory changes associated with Flu Vaccine response

    Time frame: Baseline (T0) to 28-day post IV (T3)

    Measured by a change score in inflammatory cytokines with change in HAI response

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Florida Department of Health

Registry information

Official study title

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

Acronym: VSMART

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
May 20, 2019
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.