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

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ClinicalTrials.gov Identifier: NCT03955991
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
Florida Department of Health
Information provided by (Responsible Party):
Michael H. Antoni, University of Miami

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.

Condition or disease Intervention/treatment Phase
Stress Behavioral: R-CBSM Biological: Influenza vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients
Actual Study Start Date : July 21, 2016
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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) MDD, panic 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., 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955991


Contacts
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Contact: Dolores M Perdomo, Ph.D. 305-355-9057 dperdomo@med.miami.edu

Locations
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United States, Florida
Flipse Building Recruiting
Coral Gables, Florida, United States, 33124
Contact: Dolores M Perdomo, Ph.D    305-355-9057    dperdomo@med.miami.edu   
Principal Investigator: Michael H Antoni, Ph.D.         
Sponsors and Collaborators
University of Miami
Florida Department of Health
Investigators
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Principal Investigator: Michael H Antoni, Ph.D University of Miami

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Responsible Party: Michael H. Antoni, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03955991     History of Changes
Other Study ID Numbers: 20160525
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Michael H. Antoni, University of Miami:
Breast Cancer
Flu Vaccine
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs