Back to resultsVSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer) (VSMART)
Primary Purpose
Stress
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
R-CBSM
Influenza vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Stress focused on measuring Breast Cancer, Flu Vaccine
Eligibility Criteria
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.
Sites / Locations
- Flipse Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
R-CBSM
Wait List Condition (WLC)
Arm Description
10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.
Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.
Outcomes
Primary Outcome Measures
Hemagglutination inhibition assay (HAI) - Fold response to IV
As measure HAI antibody titers change from pre-vaccine to 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.
Secondary Outcome Measures
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
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).
Change in Affective Status markers
Affective status change as measured by a Latent variable that compares the effects of the 2 groups.
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
Change in Immune Status measured by Switched B-cells (swB)
Percentage of B-cells indicator.
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
Magnitude of Inflammatory changes associated with Flu Vaccine response
Measured by a change score in inflammatory cytokines with change in HAI response
Full Information
NCT ID
NCT03955991
First Posted
May 15, 2019
Last Updated
August 4, 2023
Sponsor
University of Miami
Collaborators
Florida Department of Health
1. Study Identification
Unique Protocol Identification Number
NCT03955991
Brief Title
VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)
Acronym
VSMART
Official Title
Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2016 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Florida Department of Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress
Keywords
Breast Cancer, Flu Vaccine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R-CBSM
Arm Type
Experimental
Arm Description
10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.
Arm Title
Wait List Condition (WLC)
Arm Type
Active Comparator
Arm Description
Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.
Intervention Type
Behavioral
Intervention Name(s)
R-CBSM
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Influenza vaccine
Intervention Description
Standard of care Influenza vaccine for that given year.
Primary Outcome Measure Information:
Title
Hemagglutination inhibition assay (HAI) - Fold response to IV
Description
As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine
Time Frame
28 days post vaccine
Title
Percent of cases that achieve a clinical vaccine response of greater than or equal to 4 fold titer increase.
Description
Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum.
Time Frame
28 days post vaccine
Secondary Outcome Measure Information:
Title
Change in Affective Status
Description
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
Time Frame
Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4).
Title
Change in Circulating Cytokine levels
Description
Serum from blood samples will be evaluated for cytokine indices for Interleukin
(IL) 1, IL-6 and Tumor Necrosis Factor (TNF-Alpha).
Time Frame
Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3)
Title
Change in Affective Status markers
Description
Affective status change as measured by a Latent variable that compares the effects of the 2 groups.
Time Frame
Baseline (T0) to 28-day post IV (T3).
Title
Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG)
Description
Level of AID activity in B cells
Time Frame
Baseline (T0) to 6 months (T1).
Title
Change in Immune Status measured by Switched B-cells (swB)
Description
Percentage of B-cells indicator.
Time Frame
Baseline (T0) to 28-day post IV (T3).
Title
Magnitude of Immune changes associated with Flu Vaccine response
Description
Measured by a change score in sw B-Cell and AID response with change HAI response
Time Frame
Baseline (T0) to 28-day post IV (T3)
Title
Magnitude of Inflammatory changes associated with Flu Vaccine response
Description
Measured by a change score in inflammatory cytokines with change in HAI response
Time Frame
Baseline (T0) to 28-day post IV (T3)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Antoni, Ph.D
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flipse Building
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)
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