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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stress

Intervention / Treatment
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* Behavioral: R-CBSM
* Biological: Influenza vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-CBSM<br>10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine. | Behavioral: R-CBSM<br>* 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.<br>Biological: Influenza vaccine<br>* Standard of care Influenza vaccine for that given year.<br>|
| Active Comparator: Wait List Condition (WLC)<br>Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine. | Behavioral: R-CBSM<br>* 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.<br>Biological: Influenza vaccine<br>* Standard of care Influenza vaccine for that given year.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Flu Vaccine