Stress
Conditions
Keywords
Breast Cancer, Flu Vaccine
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.
Interventions
BEHAVIORALR-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.
BIOLOGICALInfluenza vaccine
Standard of care Influenza vaccine for that given year.
Sponsors
Florida Department of Health
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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) Major Depressive Disorder (MDD), panic disorder, Post Traumatic Stress 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., Granulocyte Macrophage Colony Stimulating Factor (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemagglutination inhibition assay (HAI) - Fold response to IV | 28 days post vaccine | 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. | 28 days post vaccine | Participant's score will be dichotomized into whether 4 fold increase was achieved. Via serum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Affective Status markers | 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. |
| Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG) | Baseline (T0) to 6 months (T1). | Level of AID activity in B cells |
| Change in Affective Status | 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 |
| Magnitude of Immune changes associated with Flu Vaccine response | Baseline (T0) to 28-day post IV (T3) | 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 | Baseline (T0) to 28-day post IV (T3) | Measured by a change score in inflammatory cytokines with change in HAI response |
| Change in Immune Status measured by Switched B-cells (swB) | Baseline (T0) to 28-day post IV (T3). | Percentage of B-cells indicator. |
| Change in Circulating Cytokine levels | 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). |
Countries
United States
Outcome results
None listed