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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
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.
Standard of care Influenza vaccine for that given year.
Flipse Building
Coral Gables, Florida, United States
Hemagglutination inhibition assay (HAI) - Fold response to IV
As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine
Time frame: 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.
Time frame: 28 days post vaccine
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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: Baseline (T0) to 6 months (T1).
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Change in Immune Status measured by Switched B-cells (swB)
Percentage of B-cells indicator.
Time frame: 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
Time frame: 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
Time frame: Baseline (T0) to 28-day post IV (T3)