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

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
R-CBSM	Influenza vaccine	10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.
Wait List Condition (WLC)	Influenza vaccine	Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.
R-CBSM	R-CBSM	10 weeks of group intervention convene by a broadband connection for approximately 75-90 minutes. Intervention given prior to Influenza Vaccine.
Wait List Condition (WLC)	R-CBSM	Persons assigned to this group will receive R-CBSM approximately 28 days after receiving the Influenza Vaccine.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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).
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 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
Change in Immune Status measured by Switched B-cells (swB)	Baseline (T0) to 28-day post IV (T3).	Percentage of B-cells indicator.
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