Clinical trial NCT03955991: VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)
Official title: Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stress
Keywords: Breast Cancer
Flu Vaccine
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2019-05-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hemagglutination inhibition assay (HAI) - Fold response to IV
timeFrame: 28 days post vaccine
measure: Percent of cases that achieve a clinical vaccine response of greater than or equal to 4 fold titer increase.
timeFrame: 28 days post vaccine
Secondary outcomes:
measure: Change in Affective Status
timeFrame: Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3), 12 month post Baseline (T4).
measure: Change in Circulating Cytokine levels
timeFrame: Baseline (T0), 6 months (T1), 7-days post IV (T2), 28-day post IV (T3)
measure: Change in Affective Status markers
timeFrame: Baseline (T0) to 28-day post IV (T3).
measure: Change in Immune Status measured by Activation Induced Cytidine Deaminase (AID) in response to Cytosine-phosphate -Guanine (CpG)
timeFrame: Baseline (T0) to 6 months (T1).
measure: Change in Immune Status measured by Switched B-cells (swB)
timeFrame: Baseline (T0) to 28-day post IV (T3).
measure: Magnitude of Immune changes associated with Flu Vaccine response
timeFrame: Baseline (T0) to 28-day post IV (T3)
measure: Magnitude of Inflammatory changes associated with Flu Vaccine response
timeFrame: Baseline (T0) to 28-day post IV (T3)
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Flipse Building
state: Florida
Study officials:
affiliation: University of Miami
name: Michael H Antoni, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: