Video-Conferenced Stress Management and Relaxation Training for the Improvement of Influenza Vaccine Response and Quality of Life in Older Patients with Stage 0-III Breast Cancer, the VSMART Trial
- Must meet the criterion of a score of > 14 on the Impact of Event Scale-Intrusion scale (IES-I) 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., human immunodeficiency virus [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)
- At least a 6th grade reading level in English and be available for follow-up
- Diagnosed with stage 0-III breast cancer
I. To test the effects of remotely-delivered group cognitive behavioral stress management (R-CBSM) intervention on hemagglutination inhibition assay (HAI)-fold increase in antibody response to influenza vaccine (IV) and to the strains contained in the vaccine.
I. To test the effects of R-CBSM on affective status (decreases in negative affect and depressive symptoms and increases in positive affect) over the intervention period (pre-IV) and during the period of IV response and relate improved affective status over these periods to greater magnitude of the IV response.
II. To examine changes in immune (numbers switched B-cells [swB cells] and B-cell functional responses [activation induced cytidine deaminase (AID) response to CpG stimulation]) and inflammatory serum measures over the initial intervention (pre-IV) period and inflammation measures and swB cells before and during the IV response period, and associate these with the in vivo vaccine response.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (R-CBSM): During the period before influenza vaccine, patients participate remotely in stress management and relaxation group meetings via videoconferencing over 75-90 minutes each once a week (QW) for 10 weeks. Patients then receive standard of care influenza vaccine.
GROUP II (WAIT LIST CONTROL [WLC]): Patients receive standard of care influenza vaccine. About 28 days post influenza vaccine, patients participate remotely in stress management and relaxation group meetings via videoconferencing over 75-90 minutes each QW for 10 weeks.
Trial Phase Phase NA
Trial Type Supportive care
University of Miami Miller School of Medicine-Sylvester Cancer Center
- Primary ID 20160525
- Secondary IDs NCI-2019-07034
- Clinicaltrials.gov ID NCT03955991