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

This trial studies how well a home-based group stress management program called remotely-delivered Cognitive Behavioral Stress Management (R-CBSM) works in improving response to the influenza (flu) vaccine and quality of life in older patients with stage 0-III breast cancer undergoing treatment. R-CBSM is a type of stress management and relaxation training provided through video-conferencing. Women with breast cancer often experience a lot of stress. Stress can also affect how the immune system works. Because treatment for breast cancer can also affect the immune system, the extra effect of stress along with cancer treatment may make patients more vulnerable to things like the flu virus. This can get worse with age. It is critical for older women getting treatment for breast cancer to get help from the flu vaccine. Stress can reduce the body's positive response to the flu vaccine, even in healthy people. Participating in R-CBSM may reduce stress and improve flu vaccine response and general quality of life. It is not yet known whether having the stress management program before the vaccine has different effects on immune response to the influenza vaccine and quality of life than having it after the vaccine in older breast cancer patients undergoing treatment.

Inclusion Criteria

• 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

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVES:

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

Lead Organization
University of Miami Miller School of Medicine-Sylvester Cancer Center

Principal Investigator
Michael Antoni

• Primary ID 20160525
• Secondary IDs NCI-2019-07034
• Clinicaltrials.gov ID NCT03955991