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

Completed · Phase 4

Conditions studied: Stress

In brief

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.

Key facts

Study ID

NCT03955991

Run by

University of Miami

People needed

109

Starts

2016-07-21

Expected to finish

2024-06-01

Last updated by the study team

2025-06-26

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Does not meet all Inclusion Criteria.

Where it is running

• Flipse Building — Coral Gables, Florida, United States

Full record on ClinicalTrials.gov

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