NCT03955991

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

Stress Management Effects on Affective Status and Influenza Vaccine Response in Older Breast Cancer Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress

Interventions

Type	Name	Description
BEHAVIORAL	R-CBSM	10 weekly educational modules via an electronic tablet. A participant workbook is also provided that contains a summary of the rationale for each module, outline of each technique, and homework exercises.
BIOLOGICAL	Influenza vaccine	Standard of care Influenza vaccine for that given year.

Timeline

• Start date: 2016-07-21
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2019-05-20
• Last updated: 2025-06-26

Locations

1 site across 1 country: United States