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

NCT03955991 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2025-06-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Florida Department of Health

    collaborator OTHER_GOV

  • University of Miami

    lead OTHER

Principal Investigators

  • Michael H Antoni, Ph.D · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-21
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03955991 on ClinicalTrials.gov