NCT03955991 (VSMART) is a Phase 4 clinical trial of R-CBSM in Stress, sponsored by University of Miami.

Who is sponsoring NCT03955991?

NCT03955991 is sponsored by University of Miami.

What drugs are being tested in NCT03955991?

Interventions in NCT03955991: R-CBSM, Influenza vaccine.

Is NCT03955991 still recruiting?

NCT03955991 is currently completed. Last updated 26 June 2025.

Last reviewed 2025-06-26 · How we verify

NCT03955991: VSMART

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Last updated 26 June 2025

What this trial tests

Phase 4 trial testing R-CBSM in Stress in 109 participants. Completed in 1 June 2024.

Timeline

21 July 2016

Primary endpoint
1 June 2024

1 June 2024

Quick facts

Lead sponsor	University of Miami
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	109
Start date	21 July 2016
Primary completion	1 June 2024
Estimated completion	1 June 2024
Sites	1 location across United States

Drugs / interventions tested

R-CBSM
Influenza vaccine — full drug profile →

Conditions studied

Stress — all drugs for Stress →

Sponsor

University of Miami

Who can join

50 and older, female only, with Stress. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Predictors of initial engagement with an asynchronous cognitive behavioral stress management website among older women with nonmetastatic breast cancer.
Walsh EA, Popok PJ, Ream M, Bainter S, et al · · 2023 · cited 3× · PMID 37452882 · DOI 10.1007/s00520-023-07939-5
Elucidating mechanisms of quality-of-life disparities in Hispanic women with breast cancer: An examination of disease stage, coping, and affect.
Ream ME, Pester MS, Goodman ZT, Bainter SA, et al · · 2021 · cited 2× · PMID 33300657 · DOI 10.1002/pon.5611
Optimism, sleep quality, physical activity, and cancer-related cognitive impairment in middle-to-older aged patients undergoing breast cancer treatment.
Hansen JL, Plotke R, Kanaya MR, Webster SN, et al · · 2025 · PMID 41049764 · DOI 10.1016/j.ijchp.2025.100626

Verify or expand the search:

Other recruiting trials for Stress

Currently open trials in the same condition.

NCT07485790 — The Effects of Yoga on Pregnant Women · NA · recruiting
NCT07469527 — Effects of Feel Free® Classic Tonic on Stress and Pharmacokinetics in Healthy Adults · NA · recruiting
NCT07387107 — Decreasing Stress Via Virtual Reality and Binaural Beats in Non-Clinical Adults · NA · recruiting
NCT07240792 — Development of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention for Rural High School Student · NA · recruiting
NCT07518056 — Relationships Between Nomophobia Levels and Perceived Stress, Body Image and Food Addiction Among University Students · recruiting

Other University of Miami trials

Trials by the same sponsor.

NCT06003712 — Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI) · NA · not yet recruiting
NCT06077071 — MRIdian "RADAR" Trial · NA · not yet recruiting
NCT07472413 — Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project · Phase 3 · not yet recruiting
NCT07322289 — Antibiotic-coated Braided Suture Study · NA · not yet recruiting
NCT07469592 — eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03955991 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 26 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03955991.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing