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NCT03955991 · ClinicalTrials.gov registry record · Phase 4
VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)
A Phase 4 study of Stress, sponsored by University of Miami.
- Completed
- Registry status
- Phase 4
- Development phase
- 109
- Enrollment target
- 1
- Study location
NCT03955991: Completed Phase 4 study of Stress, sponsored by University of Miami.
NCT03955991 is a Phase 4 study of Stress that has completed, run by University of Miami. The registered enrollment target is 109 participants, below the 785-participant average among 152 other Stress trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03955991, a Phase 4 study of Stress, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 109 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
As measure HAI antibody titers change from pre-vaccine to 28 days post vaccine
Conditions Studied
Interventions
- BEHAVIORAL R-CBSM
- BIOLOGICAL Influenza vaccine
Study Locations (1)
Florida
- Flipse Building - Coral Gables
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2016-07-21 |
| Est. Completion | 2024-06-01 |
| Phase | Phase 4 |
What the finished NCT03955991 record still lists
NCT03955991 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 785-participant average among 152 other Stress trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Stress appearing as the primary indexed condition, and to 2 interventions - of which R-CBSM is the first listed.
NCT03955991 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03955991 about?
NCT03955991 is a clinical study titled "VSMART (Video-Conference Stress Management and Relaxation Training for Older Women With Breast Cancer)". 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...
What is the current status of trial NCT03955991?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 109 participants. The study started on 2016-07-21. Estimated completion is 2024-06-01.
What conditions does trial NCT03955991 study?
This clinical trial studies the following conditions: Stress.
What interventions are being tested in trial NCT03955991?
The interventions under investigation include: R-CBSM (BEHAVIORAL), Influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03955991?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03955991 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03955991's enrollment target sits among peer trials
109 63rd of 152 higher than 90 of 152 other Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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