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NCT03253627 · ClinicalTrials.gov registry record · NA
MBSR During AI Therapy for Breast Cancer
A NA study, sponsored by New York University.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT03253627: Completed NA study, sponsored by New York University.
NCT03253627 is a NA study that has completed, run by New York University. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03253627, a NA study, has completed, sponsored by New York University.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
This study will use non-invasive neuroimaging (i.e., MRI) to examine whether Mindfulness-Based Stress Reduction (MBSR) improves neural markers of cognitive function for postmenopausal women taking aromatase inhibitor (AI) therapy for breast cancer. The pilot randomized controlled trial will obtain preliminary efficacy of MBSR versus Health Enhancement Program (HEP) active control to improve neural markers of cognitive function. The final sample will include 32 postmenopausal women with breast cancer. MBSR and HEP groups will meet for a matched schedule of 8 weekly 2.5-hour sessions and a one-day weekend retreat. Specimen and data collection will be done at three time points: pre-randomization (i.e., within three weeks before beginning the intervention), within three weeks after completion of the intervention, and approximately three months (+/- three weeks) post intervention. Change scores for neuroimaging parameter estimates will be correlated with change scores for measures of cognitive function and affect. Differential expression of genes will be correlated with neuroimaging parameter estimates.
Primary Outcome
global maximum cluster-level neural activation during task-based functional magnetic resonance imaging for MBSR group compared to Health Enhancement Program group in a whole-brain analysis; paradigm: Emotional Faces N-Back; conditions: happy face distractors minus no face distractors; value has no minimum or maximum; value has no reference ranges; higher values indicate more neural activation
Interventions
- BEHAVIORAL Health Enhancement Program
- BEHAVIORAL Mindfulness-Based Stress Reduction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-04-23 |
| Est. Completion | 2020-09-08 |
| Phase | NA |
What the finished NCT03253627 record still lists
NCT03253627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Health Enhancement Program is the first listed.
NCT03253627 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03253627 about?
NCT03253627 is a clinical study titled "MBSR During AI Therapy for Breast Cancer". This study will use non-invasive neuroimaging (i.e., MRI) to examine whether Mindfulness-Based Stress Reduction (MBSR) improves neural markers of cognitive function for postmenopausal women taking aromatase inhibitor (AI) therapy for breast cancer. The pilot randomized controlled trial will obtain p...
What is the current status of trial NCT03253627?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2018-04-23. Estimated completion is 2020-09-08.
What interventions are being tested in trial NCT03253627?
The interventions under investigation include: Health Enhancement Program (BEHAVIORAL), Mindfulness-Based Stress Reduction (BEHAVIORAL).
Who is sponsoring clinical trial NCT03253627?
This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03253627's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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