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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 is a NA study that has completed, run by New York University. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03253627
The ClinicalTrials.gov registry entry for NCT03253627 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York University, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Health Enhancement Program is the first listed.
NCT03253627 reports 0 study locations.
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.
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