Status:
COMPLETED
MBSR During AI Therapy for Breast Cancer
Lead Sponsor:
New York University
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
Conditions:
Breast Cancer
Cognitive Symptom
Eligibility:
FEMALE
18-79 years
Phase:
NA
Brief 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 aro...
Detailed Description
Adjuvant aromatase inhibitor (AI) therapy improves disease-free and overall survival for postmenopausal women after surgery for hormone receptor-positive breast cancer. Among symptoms associated with ...
Eligibility Criteria
Inclusion
- Female
- \<80 years of age by date of baseline assessment visit
- Able to speak and read English
- Post-menopausal (defined as \[A\] amenorrhea persisting for an entire year, \[B\] oophorectomy or ovarian suppression/ablation, or \[C\] hysterectomy and age \>51 years)
- Diagnosed with DCIS (stage 0) or stage I, II, or III breast cancer
- Post lumpectomy or mastectomy and any re-excisions
- Post neoadjuvant or adjuvant chemotherapy, if prescribed
- Taking aromatase inhibitor (AI) therapy OR AI therapy scheduled to begin before planned post-intervention assessment visit
Exclusion
- Stage IV (metastatic) breast cancer
- Diagnosis of a major psychiatric disorder (e.g., bipolar I disorder, schizophrenia, schizoaffective disorder)
- Suicide attempt within the last 10 years
- Hospitalization or residential treatment for psychiatric illness, eating disorder, or substance abuse within the last 2 years
- History of neurological disease (e.g., Parkinson's disease, dementia)
- History of head trauma
- Claustrophobia
- Unable to lie on the back
- Ever been told not to get an MRI
- MRI-incompatible metal implant\*
- If a potential participant reports implanted metal objects, which might be affected by MRI magnets, the study personnel and MRI technologist will screen over the phone or in person to determine whether the potential participant would be safe during the MRI scan. A current list of implants compatible with MRI will be consulted (http://www.mrisafety.com/TMDL\_list.php).
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03253627
Start Date
April 23 2018
End Date
September 8 2020
Last Update
November 2 2022
Active Locations (1)
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1
New York University
New York, New York, United States, 10010