N/A Completed N=23 Randomized Double-blind Supportive Care

MBSR During AI Therapy for Breast Cancer

Breast Cancer · Cognitive Symptom

Source: ClinicalTrials.gov NCT03253627 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2022

Primary outcomePrimary: Functional Neural Activation Parameter Estimate — -1.2; -1.8; -0.8; -0.7 beta weights — p=0.460

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Functional Neural Activation Parameter Estimate	-1.2; -1.8; -0.8; -0.7	0.460

Eligibility Criteria

Inclusion Criteria

Female
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 Criteria

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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03253627). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.