Clinical trial · Interventional
MBSR During AI Therapy for Breast Cancer
Mindfulness-Based Stress Reduction To Improve Cognitive Function for Postmenopausal Women With Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive Symptom | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Health Enhancement Program | Behavioral | — | UNRESOLVED |
| Mindfulness-Based Stress Reduction | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MBSR
- description
- Mindfulness-Based Stress Reduction
- interventionNames
- Behavioral: Mindfulness-Based Stress Reduction
- type
- ACTIVE_COMPARATOR
- label
- Health Enhancement Program
- description
- Health Enhancement Program
- interventionNames
- Behavioral: Health Enhancement Program
Primary outcomes (1)
- measure
- Functional Neural Activation Parameter Estimate
- timeFrame
- baseline, 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria:
1. Female
2. \<80 years of age by date of baseline assessment visit
3. Able to speak and read English
4. Post-menopausal (defined as \[A\] amenorrhea persisting for an entire year, \[B\] oophorectomy or ovarian suppression/ablation, or \[C\] hysterectomy and age \>51 years)
5. Diagnosed with DCIS (stage 0) or stage I, II, or III breast cancer
6. Post lumpectomy or mastectomy and any re-excisions
7. Post neoadjuvant or adjuvant chemotherapy, if prescribed
8. Taking aromatase inhibitor (AI) therapy OR AI therapy scheduled to begin before planned post-intervention assessment visit
Exclusion Criteria:
1. Stage IV (metastatic) breast cancer
2. Diagnosis of a major psychiatric disorder (e.g., bipolar I disorder, schizophrenia, schizoaffective disorder)
3. Suicide attempt within the last 10 years
4. Hospitalization or residential treatment for psychiatric illness, eating disorder, or substance abuse within the last 2 years
5. History of neurological disease (e.g., Parkinson's disease, dementia)
6. History of head trauma
7. Claustrophobia
8. Unable to lie on the back
9. Ever been told not to get an MRI
10. 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).References
Publications (0)
Data not yet available