At a glance
ClinicalIndex Comparison Record- ✓Postmenopausal status defined by amenorrhea for 1 year, oophorectomy, ovarian suppression/ablation, or hysterectomy with age >51
- ✓Diagnosed with DCIS (stage 0) or stage I, II, or III breast cancer
- ✓Completed lumpectomy or mastectomy with any re-excisions
- ✓Completed neoadjuvant or adjuvant chemotherapy if prescribed
- ✕Stage IV (metastatic) breast cancer
- ✕Major psychiatric disorder including bipolar I, schizophrenia, or schizoaffective disorder
- ✕Suicide attempt within last 10 years
- ✕Hospitalization or residential treatment for psychiatric illness, eating disorder, or substance abuse within last 2 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Mindfulness-Based Stress Reduction To Improve Cognitive Function for Postmenopausal Women With Breast Cancer
In Brief
A clinical study evaluating Health Enhancement Program and Mindfulness-Based Stress Reduction for Breast Cancer and Cognitive Symptom. Completed, enrolled 23 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.