Improving Brain Function After Breast Cancer Study
- Conditions
- Breast Cancer Survivors
- Interventions
- Behavioral: Music listening programBehavioral: Kirtan Kriya meditation
- Registration Number
- NCT03696056
- Lead Sponsor
- University of Texas at Austin
- Brief Summary
This study will explore the feasibility and potential effects of a simple, home-based daily meditation intervention on breast cancer survivors' cognitive and psychological functioning as well as inflammatory regulation.
- Detailed Description
This study will compare two home based 8-week interventions (Kirtan Kriya meditation vs.
relaxing instrumental music listening) in 40 breast cancer survivors ages 21-75 who completed chemotherapy 3 months to 5 years prior.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Individuals with a history of non-inflammatory breast cancer (stages I-IV):
- Received chemotherapy as part of their treatment
- Completed chemotherapy treatment 3 months to 10 years prior to study enrollment
- Individuals who have report cognitive deficits
- Breast cancer survivors with a history of metastases to the brain
- A physician diagnosis of: dementia, a learning disability, unmanaged major depression, psychosis, schizophrenia, bipolar, traumatic brain injury, cancer of the central nervous system, diabetes, arthritis
- Taking oral steroids within 30 days of enrolling
- A regular meditation practice (greater than 1 time per week)
- Currently taking immune modifying medications
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Relaxing instrumental music Music listening program Participants will relax listening to music for 12 minutes a day for 8 consecutive weeks. Kirtan Kriya meditation Kirtan Kriya meditation Participants will mediate for 12 minutes a day for 8 consecutive weeks.
- Primary Outcome Measures
Name Time Method Verbal learning and memory performance-Hopkins Verbal Learning Test Immediate and Delayed Recall Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline). The change of the Hopkins Verbal Learning Test-Revised scores for immediate and delayed recall from baseline to Time 3 (16 weeks after baseline) will be assessed. This test measures immediate and delayed verbal memory. Measured as words recalled and adjusted for age and education. Higher words recalled suggests greater verbal learning and memory performance.
Executive Functioning Performance- Trail Making Test Parts A & B Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline). The change in Trails A \& B scores, a measure of processing speed and executive attention, from baseline to Time 3 (16 weeks after baseline) will be assessed. Where time until completion is measured and adjusted for age and education. Faster time until completion suggests higher executive function.
Verbal Fluency Performance-Controlled Oral Word Association Test Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline). The change of the Controlled Oral Word Association Test, a measure of verbal fluency, scores from baseline to Time 3 (16 weeks after baseline) will be assessed. Measured as number of words produced and adjusted for age and education. Higher words produced suggests greater verbal fluency performance.
- Secondary Outcome Measures
Name Time Method Interleukin-13 concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interferon gamma concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-1 β concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-4 concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Granulocyte-macrophage colony-stimulating factor concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from will be assessed baseline to Time 2 (8 weeks after baseline).
Interleukin-10 concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-2 concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-5 concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-6 concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-12 concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Self-reported cognitive function Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline). The change of Functional Assessment of Cancer Therapy-Cognitive for perceived cognitive function and impact on quality of life from baseline to Time 3 (16 weeks after baseline) will be assessed. Lower scores indicate worse functioning. This scale demonstrated adequate reliability in our previous study (Cronbach's α 0.98).
Anxiety Symptoms Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline). The changes of anxiety symptoms will be assessed with the Patient-Reported Outcomes Measurement Information System scale from baseline to Time 3 (16 weeks after baseline).
The Patient-Reported Outcomes Measurement Information System (PROMIS) scale will be used to measure anxiety Short Form 8a. Higher scores indicate greater anxiety. This scale demonstrated adequate reliability in our previous study (Cronbach's α's 0.96).Interleukin-7 concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-8 concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Tumor necrosis factor alpha concentration Baseline, and Time 2 (8 weeks after baseline). The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Feelings of depression Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline). The changes of feelings of depression will be assessed with the Patient-Reported Outcomes Measurement Information System scale from baseline to Time 3 (16 weeks after baseline).
The Patient-Reported Outcomes Measurement Information System (PROMIS) scale will be used to measure depressive symptoms using the Short Form 8a. This 10-item scale measures the degree that life circumstances are appraised as having been stressful in the previous 4 weeks. Higher scores indicate greater feeling of depression. This scale demonstrated adequate reliability in our previous study (Cronbach's α's 0.96).Perceived Fatigue Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline). The changes of fatigue symptoms will be assessed with the Patient-Reported Outcomes Measurement Information System scale from baseline to Time 3 (16 weeks after baseline). The PROMIS Fatigue- Short Form 8a will be used to evaluate fatigue. Higher scores indicate greater fatigue. This measure demonstrated adequate reliability in our previous study (Cronbach's α 0.93).
Perceived stress Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline). The changes in perceived stress will be assessed with the Perceived Stress Scale from baseline to Time 3 (16 weeks after baseline). Measures the perception of stress with a 10 item scale. Higher scores indicate greater perceived stress.
Trial Locations
- Locations (1)
University of Texas at Austin
🇺🇸Austin, Texas, United States