Improving Brain Function After Breast Cancer Study
Primary Purpose
Breast Cancer Survivors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kirtan Kriya meditation
Music listening program
Sponsored by

About this trial
This is an interventional prevention trial for Breast Cancer Survivors
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kirtan Kriya meditation
Relaxing instrumental music
Arm Description
Participants will mediate for 12 minutes a day for 8 consecutive weeks.
Participants will relax listening to music for 12 minutes a day for 8 consecutive weeks.
Outcomes
Primary Outcome Measures
Verbal learning and memory performance-Hopkins Verbal Learning Test Immediate and Delayed Recall
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.
Verbal Fluency Performance-Controlled Oral Word Association Test
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.
Executive Functioning Performance- Trail Making Test Parts A & B
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.
Secondary Outcome Measures
Granulocyte-macrophage colony-stimulating factor concentration
The change of concentration in picograms per millilitre from will be assessed baseline to Time 2 (8 weeks after baseline).
Interferon gamma concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-1 β concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-2 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-4 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-5 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-6 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-7 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-8 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-10 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-12 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Interleukin-13 concentration
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
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Self-reported cognitive function
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
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).
Feelings of depression
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
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
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.
Full Information
NCT ID
NCT03696056
First Posted
September 29, 2018
Last Updated
November 6, 2020
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT03696056
Brief Title
Improving Brain Function After Breast Cancer Study
Official Title
Improving Cognition in Breast Cancer Survivors Using Meditation: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivors
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kirtan Kriya meditation
Arm Type
Experimental
Arm Description
Participants will mediate for 12 minutes a day for 8 consecutive weeks.
Arm Title
Relaxing instrumental music
Arm Type
Active Comparator
Arm Description
Participants will relax listening to music for 12 minutes a day for 8 consecutive weeks.
Intervention Type
Behavioral
Intervention Name(s)
Kirtan Kriya meditation
Intervention Description
The program incorporates song with visualization and mudras, and is a multi-faceted, multisensory exercise that appears to engage several areas of the brain implicated in cognitive decline, yet is simple to learn and practice. The meditation includes a repeated Kirtan or song, a mudra or physical/motor component, and a visualization component. The meditation sound file will contain a user friendly introduction to the Kirtan Kriya meditation technique along with detailed instructions and meditation tracks. Three tracks will contain 12 minute guided meditations with the same female voice, and 2 with nature sounds, 2 without any additional sounds. Another 2 tracks will provide only the timing cues (1 with nature sounds, 1 without) so that the participant can conduct the meditation session without guidance if they chose.
Intervention Type
Behavioral
Intervention Name(s)
Music listening program
Intervention Description
The participants will receive audio files and an instruction sheet to facilitate their practice.
The audio tracks are 12 minutes in length and contain relaxing instrumental music from Mozart, Bach, Beethoven, Debussy, and Pachebel. Participants are instructed to sit comfortably with their eyes closed and listen to a track of their choice for 12 min daily, for 8 weeks and to record each session on their practice log.
Primary Outcome Measure Information:
Title
Verbal learning and memory performance-Hopkins Verbal Learning Test Immediate and Delayed Recall
Description
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.
Time Frame
Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Title
Verbal Fluency Performance-Controlled Oral Word Association Test
Description
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.
Time Frame
Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Title
Executive Functioning Performance- Trail Making Test Parts A & B
Description
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.
Time Frame
Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Secondary Outcome Measure Information:
Title
Granulocyte-macrophage colony-stimulating factor concentration
Description
The change of concentration in picograms per millilitre from will be assessed baseline to Time 2 (8 weeks after baseline).
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interferon gamma concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-1 β concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-2 concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-4 concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-5 concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-6 concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-7 concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-8 concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-10 concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-12 concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Interleukin-13 concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Tumor necrosis factor alpha concentration
Description
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Time Frame
Baseline, and Time 2 (8 weeks after baseline).
Title
Self-reported cognitive function
Description
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).
Time Frame
Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Title
Anxiety Symptoms
Description
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).
Time Frame
Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Title
Feelings of depression
Description
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).
Time Frame
Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Title
Perceived Fatigue
Description
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).
Time Frame
Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Title
Perceived stress
Description
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.
Time Frame
Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only group averaged data will be presented and published.
Citations:
PubMed Identifier
32949954
Citation
Henneghan AM, Becker H, Harrison ML, Inselmann K, Fico B, Schafer H, King E, Patt D, Kesler S. A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability. Complement Ther Clin Pract. 2020 Nov;41:101228. doi: 10.1016/j.ctcp.2020.101228. Epub 2020 Sep 11.
Results Reference
derived
Learn more about this trial
Improving Brain Function After Breast Cancer Study
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