Improving Brain Function After Breast Cancer Study

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Ashley M. Henneghan，University of Texas at Austin

Tracking Information

First Submitted Date ^ICMJE

September 29, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

September 28, 2018

Estimated Primary Completion Date

July 4, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Verbal learning and memory performance—Hopkins Verbal Learning Test Immediate and Delayed Recall[ Time Frame: 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.

Verbal Fluency Performance—Controlled Oral Word Association Test[ Time Frame: 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.

Executive Functioning Performance— Trail Making Test Parts A & B[ Time Frame: 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Granulocyte-macrophage colony-stimulating factor concentration[ Time Frame: 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).
Interferon gamma concentration[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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-7 concentration[ Time Frame: 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[ Time Frame: 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-10 concentration[ Time Frame: 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[ Time Frame: 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-13 concentration[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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).
Feelings of depression[ Time Frame: 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[ Time Frame: 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[ Time Frame: 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.

Descriptive Information

Brief Title ^ICMJE

Improving Brain Function After Breast Cancer Study

Official Title ^ICMJE

Improving Cognition in Breast Cancer Survivors Using Meditation: A Pilot Study

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Kirtan Kriya meditation
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.
Behavioral: Music listening program
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.

Study Arms

Experimental: Kirtan Kriya meditation
Participants will mediate for 12 minutes a day for 8 consecutive weeks.
Active Comparator: Relaxing instrumental music
Participants will relax listening to music for 12 minutes a day for 8 consecutive weeks.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 4, 2019

Estimated Primary Completion Date

July 4, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Women with a history of non-inflammatory breast cancer (stages I-IV): - Received chemotherapy as part of their treatment - Completed chemotherapy treatment 3months to 5 years prior to study enrollment - Women 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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

21 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Ashley M. Henneghan，University of Texas at Austin

Study Sponsor ^ICMJE

University of Texas at Austin

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of Texas at Austin

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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