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Improving Brain Function After Breast Cancer Study

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ClinicalTrials.gov Identifier: NCT03696056
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ashley M. Henneghan, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Survivors Behavioral: Kirtan Kriya meditation Behavioral: Music listening program Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Cognition in Breast Cancer Survivors Using Meditation: A Pilot Study
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : July 4, 2019
Estimated Study Completion Date : July 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kirtan Kriya meditation
Participants will mediate for 12 minutes a day for 8 consecutive weeks.
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.

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





Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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).

  15. 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).


  16. 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).


  17. 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).

  18. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696056


Contacts
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Contact: Ashley Henneghan, PhD, RN (512)471-5412 ahenneghan@utexas.edu
Contact: Brandon Fico, MS (954)662-4318 bfico@utexas.edu

Locations
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United States, Texas
University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Ashley Henneghan, PhD, RN    512-471-5412    ahenneghan@utexas.edu   
Contact: Brandon Fico, MS    9546624318    bfico@utexas.edu   
Sponsors and Collaborators
University of Texas at Austin

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Responsible Party: Ashley M. Henneghan, Assistant Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03696056     History of Changes
Other Study ID Numbers: 2018-05-0155
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only group averaged data will be presented and published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases