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Completed

NCT Number: NCT03696056

Improving Brain Function After Breast Cancer Study

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.

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Key information

Conditions

Breast Cancer Survivors

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin

Austin, Texas, 78712, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kirtan Kriya meditation

Behavioral

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.

Music listening program

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2018
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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