Improving Brain Function After Breast Cancer Study

Breast Cancer Survivors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03696056
• Other study ID #: 2018-05-0155
• Status: Completed
• Phase: N/A
• Start date: September 28, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: November 2020
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 30, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Primary	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.	Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Primary	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.	Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Secondary	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).	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interferon gamma concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-1 ß concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-2 concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-4 concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-5 concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-6 concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-7 concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-8 concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-10 concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-12 concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	Interleukin-13 concentration	The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	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.	Baseline, and Time 2 (8 weeks after baseline).
Secondary	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 a 0.98).	Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Secondary	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 a's 0.96).	Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Secondary	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 a's 0.96).	Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Secondary	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 a 0.93).	Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Secondary	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.	Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).