Improving Brain Function After Breast Cancer Study

NCT03696056 | Completed DMC

• 1 other identifier: 2018-05-0155
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Survivors

Outcome Measures

Primary Outcomes (3)

• 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).

• 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).

• 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 Outcomes (18)

• Granulocyte-macrophage colony-stimulating factor concentration

  Baseline, and Time 2 (8 weeks after baseline).

• Interferon gamma concentration

  Baseline, and Time 2 (8 weeks after baseline).

• Interleukin-1 β concentration

  Baseline, and Time 2 (8 weeks after baseline).

• Interleukin-2 concentration

  Baseline, and Time 2 (8 weeks after baseline).

• Interleukin-4 concentration

  Baseline, and Time 2 (8 weeks after baseline).

Study Arms (2)

Kirtan Kriya meditation

EXPERIMENTAL

Participants will mediate for 12 minutes a day for 8 consecutive weeks.

Behavioral: Kirtan Kriya meditation

Relaxing instrumental music

ACTIVE COMPARATOR

Participants will relax listening to music for 12 minutes a day for 8 consecutive weeks.

Behavioral: Music listening program

Interventions

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.

Kirtan Kriya meditation

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.

Relaxing instrumental music

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

• 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.

  PMID: 32949954 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 4, 2018
• Study Start: September 28, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 30, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)