Improving Brain Function After Breast Cancer Study

NCT ID: NCT03696056

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2020-01-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Survivors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Kirtan Kriya meditation

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

Group Type EXPERIMENTAL

Kirtan Kriya meditation

Intervention Type 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.

Relaxing instrumental music

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

Group Type ACTIVE_COMPARATOR

Music listening program

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Ashley M. Henneghan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32949954 (View on PubMed)

Other Identifiers

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2018-05-0155

Identifier Type: -

Identifier Source: org_study_id