Breast Cancer SurvivorsNCT03696056
Improving Brain Function After Breast Cancer Study
A study testing Kirtan Kriya meditation and Music listening program in people with Breast Cancer Survivors, run by University of Texas at Austin at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Kirtan Kriya meditation and Music listening program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2018to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Cognition in Breast Cancer Survivors Using Meditation: A Pilot 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.
Read the 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.
- Conditions
- Breast Cancer Survivors
- Being tested
- Kirtan Kriya meditation, Music listening program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kirtan Kriya meditationBehavioural
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 programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Kirtan Kriya meditation | Experimental | Participants will mediate for 12 minutes a day for 8 consecutive weeks. Receives: Behavioral: Kirtan Kriya meditation |
| Relaxing instrumental music | Active comparator | Participants will relax listening to music for 12 minutes a day for 8 consecutive weeks. Receives: Behavioral: Music listening program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Secondary outcomes (18)
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).
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interferon gamma concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-1 β concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-2 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-4 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-5 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-6 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-7 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-8 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-10 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-12 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-13 concentration
The change of concentration in picograms per millilitre from baseline to Time 2 (8 weeks after baseline) will be assessed.
Measured: Baseline, and Time 2 (8 weeks after baseline).
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.
Measured: Baseline, and Time 2 (8 weeks after baseline).
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 α 0.98).
Measured: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
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 α's 0.96).
Measured: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
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 α's 0.96).
Measured: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
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 α 0.93).
Measured: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
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.
Measured: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start28 Sep 2018
- Primary completion1 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley M. Henneghan, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03696056
- Sponsor's protocol ID
- 2018-05-0155
- Status last verified
- Nov 2020
- First submitted
- 29 Sep 2018
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only group averaged data will be presented and published.
Publications
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.
PubMed 32949954
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cognition in Breast Cancer Survivors Using Meditation: A Pilot Study
- ClinicalTrials.gov ID
- NCT03696056
- Acronym / sponsor ID
- 2018-05-0155
- Conditions
- Breast Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kirtan Kriya meditation | Experimental | Behavioral: Kirtan Kriya meditationParticipants will mediate for 12 minutes a day for 8 consecutive weeks. |
| Relaxing instrumental music | Active comparator | Behavioral: Music listening programParticipants will relax listening to music for 12 minutes a day for 8 consecutive weeks. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kirtan Kriya meditationThe 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. | Behavioural | Kirtan Kriya meditation |
| Music listening programThe 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. | Behavioural | Relaxing instrumental music |
Primary outcome
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.
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.
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.
18 secondary outcomes
Granulocyte-macrophage colony-stimulating factor concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interferon gamma concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-1 β concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-2 concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-4 concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-5 concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-6 concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-7 concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-8 concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-10 concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-12 concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Interleukin-13 concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Tumor necrosis factor alpha concentration
Time frame: Baseline, and Time 2 (8 weeks after baseline).
Self-reported cognitive function
Time frame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Anxiety Symptoms
Time frame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Feelings of depression
Time frame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Perceived Fatigue
Time frame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Perceived stress
Time frame: Baseline, Time 2 (8 weeks after baseline), and Time 3 (16 weeks after baseline).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Derived from this study: PubMed 32949954Henneghan 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.
- Individual participant dataSharing planned: No. Only group averaged data will be presented and published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kirtan Kriya meditation and Music listening program in people with Breast Cancer Survivors, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03696056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.