Breast CancerNCT05909813
Individualized Piano Instruction (IPI) for Improving Cognition in Breast Cancer Survivors.
A study testing Individualized Piano Keyboard Instruction in people with Breast Cancer and Chemotherapy-Related Cognitive Impairment, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to test the study method and procedure for individualized piano instruction (IPI) and its impact on chemotherapy related cognitive impairment (CRCI) symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Breast Cancer, Chemotherapy-Related Cognitive Impairment
- What is being tested?
- Individualized Piano Keyboard Instruction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 29 Jun 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be included into the study who:
- Are over 18 years old
- Speaks and read English
- Have been diagnosed and treated for breast cancer (no specific etiology);
- Are experiencing cognitive issues (i.e. actively complain to their physician about struggles with cognitive skills such as memory, attention, executive function, etc.);
- Are 6 months or more out of active treatment;
- Are not currently involved in other brain training programs.
Who cannot join
- Adults who are diagnosed with a cognitive condition other than CRCI (Such as Alzheimer's, Parkinson's, dementia, Amyotrophic Lateral Sclerosis (ALS), autism, and cerebral palsy.)
- Patients who are in active treatment for breast cancer (Currently hospitalized for chemotherapy or still visiting hospital for outpatient infusion treatment)
- Adults who cannot read and write in English fluently.
- Adults who do not have functional movements in their hands, as assessed by tendon gliding and finger opposition exercises provided by a physical hand therapist.
- Adults who plan to not be in Miami for a period eight weeks or are unable to travel to Sylvester Miami on a weekly basis.
- Adults who are already proficient in piano playing, music theory and play informally or professionally at least once per week.
- Elderly adults, those older than 65 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study on Individualized Piano Instruction (IPI) for Improving Cognition in Breast Cancer Survivors.
The purpose of this study is to test the study method and procedure for individualized piano instruction (IPI) and its impact on chemotherapy related cognitive impairment (CRCI) symptoms. There have been studies that show the benefits of leaning to play the piano keyboard on cognitive skills in children and elderly populations. The information collected from the program will be used to examine the feasibility of implementing this program permanently
- Being tested
- Individualized Piano Keyboard Instruction
- Medical subject headings
- Breast Neoplasms, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Piano Keyboard InstructionBehavioural
Also called Individual Piano Instruction, IPI
During weeks two through seven, participants will receive a once a week, hour long, in-person individualized piano keyboard instruction as follows:
- Warm-up
- Scales and Chords: Consisting of scales on seven major keys (C, D, E, F, G, A and B), chord progressions on I, IV, V, I. Two different keys will be learned every week.
- 5-finger exercises will be completed four times per week.
- Piano Theory and Music
- Piano Theory: Playing through Alfred's Basic Adult All-in-One Course, Book 1, to be completed at the ability level of participant, with a least two new pages per lesson.
- Chosen Piece: Playing through an instrumental piece chosen by the participant.
Participants will be asked to practice homework from this lesson daily for 20 minutes per day, until their next weekly lesson.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Piano Instruction (IPI) | Experimental | Participants will receive six weeks of individualized piano instruction and two weeks follow-up for a total of eight weeks. Receives: Behavioral: Individualized Piano Keyboard Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Individualized Piano Instruction Feasibility Questionnaire
An investigator-designed questionnaire will be administered to participants, assessing their opinions about the program. The questionnaire includes multiple sections assessing participant session attendance, the effectiveness of the program, and how enjoyable it was. Total percentage scores will be calculated for each section.
The Participants' attendance section scores range from "1" to "4" sessions. A higher number of sessions attended indicates greater perceived program feasibility.
Questions assessing program effectiveness asked participants about their daily and weekly piano routines. Responses range from "not very easily" to "very easily". A higher positive response percentage indicates greater perceived program feasibility.
Program enjoyment questions asked participants to rate their satisfaction. Responses range from "not enjoyable" to "very enjoyable".A higher positive response percentage indicates greater perceived program feasibility.
Measured: Up to 8 weeks
Change in Cognition Scores: NIH Toolbox Cognition Battery
The National Institutes of Health Toolbox Cognition Battery (NIHTB-CB) will be administered to participants to measure change in cognition after individualized piano instruction. The NIHTB-CB consists of tests of multiple constructs, yielding individual test scores and the following summary scores: Total Cognition Composite, Fluid Composite (includes Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory (Form A), List Sorting Working Memory, and Pattern Comparison tests), and Crystallized Composite (includes Picture Vocabulary and Oral Reading Recognition tests). Scores on the NIHTB-CB will be used to assess severity of chemotherapy-related cognitive injury (CRCI) in participants. Scores range from 59-140, higher scores mean better cognition.
Measured: Weeks 1, 4 and 8, Up to 8 weeks
Change in Quality of Life (QOL) Scores: Generalized Anxiety Disorder Assessment (GAD-7)
The Generalized Anxiety Disorder Assessment (GAD-7) questionnaire will be administered to participants to measure the change in anxiety levels after individualized piano instruction. The GAD-7 consists of seven questions with each possible response scored on a four-point Likert scale ranging from "0" (not at all) to "4" (nearly every day). Higher total scores indicate greater severity of anxiety: 0-4 no to low-risk, 5-9 mild, 10-14 moderate, 15+ severe.
Measured: Weeks 1, 4 and 8, Up to 8 weeks
Change in Quality of Life (QOL) Scores: Patient Health Questionnaire (PHQ-9)
A Patient Health Questionnaire (PHQ-9) will be administered to participants to measure changes in mood after individualized piano instruction. The PHQ-9 consists of nine questions, with each possible response scored on a four-point Likert scale ranging from "0" (not at all) to "3" (nearly every day). Higher total scores indicate greater severity of depression: 0-4 none, 5-9 minimal, 10-14 moderate, 15-19 moderately severe, and 20-27 severe.
Measured: Weeks 1, 4 and 8, Up to 8 weeks
Change in Cognition Scores: FACT-Cog
The Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) will be administered to participants to measure change in cognition after individualized piano instruction. The FACT-B is a 33-item questionnaire designed to assess perceived cognitive function and impact on quality of life in cancer patients within four domains: Perceived cognitive impairments, comments from others, perceiving cognitive abilities, and impact on quality of life. Each response within each domain is scored on a five-point Likert scale ranging from "0" (not at all) to 4 (very much). Higher total scores indicate a higher level of cognition and quality of life.
Measured: Weeks 1, 4 and 8, Up to 8 weeks
Change in Quality of Life (QOL) Scores: FACT-B
The Functional Assessment of Cancer Therapy-Breast (FACT-B) will be administered to participants to measure the change in the quality of life after individualized piano instruction (IPI). The FACT-B is a 36-item questionnaire designed to measure five domains of health-related QOL in breast cancer patients: Physical, social, emotional, and functional well-being as well as a breast-cancer subscale (BCS). Each response within each domain is scored on a five-point Likert scale ranging from "0" (not at all) to 4 (very much). Higher scores indicate a better quality of life.
Measured: Weeks 1, 4 and 8, Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start8 Jan 2018
- Primary completion4 Apr 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debbie Anglade, PhD, MSN, RN, University of Miami
- Investigators
- Debbie Anglade, PhD, MSN, RN, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909813
- Sponsor's protocol ID
- 20160725
- Other IDs
- NCI-2023-00409
- Status last verified
- May 2024
- First submitted
- 25 May 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on Individualized Piano Instruction (IPI) for Improving Cognition in Breast Cancer Survivors.
- ClinicalTrials.gov ID
- NCT05909813
- Acronym / sponsor ID
- 20160725
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 18 Jun 2023 (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.
The purpose of this study is to test the study method and procedure for individualized piano instruction (IPI) and its impact on chemotherapy related cognitive impairment (CRCI) symptoms. There have been studies that show the benefits of leaning to play the piano keyboard on cognitive skills in children and elderly populations. The information collected from the program will be used to examine the feasibility of implementing this program permanently
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized Piano Instruction (IPI) | Experimental | Behavioral: Individualized Piano Keyboard InstructionParticipants will receive six weeks of individualized piano instruction and two weeks follow-up for a total of eight weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are over 18 years old
- Speaks and read English
- Have been diagnosed and treated for breast cancer (no specific etiology);
- Are experiencing cognitive issues (i.e. actively complain to their physician about struggles with cognitive skills such as memory, attention, executive function, etc.);
- Are 6 months or more out of active treatment;
Key exclusion criteria (7 listed)
- Adults who are diagnosed with a cognitive condition other than CRCI (Such as Alzheimer's, Parkinson's, dementia, Amyotrophic Lateral Sclerosis (ALS), autism, and cerebral palsy.)
- Patients who are in active treatment for breast cancer (Currently hospitalized for chemotherapy or still visiting hospital for outpatient infusion treatment)
- Adults who cannot read and write in English fluently.
- Adults who do not have functional movements in their hands, as assessed by tendon gliding and finger opposition exercises provided by a physical hand therapist.
- Adults who plan to not be in Miami for a period eight weeks or are unable to travel to Sylvester Miami on a weekly basis.
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 |
|---|---|---|
| Individualized Piano Keyboard InstructionAlso: Individual Piano Instruction, IPIDuring weeks two through seven, participants will receive a once a week, hour long, in-person individualized piano keyboard instruction as follows: 1. Warm-up 1. Scales and Chords: Consisting of scales on seven major keys (C, D, E, F, G, A and B), chord progressions on I, IV, V, I. Two different keys will be learned every week. 2. 5-finger exercises will be completed four times per week. 2. Piano Theory and Music 1. Piano Theory: Playing through Alfred's Basic Adult All-in-One Course, Book 1, to be completed at the ability level of participant, with a least two new pages per lesson. 2. Chosen Piece: Playing through an instrumental piece chosen by the participant. Participants will be asked to practice homework from this lesson daily for 20 minutes per day, until their next weekly lesson. | Behavioural | Individualized Piano Instruction (IPI) |
Primary outcome
Post-Individualized Piano Instruction Feasibility Questionnaire
Time frame: Up to 8 weeks
An investigator-designed questionnaire will be administered to participants, assessing their opinions about the program. The questionnaire includes multiple sections assessing participant session attendance, the effectiveness of the program, and how enjoyable it was. Total percentage scores will be calculated for each section. The Participants' attendance section scores range from "1" to "4" sessions. A higher number of sessions attended indicates greater perceived program feasibility. Questions assessing program effectiveness asked participants about their daily and weekly piano routines. Responses range from "not very easily" to "very easily". A higher positive response percentage indicates greater perceived program feasibility. Program enjoyment questions asked participants to rate their satisfaction. Responses range from "not enjoyable" to "very enjoyable".A higher positive response percentage indicates greater perceived program feasibility.
Change in Cognition Scores: NIH Toolbox Cognition Battery
Time frame: Weeks 1, 4 and 8, Up to 8 weeks
The National Institutes of Health Toolbox Cognition Battery (NIHTB-CB) will be administered to participants to measure change in cognition after individualized piano instruction. The NIHTB-CB consists of tests of multiple constructs, yielding individual test scores and the following summary scores: Total Cognition Composite, Fluid Composite (includes Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory (Form A), List Sorting Working Memory, and Pattern Comparison tests), and Crystallized Composite (includes Picture Vocabulary and Oral Reading Recognition tests). Scores on the NIHTB-CB will be used to assess severity of chemotherapy-related cognitive injury (CRCI) in participants. Scores range from 59-140, higher scores mean better cognition.
Change in Quality of Life (QOL) Scores: Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: Weeks 1, 4 and 8, Up to 8 weeks
The Generalized Anxiety Disorder Assessment (GAD-7) questionnaire will be administered to participants to measure the change in anxiety levels after individualized piano instruction. The GAD-7 consists of seven questions with each possible response scored on a four-point Likert scale ranging from "0" (not at all) to "4" (nearly every day). Higher total scores indicate greater severity of anxiety: 0-4 no to low-risk, 5-9 mild, 10-14 moderate, 15+ severe.
Change in Quality of Life (QOL) Scores: Patient Health Questionnaire (PHQ-9)
Time frame: Weeks 1, 4 and 8, Up to 8 weeks
A Patient Health Questionnaire (PHQ-9) will be administered to participants to measure changes in mood after individualized piano instruction. The PHQ-9 consists of nine questions, with each possible response scored on a four-point Likert scale ranging from "0" (not at all) to "3" (nearly every day). Higher total scores indicate greater severity of depression: 0-4 none, 5-9 minimal, 10-14 moderate, 15-19 moderately severe, and 20-27 severe.
Change in Cognition Scores: FACT-Cog
Time frame: Weeks 1, 4 and 8, Up to 8 weeks
The Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) will be administered to participants to measure change in cognition after individualized piano instruction. The FACT-B is a 33-item questionnaire designed to assess perceived cognitive function and impact on quality of life in cancer patients within four domains: Perceived cognitive impairments, comments from others, perceiving cognitive abilities, and impact on quality of life. Each response within each domain is scored on a five-point Likert scale ranging from "0" (not at all) to 4 (very much). Higher total scores indicate a higher level of cognition and quality of life.
Change in Quality of Life (QOL) Scores: FACT-B
Time frame: Weeks 1, 4 and 8, Up to 8 weeks
The Functional Assessment of Cancer Therapy-Breast (FACT-B) will be administered to participants to measure the change in the quality of life after individualized piano instruction (IPI). The FACT-B is a 36-item questionnaire designed to measure five domains of health-related QOL in breast cancer patients: Physical, social, emotional, and functional well-being as well as a breast-cancer subscale (BCS). Each response within each domain is scored on a five-point Likert scale ranging from "0" (not at all) to 4 (very much). Higher scores indicate a better quality of life.
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 16 May 2024.
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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.
Debbie Anglade, PhD, MSN, RN principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Piano Keyboard Instruction in people with Breast Cancer and Chemotherapy-Related Cognitive Impairment, run by University of Miami 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 7 inclusion and 7 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 16 May 2024. 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?
Post-Individualized Piano Instruction Feasibility Questionnaire (time frame: Up to 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.