Individualized Piano Instruction (IPI) for Improving Cognition in Breast Cancer Survivors.

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Individualized Piano Keyboard Instruction

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Individualized Piano Instruction (IPI)

Arm Description

Participants will receive six weeks of individualized piano instruction and two weeks follow-up for a total of eight weeks.

Outcomes

Primary Outcome Measures

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.

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.

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.

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.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05909813

First Posted

May 25, 2023

Last Updated

June 9, 2023

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT05909813

Brief Title

Individualized Piano Instruction (IPI) for Improving Cognition in Breast Cancer Survivors.

Official Title

A Feasibility Study on Individualized Piano Instruction (IPI) for Improving Cognition in Breast Cancer Survivors.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

January 8, 2018 (Actual)

Primary Completion Date

April 4, 2018 (Actual)

Study Completion Date

June 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Chemotherapy-Related Cognitive Impairment

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Individualized Piano Instruction (IPI)

Arm Type

Experimental

Arm Description

Participants will receive six weeks of individualized piano instruction and two weeks follow-up for a total of eight weeks.

Intervention Type

Behavioral

Intervention Name(s)

Individualized Piano Keyboard Instruction

Other Intervention Name(s)

Individual Piano Instruction, IPI

Intervention Description

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.

Primary Outcome Measure Information:

Title

Post-Individualized Piano Instruction Feasibility Questionnaire

Description

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.

Time Frame

Up to 8 weeks

Title

Change in Cognition Scores: NIH Toolbox Cognition Battery

Description

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.

Time Frame