A Feasibility Study on Individualized Piano Instruction (IPI) for Improving Cognition in Breast Cancer Survivors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Cognition Scores: NIH Toolbox Cognition Battery
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Cognition Scores: NIH Toolbox Cognition Battery
时间窗: 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: Patient Health Questionnaire (PHQ-9)
时间窗: 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
时间窗: 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.
Post-Individualized Piano Instruction Feasibility Questionnaire
时间窗: 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 Quality of Life (QOL) Scores: Generalized Anxiety Disorder Assessment (GAD-7)
时间窗: 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: FACT-B
时间窗: 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.
次要结局
未报告次要终点
研究者
Debbie Anglade, PhD, MSN, RN
Associate Professor of Clinical
University of Miami