Clinical trial NCT05909813: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Chemotherapy-Related Cognitive Impairment
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Post-Individualized Piano Instruction Feasibility Questionnaire
timeFrame: Up to 8 weeks
measure: Change in Cognition Scores: NIH Toolbox Cognition Battery
timeFrame: Weeks 1, 4 and 8, Up to 8 weeks
measure: Change in Quality of Life (QOL) Scores: Generalized Anxiety Disorder Assessment (GAD-7)
timeFrame: Weeks 1, 4 and 8, Up to 8 weeks
measure: Change in Quality of Life (QOL) Scores: Patient Health Questionnaire (PHQ-9)
timeFrame: Weeks 1, 4 and 8, Up to 8 weeks
measure: Change in Cognition Scores: FACT-Cog
timeFrame: Weeks 1, 4 and 8, Up to 8 weeks
measure: Change in Quality of Life (QOL) Scores: FACT-B
timeFrame: Weeks 1, 4 and 8, Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Debbie Anglade, PhD, MSN, RN
role: PRINCIPAL_INVESTIGATOR
References: