Completed

A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer

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What is being tested

Art Therapy

+ Music Therapy

Behavioral
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: April 2021
See protocol details

Summary

Principal SponsorCase Comprehensive Cancer Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 21, 2021

Actual date on which the first participant was enrolled.

A cancer diagnosis is often associated with adverse psychosocial effects, including: increased stress and anxiety, fatigue and sleep disturbance, impaired memory and cognition, and poor quality of life. Chemotherapy can cause a cognitive decline in up to 75% of patients; an impairment that oftentimes persists beyond completion of the regimen. This is known as "chemobrain". Integrative therapies are actively being investigated to help improve psychological wellbeing among cancer patients and survivors. The current standard at this institution is to inform patients of different complementary services that are available, including art therapy, music therapy or acupuncture, but not require patients to use them. Participants in this study will be randomized to one of three arms 1) Art therapy program, 2) Music therapy program, or 3) Standard of care (SOC). In-person and at-home therapy sessions will be scheduled in alternating, weekly sessions, to allow one week of self-reflection and remote therapy between in-person sessions. Each participant will be asked to attend two in-person therapy sessions per month (total of 6). The primary objective of this study is to determine the efficacy of a 3-month, therapist-led art or music therapy program to improve quality of life in breast cancer patients currently receiving therapy and in cancer survivors. Secondary objectives of this study are: To determine the effect of these programs on patient cognition in this population. To determine the effect of these programs symptoms of anxiety and depression in this population. To assess whether the effect of these programs is sustained at a 3-month follow-up.

Official TitleA Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer
NCT04493034
Principal SponsorCase Comprehensive Cancer Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

73 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

6 inclusion criteria required to participate
Breast cancer diagnosis (stage 0-III)

Treated at Cleveland Clinic by medical oncologist, radiation oncologist, and/or breast surgeon Patients currently undergoing treatment or have completed active treatment (surgery, radiation or chemotherapy) within past 5 years.

Able and willing to participate in art or music therapy programs at Maroone Cancer Center

Subjects must have the ability to understand and the willingness to sign a written informed consent document

Show More Criteria

4 exclusion criteria prevent from participating
No prior history of breast cancer

History of metastatic disease (Stage IV)

Not being followed by medical oncologist, radiation oncologist, and/or breast surgeon at Cleveland Clinic

Unable or unwilling to participate in art or music therapy program at Maroone Cancer Center

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)

Group II

Experimental
Weekly sessions, alternating: in-person sessions (6 over 3 months), home assignments (6 over 3 months)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center

Weston, United StatesOpen Cleveland Clinic Florida Weston, Case Comprehensive Cancer Center in Google Maps
CompletedOne Study Center
A Randomized Controlled Trial to Assess the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer | PatLynk