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Art and Music Therapy for Breast Cancer

N/A

Recruiting

Led By Zeina Nahleh, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Breast cancer diagnosis (stage 0-III) treated at Cleveland Clinic by medical oncologist, radiation oncologist, and/or breast surgeon

Performance status 0 or 1 as per ECOG scale

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial looks at the benefits of art and music therapy for breast cancer patients during and after treatment.

Who is the study for?

This trial is for breast cancer patients with a good performance status who are currently in treatment or have finished within the last 5 years. They must be able to sign consent, read and write English, and attend therapy at Maroone Cancer Center. It's not for those without a history of breast cancer or with metastatic disease.Check my eligibility

What is being tested?

The study tests art and music therapy programs over three months plus follow-up to see if they improve life quality in people getting treated for breast cancer or those who've survived it.See study design

What are the potential side effects?

Art and music therapies are generally safe but may bring up emotional responses or stress related to cancer experience. Physical side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was treated for breast cancer (stage 0-III) at Cleveland Clinic.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 180-days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 180-days

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 180-days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

FACT-B questionnaire scores

Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B) questionnaire scores

Secondary outcome measures

Attitudes towards art/music scores

FACT-Cog questionnaire scores

Functional Assessment of Cancer Therapy - Cognition (FACT-Cog) questionnaire scores

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Music TherapyExperimental Treatment1 Intervention

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

Group II: Art TherapyExperimental Treatment1 Intervention

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

Group III: Standard Of CareActive Control1 Intervention

A list of support services is provided. No requirement to attend sessions and no home assignments

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Art Therapy

2016

Completed Phase 2

~750

Music Therapy

2019

Completed Phase 3

~1660

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,838 Total Patients Enrolled

54 Trials studying Breast Cancer

4,895 Patients Enrolled for Breast Cancer

Zeina Nahleh, MDPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center

6 Previous Clinical Trials

409 Total Patients Enrolled

4 Trials studying Breast Cancer

218 Patients Enrolled for Breast Cancer

Media Library

Art Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04493034 — N/A

Breast Cancer Research Study Groups: Art Therapy, Music Therapy, Standard Of Care

Breast Cancer Clinical Trial 2023: Art Therapy Highlights & Side Effects. Trial Name: NCT04493034 — N/A

Art Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04493034 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this experiment?

"In accordance with clinicaltrials.gov, this trial is currently enrolling participants to take part in the study which was first announced on December 28th 2020 and last updated March 22nd 2022."

Answered by AI

How many people have been recruited to take part in this investigation?

"Correct. Records hosted on clinicaltrials.gov substantiate that this experiment, which was originally advertised on December 28th 2020, is still recruiting patients. Approximately 72 participants are needed for the trial to be conducted at a single medical centre."

Answered by AI

What conclusions do you hope to reach through this clinical experiment?

"The primary aim of this 180-day long trial is to measure Functional Assessment of Cancer Therapy: Breast cancer (FACT-B) questionnaire scores. Secondary objectives are assessing Intervention efficacy by gauging Attitudes towards art/music, which will be done through 4 Likert questions with a 0 - 40 score range; the higher the score, the better the attitude. Additionally, cognition will also be evaluated via FACT-Cog questionnaires divided into four subscales and featuring a 0 - 72 or 16 point scale for each one. Higher numbers indicate worse cognitive deficits in all cases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessing the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer

2021. "Assessing the Benefit of Art & Music Therapy on Quality of Life in Patients With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04493034.

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