NCT03683420

Brief Summary

This trial studies how well music works in reducing distress in participants with cancer during chemotherapy treatment. Music in participants receiving cancer treatment such as infusion treatment and caregiver may reduce pain, anxiety, and distress and improve participant's psychological and physiological wellbeing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

April 22, 2018

Last Update Submit

January 7, 2025

Conditions

CaregiverMalignant Neoplasm

Outcome Measures

Primary Outcomes (3)

  • Changes in pain assessed by Visual Analogue Scale

    Clinical variables will be summarized by median and range for continuous variables and by count and percentage for categorical variables. The changes between pre- and post-survey will be compared between control and experimental groups using an unpaired t-test. Total scores are reported with the total scores ranging from 0-10; higher scores indicate more pain.

    1 hour

  • Changes in mood assessed by Positive and Negative Affect Scale

    Clinical variables will be summarized by median and range for continuous variables and by count and percentage for categorical variables. The changes between pre- and post-survey will be compared between control and experimental groups using an unpaired t-test. There are two subscales: Positive Affect and Negative Affect. Scores for each subscale (10 items each) range from 10 to 50 with higher scores meaning higher levels of affect (either higher positive or higher negative affect).

    1 hour

  • Changes in distress assessed by Distress Thermometer.

    Clinical variables will be summarized by median and range for continuous variables and by count and percentage for categorical variables. The changes between pre- and post-survey will be compared between control and experimental groups using an unpaired t-test. Total scores are reported with the total scores ranging from 0-10; higher scores indicate more pain.

    1 hour

Study Arms (2)

Group I (music)

EXPERIMENTAL

The intervention is a behavioral intervention, which consists of giving patients and caregivers iPods to listen to music for up to 60 minutes while the patient is receiving a chemo infusion. The study consists of a presurvey, active listening period, and a post-survey.

Behavioral: Music Therapy

Group II (control)

NO INTERVENTION

The intervention is a behavioral intervention, which consists of giving patients and caregivers iPods to listen to music for up to 60 minutes while the patient is receiving a chemo infusion. Participants and caregivers in the control condition complete a presurvey and post survey but do not listen to music during infusion session .

Interventions

Music TherapyBEHAVIORAL

The intervention consists of using an iPod to listen to music for up to 60 minutes while patients are receiving chemo infusion. There are no on components to the study.

Group I (music)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to speak, read, write and understand English
  • Have sufficient hearing capacity to hear music

You may not qualify if:

  • Patients with cognitive or perceptual disturbances will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

  • Harper FWK, Heath AS, Moore TF, Kim S, Heath EI. Using Music as a Tool for Distress Reduction During Cancer Chemotherapy Treatment. JCO Oncol Pract. 2023 Dec;19(12):1133-1142. doi: 10.1200/OP.22.00814. Epub 2023 Jul 11.

    PMID: 37433094DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Felicity Harper

    Barbara Ann Karmanos Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 22, 2018

First Posted

September 25, 2018

Study Start

February 14, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

US(1)