Music in Reducing Distress in Participants with Cancer During Chemotherapy Treatment

Not Applicable

Completed

• Conditions: Caregiver; Malignant Neoplasm
• Interventions: Behavioral: Music Therapy

• Registration Number: NCT03683420
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To test the effect of patients? listening to music on level of distress during cancer treatment.

SECONDARY OBJECTIVES:

I. To explore the influence of covariates (patients? sociodemographics, musical background, and clinical variables) on the association between patients? listening to music and level of distress during cancer treatment.

II. To explore the interdependence of adjustment among patients and their caregivers on the association between.

OUTLINE: Participants and caregivers are randomized to 1 of 2 groups.

GROUP I: Participants and caregivers listen to music of their choice for up to 60 minutes during infusion session.

GROUP II: Participants and caregivers do not listen to music during infusion session and are placed on music waitlist.

Study Timeline

• Study Start: 2018-02-14
• Study First Submitted: 2018-04-22
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

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

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Exclusion Criteria

• Patients with cognitive or perceptual disturbances will be excluded

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (music)	Music Therapy	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.

Primary Outcome Measures

Name	Time	Method
Changes in pain assessed by Visual Analogue Scale	1 hour	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.
Changes in mood assessed by Positive and Negative Affect Scale	1 hour	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).
Changes in distress assessed by Distress Thermometer.	1 hour	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.

Trial Locations

Locations (1)

Wayne State University/Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States