Music in Reducing Distress in Participants With Cancer During Chemotherapy Treatment

Malignant Neoplasm Clinical Trial

Official title:

Using Music as a Tool for Distress Reduction During Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683420
• Other study ID #: 2017-130
• Secondary ID: NCI-2018-0045420
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2021
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to speak, read, write and understand English

• Have sufficient hearing capacity to hear music

Exclusion Criteria:

• Patients with cognitive or perceptual disturbances will be excluded

Related Conditions & MeSH terms

• Caregiver
• Malignant Neoplasm
• Neoplasms

Intervention

Behavioral:
• Music Therapy
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.

Locations

Country	Name	City	State
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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