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Completed

NCT Number: NCT03683420

Music in Reducing Distress in Participants with Cancer During Chemotherapy Treatment

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.

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Key information

Conditions

Caregiver Malignant Neoplasm Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy

Behavioral

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.

Primary outcomes

  1. Changes in pain assessed by Visual Analogue Scale

    Time frame: 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.

  2. Changes in mood assessed by Positive and Negative Affect Scale

    Time frame: 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).

  3. Changes in distress assessed by Distress Thermometer.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Barbara Ann Karmanos Cancer Institute

Other

Registry information

Official study title

Using Music As a Tool for Distress Reduction During Cancer Treatment

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2018
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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