Music in Reducing Distress in Participants with Cancer During Chemotherapy Treatment

Barbara Ann Karmanos Cancer Institute

Status: Completed

Conditions: Malignant Neoplasm; Caregiver

Treatments: Behavioral: Music Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03683420

2017-130 (Other Identifier)

NCI-2018-00454 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Group I (music)

Experimental group

Description:

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.

Treatment:

Behavioral: Music Therapy

Group II (control)

No Intervention group

Description:

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 .