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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,000
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.
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
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.
Time frame: 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).
Time frame: 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.
Time frame: 1 hour
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