Caregiver, Malignant Neoplasm
Conditions
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.
Interventions
BEHAVIORALMusic 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.
Sponsors
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed