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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00454 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-130 | Other Identifier | Wayne State University/Karmanos Cancer Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (music) | Experimental | 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. |
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| Group II (control) | No Intervention | 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 . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felicity Harper | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40554733 | Derived | Harper FWK, Moore TF, Heath AS, Kim S, Heath EI. What About the Caregivers? Music Medicine as a Tool for Improving Psychological Well-Being Among Caregivers During Cancer Chemotherapy Treatment. JCO Oncol Pract. 2026 Mar;22(3):434-444. doi: 10.1200/OP-24-00818. Epub 2025 Jun 24. | |
| 37433094 | Derived | Harper FWK, Heath AS, Moore TF, Kim S, Heath EI. Using Music as a Tool for Distress Reduction During Cancer Chemotherapy Treatment. JCO Oncol Pract. 2023 Dec;19(12):1133-1142. doi: 10.1200/OP.22.00814. Epub 2023 Jul 11. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |