CaregiverNCT03683420
Music in Reducing Distress in Participants with Cancer During Chemotherapy Treatment
A study testing Music Therapy in people with Caregiver and Malignant Neoplasm, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver, Malignant Neoplasm
- What is being tested?
- Music Therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to speak, read, write and understand English
- Have sufficient hearing capacity to hear music
Who cannot join
- Patients with cognitive or perceptual disturbances will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
About this study
Official title: Using Music As a Tool for Distress Reduction During Cancer 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To test the effect of patients? listening to music on level of distress during cancer treatment.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Caregiver, Malignant Neoplasm
- Being tested
- Music Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music Therapy |
| 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 . |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start14 Feb 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CaregiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felicity Harper, Barbara Ann Karmanos Cancer Institute
- Investigators
- Felicity Harper, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683420
- Sponsor's protocol ID
- 2017-130
- Other IDs
- NCI-2018-00454, 2017-130
- Status last verified
- Jan 2025
- First submitted
- 22 Apr 2018
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40554733Harper 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.
PubMed 37433094
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Music As a Tool for Distress Reduction During Cancer Treatment
- ClinicalTrials.gov ID
- NCT03683420
- Acronym / sponsor ID
- 2017-130
- Conditions
- Caregiver, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To test the effect of patients? listening to music on level of distress during cancer treatment.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (music) | Experimental | Behavioral: Music TherapyThe 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. |
| 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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to speak, read, write and understand English
- Have sufficient hearing capacity to hear music
Key exclusion criteria (1 listed)
- Patients with cognitive or perceptual disturbances will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TherapyThe 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. | Behavioural | Group I (music) |
Primary outcome
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 40554733Harper 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.
- Derived from this study: PubMed 37433094Harper 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felicity Harper principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Caregiver and Malignant Neoplasm, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain assessed by Visual Analogue Scale (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683420, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.