Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001495718
Ethics application status
Approved
Date submitted
10/11/2022
Date registered
29/11/2022
Date last updated
29/11/2022
Date data sharing statement initially provided
29/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Music therapy for chemotherapy induced nausea and vomiting
Scientific title
Prevention and treatment of chemotherapy induced nausea and vomiting using music therapy interventions for people undergoing medium or high risk emetogenic chemotherapy
Secondary ID [1] 307468 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 326858 0
Chemotherapy induced nausea and vomiting 328234 0
Condition category
Condition code
Cancer 324074 324074 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Brief Name: Music therapy for chemotherapy induced nausea and vomiting

2. Why: There is currently insufficient treatment for chemotherapy induced nausea and vomiting. Nausea is poorly controlled with current pharmacological therapies. Among the non-pharmacological interventions, music therapy intervention appears promising based on its previously demonstrated health benefits.

3. What: Participants will be provided with an iPod touch and headphones. The iPod will have an application where participants can listen to 5 different pieces of music written and recorded specifically for this project. The application will incorporate the following questionnaires for assessment - Functional Living Index Emesis (FLIE 5D), Edmonton Symptom Assessment System (ESAS) and Pittsburgh Sleep Quality Index (PSQI).

4. Procedures: Participants will be asked to engage with the music therapy intervention on days 1-6 of both their first and second treatment cycles, with the addition of completing surveys and questionnaires the day after each cycle (Day 7), totalling 14 days of engagement with the study.

On the first day of the first cycle of treatment, participants will be met by a researcher who will provide consultation and an information sheet before obtaining signed consent, this will take approximately 30mins

On each of the 12 days of the music therapy intervention, participants will be asked to listen to a minimum of 5-15 minutes of music through the application. There is no maximum time that participants can listen to the music, however, the application will not allow access to music outside of the treatment cycles. Music listening will be unsupervised and will be available for participants to engage with at the infusion suite or any other place of their choosing.
All interaction of music listening will be tracked through the application and made available as data for the researchers but not participants.

Immediately prior to each cycle, participants will be prompted and supported by the researcher to use the application to complete the FLIE 5D, ESAS and PSQI, these will take approximately 10 minutes to complete on each occasion. On the day following the end of each cycle, the application will prompt the participant through a notification to again complete the FLIE 5D, ESAS and PSQI, again these will take approximately 10 minutes to complete on each occasion. Additionally, on the first day of their treatment, prior to beginning the music therapy intervention, participants will be asked to complete a one-time questionnaire about the music on the application.

5. Who Provided: The research coordinator will provide and train the participants for using the device and filling questionnaires.

6. The project is being conducted through the cancer clinic of a hospital. Recruitment and initial consolation will be conducted with the participant at the cancer clinic, participants will engage with the intervention at the cancer clinic and will also have the option to participate with the intervention outside of the clinic.
Intervention code [1] 323925 0
Prevention
Intervention code [2] 324884 0
Treatment: Devices
Comparator / control treatment
No control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331875 0
To assess the feasibility and acceptability of music medicine and music therapy intervention by patients undergoing chemotherapy. This will be measured using a 16 question questionnaire developed specifically for this project
Timepoint [1] 331875 0
This outcome will assessed on the first day of cycle 1 of the treatment directly after signing consent, prior to the participant beginning their chemotherapy treatment.
Primary outcome [2] 331877 0
To evaluate preliminary efficacy of the music therapy intervention on chemotherapy induced symptoms using the Functional Living Index – Emesis 5 day (FLIE 5D) questionnaire
Timepoint [2] 331877 0
Day 1 - Baseline is assessed prior to the participant beginning their chemotherapy treatment or the music therapy intervention, assessed again the day after the completion of the first cycle of chemotherapy (Day 7) (primary timepoint).

They are assessed again at the beginning of their second cycle of chemotherapy (Day1, Cycle 2) and the day after the completion of the second cycle of chemotherapy (Day 7, Cycle 2).
Primary outcome [3] 333235 0
To evaluate preliminary efficacy of the music therapy intervention on chemotherapy induced symptoms using the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [3] 333235 0
Day 1 - Baseline is assessed prior to the participant beginning their chemotherapy treatment or the music therapy intervention, assessed again the day after the completion of the first cycle of chemotherapy (Day 7) (primary timepoint).

They are assessed again at the beginning of their second cycle of chemotherapy (Day1, Cycle 2) and the day after the completion of the second cycle of chemotherapy (Day 7, Cycle 2).
Secondary outcome [1] 416290 0
Primary Outcome

To evaluate preliminary efficacy of the music therapy intervention on chemotherapy induced symptoms using the Edmonton Symptom Assessment System (ESAS)
Timepoint [1] 416290 0
Day 1 - Baseline is assessed prior to the participant beginning their chemotherapy treatment or the music therapy intervention, assessed again the day after the completion of the first cycle of chemotherapy (Day 7) (primary timepoint).

They are assessed again at the beginning of their second cycle of chemotherapy (Day1, Cycle 2) and the day after the completion of the second cycle of chemotherapy (Day 7, Cycle 2).

Eligibility
Key inclusion criteria
1. Participants who are planned to undergo systemic therapy for their cancer with regimen that are medium emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy.
2. Capable of giving signed informed consent.
3. Able to understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previously have had chemotherapy
2. Planned for or prior cranial radiotherapy
3. Established cognitive impairment
4. Significant baseline nausea and vomiting from cancer or other diseases such as bowel or gastric outlet obstruction
5. Pregnant at study entry
6. Known significant hearing impairment not corrected by hearing aids

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Approximately 40 participants will be screened to achieve 30 assigned to study intervention, for an estimated total of 24 evaluable participants

The proposed sample size for this feasibility trial is 30 patients with a drop-out rate of 20% to provide a final sample size of 24 participants. With the current triple combination of antiemetics, the overall complete control of both acute and delayed cancer induced nausea and vomiting over day 1-5 of each cycle is 74% for medium emetogenic chemotherapy agents while 76% for Highly emetogenic chemotherapy agents.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
1/08/2023
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 22667 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 37945 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 311744 0
Charities/Societies/Foundations
Name [1] 311744 0
Flinders Foundation
Country [1] 311744 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Flinders Foundation
Address
Flinders Dr, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 314241 0
None
Name [1] 314241 0
Address [1] 314241 0
Country [1] 314241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311188 0
South Adelaide Clinical - Reviewing Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 311188 0
Ethics committee country [1] 311188 0
Australia
Date submitted for ethics approval [1] 311188 0
15/10/2021
Approval date [1] 311188 0
20/10/2021
Ethics approval number [1] 311188 0
123.21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120262 0
Dr Ganessan Kichenadasse
Address 120262 0
Flinders Medical Centre, Flinders Centre for Innovation in Cancer

Flinders Dr, Bedford Park SA 5042
Country 120262 0
Australia
Phone 120262 0
+61 08 8204 2819
Fax 120262 0
Email 120262 0
[email protected]
Contact person for public queries
Name 120263 0
Jake Goss
Address 120263 0
Flinders Medical Centre

Flinders Dr, Bedford Park SA 5042
Country 120263 0
Australia
Phone 120263 0
+61 08 82043096
Fax 120263 0
Email 120263 0
[email protected]
Contact person for scientific queries
Name 120264 0
Jake Goss
Address 120264 0
Flinders Medical Centre

Flinders Dr, Bedford Park SA 5042
Country 120264 0
Australia
Phone 120264 0
+61 08 82043096
Fax 120264 0
Email 120264 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the published deidentified individual participant data collected during the trial will be made available on request
When will data be available (start and end dates)?
24 months after the last patient in.
5 years after publication
Available to whom?
Requesting researchers and publishing journals
Available for what types of analyses?
For any secondary analyses
How or where can data be obtained?
Contacting the principal investigator
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.