CancerNCT02583139
Designed Music Narratives for the Reduction of Side Effects of Chemotherapy in Children (7-12 Years) With Cancer
A study testing Designed Music Narratives in people with Cancer and Chemotherapy-induced Nausea and Vomiting, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether a specially-designed music-narratives are effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cancer, Chemotherapy-induced Nausea and Vomiting, Effects of Chemotherapy
- What is being tested?
- Designed Music Narratives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Dec 2018
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Previous and/or acute psychiatric diagnosis
- Cognitive and mental deficits or impaired functioning
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Lisbeth Rasmussen, +45 78 45 14 70, lisbeth.rasmussen@skejby.rm.dk
Henrik Hasle, Prof. PhD MD
About this study
Official title: The Effect and Meaning of Designed Music Narratives on Anticipatory, Acute, and Delayed Side Effect of Chemotherapy in Children (7-12 Years) With Cancer: a Randomized Controlled Multisite Study
The purpose of this study is to determine whether a specially-designed music-narratives are effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.
Read the detailed description
(Will be added later)
- Being tested
- Designed Music Narratives
- Keywords
- Children, Moderate and/or highly emetogenic chemotherapy
- Medical subject headings
- Neoplasms, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Designed Music NarrativesBehavioural
Four music narratives for children each comprising an introductory relaxation exercise, a resource-oriented narrative including guided imagery suggestions and relaxing nature scenarios plus especially composed music.
The narrative and music reflect and support each other.
| Study group | Role | What they receive |
|---|---|---|
| Music Narrative Group | Experimental | Prescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives Receives: Behavioral: Designed Music Narratives |
| Control Group | No intervention | Prescribed medical/chemotherapy treatment plus standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration (minutes) of Acute Nausea
Self-reported duration og nausea in minutes within the first 32 hours after onset of chemothera
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Secondary outcomes (13)
Intensity of Acute Nausea as measured by the Visual Analogue Scale
Self-reported intensity of nausea, calculated as the average of the two measurements
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Distress regarding Acute Nausea as measured by the Visual Analogue Scale
Self-reported distress regarding nausea, calculated as the average of the two measurements
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Amount (mg/m2) of Nausea Reducing Medicine Consumed
Measured: During admission (an expected average of 3 days) and the first three days after discharge regarding 5th cycle of chemotherapy after enrolment in study
Multiple Acute Side Effects of Chemotherapy as measured by the Memorial Symptom Assessment Scale
Self-reported side effects, calculated as the average of the two measurements. The Memorial Symptom Assessment Scale is a self-report composite measure that measures bodily and psychological symptoms of side effects
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Numbers of Acute Vomiting
Self-reported numbers of vomiting during the first 32 hours
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Duration (minutes) of Acute Pain
Self-reported duration of acute pain in minutes within the first 32 hours after onset of chemotherapy
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Acute Pain Intensity as measured by the Visual Analogue Scale
Self-reported intensity of pain, calculated as the average of the two measurements
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Number of Days to Absolute Neutrophil Count Recovery (ANCR) defined as ANCR ≥ 0.5 x 109/L
Number of days before the immune system recovers after chemotherapy. In the study, Absolute Neutrophil Count Recovery (ANCR) is defined as ANCR ≥ 0.5 x 109/L. In addition, if no nadir < 0.5 x 109/L occurs the period is 0 (zero)
Measured: Time to Event: Measured Day 1 in 5th cycle of chemotherapy after enrolment in study - until first day with ANC ≥ 0.5 x 109/L after the nadir period (an expected average of 9-15 days)
Duration (minutes) of Acute Fatigue
Self-reported duration of acute fatigue in minutes within the first 32 hours after onset of chemotherapy
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Distress of Acute Fatigue as measured by a 5-point Likert-type Scale
Self-reported Distress regarding Acute Fatigue, calculated as the average of the two measurements
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Appraised Food Intake and Appetite as measured by a 5-point Likert-type Scale
Self-reported appraised food intake, calculated as the average of the two measurements
Measured: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Weight (kg)
Measured: Change between weight from during course 1 and course 5 after inclusion in study
Satisfaction with Applied Music Intervention as measured by a Likert-type Scale (participants in music group only)
Self-report, registered once during 5th cycle of chemotherapy
Measured: Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startAug 2014
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, Børnecancerfonden, Ronald McDonalds Børnefond, TrygFonden, Denmark
- Responsible party
- Principal investigator, Ilan Sanfi, University of Aarhus
- Investigators
- Ilan Sanfi, PhD, Principal investigator, Aarhus University Hospistal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583139
- Sponsor's protocol ID
- MF-Cancer-Children-1
- Status last verified
- May 2016
- First submitted
- 3 Feb 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Meaning of Designed Music Narratives on Anticipatory, Acute, and Delayed Side Effect of Chemotherapy in Children (7-12 Years) With Cancer: a Randomized Controlled Multisite Study
- ClinicalTrials.gov ID
- NCT02583139
- Acronym / sponsor ID
- MF-Cancer-Children-1
- Keywords
- Children, Moderate and/or highly emetogenic chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Cancer Society, Børnecancerfonden, Ronald McDonalds Børnefond, TrygFonden, Denmark
- Study start
- Aug 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- 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.
The purpose of this study is to determine whether a specially-designed music-narratives are effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.
Detailed description
(Will be added later)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Narrative Group | Experimental | Behavioral: Designed Music NarrativesPrescribed medical/chemotherapy treatment plus standard care + Designed Music Narratives |
| Control Group | No intervention | –Prescribed medical/chemotherapy treatment plus standard care |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Previous and/or acute psychiatric diagnosis
- Cognitive and mental deficits or impaired functioning
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 |
|---|---|---|
| Designed Music NarrativesFour music narratives for children each comprising an introductory relaxation exercise, a resource-oriented narrative including guided imagery suggestions and relaxing nature scenarios plus especially composed music. The narrative and music reflect and support each other. | Behavioural | Music Narrative Group |
Primary outcome
Duration (minutes) of Acute Nausea
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Self-reported duration og nausea in minutes within the first 32 hours after onset of chemothera
13 secondary outcomes
Intensity of Acute Nausea as measured by the Visual Analogue Scale
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Distress regarding Acute Nausea as measured by the Visual Analogue Scale
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Amount (mg/m2) of Nausea Reducing Medicine Consumed
Time frame: During admission (an expected average of 3 days) and the first three days after discharge regarding 5th cycle of chemotherapy after enrolment in study
Multiple Acute Side Effects of Chemotherapy as measured by the Memorial Symptom Assessment Scale
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Numbers of Acute Vomiting
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Duration (minutes) of Acute Pain
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Acute Pain Intensity as measured by the Visual Analogue Scale
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Number of Days to Absolute Neutrophil Count Recovery (ANCR) defined as ANCR ≥ 0.5 x 109/L
Time frame: Time to Event: Measured Day 1 in 5th cycle of chemotherapy after enrolment in study - until first day with ANC ≥ 0.5 x 109/L after the nadir period (an expected average of 9-15 days)
Duration (minutes) of Acute Fatigue
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Distress of Acute Fatigue as measured by a 5-point Likert-type Scale
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Appraised Food Intake and Appetite as measured by a 5-point Likert-type Scale
Time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study
Weight (kg)
Time frame: Change between weight from during course 1 and course 5 after inclusion in study
Satisfaction with Applied Music Intervention as measured by a Likert-type Scale (participants in music group only)
Time frame: Last day (i.e. expected 3rd or 4th day) of 5th cycle of chemotherapy after enrolment in study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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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.
Ilan Sanfi, PhD principal investigator
Aarhus University Hospistal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Designed Music Narratives in people with Cancer and Chemotherapy-induced Nausea and Vomiting, run by University of Aarhus at 1 site in Denmark.
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 0 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 May 2016. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Sanfi, PhD (+4522973661, ilan@sanfi.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration (minutes) of Acute Nausea (time frame: Registered the two first evenings within the first 32 hours after onset of chemotherapy during 5th cycle of chemotherapy after enrolment in study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2016.