NauseaNCT04678947
The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children
A study testing Baxter Retching Faces (BARF) scale in people with Nausea, run by Washington University School of Medicine at 1 site in United States.
Trial summary
In this pilot study, the Baxter Retching Faces (BARF) Scale will be used to assess chemotherapy induced nausea and vomiting (CINV) in the pediatric cancer population during chemotherapy admissions, and the corresponding administration of anti-emetic medications will be reviewed. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Nausea
- What is being tested?
- Baxter Retching Faces (BARF) scale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2021to 25 Mar 2021
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients diagnosed with cancer of any kind.
- Patients receiving inpatient chemotherapy at SLCH on the general pediatric oncology service
- Patients admitted for a course of inpatient chemotherapy scheduled to last at least 24 hours and but no more than 7 days.
- Patients who have received any prior cancer treatment, including radiation therapy, and/or surgery.
- Patients ages 4 to 12 years of age.
- Patient with a guardian who has the ability to understand English and the willingness to sign an IRB approved written informed consent document.
Who cannot join
- Any patient who is not undergoing inpatient chemotherapy on the general pediatric oncology service, including patients undergoing chemotherapy as conditioning for hematopoietic stem cell transplantation or other cellular therapy.
- Any patient who is receiving their first cycle of inpatient chemotherapy (however, they can be included during a future cycle).
- Any patient who is blind or unable to communicate by speaking or pointing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
In this pilot study, the Baxter Retching Faces (BARF) Scale will be used to assess chemotherapy induced nausea and vomiting (CINV) in the pediatric cancer population during chemotherapy admissions, and the corresponding administration of anti-emetic medications will be reviewed.
- Conditions
- Nausea
- Being tested
- Baxter Retching Faces (BARF) scale
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baxter Retching Faces (BARF) scaleBehavioural
- Pictorial scale that was developed for use by pediatric patients in self-reported assessments of nausea severity
- A patient will respond by choosing a picture or a number on the scale that best represents how they feel. The patient may speak or simply point to their response. While the numbers 0-2-4-6-8-10 are listed alongside the pictures, patients are also allowed to choose "in between" or odd numbers. If a patient is unwilling to participate, the patient's parent or guardian may serve as their proxy and choose a number for them, based off of their symptoms.
- The BARF scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea).
| Study group | Role | What they receive |
|---|---|---|
| BARF scale | Experimental | * Nursing staff (which may include patient technicians and nursing assistants) will use the scale to assess the patient's nausea for the entire duration of the admission. These assessments will take place in conjunction with vital sign monitoring, every 4 hours. The associated script will be read while the laminated scale is shown to the patient.
* The nurse will then log the patient's response in the patient's electronic medical record Receives: Behavioral: Baxter Retching Faces (BARF) scale |
| No intervention | No intervention | -Patients in the control group will proceed with their inpatient chemotherapy admissions without any interventions. These admissions will take place prior to the admissions of the experimental group, so as not to bias providers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doses of anti-emetic medication administered during inpatient chemotherapy admissions
Measured: 24 hours - 7 days (estimated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start17 Mar 2021
- Primary completion25 Mar 2021
- Study completion25 Mar 2021
Why it stopped: Original investigator left the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Armstrong, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678947
- Sponsor's protocol ID
- 202012147
- Status last verified
- Nov 2021
- First submitted
- 16 Dec 2020
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children
- ClinicalTrials.gov ID
- NCT04678947
- Acronym / sponsor ID
- 202012147
- Conditions
- Nausea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original investigator left the university
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 22 Dec 2020 (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.
In this pilot study, the Baxter Retching Faces (BARF) Scale will be used to assess chemotherapy induced nausea and vomiting (CINV) in the pediatric cancer population during chemotherapy admissions, and the corresponding administration of anti-emetic medications will be reviewed.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BARF scale | Experimental | Behavioral: Baxter Retching Faces (BARF) scale* Nursing staff (which may include patient technicians and nursing assistants) will use the scale to assess the patient's nausea for the entire duration of the admission. These assessments will take place in conjunction with vital sign monitoring, every 4 hours. The associated script will be read while the laminated scale is shown to the patient. * The nurse will then log the patient's response in the patient's electronic medical record |
| No intervention | No intervention | –-Patients in the control group will proceed with their inpatient chemotherapy admissions without any interventions. These admissions will take place prior to the admissions of the experimental group, so as not to bias providers. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients diagnosed with cancer of any kind.
- Patients receiving inpatient chemotherapy at SLCH on the general pediatric oncology service
- Patients admitted for a course of inpatient chemotherapy scheduled to last at least 24 hours and but no more than 7 days.
- Patients who have received any prior cancer treatment, including radiation therapy, and/or surgery.
- Patients ages 4 to 12 years of age.
Key exclusion criteria (3 listed)
- Any patient who is not undergoing inpatient chemotherapy on the general pediatric oncology service, including patients undergoing chemotherapy as conditioning for hematopoietic stem cell transplantation or other cellular therapy.
- Any patient who is receiving their first cycle of inpatient chemotherapy (however, they can be included during a future cycle).
- Any patient who is blind or unable to communicate by speaking or pointing.
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 |
|---|---|---|
| Baxter Retching Faces (BARF) scale* Pictorial scale that was developed for use by pediatric patients in self-reported assessments of nausea severity * A patient will respond by choosing a picture or a number on the scale that best represents how they feel. The patient may speak or simply point to their response. While the numbers 0-2-4-6-8-10 are listed alongside the pictures, patients are also allowed to choose "in between" or odd numbers. If a patient is unwilling to participate, the patient's parent or guardian may serve as their proxy and choose a number for them, based off of their symptoms. * The BARF scale has 6 faces with assigned scores ranging from 0 to 10 with a score difference of 2 between each face (a higher score indicates more nausea). | Behavioural | BARF scale |
Primary outcome
Doses of anti-emetic medication administered during inpatient chemotherapy admissions
Time frame: 24 hours - 7 days (estimated)
Results and safety
The study was stopped early (reason given: Original investigator left the university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Amy Armstrong, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baxter Retching Faces (BARF) scale in people with Nausea, run by Washington University School of Medicine 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 17 Nov 2021. 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 was stopped early (reason given: Original investigator left the university). Results are not available in the source record.
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?
Doses of anti-emetic medication administered during inpatient chemotherapy admissions (time frame: 24 hours - 7 days (estimated)). 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 17 Nov 2021.