The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children
NCT ID: NCT04678947
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
6 participants
INTERVENTIONAL
2021-03-17
2021-03-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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).
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
4 Years
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amy Armstrong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202012147
Identifier Type: -
Identifier Source: org_study_id