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The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children

Primary Purpose

Nausea

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baxter Retching Faces (BARF) scale
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Nausea

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BARF scale

No intervention

Arm Description

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

-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.

Outcomes

Primary Outcome Measures

Doses of anti-emetic medication administered during inpatient chemotherapy admissions

Secondary Outcome Measures

Full Information

First Posted
December 16, 2020
Last Updated
November 9, 2021
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04678947
Brief Title
The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children
Official Title
The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Original investigator left the university
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
March 25, 2021 (Actual)
Study Completion Date
March 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BARF scale
Arm Type
Experimental
Arm Description
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
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
-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.
Intervention Type
Behavioral
Intervention Name(s)
Baxter Retching Faces (BARF) scale
Intervention Description
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).
Primary Outcome Measure Information:
Title
Doses of anti-emetic medication administered during inpatient chemotherapy admissions
Time Frame
24 hours - 7 days (estimated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Armstrong, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children

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