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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04678947
• Other study ID #: 202012147
• Status: Terminated
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: March 25, 2021

Study information

• Verified date: November 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: March 25, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Doses of anti-emetic medication administered during inpatient chemotherapy admissions		24 hours - 7 days (estimated)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine