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

NCT04678947 | Terminated

• 1 other identifier: 202012147
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea

Outcome Measures

Primary Outcomes (1)

• Doses of anti-emetic medication administered during inpatient chemotherapy admissions

  24 hours - 7 days (estimated)

Study Arms (2)

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

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.

Interventions

Baxter Retching Faces (BARF) scale BEHAVIORAL

* 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).

BARF scale

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Nausea

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Amy Armstrong, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: March 17, 2021
• Primary Completion: March 25, 2021
• Study Completion: March 25, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)