Online Educational Tool for Caregivers of Pediatric Oncology Patients

Online Educational Tool to Increase Knowledge and Decrease Anxiety in Caregivers of Pediatric Oncology Patients

The goal of this study is to assess the feasibility of using a game-based tool for caregivers of pediatric oncology patients to increase caregiver knowledge about supportive care for oncology patients while simultaneously reducing caregiver anxiety.

Study Overview

• Status: Completed
• Conditions: Caregiver Burden; Pediatric Cancer; Care Giving Burden
• Intervention / Treatment: Behavioral: OncoWhiz

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melanie Fields, M.D.; Phone Number: 314-286-0344; Email: fields_m@wustl.edu
• Study Contact Backup: Name: Shilpa Rampey Venkata Naga, M.D.; Phone Number: 973-954-6149; Email: rshilpa@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Caregiver of a pediatric cancer patient who was recently diagnosed with cancer, including all pediatric malignancies. Multiple caregivers can be enrolled. Caregiver is defined as a person who is responsible for the direct care, protection, and supervision of the pediatric cancer patient. In this context, a caregiver is not required to be the parent or legal guardian.

• Caregivers must have completed oncology nursing education either in the inpatient or outpatient setting.

  • Inpatient setting: Before discharge from hospital after nursing education
  • Outpatient setting: Within 15 days of discharge from the inpatient setting after nursing education or within 21 days of nursing education if diagnosis made in the outpatient setting

Exclusion Criteria:

• If less than 18 years of age
• Unable to utilize the electronic tool, complete the pre/post questionnaires and anxiety scale due to reading abilities, intellectual or physical disabilities.
• Cared for another child with cancer or secondary diagnosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caregiver; After consent, the study visit will occur. The study visit will consist of a brief set of demographic questions and a pre-game play knowledge assessment and anxiety assessment, followed by completion of the OncoWhiz game. Immediately after utilizing OncoWhiz, the participant will complete a knowledge assessment and anxiety assessment, in addition to a satisfaction survey.	Behavioral: OncoWhiz; OncoWhiz is an online educational tool designed to supplement current institutional caregiver education. OncoWhiz requires low graphical demands, has no-end user downloads, and is compatible with both desktop and mobile phones. Questions are derived from the institutional binder and are written at a fifth-grade reading level for user accessibility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility of using game-based tool to augment oncological education in caregivers of children newly diagnosed with cancer as measured by percentage of caregivers that enroll and complete study visit.	Through completion of study visit (Day 1) for all participants (estimated to be 1 year)
Feasibility of using game-based tool to augment oncological education in caregivers of children newly diagnosed with cancer as measured by the average time to completion of the educational tool.	Through completion of study visit (Day 1) for all participants (estimated to be 1 year)
Feasibility of using game-based tool to augment oncological education in caregivers of children newly diagnosed with cancer as measured by average time to complete the study visit.	Through completion of study visit (Day 1) for all participants (estimated to be 1 year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the impact of a game-based tool in decreasing anxiety of caregivers of children newly diagnosed with cancer as measured by change in anxiety.	Anxiety will be quantified by the State-Trait Anxiety Inventory (STAI) Form. Participants will answer 40 questions regarding how they generally feel. There are 2 subscales within this assessment, both consisting of 20 separate items on a 4-point scale. The State Anxiety Scale (Y-1) evaluates the current state of anxiety while the Trait Anxiety Scale (Y-2) evaluates anxiety-proneness as a personality trait. A higher score indicates greater anxiety.	Prior to OncoWhiz and after OncoWhiz (Day 1)
Determine the impact of a game-based tool in increasing knowledge of caregivers of children newly diagnosed with cancer as measure by change in knowledge.	The knowledge assessment consists of 20 multiple choice questions related to caregiving for children with cancer. The percentage of questions answered correctly before and after utilization of the tool will be compared.	Prior to OncoWhiz and after OncoWhiz (Day 1)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Melanie Fields, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: caregiver; pediatric oncology
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 202207059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlies the published results will be available after deidentification.
• IPD Sharing Time Frame: The shared data will be available 6 months after publication, ending 36 months after article publication.
• IPD Sharing Access Criteria: These data will be available to researchers that provide a methodologically sound proposal. The data will be available to achieve the aims of the approved proposal. Proposals should be directed to fields_m@wustl.edu.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No