NCT05616572

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

November 29, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

November 2, 2022

Last Update Submit

June 13, 2023

Conditions

Keywords

caregiverpediatric oncology

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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.

    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.

    Prior to OncoWhiz and after OncoWhiz (Day 1)

Study Arms (1)

Caregiver

EXPERIMENTAL

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

Interventions

OncoWhizBEHAVIORAL

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.

Caregiver

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Caregiver BurdenNeoplasms

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Melanie Fields, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 15, 2022

Study Start

November 29, 2022

Primary Completion

May 23, 2023

Study Completion

May 23, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Individual participant data that underlies the published results will be available after deidentification.

Time Frame
The shared data will be available 6 months after publication, ending 36 months after article publication.
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.

Locations