Back to resultsOnline Educational Tool for Caregivers of Pediatric Oncology Patients
Primary Purpose
Caregiver Burden, Care Giving Burden, Pediatric Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OncoWhiz
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burden focused on measuring caregiver, pediatric oncology
Eligibility Criteria
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Caregiver
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05616572
First Posted
November 2, 2022
Last Updated
June 13, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05616572
Brief Title
Online Educational Tool for Caregivers of Pediatric Oncology Patients
Official Title
Online Educational Tool to Increase Knowledge and Decrease Anxiety in Caregivers of Pediatric Oncology Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
May 23, 2023 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Care Giving Burden, Pediatric Cancer
Keywords
caregiver, pediatric oncology
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caregiver
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
OncoWhiz
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
Through completion of study visit (Day 1) for all participants (estimated to be 1 year)
Title
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.
Time Frame
Through completion of study visit (Day 1) for all participants (estimated to be 1 year)
Title
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.
Time Frame
Through completion of study visit (Day 1) for all participants (estimated to be 1 year)
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Prior to OncoWhiz and after OncoWhiz (Day 1)
Title
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.
Description
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.
Time Frame
Prior to OncoWhiz and after OncoWhiz (Day 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Fields, 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
Yes
IPD Sharing 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.
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
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Online Educational Tool for Caregivers of Pediatric Oncology Patients
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