Caregiver BurdenNCT05616572
Online Educational Tool for Caregivers of Pediatric Oncology Patients
A study testing OncoWhiz in people with Caregiver Burden and Care Giving Burden, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden, Care Giving Burden, Pediatric Cancer
- What is being tested?
- OncoWhiz
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2022to 23 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Caregiver Burden, Care Giving Burden, Pediatric Cancer
- Being tested
- OncoWhiz
- Keywords
- caregiver, pediatric oncology
- Medical subject headings
- Caregiver Burden, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoWhizBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: OncoWhiz |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: Prior to OncoWhiz and after OncoWhiz (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start29 Nov 2022
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Fields, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616572
- Sponsor's protocol ID
- 202207059
- Status last verified
- Jun 2023
- First submitted
- 2 Nov 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlies the published results will be available after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Educational Tool to Increase Knowledge and Decrease Anxiety in Caregivers of Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT05616572
- Acronym / sponsor ID
- 202207059
- Conditions
- Caregiver Burden, Care Giving Burden, Pediatric Cancer
- Keywords
- caregiver, pediatric oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver | Experimental | Behavioral: OncoWhizAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncoWhizOncoWhiz 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. | Behavioural | Caregiver |
Primary outcome
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)
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)
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)
2 secondary outcomes
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.
Time frame: 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.
Time frame: Prior to OncoWhiz and after OncoWhiz (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlies the published results will be available after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Fields, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OncoWhiz in people with Caregiver Burden and Care Giving Burden, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.