Digital Training Module for Sustainable Education of Pediatric Oncology Nurses

August 16, 2024 updated by: Eysan Hanzade Umac, Koç University

Development of a Digital Training Module for Sustainable Education of Pediatric Oncology Nurses and Evaluation of Its Effectiveness

Pediatric oncology nurses are healthcare professionals who constantly communicate with children and their families for 24 hours, and take professional roles and responsibilities in areas such as care planning, a continuation of treatment, and symptom management.However, there is no standard undergraduate education program accepted worldwide in the field of pediatric oncology nursing. For example, undergraduate nursing education in Türkiye is carried out in line with the Nursing National Core Education Program (NNCEP), and information about pediatric oncology nursing is included in the curriculum of specific courses in undergraduate programs. In addition, nurses graduate without specializing in any field in our country. Therefore, the education of pediatric oncology nurses and the continuity of education is an essential problem in developing and low-middle-income countries like our country. This prospective study in randomized controlled pre-test-post-test design aimed to develop an online website consisting of information and support modules for the care of children with cancer for sustainable pediatric oncology nursing education in Türkiye.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In developed countries, there are various programs for pediatric oncology nurses to improve the quality of nursing care. Unfortunately, the inadequacy of these education programs in developing countries may prevent childhood cancer patients from receiving advanced care but may cause health inequalities. For this reason, it is very important to strengthen pediatric oncology nurses in terms of education and to develop platforms that will provide education continuity in low and middle-income countries. Today, one of the methods used to ensure the continuity and easy accessibility of education is digital education programs. Web-based education programs can increase nurses' knowledge and competence in related care issues. In studies, nurses state that planned educations were beneficial and increased their knowledge level. An accessible and sustainable web-based standard education program will enable nurses to become more competent in pediatric oncology and increase the quality of care. In Türkiye, which is a middle-income country, there is no standard curriculum for pediatric oncology nurses. Although pediatric oncology nursing is partially included in the oncology nursing certification program by the Oncology Nursing Association, we could say that it is insufficient to meet nurses' sustainability and educational needs. Therefore, there is a need for a digital website consisting of information and support modules to care for children with cancers for sustainable pediatric oncology nursing education in Türkiye.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Koc University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteer to participate in the research,
  • Working in a pediatric oncology clinic,
  • Having at least one year of experience in pediatric oncology.

Exclusion Criteria:

  • Lack of Internet literacy,
  • Incomplete filling of data collection forms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control-Standard care
No intervention will be performed on the nurses in this group. After the research is completed, access to the website will be provided to the nurses in the control group.
Experimental: Intervention Group
The group will use the digital training modules developed for sustainable pediatric oncology nursing education for six months.
Other: Digital training module
The intervention is a 24/7 accessible educational website for pediatric oncology nurses, based on the EONS Cancer Nursing Education Framework. It features five validated training modules, enhanced with visual and auditory materials such as videos and infographics. Nurses will receive login credentials, allowing them to access the platform and participate in the training. Each module ends with a 20-question test, requiring a score of 60 to advance. A support line enables nurses to ask questions directly to researchers. Successful completion of each module earns a certificate. The website will be piloted with 15 nurses, and feedback will be used to refine its design and content.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pediatric Oncology Nurses' Educational Needs Scale
Time Frame: It will be applied to nurses in the experimental and control groups before (1 week before) and after (immediately after and 6 months later) the intervention.
The scale consists of five sub-dimensions: disease, chemotherapy, and its side effects, other treatments and their side effects, palliative care, and supportive care. From the scale, a minimum of 42 points and a maximum of 210 points can be obtained. The increase in the total score of the scale and the mean score of the sub-dimensions indicate that the education needs of the nurses regarding that sub-dimension have increased.
It will be applied to nurses in the experimental and control groups before (1 week before) and after (immediately after and 6 months later) the intervention.
Knowledge Levels of Pediatric Oncology Nurses on Childhood Cancers and Care
Time Frame: It will be applied to nurses in the experimental and control groups before (1 week before) and after (immediately after and 6 months later) the intervention.
To evaluate the knowledge levels of pediatric oncology nurses on childhood cancers and care, test questions will be created by the digital education modules.
It will be applied to nurses in the experimental and control groups before (1 week before) and after (immediately after and 6 months later) the intervention.
Ateşman Readability Index
Time Frame: The data collection process will begin one day after the digital booklet is created.
To determine the readability level of the digital training booklet, the Ateşman Readability Index will be used.
The data collection process will begin one day after the digital booklet is created.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Koç University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Eyşan Hanzade Savaş, PhD, Koc University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KOCUNI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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