Evaluation of an Interactive E-learning Environment to Enhance Digital Health Literacy in Cancer Patients
NCT ID: NCT07200453
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
660 participants
INTERVENTIONAL
2025-01-16
2025-10-01
Brief Summary
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• Do people with cancer who use the online learning tool improve their skills more than those who don't use the tool?
The investigators will test this idea in a study. The investigators will put people into different groups by chance and compare the results. 660 people with cancer will participate. These people will be chosen to represent different types of cancer.
* Group 1: Uses the online learning too (3 versions)
* Group 2: Uses a PDF with the same information
* Control Group: Receives no intervention
What Participants Will Do:
Use the online tool or PDF to learn how to find reliable cancer information online.
Answer questions about their digital health skills before starting, after 2 weeks, and after 8 weeks.
Development:
Before the start of the main study the online tool will be developed and tested. The investigators will first show a prototype of the tool to two discussion groups and use their feedback to improve it. Then, experts and people with cancer will test the final version
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Detailed Description
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Objective: An interactive e-learning environment to promote digital health literacy will be developed and evaluated for effectiveness. The primary hypothesis is: Cancer patients who use the e-learning environment (IG1.1-IG1.3) or the content of the environment as a non-interactive PDF file (IG2) will show greater improvement in their digital health literacy from baseline to eight weeks after baseline compared to patients who do not receive such an intervention.
Methods: The hypothesis will be tested in a randomized controlled trial (RCT). In the e-learning environment, patients will learn strategies (e.g., checking information on different websites) to use when searching for reliable cancer-related online information. During the development, a prototype will be presented to two focus groups. The results of the focus groups will be implemented in a final prototype. The usability of this prototype will then be tested by usability experts and patients. 660 cancer patients will be recruited and randomly assigned in a 3:1:1 ratio to IG1.1-IG1.3 (three variants of the environment), IG2 (a PDF containing the same content as the environment), or the control group. Two thirds of the 660 participants will be recruited through the German Cancer Information Service (CIS) and one third will be recruited through non-CIS routes. A proportionally stratified sample will be drawn according to the cancer incidence. The primary outcome, digital health literacy, will be measured at baseline, two weeks, and eight weeks after baseline.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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e-learning - intervention group 1.1
Participants in intervention group 1.1 will be given access to an e-learning environment with all the persuasive primary task support elements (reduction, tunneling, rehearsal). Participants can complete the e-learning within 2 weeks. The e-learning program takes approximately 20-45 minutes to complete.
intervention group 1.1 - e-learning
The e-learning environment will include text, images, and short videos created using Articulate Rise 360, an easy-to-use e-learning authoring tool, with the following content to improve the different skills of digital health literacy:
1. Evaluating reliability skills: Participants will get to know criteria and indicators for evaluating the content of the information they find and for assessing the trustworthiness of website providers.
2. Improving information skills: Participants will learn simple rules on how to optimize their Google searches.
3. Improving navigation skills: Participants will learn simple rules for navigation; using the back button; using more than one tab; drop-down lists and anchor links are introduced.
4. Additional goals are to raise awareness about various aspects related to online searches, including the exploration of alternative and complementary therapies, and the importance of data protection.
e-learning - intervention-group 1.2
Participants in intervention group 1.2 are given access to the same e-learning environment without the persuasive primary task support element, tunneling. Tunneling means that the educational content is organized step by step in separate chapters of the program. Participants can complete the e-learning within 2 weeks. The e-learning program takes approximately 20-45 minutes to complete.
intervention-group 1.2 - e-learning
Participants are also given access to the e-learning environment. However, they will not be taken step-by-step through the content (tunneling). They can choose the order of the content.
e-learning - intervention-group 1.3
Participants in intervention group 1.3 are given access to the same e-learning environment without the persuasive primary task support element, rehearsal. All rehearsal elements such as quizzes will be removed from the e-learning environment. Participants can complete the e-learning within 2 weeks. The e-learning program takes approximately 20-45 minutes to complete.
intervention-group 1.3 - e-learning
Participants are also given access to the e-learning environment, but all rehearsal elements such as quizzes will be removed from the e-learning environment.
PDF document - intervention-group 2
This intervention group is given access to a PDF document with the same content as in the e-learning environment. Participants can complete the website content within 2 weeks. The PDF document takes approximately 20-45 minutes to complete.
intervention-group 2 - PDF
Participants in IG2 will receive the same content as participants in the IG1.1, but not within the interactive learning environment, but in a non-interactive PDF format.
No Intervention/ treatment as usual
The last group (treatment as usual) receives no intervention. However, they are sent a brochure that has nothing to do with digital health literacy.
No interventions assigned to this group
Interventions
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intervention group 1.1 - e-learning
The e-learning environment will include text, images, and short videos created using Articulate Rise 360, an easy-to-use e-learning authoring tool, with the following content to improve the different skills of digital health literacy:
1. Evaluating reliability skills: Participants will get to know criteria and indicators for evaluating the content of the information they find and for assessing the trustworthiness of website providers.
2. Improving information skills: Participants will learn simple rules on how to optimize their Google searches.
3. Improving navigation skills: Participants will learn simple rules for navigation; using the back button; using more than one tab; drop-down lists and anchor links are introduced.
4. Additional goals are to raise awareness about various aspects related to online searches, including the exploration of alternative and complementary therapies, and the importance of data protection.
intervention-group 1.2 - e-learning
Participants are also given access to the e-learning environment. However, they will not be taken step-by-step through the content (tunneling). They can choose the order of the content.
intervention-group 1.3 - e-learning
Participants are also given access to the e-learning environment, but all rehearsal elements such as quizzes will be removed from the e-learning environment.
intervention-group 2 - PDF
Participants in IG2 will receive the same content as participants in the IG1.1, but not within the interactive learning environment, but in a non-interactive PDF format.
Eligibility Criteria
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Inclusion Criteria
* sufficient knowledge of the German language as all study content and questionnaires will be in German only
* Participants must also have and be able to use a digital device (smartphone, tablet, PC, laptop, etc.) with an internet connection
* Confirm consent to participate in the study
Exclusion Criteria
* Patients who are unable to operate a digital device
18 Years
ALL
No
Sponsors
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German Cancer Research Center
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Holger Schulz, Prof.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Susanne Weg-Remers, Dr.
Role: PRINCIPAL_INVESTIGATOR
German Cancer Research Center
Locations
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University Medical Center Hamburg-Eppendorf
Hamburg, City state of Hamburg, Germany
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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S-158/2024
Identifier Type: -
Identifier Source: org_study_id
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