NCT07200453

Evaluation of an Interactive E-learning Environment to Enhance Digital Health Literacy in Cancer Patients

Development and Effectiveness Evaluation of an Interactive E-learning Environment to Enhance Digital Health Literacy in Cancer Patients: Study Protocol for a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to create and test an online learning tool to help people with cancer improve their skills in finding and understanding health information online. The main question it aims to answer is: • 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

Detailed description

Background: The Internet allows cancer patients to access information about their disease at any time. However, the quality of online information varies widely. Information is often inaccurate or does not provide all the details patients need to make informed decisions. Patients' often inadequate ability to find and critically evaluate cancer-related information online can lead to misinformation. 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

• Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-01-16
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2025-10-01
• Last updated: 2025-10-01

Locations

1 site across 1 country: Germany