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

NCT07200453 | Recruiting

• 1 other identifier: S-158/2024
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neoplasms

Keywords

digital health; eHealth; health literacy; eHealth literacy; health information; e-learning; medical education; digital health literacy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the patient-reported digital health literacy measured by the Digital health literacy Instrument (DHLI) at 8 weeks

  The primary outcome is the patient-reported digital health literacy based on the German version of the Digital health literacy Instrument (DHLI), resulting from the mean of the 21 items included. All 21 items are answered on a four-point scale (1="very difficult" to 4="very easy" and from 1="never" to 4="often"). A higher mean score indicates higher digital health literacy.

  The questionnaire will be administered at baseline (TO), follow-up at 2 weeks (T1), and follow-up at 8 weeks (T8).

Secondary Outcomes (5)

• Digital health literacy measured with the performance-based items of the DHLI

  The questionnaire will be administered at baseline (TO), follow-up at 2 weeks (T1), and follow-up at 8 weeks (T8).

• Participants' motivation to use the e-learning environment measured with the Reduced Instructional Materials Motivation (RIMMS)

  The questionnaire will be administered at follow-up at 2 weeks (T1).

• Acceptability of the e-learning environment as measured by the Acceptability of Intervention Measure (AIM) questionnaire.

  The questionnaire will be administered at follow-up at 2 weeks (T1).

• Appropriateness of the e-learning environment as measured by the Intervention Appropriateness Measure (IAM) questionnaire.

  The questionnaire will be administered at follow-up at 2 weeks (T1).

• Feasibility of the e-learning environment as measured by the Feasibility of Intervention Measure (FIM) questionnaire.

  The questionnaire will be administered at follow-up at 2 weeks (T1).

Study Arms (5)

e-learning - intervention group 1.1

EXPERIMENTAL

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.

Behavioral: intervention group 1.1 - e-learning

e-learning - intervention-group 1.2

EXPERIMENTAL

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.

Behavioral: intervention-group 1.2 - e-learning

e-learning - intervention-group 1.3

EXPERIMENTAL

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.

Behavioral: intervention-group 1.3 - e-learning

PDF document - intervention-group 2

ACTIVE COMPARATOR

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.

Behavioral: intervention-group 2 - PDF

No Intervention/ treatment as usual

NO INTERVENTION

The last group (treatment as usual) receives no intervention. However, they are sent a brochure that has nothing to do with digital health literacy.

Interventions

intervention group 1.1 - e-learning BEHAVIORAL

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 1.1

intervention-group 1.2 - e-learning BEHAVIORAL

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 1.2

intervention-group 1.3 - e-learning BEHAVIORAL

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.

e-learning - intervention-group 1.3

intervention-group 2 - PDF BEHAVIORAL

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.

PDF document - intervention-group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cancer diagnosis
• 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

You may not qualify if:

• Patients who are severely cognitively impaired due to their cancer or other illness
• Patients who are unable to operate a digital device

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• German Cancer Research Center: collaborator

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Holger Schulz, Prof.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Susanne Weg-Remers, Dr.

  German Cancer Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Lange-Drenth, Dr.

CONTACT

+49 (0) 40 7410-56811; lu.lange@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will be maintained throughout the duration of the study to increase the objectivity of the results and to minimize the influence of participants' expectations on the study results. Participants in the control group will not receive any intervention and will be referred to the CIS brochure "Your journey through cancer", which will not include any information on how to search for cancer-related information online. In the dataset and in REDCap, the 5 randomization groups are referred to as groups A, B, C, D and E, so that it is not clear to the research staff evaluating the data which intervention the patients received.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial is designed as a randomized controlled superiority trial with five parallel groups and a primary endpoint of digital health literacy. The study also includes intervention development and pre-testing. Randomization will be performed as a proportionally stratified randomization with variable block length and 1:1:1:1:1 allocation.

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: October 1, 2025
• Study Start: January 16, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: The data will be available a few days before the study results are released.
• Access Criteria: Figshare uses Creative Commons licenses, which give other researchers the right to use and build upon a dataset.

Locations

DE (1)