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

U

Universitätsklinikum Hamburg-Eppendorf

Status

Enrolling

Conditions

Neoplasms

Treatments

Behavioral: intervention group 1.1 - e-learning
Behavioral: intervention-group 2 - PDF
Behavioral: intervention-group 1.3 - e-learning
Behavioral: intervention-group 1.2 - e-learning

Study type

Interventional

Funder types

Other

Identifiers

NCT07200453
S-158/2024

Details and patient eligibility

About

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

Full 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.

Enrollment

660 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

660 participants in 5 patient groups

e-learning - intervention group 1.1
Experimental group
Description:
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.
Treatment:
Behavioral: intervention group 1.1 - e-learning
e-learning - intervention-group 1.2
Experimental group
Description:
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.
Treatment:
Behavioral: intervention-group 1.2 - e-learning
e-learning - intervention-group 1.3
Experimental group
Description:
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.
Treatment:
Behavioral: intervention-group 1.3 - e-learning
PDF document - intervention-group 2
Active Comparator group
Description:
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.
Treatment:
Behavioral: intervention-group 2 - PDF
No Intervention/ treatment as usual
No Intervention group
Description:
The last group (treatment as usual) receives no intervention. However, they are sent a brochure that has nothing to do with digital health literacy.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Lukas Lange-Drenth, Dr.

Data sourced from clinicaltrials.gov

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