NCT Number: NCT07200453
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany
Location status: Recruiting
Holger Schulz, Prof
CONTACT
Lukas Lange-Drenth, Dr.
CONTACT
Lukas Lange-Drenth, Dr.
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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.
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.
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.
Time frame: The questionnaire will be administered at baseline (TO), follow-up at 2 weeks (T1), and follow-up at 8 weeks (T8).
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.
Time frame: The questionnaire will be administered at baseline (TO), follow-up at 2 weeks (T1), and follow-up at 8 weeks (T8).
The digital health literacy of the participants will also be measured using six performance-based items of the DHLI - one item each for the sub-skills: operational skills, navigation skills, evaluating reliability, information searching, determining relevance and protecting privacy. Responses will be coded as correct (score=1) or incorrect (score=0) and then the scores of all six items will be added together to form a total score.
Time frame: The questionnaire will be administered at follow-up at 2 weeks (T1).
The RIMMS is a 4-dimensional (attention, relevance, confidence, satisfaction), 12-item short version of the "Instructional Materials Motivation Survey". The items will be rated by the participants on a 5-point scale from 1="strongly disagree" to 5="strongly agree". The resulting mean value across all 12 items will be used for the overall assessment of motivation.
Time frame: The questionnaire will be administered at follow-up at 2 weeks (T1).
The AIM contains 4 items that will be rated by the participants on a 5-point scale from 1 = "disagree" to 5 = "agree". Acceptability will be reported as the mean value of the four items, with a higher score indicating greater acceptance.
Time frame: The questionnaire will be administered at follow-up at 2 weeks (T1).
The IAM contains 4 items that will be rated by the participants on a 5-point scale from 1 = "disagree" to 5 = "agree". Appropriateness is presented as the mean value of the four items, with a higher score indicating greater appropriateness.
Time frame: The questionnaire will be administered at follow-up at 2 weeks (T1).
The FIM contains 4 items that will be rated by the participants a 5-point scale from 1 = "disagree" to 5 = "agree". Feasibility is presented as the mean value of the four items, with a higher score indicating greater feasibility.
Contact information is provided by the study sponsor or research team.
Universitätsklinikum Hamburg-Eppendorf
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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