NeoplasmsNCT07200453
Evaluation of an Interactive E-learning Environment to Enhance Digital Health Literacy in Cancer Patients
A study testing intervention group 1.1 - e-learning, intervention-group 1.2 - e-learning and intervention-group 1.3 - e-learning in people with Neoplasms, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- intervention group 1.1 - e-learning, intervention-group 1.2 - e-learning and intervention-group 1.3 - e-learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteGermany
- Study dates
- 16 Jan 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who are severely cognitively impaired due to their cancer or other illness
- Patients who are unable to operate a digital device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Holger Schulz, Prof, +49 (0) 40 7410 - 56806, schulz@uke.de
Lukas Lange-Drenth, Dr., +49 (0) 40 7410 - 56811, lu.lange@uke.de
About this study
Official title: 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
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?
Read more
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
Read the 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
- Being tested
- intervention group 1.1 - e-learning, intervention-group 1.2 - e-learning, intervention-group 1.3 - e-learning, intervention-group 2 - PDF
- Keywords
- digital health, eHealth, health literacy, eHealth literacy, health information, e-learning, medical education, digital health literacy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention group 1.1 - e-learningBehavioural
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:
- 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.
- Improving information skills: Participants will learn simple rules on how to optimize their Google searches.
- 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.
- 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-learningBehavioural
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-learningBehavioural
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 - PDFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: The questionnaire will be administered at follow-up at 2 weeks (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start16 Jan 2025
- Primary completion1 Sep 2025
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Research Center
- Responsible party
- Sponsor
- Investigators
- Holger Schulz, Prof., Principal investigator, Universitätsklinikum Hamburg-EppendorfSusanne Weg-Remers, Dr., Principal investigator, German Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200453
- Sponsor's protocol ID
- S-158/2024
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * The study protocol was submitted to Frontiers in Public Health on June 24, 2024. * The statistical analysis plan will be uploaded prior to unblinding for data analysis. * The study data will be made available to other scientists via the online open access repository Figshare (https://figshare.com/) Figshare uses Creative Commons licenses, which give other researchers the right to use and build upon a dataset.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07200453
- Acronym / sponsor ID
- S-158/2024
- Conditions
- Neoplasms
- Keywords
- digital health, eHealth, health literacy, eHealth literacy, health information, e-learning, medical education, digital health literacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Cancer Research Center
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| e-learning - intervention group 1.1 | Experimental | Behavioral: intervention group 1.1 - e-learningParticipants 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. |
| e-learning - intervention-group 1.2 | Experimental | Behavioral: intervention-group 1.2 - e-learningParticipants 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. |
| e-learning - intervention-group 1.3 | Experimental | Behavioral: intervention-group 1.3 - e-learningParticipants 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. |
| PDF document - intervention-group 2 | Active comparator | Behavioral: intervention-group 2 - PDFThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are severely cognitively impaired due to their cancer or other illness
- Patients who are unable to operate a digital device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervention group 1.1 - e-learningThe 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. | Behavioural | e-learning - intervention group 1.1 |
| intervention-group 1.2 - e-learningParticipants 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. | Behavioural | e-learning - intervention-group 1.2 |
| intervention-group 1.3 - e-learningParticipants are also given access to the e-learning environment, but all rehearsal elements such as quizzes will be removed from the e-learning environment. | Behavioural | e-learning - intervention-group 1.3 |
| intervention-group 2 - PDFParticipants 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. | Behavioural | PDF document - intervention-group 2 |
Primary outcome
Change from baseline in the patient-reported digital health literacy measured by the Digital health literacy Instrument (DHLI) at 8 weeks
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.
5 secondary outcomes
Digital health literacy measured with the performance-based items of the DHLI
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The questionnaire will be administered at follow-up at 2 weeks (T1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Yes. * The study protocol was submitted to Frontiers in Public Health on June 24, 2024. * The statistical analysis plan will be uploaded prior to unblinding for data analysis. * The study data will be made available to other scientists via the online open access repository Figshare (https://figshare.com/) Figshare uses Creative Commons licenses, which give other researchers the right to use and build upon a dataset.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holger Schulz, Prof. principal investigator
Universitätsklinikum Hamburg-Eppendorf
Susanne Weg-Remers, Dr. principal investigator
German Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention group 1.1 - e-learning, intervention-group 1.2 - e-learning and intervention-group 1.3 - e-learning in people with Neoplasms, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lukas Lange-Drenth, Dr. (+49 (0) 40 7410-56811, lu.lange@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the patient-reported digital health literacy measured by the Digital health literacy Instrument (DHLI) at 8 weeks (time frame: The questionnaire will be administered at baseline (TO), follow-up at 2 weeks (T1), and follow-up at 8 weeks (T8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.