ManagementCARESNCT07330323
CARES : Customized Aftercare Report for Evaluated Skin Cancer Patients
A study testing Verbal information only, Personalized Discharge Letter and Personalized Discharge Letter + IntelliStudio in people with Management and Low Risk, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Current clinical practices often provide general verbal advice to low-risk patients, which may not sufficiently address individual concerns or offer actionable steps. Generic information on the internet can be overwhelming or unreliable, leading to confusion and unnecessary follow-up visits. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Management, Low Risk, Skin Cancer
- What is being tested?
- Verbal information only, Personalized Discharge Letter and Personalized Discharge Letter + IntelliStudio
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 20 May 2026to Jun 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Low-risk skin cancer patients:
- Negative personal history for melanoma
- Less than 100 naevi
- Less than 5 clinically atypical naevi
- Maximum 1 BCC in history
Show all 10Show fewer
- Maximum 1 SCC, and at least 5 years ago
- AK: treated and controlled with clinical response
- M Bowen: treated and controlled with clinical response
- Adult subjects (between 18 years of age and 80 years) at time of enrolment
Who cannot join
- Presence of dermatological lesions requiring immediate treatment at the time of consultation.
- History of solid organ transplantation (Organ Transplant Recipient, OTR).
- Known carriers or suspected carriers (based on family history) of germline mutations associated with increased skin cancer risk (e.g. CDKN2A, PTCH1, XP genes).
- Failure to meet one or more of the inclusion criteria.
- Any condition or comorbidity that, in the opinion of the investigator, may interfere with study participation or data interpretation (e.g. severe cognitive impairment, language barrier).
- Participation in another interventional clinical trial that may interfere with the outcomes of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZLeuven, Department of Dermatology
Leuven, Vlaams-Brabant, 3000
Sofie Van Kelst, Bsc, sofie.vankelst@kuleuven.be
Annemiek Leeman, Prof. Dr.
About this study
Official title: Development and Evaluation of a Personalized Discharge Letter for Low-risk Skin Cancer Patients After Dermatological Screening.
Current clinical practices often provide general verbal advice to low-risk patients, which may not sufficiently address individual concerns or offer actionable steps. Generic information on the internet can be overwhelming or unreliable, leading to confusion and unnecessary follow-up visits.
This project introduces a tailored approach by combining evidence-based guidelines with personalized details about the patient's risk profile. The discharge letter bridges the gap between clinical expertise and patient understanding, offering clear, specific, and actionable advice that has been shown to improve health behaviors and outcomes in other contexts .
The personalized discharge letters are generated using an AI agent trained on validated letters from the hospital's electronic health record system (KWS). Each letter is reviewed and approved by a physician before being provided to the patient, ensuring both accuracy and clinical relevance.
Read the detailed description
This study is a prospective, parallel-group, open-label, randomized controlled trial designed to evaluate the impact of a personalized discharge letter-with or without digital visual support -on reassurance, knowledge, and self-management in low-risk skin cancer patients following dermatological screening.
Study Arms: Participants will be randomly assigned to one of three groups:
- Group A - Standard of Care: Verbal information only.
- Group B - Personalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings.
- Group C - Personalized Discharge Letter + digital visual support: Tailored written information plus digital visual support (e.g. annotated images, visual summaries).
Scientific Rationale Current discharge practices for low-risk skin cancer patients often rely on general verbal advice, which may not sufficiently address individual concerns or promote long-term self-care. Evidence from other medical domains suggests that personalized communication improves patient understanding, satisfaction, and adherence to follow-up recommendations.
This study introduces an AI agent trained on validated discharge letters from the hospital's electronic health record system (KWS). The AI helpt collect information from the electronic health record that is relevant for creating personalized letters that are reviewed by a physician before being provided to the patient. These letters aim to improve understanding of personal skin cancer risk, sun protection, and self-monitoring practices.
The addition of visual digital support (IntelliStudio) is hypothesized to further enhance patient engagement and confidence by providing clear, visual explanations of findings and next steps. This design allows for a direct comparison of standard care versus increasingly personalized interventions, enabling the evaluation of both individual and combined effects.
- Conditions
- Management, Low Risk, Skin Cancer
- Being tested
- Verbal information only, Personalized Discharge Letter, Personalized Discharge Letter + IntelliStudio
- Keywords
- Skin cancer risk and management, personalized discharge letter, low-risk skin cancer patients
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal information onlyBehavioural
Verbal information only
Personalized Discharge LetterBehavioural
Personalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings.
Personalized Discharge Letter + IntelliStudioBehavioural
Personalized Discharge Letter + IntelliStudio: Tailored written information plus digital visual support (e.g. annotated images, visual summaries).
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standard of Care | Active comparator | Verbal information only. Receives: Behavioral: Verbal information only |
| Group B: Personalized Discharge Letter | Experimental | Tailored written information based on individual risk profile, skin type and consultation findings. Receives: Behavioral: Personalized Discharge Letter |
| Group C: Personalized Discharge Letter + Digital Visual Support (IntelliStudio) | Experimental | Tailored written information plus digital visual support (e.g. annotated images, visual summaries). Receives: Behavioral: Personalized Discharge Letter + IntelliStudio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Reassurance Immediately Post-Consultation
Measured via a questionnaire.
Hypothesis: Patients in the IntelliStudio group will report the highest levels of reassurance.
Measured: Through study completion, an average of 1 year
Knowledge of Personal Skin Cancer Risk
Assessed through a pre- and post-intervention knowledge questionnaire.
Hypothesis: Personalized information (Groups B and C) improves risk awareness compared to standard care.
Measured: Through study completion, an average of 1 year
Confidence in Performing Self-Skin Checks
Measured via self-reported confidence and frequency of self-checks.
Hypothesis: Groups B and C will report higher confidence than Group A.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start20 May 2026
- Primary completionJan 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ManagementStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330323
- Sponsor's protocol ID
- S70829
- Acronym
- CARES
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Personalized Discharge Letter for Low-risk Skin Cancer Patients After Dermatological Screening.
- ClinicalTrials.gov ID
- NCT07330323
- Acronym / sponsor ID
- CARES / S70829
- Conditions
- Management, Low Risk, Skin Cancer
- Keywords
- Skin cancer risk and management, personalized discharge letter, low-risk skin cancer patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 9 Jan 2026 (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.
Current clinical practices often provide general verbal advice to low-risk patients, which may not sufficiently address individual concerns or offer actionable steps. Generic information on the internet can be overwhelming or unreliable, leading to confusion and unnecessary follow-up visits.
This project introduces a tailored approach by combining evidence-based guidelines with personalized details about the patient's risk profile. The discharge letter bridges the gap between clinical expertise and patient understanding, offering clear, specific, and actionable advice that has been shown to improve health behaviors and outcomes in other contexts .
The personalized discharge letters are generated using an AI agent trained on validated letters from the hospital's electronic health record system (KWS). Each letter is reviewed and approved by a physician before being provided to the patient, ensuring both accuracy and clinical relevance.
Detailed description
This study is a prospective, parallel-group, open-label, randomized controlled trial designed to evaluate the impact of a personalized discharge letter-with or without digital visual support -on reassurance, knowledge, and self-management in low-risk skin cancer patients following dermatological screening.
Study Arms: Participants will be randomly assigned to one of three groups:
- Group A - Standard of Care: Verbal information only.
- Group B - Personalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings.
- Group C - Personalized Discharge Letter + digital visual support: Tailored written information plus digital visual support (e.g. annotated images, visual summaries).
Scientific Rationale Current discharge practices for low-risk skin cancer patients often rely on general verbal advice, which may not sufficiently address individual concerns or promote long-term self-care. Evidence from other medical domains suggests that personalized communication improves patient understanding, satisfaction, and adherence to follow-up recommendations.
This study introduces an AI agent trained on validated discharge letters from the hospital's electronic health record system (KWS). The AI helpt collect information from the electronic health record that is relevant for creating personalized letters that are reviewed by a physician before being provided to the patient. These letters aim to improve understanding of personal skin cancer risk, sun protection, and self-monitoring practices.
The addition of visual digital support (IntelliStudio) is hypothesized to further enhance patient engagement and confidence by providing clear, visual explanations of findings and next steps. This design allows for a direct comparison of standard care versus increasingly personalized interventions, enabling the evaluation of both individual and combined effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Standard of Care | Active comparator | Behavioral: Verbal information onlyVerbal information only. |
| Group B: Personalized Discharge Letter | Experimental | Behavioral: Personalized Discharge LetterTailored written information based on individual risk profile, skin type and consultation findings. |
| Group C: Personalized Discharge Letter + Digital Visual Support (IntelliStudio) | Experimental | Behavioral: Personalized Discharge Letter + IntelliStudioTailored written information plus digital visual support (e.g. annotated images, visual summaries). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Low-risk skin cancer patients:
- Adult subjects (between 18 years of age and 80 years) at time of enrolment
Key exclusion criteria (6 listed)
- Presence of dermatological lesions requiring immediate treatment at the time of consultation.
- History of solid organ transplantation (Organ Transplant Recipient, OTR).
- Known carriers or suspected carriers (based on family history) of germline mutations associated with increased skin cancer risk (e.g. CDKN2A, PTCH1, XP genes).
- Failure to meet one or more of the inclusion criteria.
- Any condition or comorbidity that, in the opinion of the investigator, may interfere with study participation or data interpretation (e.g. severe cognitive impairment, language barrier).
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 |
|---|---|---|
| Verbal information onlyVerbal information only | Behavioural | Group A: Standard of Care |
| Personalized Discharge LetterPersonalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings. | Behavioural | Group B: Personalized Discharge Letter |
| Personalized Discharge Letter + IntelliStudioPersonalized Discharge Letter + IntelliStudio: Tailored written information plus digital visual support (e.g. annotated images, visual summaries). | Behavioural | Group C: Personalized Discharge Letter + Digital Visual Support (IntelliStudio) |
Primary outcome
Level of Reassurance Immediately Post-Consultation
Time frame: Through study completion, an average of 1 year
Measured via a questionnaire. Hypothesis: Patients in the IntelliStudio group will report the highest levels of reassurance.
Knowledge of Personal Skin Cancer Risk
Time frame: Through study completion, an average of 1 year
Assessed through a pre- and post-intervention knowledge questionnaire. Hypothesis: Personalized information (Groups B and C) improves risk awareness compared to standard care.
Confidence in Performing Self-Skin Checks
Time frame: Through study completion, an average of 1 year
Measured via self-reported confidence and frequency of self-checks. Hypothesis: Groups B and C will report higher confidence than Group A.
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 22 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal information only, Personalized Discharge Letter and Personalized Discharge Letter + IntelliStudio in people with Management and Low Risk, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 10 inclusion and 6 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 22 May 2026. 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 Belgium. 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 Annemiek Leeman, Prof. Dr. (0032 16 33 79 50, annemiek.leeman@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Reassurance Immediately Post-Consultation (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 22 May 2026.