CARES : Customized Aftercare Report for Evaluated Skin Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
Negative personal history for melanoma
Less than 100 naevi
Less than 5 clinically atypical naevi
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Verbal information only
BehavioralVerbal information only
Personalized Discharge Letter
BehavioralPersonalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings.
Personalized Discharge Letter + IntelliStudio
BehavioralPersonalized Discharge Letter + IntelliStudio: Tailored written information plus digital visual support (e.g. annotated images, visual summaries).
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Group A: Standard of CareActive comparator 1 intervention
Group B: Group B: Personalized Discharge LetterExperimental treatment 1 intervention
Group C: Group C: Personalized Discharge Letter + Digital Visual Support (IntelliStudio)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Level of Reassurance Immediately Post-Consultation
Measured via a questionnaire. Hypothesis: Patients in the IntelliStudio group will report the highest levels of reassurance.
Time frame
Through study completion, an average of 1 year2
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.
Time frame
Through study completion, an average of 1 year3
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.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov