Personalized discharge letters for low-risk skin cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label study compares three approaches to aftercare communication for adults with low-risk skin cancer after dermatology screening: standard verbal information, a personalized discharge letter based on the patient’s risk profile, and the personalized letter plus digital visual support. An AI agent extracts relevant details from the electronic health record to generate the personalized letters, which are reviewed by a physician before delivery. The trial aims to see if these approaches improve reassurance, knowledge, and self-management behaviors compared with usual care. Enrollment is at Universitaire Ziekenhuizen KU Leuven, Leuven, Belgium, and participants are adults aged 18 to 80 who meet specific low-risk criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. Negative personal history for melanoma
  2. Less than 100 naevi
  3. Less than 5 clinically atypical naevi
  4. Maximum 1 BCC in history
  5. Maximum 1 SCC, and at least 5 years ago
  6. AK: treated and controlled with clinical response
  7. M Bowen: treated and controlled with clinical response
* Adult subjects (between 18 years of age and 80 years) at time of enrolment

Exclusion Criteria:

* 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.

Where it's running

• UZLeuven, Department of Dermatology
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Study coordinator: Annemiek Leeman, Prof. Dr.
• Email: annemiek.leeman@uzleuven.be
• Phone: 0032 16 33 79 50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.