CARES : Customized Aftercare Report for Evaluated Skin Cancer Patients (CARES)

May 20, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZLeuven, Department of Dermatology
        • Principal Investigator:
          • Annemiek Leeman, Prof. Dr.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Standard of Care
Verbal information only.
Behavioral: Verbal information only
Verbal information only
Experimental: Group B: Personalized Discharge Letter
Tailored written information based on individual risk profile, skin type and consultation findings.
Behavioral: Personalized Discharge Letter
Personalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings.
Experimental: Group C: Personalized Discharge Letter + Digital Visual Support (IntelliStudio)
Tailored written information plus digital visual support (e.g. annotated images, visual summaries).
Behavioral: Personalized Discharge Letter + IntelliStudio
Personalized Discharge Letter + IntelliStudio: Tailored written information plus digital visual support (e.g. annotated images, visual summaries).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S70829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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