CARES : Customized Aftercare Report for Evaluated Skin Cancer Patients

NCT ID: NCT07330323

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-06-30

Brief 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.

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.

Conditions

Management; Low Risk; Skin Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Group A: Standard of Care

Verbal information only.

Group Type: ACTIVE_COMPARATOR

Verbal information only

Intervention Type: BEHAVIORAL

Verbal information only

Group B: Personalized Discharge Letter

Tailored written information based on individual risk profile, skin type and consultation findings.

Group Type: EXPERIMENTAL

Personalized Discharge Letter

Intervention Type: BEHAVIORAL

Personalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings.

Group C: Personalized Discharge Letter + Digital Visual Support (IntelliStudio)

Tailored written information plus digital visual support (e.g. annotated images, visual summaries).

Group Type: EXPERIMENTAL

Personalized Discharge Letter + IntelliStudio

Intervention Type: BEHAVIORAL

Personalized Discharge Letter + IntelliStudio: Tailored written information plus digital visual support (e.g. annotated images, visual summaries).

Interventions

Verbal information only

Verbal information only

Intervention Type: BEHAVIORAL

Personalized Discharge Letter

Personalized Discharge Letter: Tailored written information based on individual risk profile, skin type and consultation findings.

Intervention Type: BEHAVIORAL

Personalized Discharge Letter + IntelliStudio

Personalized Discharge Letter + IntelliStudio: Tailored written information plus digital visual support (e.g. annotated images, visual summaries).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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.

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZLeuven, Department of Dermatology

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Central Contacts

Annemiek Leeman, Prof. Dr.

Role: CONTACT

annemiek.leeman@uzleuven.be

0032 16 33 79 50

Sofie Van Kelst, Bsc.

Role: CONTACT

sofie.vankelst@kuleuven.be

0032 16 33 78 64

Facility Contacts

Sofie Van Kelst, Bsc

Role: primary

sofie.vankelst@kuleuven.be

Other Identifiers

S70829

Identifier Type: -

Identifier Source: org_study_id