Patient Decision Aid for the Treatment of Actinic Keratosis

Not Applicable

Active, not recruiting

• Conditions: Actinic Keratoses; Patient Decision Aid
• Interventions: Other: Patient Decision Aid

• Registration Number: NCT06008171
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

This study evaluates whether a Patient Decision Aid for the field-directed treatment of actinic keratosis has an effect on shared decision making and patient satisfaction.

Detailed Description

Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race. With an increase in prevalence worldwide due to an aging population and rise of ultraviolet exposure actinic keratosis are among the most frequently encountered skin lesions in clinical practice.

There are many therapeutic modalities for the treatment of actinic keratosis, depending on multiple factors such as distribution, characteristics, patient preference, side effects, availability and costs. Treatment options can be divided into: lesion directed therapy en field directed therapy.

A Patient Decision Aid for field-directed therapies for actinic keratosis may attribute to better shared-decision making and patient satisfaction which on their part may benefits treatment compliance and health outcomes and may lead to fewer disputes between patients and doctors.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-23
• Primary Completion: 2024-08-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• diagnosis actinic keratosis in MaastrichtUMC+ or CatharinaHospital, Eindhoven
• age >18 years

Exclusion Criteria

• no knowledge of Dutch language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Decision Aid	Patient Decision Aid	Consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, with the use of a Patient Decision Aid.

Primary Outcome Measures

Name	Time	Method
Difference in shared decision making	First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).	Difference in shared decision making in the group with Patient Decision Aid and the group without Patient Decision Aid, measured with Shared Decision Making-Q-9 questionnaire Dutch version.; This scale uses 9 questions with a maximum score of 45. 0 indicating the lowest and 45 indicating the highest level of perceived shared decision making.
Difference in patient satisfaction	First questionnaire at moment of consultation, between November 2022 and January 2024 (expected). Second questionnaire after finishing the treatment (1 week after consultation up to 6 months after consultation).	Difference in patient satisfaction making in the group with Patient Decision Aid and the group without Patient Decision Aid, measured with Decision Evaluation Scales.; This scale uses 15 questions with a maximum score of 75. Higher scores mean more satisfaction and less insecurity.

Trial Locations

Locations (1)

Ellen Oyen; 🇳🇱 Maastricht, Netherlands