Patient Decision Aid for the Treatment of Actinic Keratosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient Decision Aid for the Treatment of Actinic Keratosis

Conditions
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Actinic Keratoses, Patient Decision Aid

Intervention / Treatment
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* Other: Patient Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis actinic keratosis in MaastrichtUMC+ or CatharinaHospital, Eindhoven age >18 years Exclusion Criteria: no knowledge of Dutch language

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with an indication for treatment of field therapy for actinic keratosis will be consulted with patient decision aid or without patient decision aid (conventional)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient Decision Aid<br>Consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, with the use of a Patient Decision Aid. | Other: Patient Decision Aid<br>* A designed tool (by us) that help patients and providers talk and decide together about field-directed treatment options for actinic keratosis.<br>|
| No Intervention: Without Patient Decision Aid (conventional)<br>Conventional consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, without the use of a Patient Decision Aid. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in patient satisfaction | 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. | 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 | 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. | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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actinic keratosis