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Clinical Trials/NCT06008171
NCT06008171
Active, not recruiting
Not Applicable

Patient Decision Aid for the Treatment of Actinic Keratosis

Maastricht University Medical Center1 site in 1 country106 target enrollmentNovember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Actinic Keratoses
Sponsor
Maastricht University Medical Center
Enrollment
106
Locations
1
Primary Endpoint
Difference in shared decision making
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • no knowledge of Dutch language

Outcomes

Primary Outcomes

Difference in shared decision making

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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