Patient Decision Aid for the Treatment of Actinic Keratosis

Actinic Keratoses Clinical Trial

Official title:

Patient Decision Aid for the Treatment of Actinic Keratosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008171
• Other study ID #: 2022-3292
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Maastricht University Medical Center
• Contact: Ellen Oyen, drs
• Phone: +31(0)43-3877289
• Email: ellen.oyen[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis actinic keratosis in MaastrichtUMC+ or CatharinaHospital, Eindhoven

• age >18 years

Exclusion Criteria:

• no knowledge of Dutch language

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic
• Patient Decision Aid

Intervention

Other:
• Patient Decision Aid
A designed tool (by us) that help patients and providers talk and decide together about field-directed treatment options for actinic keratosis.

Locations

Country	Name	City	State
Netherlands	Ellen Oyen	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).