Patient Decision Aid for the Treatment of Actinic Keratosis

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06008171

Collaborator

Catharina Ziekenhuis Eindhoven (Other)

106

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Actinic Keratoses Patient Decision Aid	Other: Patient Decision Aid	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention 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)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)

Primary Purpose:

Other

Official Title:

Patient Decision Aid for the Treatment of Actinic Keratosis

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
No Intervention: Without Patient Decision Aid (conventional) Conventional consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, without the use of a Patient Decision Aid.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

No Intervention: Without Patient Decision Aid (conventional)

Conventional consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, without the use of a Patient Decision Aid.

Outcome Measures

Primary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

no knowledge of Dutch language

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ellen Oyen	Maastricht		Netherlands

Sponsors and Collaborators

Maastricht University Medical Center
Catharina Ziekenhuis Eindhoven

Investigators

Principal Investigator: Klara Mosterd, prof.dr., Maastricht UMC+

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT06008171

Other Study ID Numbers:

2022-3292

First Posted:

Aug 23, 2023

Last Update Posted:

Aug 23, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maastricht University Medical Center

actinic keratosis

Additional relevant MeSH terms:

Keratosis, Actinic

Keratosis

Study Results

No Results Posted as of Aug 23, 2023