Patient Decision Aid for the Treatment of Actinic Keratosis
Primary Purpose
Actinic Keratoses, Patient Decision Aid
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Patient Decision Aid
Sponsored by
About this trial
This is an interventional other trial for Actinic Keratoses focused on measuring actinic keratosis
Eligibility Criteria
Inclusion Criteria: diagnosis actinic keratosis in MaastrichtUMC+ or CatharinaHospital, Eindhoven age >18 years Exclusion Criteria: no knowledge of Dutch language
Sites / Locations
- Ellen OyenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Patient Decision Aid
Without Patient Decision Aid (conventional)
Arm Description
Consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, with the use of a Patient Decision Aid.
Conventional consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, without the use of a Patient Decision Aid.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06008171
First Posted
July 20, 2023
Last Updated
August 15, 2023
Sponsor
Maastricht University Medical Center
Collaborators
Catharina Ziekenhuis Eindhoven
1. Study Identification
Unique Protocol Identification Number
NCT06008171
Brief Title
Patient Decision Aid for the Treatment of Actinic Keratosis
Official Title
Patient Decision Aid for the Treatment of Actinic Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Catharina Ziekenhuis Eindhoven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses, Patient Decision Aid
Keywords
actinic keratosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient Decision Aid
Arm Type
Active Comparator
Arm Description
Consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, with the use of a Patient Decision Aid.
Arm Title
Without Patient Decision Aid (conventional)
Arm Type
No Intervention
Arm Description
Conventional consult about treatment options for field-directed therapies for actinic keratosis by the dermatologist, without the use of a Patient Decision Aid.
Intervention Type
Other
Intervention Name(s)
Patient Decision Aid
Intervention Description
A designed tool (by us) that help patients and providers talk and decide together about field-directed treatment options for actinic keratosis.
Primary Outcome Measure Information:
Title
Difference in patient satisfaction
Description
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.
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).
Title
Difference in shared decision making
Description
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.
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis actinic keratosis in MaastrichtUMC+ or CatharinaHospital, Eindhoven
age >18 years
Exclusion Criteria:
no knowledge of Dutch language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ellen Oyen, drs
Phone
+31(0)43-3877289
Email
ellen.oyen@mumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Klara Mosterd, prof.dr.
Phone
+31(0)43-3877289
Email
k.mosterd@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klara Mosterd, prof.dr.
Organizational Affiliation
Maastricht UMC+
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ellen Oyen
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellen Oyen, drs
Phone
+31(0)43-3877289
Email
ellen.oyen@mumc.nl
First Name & Middle Initial & Last Name & Degree
Klara Mosterd, prof. dr.
Phone
+31(0)43-3877289
Email
k.mosterd@mumc.nl
First Name & Middle Initial & Last Name & Degree
Ellen Oyen, drs
First Name & Middle Initial & Last Name & Degree
Klara Mosterd, prof. dr.
12. IPD Sharing Statement
Learn more about this trial
Patient Decision Aid for the Treatment of Actinic Keratosis
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