Patient Decision Aid for the Treatment of Actinic Keratosis

NCT06008171 | Active Not Recruiting

• 1 other identifier: 2022-3292
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses; Patient Decision Aid

Keywords

actinic keratosis

Outcome Measures

Primary Outcomes (2)

• 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).

Study Arms (2)

Patient Decision Aid

ACTIVE COMPARATOR

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

Without Patient Decision Aid (conventional)

NO INTERVENTION

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

Interventions

Patient Decision Aid OTHER

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

Patient Decision Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• no knowledge of Dutch language

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Catharina Ziekenhuis Eindhoven: collaborator

Study Sites (1)

Ellen Oyen

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Klara Mosterd, prof.dr.

  Maastricht UMC+

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 23, 2023
• Study Start: November 1, 2022
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)