NCT05628714

Brief Summary

A patient decision aid (PDA) was tested in a population of patients with superficial basal cell carcinoma. This study evaluates whether the use of a PDA improved outcomes like decisional conflict and knowledge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

1.6 years

First QC Date

November 8, 2022

Last Update Submit

November 16, 2022

Conditions

Superficial Basal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Decisional conflict

    The primary outcome was the level of decisional conflict measured by the total mean score on the 'decisional conflict scale' (DCS) directly before treatment. Higher scores correspond with higher levels of decisional conflict (scale 0-100).

    Before treatment

Secondary Outcomes (2)

  • Knowledge

    Before treatment

  • Patient satisfaction

    3 Months post-treatment

Study Arms (2)

Control group

Patients who did not use the PDA

PDA-group

Patients who did use the PDA

Other: Patient decision aid for patients with superficial basal cell carcinoma

Interventions

Patient decision aid for patients with superficial basal cell carcinomaOTHER

An online WebApp

Also known as: PDA
PDA-group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* patients older than 18 years * patients that could read (Dutch) * patients with a clinically or histologically confirmed sBCC

You may qualify if:

  • patients older than 18 years
  • patients with a clinically or histologically confirmed sBCC

You may not qualify if:

  • \- patients that could not read (Dutch)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6211HX, Netherlands

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 29, 2022

Study Start

January 1, 2018

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

November 29, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)