A Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma
NCT ID: NCT05628714
Last Updated: 2022-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
222 participants
OBSERVATIONAL
2018-01-01
2019-07-30
Brief Summary
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Detailed Description
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Objectives This study evaluates whether the use of a PDA results in a decreased level of decisional conflict, improved satisfaction with the treatment decision, and increased knowledge on prevention, recognition of BCC, and treatment options.
Methods A prospective multicentre pre- and post-implementation study was performed amongst patients with a newly diagnosed sBCC comparing a group that did not use the PDA (control group) with a group that did (PDA group). 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). Knowledge of disease and treatment options was evaluated by using a questionnaire.
Results Questionnaires were completed by 103 patients in the control group and 109 patients in the PDA group. The mean total score on the DCS in the control group was 22.78 (SD 14.76) compared to 22.34 (SD 14.54) in the PDA group. The adjusted mean difference was -0.39 (95% CI -4.47-3.70, p=0.851). Cohen's effect size for the total score on the DCS was 0.03. Use of the PDA resulted in a significant increase of knowledge on recognition of BCC (p\<0.001) and treatment options for sBCC (p=0.005). According to exploratory subgroup analyses the unadjusted mean difference in DCS score was higher in patients with sBCC in the head and neck area (-4.53, p=0.378), patients without a history of BCC (-3.76, p=0.251), and patients with higher educational level (-4.71, p=0.196).
Conclusion In the total study population with newly diagnosed sBCC, use of a PDA increased knowledge on relevant issues, but had no significant effect on the level of decisional conflict when compared with a control group. Exploratory subgroup analyses suggest that specific subgroups of patients may benefit from the use of a PDA, but these results need to be verified in larger studies.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Control group
Patients who did not use the PDA
No interventions assigned to this group
PDA-group
Patients who did use the PDA
Patient decision aid for patients with superficial basal cell carcinoma
An online WebApp
Interventions
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Patient decision aid for patients with superficial basal cell carcinoma
An online WebApp
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients with a clinically or histologically confirmed sBCC
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Catharina Ziekenhuis Eindhoven
OTHER
Radboud University Medical Center
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Locations
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Maastricht University Medical Centre+
Maastricht, Limburg, Netherlands
Countries
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Other Identifiers
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2018-0624
Identifier Type: -
Identifier Source: org_study_id
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