A Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma
Effectiveness of a Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma: a Pre- and Post-implementation Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background Patients with a superficial basal cell carcinoma (sBCC) can choose between several treatment options with specific advantages and disadvantages. A patient decision aid (PDA) might facilitate a personalized decision.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Limburg
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Maastricht, Limburg, Netherlands, 6211HX
- Maastricht University Medical Centre+
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- patients older than 18 years
- patients that could read (Dutch)
- patients with a clinically or histologically confirmed sBCC
Description
Inclusion criteria:
- patients older than 18 years
- patients with a clinically or histologically confirmed sBCC
Exclusion criteria:
- patients that could not read (Dutch)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Control group
Patients who did not use the PDA
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PDA-group
Patients who did use the PDA
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An online WebApp
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Decisional conflict
Time Frame: Before treatment
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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).
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Before treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Knowledge
Time Frame: Before treatment
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To evaluate patient knowledge, we used a questionnaire adapted by our research group from a knowledge assessment for melanoma.
[14, 15] (Appendix B) The questionnaire included items on sun-protection (7 statements), risk factors for developing a BCC (10 statements), treatment options for sBCC (7 statements), and ways to recognize a BCC (6 statements).
The proportions of patients with correct answers (true/false) for all statements within a domain were compared between the two groups.
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Before treatment
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Patient satisfaction
Time Frame: 3 Months post-treatment
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Patient satisfaction with treatment decision was measured using the mean scores on the subscale 'effective decision making' and separate questions of this subscale of the DCS at 3 months post-treatment
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3 Months post-treatment
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-0624
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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