A Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma

Superficial Basal Cell Carcinoma Clinical Trial

Official title:

Effectiveness of a Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma: a Pre- and Post-implementation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05628714
• Other study ID #: 2018-0624
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: November 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• patients older than 18 years

• patients with a clinically or histologically confirmed sBCC

Exclusion criteria:

• patients that could not read (Dutch)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Superficial Basal Cell Carcinoma

Intervention

Other:
• Patient decision aid for patients with superficial basal cell carcinoma
An online WebApp

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre+	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Catharina Ziekenhuis Eindhoven, Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knowledge	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.	Before treatment
Secondary	Patient satisfaction	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	3 Months post-treatment