Clinical trial NCT05628714: A Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma
Official title: Effectiveness of a Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma: a Pre- and Post-implementation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superficial Basal Cell Carcinoma
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Catharina Ziekenhuis Eindhoven
name: Radboud University Medical Center
First posted: 2022-11-29
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * patients older than 18 years
* patients that could read (Dutch)
* patients with a clinically or histologically confirmed sBCC

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.

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.

Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

- patients that could not read (Dutch)

Primary outcomes:
measure: Decisional conflict
timeFrame: Before treatment
Secondary outcomes:
measure: Knowledge
timeFrame: Before treatment
measure: Patient satisfaction
timeFrame: 3 Months post-treatment
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre+
state: Limburg
Study officials:
References: