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NCT Number: NCT05628714

A Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma

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.

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Key information

Conditions

Superficial Basal Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Centre+

Maastricht, Limburg, 6211HX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients that could not read (Dutch)

Treatment and study plan

Patient decision aid for patients with superficial basal cell carcinoma

Other

An online WebApp

Other names: PDA

Primary outcomes

  1. Decisional conflict

    Time frame: Before treatment

    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).

Secondary outcomes

  1. Knowledge

    Time frame: Before treatment

    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.

  2. Patient satisfaction

    Time frame: 3 Months post-treatment

    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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Catharina Ziekenhuis Eindhoven
  • Radboud University Medical Center

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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