Superficial Basal Cell CarcinomaNCT05628714
A Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma
An observational study of Superficial Basal Cell Carcinoma, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Basal Cell Carcinoma
- What is being tested?
- Patient decision aid for patients with superficial basal cell carcinoma
- How many people
- 222 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2018to 30 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * patients older than 18 years * patients that could read (Dutch) * patients with a clinically or histologically confirmed sBCC
Who may be able to join
- patients older than 18 years
- patients with a clinically or histologically confirmed sBCC
Who cannot join
- patients that could not read (Dutch)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre+
Maastricht, Limburg, 6211HX
About this study
Official title: Effectiveness of a Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma: a Pre- and Post-implementation Study
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.
Read the 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.
- Conditions
- Superficial Basal Cell Carcinoma
- Being tested
- Patient decision aid for patients with superficial basal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient decision aid for patients with superficial basal cell carcinomaOther
Also called PDA
An online WebApp
| Study group | Role | What they receive |
|---|---|---|
| Control group | Patients who did not use the PDA | |
| PDA-group | Patients who did use the PDA Receives: Other: Patient decision aid for patients with superficial basal cell carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before treatment
Secondary outcomes (2)
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.
Measured: Before treatment
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
Measured: 3 Months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Jan 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628714
- Sponsor's protocol ID
- 2018-0624
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Patient Decision Aid for Patients With Superficial Basal Cell Carcinoma: a Pre- and Post-implementation Study
- ClinicalTrials.gov ID
- NCT05628714
- Acronym / sponsor ID
- 2018-0624
- Conditions
- Superficial Basal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Radboud University Medical Center
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Patients who did not use the PDA |
| PDA-group | – | Other: Patient decision aid for patients with superficial basal cell carcinomaPatients who did use the PDA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * patients older than 18 years * patients that could read (Dutch) * patients with a clinically or histologically confirmed sBCC
Key inclusion criteria (2 listed)
- patients older than 18 years
- patients with a clinically or histologically confirmed sBCC
Key exclusion criteria (1 listed)
- patients that could not read (Dutch)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient decision aid for patients with superficial basal cell carcinomaAlso: PDAAn online WebApp | Other | PDA-group |
Primary outcome
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).
2 secondary outcomes
Knowledge
Time frame: Before treatment
Patient satisfaction
Time frame: 3 Months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Basal Cell Carcinoma, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict (time frame: Before treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.