The impact of a SmartPhone applicatiOn for skin cancer risk assessmenT on the healthcare system (SPOT-study): A randomized controlled trial.
- Conditions
- Premalignant skin lesions, skin malignancies (including: melanomas, basal cell carcinomas, cutaneous squamous cell carcinomas and rare skin cancers) and benign skin tumors.
- Registration Number
- NL-OMON24380
- Lead Sponsor
- Department of Dermatology, Erasmus MC Cancer Institute Dr. Molewaterplein 40, 3015 GD Rotterdam, the Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 200000
Inclusion Criteria
To be eligible to participate in this study, a subject must meet all of the following inclusion criteria:
-Ability to give informed consent for this study.
-= 18 years old.
-Receive health care insurance from DSW.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Persons without an email address.
-Persons without a (compatible) smartphone.
-Persons without an internet connection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome of this study is the difference in skin tumor related care between the intervention group and the control group during 12 months, which is assessed by comparison of:<br>- The incidence of malignant skin tumors in Palga (national pathology database).<br>- The incidence of claims for benign skin tumors.<br>- The incidence of claims for (pre)malignant skin tumors.
- Secondary Outcome Measures
Name Time Method The secondary outcomes have been defined as:<br>- The cost-effectiveness of the SVA, which will be measured by the costs per detected skin cancer.<br>- The impact of SVA usage on primary care, which will be measures by surgical claims in primary care, although rather general coding will be a limiting factor.<br>- Comparison of the proportion of dermatological care received between the intervention group and the control group: Dermatological care will be specified for new dermatology consultations, follow-up visits, performed biopsies and excisions. <br>- The proportion of false negative melanomas within 2 years after using the SVA based on linkage with Palga.