Basal Cell Carcinoma
Conditions
Brief summary
While current guidelines call for annual follow-up for patients with a history of basal cell carcinoma, compliance with these guidelines is imperfect. It is hypothesized that if patients are informed of the quantitative risk of a subsequent basal cell carcinoma based on individualized risk factors, the compliance rate for follow-up will improve. The primary objective of this study is to assess one-year compliance with requested follow-up for patients with recent history of basal cell carcinoma, among those who receive standard sun avoidance counseling and request for follow-up compared to those who receive, in addition, an estimate of their mathematical risk of a subsequent basal cell carcinoma based on individualized risk factors.
Detailed description
This is an open-label, single-blind study to evaluate the effect of informing subjects of their individualized risk of a subsequent basal cell carcinoma on proportion of subjects who achieve compliance with requested follow-up with a dermatology healthcare provider, defined as in-person follow-up within 365 days following diagnosis of initial basal cell carcinoma. Subjects will be randomized 1:1 to intervention (knowledge of individualized risk) or control (lack of awareness of individualized risk). Investigators will be aware of the modelled risk of a subsequent basal cell carcinoma for all subjects, but only subjects randomized to the intervention arm will be informed of their modelled risk. All subjects will receive standard sun avoidance counseling and will be requested to follow-up no later than 365 days from initial basal cell carcinoma diagnosis.
Interventions
OTHERindividualized risk assessment
Individualized risk assessment of developing a second basal cell carcinoma
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Diagnosed with at least one Basal Cell Carcinoma within 30 days prior to enrollment * Able and willing to answer all questions accurately in the Individualized Risk Assessment
Exclusion criteria
* History of Basal Cell Carcinoma 31 or more days prior to enrollment * Solid Organ Transplant Recipient * History of Immunodeficiency (e.g., HIV infection, AIDS, genetic immunodeficiency * Prisoner * Psychiatric inpatients or people who are institutionalized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who have a followup second skin exam by a dermatologist within 1 year of diagnosis of their first basal cell carcinoma (BCC) | up to 13 months | Number of participants who have a followup second skin exam by a dermatologist within 1 year of diagnosis of their first basal cell carcinoma (BCC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of sunscreen use when out in sun | up to 13 months | Frequency of sunscreen use when out in sun Participants will be instructed to use sunscreen on a daily basis during April - October. Regularity of sunscreen use will be queried during sunny parts of the year (spring to fall). Frequency of sunscreen use will be measured as daily use during the months of April - October |
| Frequency of sunburns within the past year | up to 13 months | Frequency of sunburns within the past year |
Outcome results
None listed