NCT04093401

The VIDYA Study-designed to Determine if Patients With a History of Basal Cell Carcinoma Are More Inclined to Return for Follow-up if Their Risk of a Subsequent Basal Cell Carcinoma is Quantitated.

Trial number:: NCT04093401

Trial phase:: N/A

Study type:: Observational, Supportive interventions

Overall status:: Recruiting

Study start date

June, 2021

Scientific title

An Open-Label, Single Blind Study of How Knowledge of Risk of Subsequent Basal Cell Carcinoma Affects Compliance With Requested Follow-Up in Patients With First Basal Cell Carcinoma

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.

Inclusion criteria

Exclusion 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

- 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

Study design

Primary purpose: Supportive Care, Allocation: Randomized, Intervention model: Parallel Assignment, Masking: Single, Subject masked: Yes,

Conditions

Basal Cell Carcinoma

Other study ID numbers

UW19002; 2019-0077; A534300; SMPH/DERMATOLOGY/DERMATOLOG