Clinical trial 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.
Official 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Basal Cell Carcinoma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: up to 13 months
Secondary outcomes:
measure: Frequency of sunscreen use when out in sun
timeFrame: up to 13 months
measure: Frequency of sunburns within the past year
timeFrame: up to 13 months
Other outcomes:
Locations:
Study officials:
affiliation: clinical professor
name: Robert J Glinert, MD
role: PRINCIPAL_INVESTIGATOR
References: