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.

University of Wisconsin (UW)

Status: Withdrawn

Conditions: Basal Cell Carcinoma

Treatments: Other: individualized risk assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04093401

SMPH/DERMATOLOGY/DERMATOLOG (Other Identifier)

A534300 (Other Identifier)

2019-0077 (Other Identifier)

UW19002

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Control

No Intervention group

Description:

Subjects will be assigned to the control arm if their subject ID is an odd number. Control arm subjects will not receive counseling for individualized risk assessment for developing a second basal cell carcinoma.

Individualized risk assessment

Experimental group

Description:

Subjects will be assigned to the intervention arm (i.e., informed of their individualized risk assessment) if their subject ID is an even number. Subjects in the intervention arm will be informed of their estimated 1-year, 3-year, and 5-year risk of developing a second basal cell carcinoma.

Treatment:

Other: individualized risk assessment