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.

NCT ID: NCT04093401

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2021-11-30

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.

Conditions

Basal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Individualized risk assessment

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.

Group Type: EXPERIMENTAL

individualized risk assessment

Intervention Type: OTHER

Individualized risk assessment of developing a second basal cell carcinoma

Interventions

individualized risk assessment

Individualized risk assessment of developing a second basal cell carcinoma

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J Glinert, MD

Role: PRINCIPAL_INVESTIGATOR

clinical professor

Other Identifiers

2019-0077

Identifier Type: OTHER

Identifier Source: secondary_id

A534300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/DERMATOLOGY/DERMATOLOG

Identifier Type: OTHER

Identifier Source: secondary_id

UW19002

Identifier Type: -

Identifier Source: org_study_id