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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04093401
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Other: individualized risk assessment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Arm Intervention/treatment
No Intervention: 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.
Experimental: 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.
Other: individualized risk assessment
Individualized risk assessment of developing a second basal cell carcinoma




Primary Outcome Measures :
  1. 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) [ Time Frame: 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 Outcome Measures :
  1. Frequency of sunscreen use when out in sun [ Time Frame: 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

  2. Frequency of sunburns within the past year [ Time Frame: up to 13 months ]
    Frequency of sunburns within the past year



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093401


Contacts
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Contact: Christina Sheehan (608) 287-2006 csheehan@dermatology.wisc.edu
Contact: Heather Neils (608) 287-2640 hneils@dermatology.wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Carbone Cancer Center Recruiting
Madison, Wisconsin, United States, 53792
Contact: Cancer Connect    800-622-8922    skotila@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Robert J Glinert, MD clinical professor
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04093401    
Other Study ID Numbers: UW19002
2019-0077 ( Other Identifier: Institutional Review Board )
A534300 ( Other Identifier: UW Madison )
SMPH/DERMATOLOGY/DERMATOLOG ( Other Identifier: UW Madison )
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell