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.
Primary Purpose
Basal Cell Carcinoma
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
individualized risk assessment
Sponsored by
About this trial
This is an interventional supportive care trial for Basal Cell Carcinoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Individualized risk assessment
Arm 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.
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.
Outcomes
Primary Outcome Measures
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)
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
Frequency of sunscreen use when out in sun
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
Frequency of sunburns within the past year
Frequency of sunburns within the past year
Full Information
NCT ID
NCT04093401
First Posted
September 16, 2019
Last Updated
July 12, 2021
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT04093401
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Resources
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Individualized risk assessment
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
individualized risk assessment
Intervention Description
Individualized risk assessment of developing a second basal cell carcinoma
Primary Outcome Measure Information:
Title
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)
Description
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
Secondary Outcome Measure Information:
Title
Frequency of sunscreen use when out in sun
Description
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
Time Frame
up to 13 months
Title
Frequency of sunburns within the past year
Description
Frequency of sunburns within the past year
Time Frame
up to 13 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Glinert, MD
Organizational Affiliation
clinical professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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