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.
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
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.
調査の概要
詳細な説明
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.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：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.
|
|
|
実験的：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.
|
Individualized risk assessment of developing a second basal cell carcinoma
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
時間枠：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)
|
up to 13 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Frequency of sunscreen use when out in sun
時間枠：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
|
up to 13 months
|
|
Frequency of sunburns within the past year
時間枠：up to 13 months
|
Frequency of sunburns within the past year
|
up to 13 months
|
協力者と研究者
捜査官
- 主任研究者：Robert J Glinert, MD、clinical professor
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- UW19002
- A534300 (その他の識別子：UW Madison)
- 2019-0077 (その他の識別子：Institutional Review Board)
- SMPH/DERMATOLOGY/DERMATOLOG (その他の識別子：UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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