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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune 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.
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Expérimental: 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.
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Individualized risk assessment of developing a second basal cell carcinoma
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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)
Délai: up to 13 months
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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)
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up to 13 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Frequency of sunscreen use when out in sun
Délai: up to 13 months
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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
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up to 13 months
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Frequency of sunburns within the past year
Délai: up to 13 months
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Frequency of sunburns within the past year
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up to 13 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Robert J Glinert, MD, clinical professor
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UW19002
- A534300 (Autre identifiant: UW Madison)
- 2019-0077 (Autre identifiant: Institutional Review Board)
- SMPH/DERMATOLOGY/DERMATOLOG (Autre identifiant: UW Madison)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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