- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00416988
Educational Program in Skin Self-Examination To Detect Melanoma in Healthy Participants
Skin Self-Examination for Early Detection of Melanoma: Intervention and Consequence
RATIONALE: An educational program may be effective in increasing monthly skin self-examinations to detect melanoma in healthy participants.
PURPOSE: This randomized clinical trial is studying how well an educational program works in increasing monthly skin self-examinations to detect melanoma in healthy participants.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
- Determine the incidence of monthly thorough skin self-examinations (TSE) for early detection of melanoma in healthy participants who are under routine care by their primary care physician.
- Determine the impact of the intervention package and the resulting change in TSE performance, in terms of visits to healthcare providers for skin problems, in these participants.
- Evaluate the efficacy of this intervention package in improving performance of TSE in these participants.
- Estimate potential effect of this intervention on health care resource use.
OUTLINE: This is a controlled, randomized study.
Two weeks prior to their appointment with their physician, participants undergo a baseline assessment. During the appointment, participants are randomized to 1 of 2 intervention arms.
- Arm I (control): Participants receive written educational materials and watch a video on healthy dietary habits during their appointment. They receive nutrition tip sheets, including information related to reducing fat, saturated fat, and cholesterol in the diet, at 2 and 6 months after their initial appointment. Participants also undergo telephone assessments at 2, 6, and 12 months after their initial appointment.
- Arm II (skin self-examinations): Participants undergo a 10- to 15-minute face-to-face counseling session with the study intervention specialist and receive training in thorough skin self-examination (TSE) directly after their appointment. They also receive written educational materials and watch a 25-minute video designed to motivate and teach them to do TSE. Two weeks later, participants receive a follow-up call from the same study intervention specialist. Participants receive tailored feedback at 2 and 6 months and a motivational postcard at 4 months after their initial appointment. Participants also undergo telephone assessments as in arm I.
Participating physicians seeing participants in both arms attend a 60-minute educational session regarding skin cancer detection, prevention, identification, and triage, supplemented by written materials. They are also trained and prompted to deliver a 30-second message emphasizing the desirability of performing monthly TSE during their appointment with participants.
After completion of the study intervention, participants are offered the educational materials of the intervention arm to which they were not randomized.
PROJECTED ACCRUAL: A total of 1,135 participants will be accrued for this study.
Type d'étude
Inscription (Anticipé)
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
DISEASE CHARACTERISTICS:
Healthy participants who are scheduled for a routine or health maintenance visit with a participating primary care office that meets all of the following criteria:
- At least 50% of patients are being seen for regular ongoing general medical care
- Specializes in internal medicine (subspecialties allowed), family medicine, or obstetrics/gynecology
Employs at least 2 physicians who meet all of the following requirements:
- Agree to participate
- Work full-time, defined as at least 8 sessions per week of 3 or more hours
- Completed post-graduate training
- Not a federal employee or full-time hospital-based faculty
- Have been in practice at least 1 year
- Not planning on relocating or retiring within the next 3 years
PATIENT CHARACTERISTICS:
- Must be able to read in either English or Spanish
- Has no household member who has been previously enrolled on this study, including a person who has the same telephone number or address
- Not in acute discomfort
- Able to comply with intervention
- No impairment that would preclude skin self-examination
- Must be able to view video
- No illness or disability that would preclude participation in the study interview
PRIOR CONCURRENT THERAPY:
- Must not have been previously enrolled on this study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Martin A. Weinstock, MD, PhD, Rhode Island Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDR0000454855
- RIH-R01-CA78800
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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