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L'essai clinique NCT05712668 pour Télémédecine, Conseil est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Telemedicine Use in Preoperative Counseling for Endometrial Cancer Survivors 100
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT05712668 est une étude interventionnel pour Télémédecine, Conseil. Son statut actuel est : en recrutement. L'étude a débuté le 9 mai 2022 et vise à recruter 100 participants. Dirigée par Carilion Clinic, l'étude devrait être terminée d'ici le 1 mai 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 12 mars 2024.
Résumé succinct
To determine whether telemedicine is an acceptable addition to pre-operative counseling, compared to face-to-face communication alone for patients with endometrial cancer.
Description détaillée
Newly diagnosed endometrial cancer survivors, who are presenting for their initial consultation with a plan for minimally invasive surgery, will be randomized 1:1 to standard counseling or standard counseling plus asynchronous telemedicine video. The asynchronous video will be available outside of the office and can be viewed multiple times. The primary endpoint is patient anxiety, measured via the State-Trait Anxiet...Afficher plus
Titre officiel
A Randomized, Controlled Trial for Asynchronous Telemedicine Use in Preoperative Counseling for Individuals With Endometrial Cancer
Pathologies
TélémédecineConseilAutres identifiants de l'étude
- IRB 21-1305
Numéro NCT
Date de début (réel)
2022-05-09
Dernière mise à jour publiée
2024-03-12
Date de fin (estimée)
2025-05
Inscription (estimée)
100
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Telemedicine
Preoperative Counseling
Preoperative Counseling
Objectif principal
Soins de soutien
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur actifStandard Pre-operative Counseling Participants will receive standard counseling. | Preoperative Counseling Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care. |
ExpérimentalStandard Pre-operative Counseling plus Asynchronous Telemedicine Participants will receive standard counseling plus access to a 5 minute video reviewing their in-office counseling. | Preoperative Counseling Providers will review the diagnosis, surgical planning, risks/benefits/alternatives to surgery, post-operative care, and long term scope of care. Asynchronous telemedicine An asynchronous video will be delivered by Mytonomy. This platform allows investigators to track user analytics relating to the time, frequency, or duration watched by the user. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Anxiety related to preoperative counseling | It will be measured via the State-Trait Anxiety Inventory (STAI) questionnaire, a validated tool used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. STAI is comprised of 20 concise questions on a 4-point Likert scale. | Following the initial office visit or online viewing session, prior to surgery |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Patient satisfaction with preoperative counseling | It will be measured via the Patient Satisfaction Questionnaire (PSQ-18), which is also a validated questionnaire. It is comprised of 18 questions, also on a Likert scale, used to assess 7 dimensions of patient satisfaction. | Following the initial office visit or online viewing session, prior to surgery |
Patient satisfaction with preoperative counseling, surgical impact | It will be measured via the Patient Satisfaction Questionnaire (PSQ-18), which is also a validated questionnaire. It is comprised of 18 questions, also on a Likert scale, used to assess 7 dimensions of patient satisfaction. | At the postoperative exam, approximately 2-4 weeks from surgery |
Anxiety related to preoperative counseling, surgical impact | It will be measured via the State-Trait Anxiety Inventory (STAI) questionnaire, a validated tool used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. STAI is comprised of 20 concise questions on a 4-point Likert scale. | At the postoperative exam, approximately 2-4 weeks from surgery |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Sexes éligibles
Femme
- Patients with clinical stage I histologically confirmed endometrial carcinoma, which is clinically confined to the uterus and comprises approximately two-thirds of all endometrial carcinoma cases
- Patients undergoing planned minimally invasive surgical procedures, such as a minimally invasive technique such as conventional laparoscopy or robotic-assisted laparoscopy, as part of treatment at the Division of Gynecologic Oncology at Carilion Clinic, Roanoke, VA
- Internet/cellular access at home
- Ability to read and comprehend materials on questionnaires
1 Patients that do not meet the inclusion criteria
Carilion ClinicInstitut polytechnique et université d'État de VirginiePartie responsable de l'étude
Shannon Armbruster, Investigateur principal, Assistant Professor, Carilion Clinic
Contact central de l'étude
Contact: Shannon Armbruster, MD, (540) 581-0275, [email protected]
Contact: Caroline Kim, [email protected]
1 Centres de l'étude dans 1 pays
Virginia
Carilion Clinic, Roanoke, Virginia, 24016, United States
Shannon D Armbruster, MD, MPH, Investigateur principal
David A Iglesias, MD, MS, Investigateur associé
En recrutement