- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04030624
Remote Electronic Patient Monitoring in Gastrointestinal Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.
The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.
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 or older
- Diagnosed with gastrointestinal cancer
- Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
- Planning to receive outpatient care at the MGH Cancer Center
- Ability to read and respond to questions in English
Exclusion Criteria:
- Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
- Enrolled in hospice
- Planning to be discharged to any location other than their home
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Remote Electronic Patient Monitoring
|
The Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings.
Patient information is displayed on a computer located at the medical institution.
Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate).
Data are transmitted from sensors to the patient's smart phone.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
The Feasibility of Remote Electronic Patient Monitoring Intervention
Délai: 4 weeks
|
The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.
|
4 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period
Délai: 4 weeks
|
4 weeks
|
|
Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period
Délai: 4 weeks
|
4 weeks
|
|
Number of concerning issues identified per patient during study period
Délai: 4 weeks
|
4 weeks
|
|
Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period
Délai: 4 weeks
|
4 weeks
|
|
Number of intervention-triggered emails generated to the primary oncology team during study period
Délai: 4 weeks
|
4 weeks
|
|
Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period
Délai: 4 weeks
|
4 weeks
|
|
Acceptability of Remote Electronic Patient Monitoring Intervention
Délai: 4 weeks
|
Participant report of perceptions of the usefulness, effectiveness, and relevance of the intervention per acceptability ratings and qualitative interviews with patient participants and their clinicians.
|
4 weeks
|
Patient-Reported Quality of Life
Délai: 2 weeks and 4 weeks
|
Change in patient-reported quality of life from baseline to 2 and 4 weeks per the Functional Assessment of Cancer Therapy-General
|
2 weeks and 4 weeks
|
Patient-Reported Symptoms
Délai: 2 weeks and 4 weeks
|
Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised
|
2 weeks and 4 weeks
|
Patient-Reported Depression and Anxiety Symptoms
Délai: 2 weeks and 4 weeks
|
Change in patient-reported depression and anxiety symptoms from baseline to 2 and 4 weeks per the Patient Health Questionnaire-4
|
2 weeks and 4 weeks
|
Health Care Utilization
Délai: 4 weeks
|
Number of urgent clinic visits, emergency department visits, and hospital admissions during study period
|
4 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Joseph Greer, MD, Massachusetts General Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- 19-329
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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