Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer (TS-PAC)
Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required).
In parallel, patient will continue standard follow-up with their referring oncologist and, if necessary (age ≥ 70 years and G8 score ≤ 14), will benefit from an onco-geriatric evaluation at inclusion then at 3 and 6 months.
At the end of 6 months of remote monitoring, the Coordinating Nurse will inform the patient of the end of study participation. Within one month of the end of the remote monitoring, the nurse will also remove the installation of the application and will organize the return of the equipment (tablet and/or 4G LTE key (4th Generation Long Term Evaluation)) if these were lent for the study.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mathilde CABART, MD
- Numéro de téléphone: +33 (0)5.56.33.19.65
- E-mail: m.cabart@bordeaux.unicancer.fr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients 65 years of age and over.
- Histologically proven cancer: breast, lung, ovary, prostate, bladder, kidney, ear-nose-throat, colon-rectum, melanoma, sarcoma, lymphoma, myeloma, or myelodysplastic syndrome.
- Included before starting medical treatment (chemotherapy, hormone therapy, targeted therapy, immunotherapy or combination).
- Informed consent dated and signed.
- Patients affiliated with a French social security scheme in accordance with the French law on biomedical research (Article 1121-11 of the French Code of Public Health).
Exclusion Criteria:
Life expectancy less than 12 months. 2. Patient declining to use a tablet, computer, mobile phone or the Internet. 3. Patient not knowing how to read and understand French. 4. Technical impossibility of connecting to the Internet in the patient's living area.
5. Patient already included in this study or in another study evaluating a remote monitoring system.
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 |
|---|---|
|
Autre: Remote monitoring for elderly patients with cancer
|
Online remote monitoring tool during the care of patients over the age of 65 who are receiving medical treatment for cancer
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Proportion of patients who completed at least all of 9 questionnaires at 3 months
Délai: 3 months
|
3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of toxicities and clinical symptoms reported by patients triggering a "red" alert.
Délai: Weekly during 6 months
|
Toxicities and symptoms will be assessed weekly using 20 questions selected and adapted from the French version of the CTCAE PRO (Basch et al., 2014; National Cancer Institute, 2017).
For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required).
The number of red alerts will be collected for each patient.
|
Weekly during 6 months
|
|
Rate of patients according to the compliant score.
Délai: Monthly during 6 months
|
Patient compliance with oral treatment will be assessed on a monthly basis during the treatment from the self-questionnaire MMAS-4 (Morisky et al., 1986) which has a range from 0 to 4. A high compliant score is defined by a score of 0, a medium compliance score (score=1 or 2) and a low compliance score (score=3 or 4).
|
Monthly during 6 months
|
|
Rate of patients with perceived benefit of treatment.
Délai: 3 months and 6 months
|
The subjective evaluation of the perceived benefit of treatment will be evaluated at 3 and 6 months by a questionnaire developed specifically for this project.
It comprises 3 items.The proportion of patients will be reported for each item of the questionnaire.
|
3 months and 6 months
|
|
Rate of patients with satisfaction with the use of the remote monitoring tool
Délai: 3 months and 6 months
|
Patient satisfaction with the use of the remote monitoring tool will be evaluated at 3 and 6 months by a questionnaire developed specifically for this project.
It comprises 2 items.
The rate will be reported for each item.
|
3 months and 6 months
|
|
Number of unscheduled hospitalizations> 24 hours and emergency room visits
Délai: 3 months and 6 months
|
3 months and 6 months
|
Collaborateurs et enquêteurs
Parrainer
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
Autres numéros d'identification d'étude
- IB 2020-03
- 2020-A02584-35 (Autre identifiant: ANSM IDRCB number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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