- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02921724
Participatory Research for Fine-tuning of a 2.0 System to Optimise Home Management of Oral Cancer Therapies.
This is a prospective testing-validation, interventional, non-pharmacological study on a new app for oral anticancer therapy management.
A total of 80 patients will be considered: 20 evaluable patients in the training step; 60 patients in the validation step. In the training step will be considered evaluable the patients with: at least 6 weeks of treatment; visit at 6 weeks after the start of treatment performed and questionnaires self-administered.
Patients will be visited every 6 weeks. In the training step, patients will remain under observation for a minimum of 6 weeks, until change of therapy (due to progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 12 weeks. Patients enrolled in the validation step will remain under observation until change of therapy (due to progression of disease, unacceptable toxicity, death, discontinuation) or for a maximum of 24 weeks.
The objective of this study is to assess the capability of a newly developed interactive health care application to support patients and health professionals in the shared management of oral anticancer therapies, improving adherence, preventing complications at home, toxicities, improper treatment reductions or interruptions, emergency accesses and to assess the system usability and acceptability by patients and health professionals, integration in the hospital workflow, monitoring over time patient perceived levels of quality of care, quality of life, social support, anxiety, and self-care capability.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This is a prospective, interventional, non pharmacological study for testing-validation of a new app for optimising home management of oral therapies for cancer treatment.
All patients will be treated according to the local clinical practice. Enrolment period: 8 (training step) + 12 (validation step) months. Total duration of the study: 36 months. This is a multicenter study. Objective of the study is to assess the capability of a newly developed interactive health care application to support patients and health professionals in the shared management of oral anticancer therapies, and to assess the system usability and acceptability by patients and health professionals.
Eligible patients must meet the following criteria:
- adult 18-75 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;
- candidate for treatment with capecitabine or sunitinib as monotherapy (adjuvant and advanced settings allowed);
- sufficient ability to manage mobile devices after basic training course held at baseline;
- clear understanding of the Italian language;
- written informed consent.
Health professionals and patients define the items of the system through participatory design techniques (e.g. focus group sessions, joint review).
To define whether the system is capable of monitoring patient adherence, the number of pills counted by the system (self-reported by the patient at home) will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit. A difference in the number of pills within +/- 10% will be considered acceptable. A comparison of type and grade of toxicity will be made between the adverse events indicated by the system and those reported by the patient at the clinical visit. The quality of the system will be considered adequate if all the grade 3 and at least 80% of the grade 2 or more toxicity data reported by the patient at the time of the visit is recorded in the app.
To investigate system usability and acceptability, Functional Assessment of Cancer Therapy-General (FACT-G) and Hospital Anxiety and Depression Scale (HADS) questionnaires will be used. Scores will be subdivided into different subscales and analyzed using the Wilcoxon rank-sum test. Two new questionnaires have been developed and will be used to evaluate patient expectations of the system, and system acceptability + patient-doctor communication. An internationally validated questionnaire translated into Italian on system usability (SUS) will be also administered at the end of observation. Conversational interviews will be audio-recorded, transcribed and analyzed.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Bergamo, Italie, 24127
- Azienda Ospedaliera Papa Giovanni XXIII, Bergamo
-
Meldola (FC), Italie, 47014
- Irst-Irccs
-
Trento, Italie, 38123
- Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- ECOG-Performance Status (PS) less or equal to 1;
- life expectancy > 12 weeks;
- candidate for treatment with capecitabine or sunitinib as monotherapy (adjuvant and advanced settings allowed);
- clear understanding of the Italian language;
- subjects who are, in the opinion of the Investigator, able to understand this study, to cooperate with the study procedures and able to manage mobile devices after basic training course held at baseline;
- written informed consent
Exclusion Criteria:
- Patients receiving also intravenous anticancer treatment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Cancer patients undergoing oral therapy
At the time of therapy prescription, patients candidate for oral therapy with capecitabine or sunitinib will be provided with informations on the side-effects of therapy and on the use and functions of the mobile diary app TreC-Onco.
Patients are required to manually insert data into the mobile diary app at least once a day.
Patients will be visited every 6 weeks.
During the visit, the clinician will compare adherence and toxicity data entered into the mobile diary app with those directly reported by the patient and by drug accountability.
|
TreC-Onco is composed of two tools aimed at supporting patient self-care and health professional monitoring and intervention:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Drug accountability comparison
Délai: 3 years
|
the number of pills counted by the system (self-reported by the patient at home) will be compared with that counted by the physician as residual pills returned by the patient at the hospital visit.
A difference in the number of pills within +/- 10% will be considered acceptable.
|
3 years
|
Toxicity reporting comparison
Délai: 3 years
|
A comparison of type and grade of toxicity will be made between the adverse events indicated by the system and those reported by the patient/detected by the doctor at the clinical visit.
The quality of the system will be considered adequate if all the grade 3 and at least 80% of the grade 2 toxicity data reported by the patient at the time of the visit is recorded in the app.
A comparison will be made between the adverse event start time reported by the system and the time of data-entry by the patient into the system.
|
3 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
System acceptability: HADS questionaire
Délai: 3 years
|
HADS questionaire will be analyzed using the Wilcoxon rank-sum test
|
3 years
|
System acceptability: FACT-B questionaire
Délai: 3 years
|
FACT-B questionaire will be analyzed using the Wilcoxon rank-sum test
|
3 years
|
System usability: system usability scale (SUS) questionaire
Délai: 3 years
|
system usability scale (SUS) will be analyzed using the Wilcoxon rank-sum test
|
3 years
|
System acceptability by the Q-pre questionaire
Délai: 3 years
|
System acceptability by the Q-pre questionaire using content and template qualitative sociological analysis
|
3 years
|
System acceptability by the Q-post questionaire
Délai: 3 years
|
System acceptability by the Q-post questionaire using content and template qualitative sociological analysis
|
3 years
|
System acceptability by semi-structured interviews
Délai: 3 years
|
System acceptability by semi-structured interviews using content and template qualitative sociological analysis
|
3 years
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Alessandro Passardi, MD, IRST IRCCS, Meldola (FC)
Publications et liens utiles
Publications générales
- Passardi A, Foca F, Caffo O, Tondini CA, Zambelli A, Vespignani R, Bartolini G, Sullo FG, Andreis D, Dianti M, Eccher C, Piras EM, Forti S. A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial. J Med Internet Res. 2022 Jan 26;24(1):e27349. doi: 10.2196/27349.
- Passardi A, Rizzo M, Maines F, Tondini C, Zambelli A, Vespignani R, Andreis D, Massa I, Dianti M, Forti S, Piras EM, Eccher C. Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study. BMJ Open. 2017 May 29;7(5):e014617. doi: 10.1136/bmjopen-2016-014617.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Estimation)
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
- IRST100.18
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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 .
Essais cliniques sur TreC-Onco
-
Istituto Scientifico Romagnolo per lo Studio e...RecrutementCancer | Tumeur solide | Hématologie maligne | Administration de médicaments par voie oraleItalie
-
Azienda Provinciale per i Servizi Sanitari, Provincia...Ministero della Salute, Italy; Fondazione Bruno Kessler; Provincia Autonoma... et autres collaborateursRecrutement
-
Maxivax SACATO-SMSRetiré
-
Quanta MedicalNAOS Institute of Life ScienceComplétéSyndrome main-pied de grade 2France
-
Hospices Civils de LyonPas encore de recrutementTumeurs de la tête et du cou | Carcinome pulmonaire non à petites cellules | Tumeurs colorectalesFrance
-
Centre Hospitalier Universitaire de Saint EtienneInstitut de Cancérologie de la Loire; Centre Antoine LacassagneRésilié
-
Hôpital Européen MarseillePas encore de recrutement
-
Centre hospitalier de l'Université de Montréal...RecrutementRonflement | Apnée du sommeil | Cancer de la bouche | Carcinome épidermoïde buccal | Cancer du pharynxCanada
-
Seoul National University HospitalComplétéCancer de l'estomacCorée, République de