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Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

ABSTRACT: INTRODUCTION:Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system. METHODS AND ANALYSIS:We plan to customise and fine-tune an existing monitoring TreC platform used in different chronic diseases in the oncology setting. This project follows a multistep approach with two major purposes: 1. participatory design techniques driven by Health Literacy and Patient Reported Outcomes principles in order to adapt the system to the oncology setting involving patients and healthcare providers; 2. a prospective training-validation, interventional, non-pharmacological, multicentre study on a series of consecutive patients with cancer (20 and 60 patients in the training and validation steps, respectively) in order to assess system capability, usability and acceptability. The novel Onco-TreC 2.0 is expected to contribute to improving the adherence and safety of cancer care, promoting patient empowerment and patient-doctor communication. ETHICS AND DISSEMINATION:Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol Number 2549/2015; reference Number 1315-PU). Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov (NCT02921724); (Pre-results). Other study ID Number: IRST100.18.

SUBMITTER: Passardi A

PROVIDER: S-EPMC5729988 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

Passardi Alessandro A Rizzo Mimma M Maines Francesca F Tondini Carlo C Zambelli Alberto A Vespignani Roberto R Andreis Daniele D Massa Ilaria I Dianti Marco M Forti Stefano S Piras Enrico Maria EM Eccher Claudio C

BMJ open 20170529 5

<h4>Introduction</h4>Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system.<h4>Methods and analysis</h4>We plan to customise and fine-tune an existing monitoring TreC platform ...[more]

PMID: 28554917

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Project description:BackgroundA platform designed to support the home management of oral anticancer treatments and provide a secure web-based patient-health care professional communication modality, ONCO-TreC, was tested in 3 cancer centers in Italy.ObjectiveThe overall aims of the trial are to customize the platform; assess the system's ability to facilitate the shared management of oral anticancer therapies by patients and health professionals; and evaluate system usability and acceptability by patients, caregivers, and health care professionals.MethodsPatients aged ≥18 years who were candidates for oral anticancer treatment as monotherapy with an Eastern Cooperative Oncology Group performance status score of 0 to 1 and a sufficient level of familiarity with mobile devices were eligible. ONCO-TreC consisted of a mobile app for patients and a web-based dashboard for health care professionals. Adherence to treatment (pill count) and toxicities reported by patients through the app were compared with those reported by physicians in medical records. Usability and acceptability were evaluated using questionnaires.ResultsA total of 40 patients were enrolled, 38 (95%) of whom were evaluable for adherence to treatment. The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95% CI 86.1%-99.9%) between the investigator and system pill count. Only 60% (3/5) of grade 3, 54% (13/24) of grade 2, and 19% (7/36) of grade 1 adverse events reported by physicians in the case report forms were also reported in the app directly by patients. In total, 94% (33/35) of patients had ≥1 app launch each week, and the median number of daily accesses per patient was 2. Approximately 71% (27/38) and 68% (26/38) of patients used the app for messages and vital sign entering, respectively, at least once during the study period.ConclusionsONCO-TreC is an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved.Trial registrationClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724.

Project description:BackgroundPulmonary rehabilitation is an effective treatment for patients with COPD, but patient uptake and adherence to the current offering of center-based pulmonary rehabilitation is modest due to transportation, access, poverty, and frailty, and even more so in the context of the COVID pandemic. Home-based options have been proposed and were found noninferior to center-based rehabilitation; however, there is a lack of home-based programs, and more understanding is needed. We aimed to test the feasibility, uptake, and adherence to a home-based program for COPD rehabilitation with health coaching.MethodsWe conducted a randomized trial with a wait-list controlled design to evaluate the effects of a home-based program with health coaching on breathlessness in subjects with moderate to severe COPD unable to attend the regular pulmonary rehabilitation program. The 8-week intervention consisted of video-guided exercises to be done 6 times a week and captured with a computer tablet. Health coaching was done weekly over the telephone to review subject activity and symptoms and to provide an opportunity for the subject to define their weekly goals. The primary outcomes were uptake, adherence, and Chronic Respiratory Questionnaire (CRQ) Dyspnea Domain. Secondary outcomes were self-management abilities and CRQ Emotions-Mastery-Fatigue.Results154 subjects with moderate to severe COPD were randomized. Subject adherence was 86% to the proposed 6-times a week exercise routine. There (P = .062) was no significant difference in breathlessness (CRQ dyspnea). There was a significant improvement in self-management abilities (P < .001). The results of the qualitative interviews showed high levels of acceptability of the program.ConclusionsThe tested home-based rehabilitation program with health coaching was feasible, highly acceptable, showed a high degree of adherence, and improved self-management abilities. This study offers seminal information for home-based rehabilitation programs to design alternative options of rehabilitation to individuals with COPD that cannot attend to the well-established center-based pulmonary rehabilitation. (ClinicalTrials.gov registration NCT02557178.).

Project description:BackgroundHospital stays after colorectal surgery are increasingly being reduced by enhanced recovery and early discharge protocols. As a result, postoperative complications may frequently manifest after discharge in the home setting, potentially leading to emergency room presentations and readmissions. Virtual care interventions after hospital discharge may capture clinical deterioration at an early stage and hold promise for the prevention of readmissions and overall better outcomes. Recent technological advances have enabled continuous vital sign monitoring by wearable wireless sensor devices. However, the potential of these devices for virtual care interventions for patients discharged after colorectal surgery is currently unknown.ObjectiveWe aimed to determine the feasibility of a virtual care intervention consisting of continuous vital sign monitoring with wearable wireless sensors and teleconsultations for patients discharged after colorectal surgery.MethodsIn a single-center observational cohort study, patients were monitored at home for 5 consecutive days after discharge. Daily vital sign trend assessments and telephone consultations were performed by a remote patient-monitoring department. Intervention performance was evaluated by analyzing vital sign trend assessments and telephone consultation reports. Outcomes were categorized as "no concern," "slight concern," or "serious concern." Serious concern prompted contact with the surgeon on call. In addition, the quality of the vital sign data was determined, and the patient experience was evaluated.ResultsAmong 21 patients who participated in this study, 104 of 105 (99%) measurements of vital sign trends were successful. Of these 104 vital sign trend assessments, 68% (n=71) did not raise any concern, 16% (n=17) were unable to be assessed because of data loss, and none led to contacting the surgeon. Of 62 of 63 (98%) successfully performed telephone consultations, 53 (86%) did not raise any concerns and only 1 resulted in contacting the surgeon. A 68% agreement was found between vital sign trend assessments and telephone consultations. Overall completeness of the 2347 hours of vital sign trend data was 46.3% (range 5%-100%). Patient satisfaction score was 8 (IQR 7-9) of 10.ConclusionsA home monitoring intervention of patients discharged after colorectal surgery was found to be feasible, given its high performance and high patient acceptability. However, the intervention design needs further optimization before the true value of remote monitoring for early discharge protocols, prevention of readmissions, and overall patient outcomes can be adequately determined.

Dataset Information

Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

Publications

Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

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