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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: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:Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery.STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ?cT3b (up to 5?mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2.The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals.ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016.

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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