Cancer outpatients (OP) will face a maximum of potentially serious side effects (SAEI) and complications (C) at home and at distance from their caregivers (CG). This may lead to insufficent management as the care takers ignore complications and will not carry out early intervention. Worsening of quality of life (QoL) and (prolonged) hospitalisation may be the consequence. Studies have provided evidence that e-tools inquiring about the patients' well-being at home may be useful for early intervention, thus providing better quality of life and less hospitalisations. It is unclear whether these benefits could be obtained by patients' self-management or require pro active intervention (PAI) by CG. We therefore carry out a study (PRO-ELECTS= PE) using a web-based e-tool we developed based on the Edmondson Symptom Scale (ESAS). A pilot study had proved feasability in OU of the Oncology Outpatient Unit (OOU) of the CHEM general hospital.
This prospective randomized study compares: - I. OP documenting QoL, hospital stays/consult. during treatment intervals while under OOU visits, with:- II. P receiving daily inquiries, automated advice and alerts to contact OOU in the case of SAE, with: III. P receiving daily inquiry superised by the OOU CG and intervention in case of alarming sypmtoms. All P apart from I receive daily customized questionnaires integrating an algorithm with automated answers to standard situations and alert messages inviting the P to contact the OOU tal in case of SAE. In group III, CG of the OOU will be notified of the daily response and alerted in case of SAE. They are mandated to contact the P to provide advice or convocate him to the hospital.PRO-ELECTS should be able to determine whether active electronic patient surveillance and pro active intervention is superior to patient self -management assisted by a web tool in maintaining good quality of life and limit the severity of complications. The study will also determine which strategy provideds more patient adherence and satisfaction. So far 15 of a total of 120 P have been randomized. Patient acceptance is excellent. 3 serious side effects have been anticipated through active intervention. Data concerning P adherence, satisfaction, QoL ad complication data will be presented.
Clinical trial identification
Legal entity responsible for the study
CHEM, Fondation Cancer Luxembourg, Integrated Biobank Luxembourg, CHEM, Janssen Cilag, Chugai
A. Hagemann: eHealth Consultant of the company Sananet providing the web site for the study All other authors have declared no conflicts of interest.