eSMART Trial to Evaluate ASyMS

Summary

Chemotherapy may cause distressing symptoms which can impact on patients' quality of life. Chemotherapy is frequently given on an outpatient basis therefore patients are often required to manage the symptoms they experience at home without direct supervision from healthcare professionals. This study aims to evaluate the impact of a mobile phone based, remote monitoring, symptom management system (ASyMS) on the delivery of care to people with nonmetastatic breast, colorectal or haematological cancer during chemotherapy and for one year following treatment. The study aims to compare a number of outcomes of patients using the ASyMS intervention with outcomes of patients who receive normal care at their hospital. For up to 6 cycles of chemotherapy treatment, once a day and any other time they feel unwell, patients allocated to the mobile phone group will enter information on the phone regarding any symptoms they are experiencing, take their temperature and enter this on the phone. The information is sent via secure connection to a computer, which assesses the information and sends an alert to their health care professional in the hospital, who will call the patient at home if the patient has reported problematic symptoms. Patients in the normal care group will receive care as normal at their hospital. Both groups of patients will be asked to complete a series of questionnaires before they start treatment, after each chemotherapy cycle (for a maximum of 6 cycles) and at 3 monthly intervals for up to one year thereafter (a subset of patients will also be asked to complete midcycle symptom assessments). The study will also evaluate the cost benefit of ASyMS, assess changes in clinical practice as a result of ASyMS and develop a predictive risk model (statistical model) for use in future care of patients receiving chemotherapy for these cancers. This multicentre study is taking place across a number of European countries.

Conditions

• Cancer

Interventions

OTHER

ASyMS intervention Group

ASyMS is a mobile phone-based remote-monitoring system that enables the 'real-time' monitoring of patients' symptoms through use of a patient-reported outcome measure (PROM)

Sponsors & Collaborators

• University College Dublin

  collaborator OTHER

• King's College London

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• University of Athens

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• University of Dundee

  collaborator OTHER

• European Cancer Patient Coalition (ECPC)

  collaborator UNKNOWN

• Docobo Ltd.

  collaborator INDUSTRY

• University of Surrey

  collaborator OTHER

• Sykehuset Innlandet HF

  collaborator OTHER

• Louise McKean

  lead OTHER

Principal Investigators

• Roma Maguire · University of Strathclyde

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2019-03-31

Completion

2019-03-31

Countries

• Austria
• Greece
• Ireland
• Norway
• United Kingdom

Study Locations