The solution for questioning patients via mobile devices.
Questioning patients via mobile devices.

Clinical Study "MoRiTS"

Testing of various models for risk evaluation of toxicity and morbidity in elderly patients with sarcoma

First Patient In Study Design Number of Patients Coordinating Principal Investigator Study Centers
Nov 2013 non-interventional, prospective observation study. 170 Dr. med. Markus Schuler,
Universitätsklinikum Dresden
Universitätsklinikum Dresden and
Sarcoma Center Berlin-Brandenburg

Project Details

  • About 180 questions
  • Direct evaluation and presentation of answers
  • Management of iPads via our mobile device management system

Background of the Study

Demographic developments have led to a rise in the number of elderly patients suffering and dying from a malignant tumor. While taking into account the special problems and needs of the elderly, the future challenge for individualized therapy will be to avoid faulty diagnoses and concomitant risks to the patient.

Various studies have shown that with regard to the prognosis of toxicity, the patient’s judgment - although largely based on personal impressions - is superior to the physician’s evaluation alone. Furthermore, individual elements of the abbreviated geriatric assessment have been shown to originate from tests of the patient’s functional and cognitive capacity, used to assess the risk of death within the first 6 months after commencement of therapy. The predictive power of the risk assessment based on such measuring tools was recently confirmed in the case of colorectal carcinoma.

Study Design and Goals

Against this background, there appears to be an urgent need for future treatment plans to be determined from risk assessments derived from evidence-based knowledge. The study presented here from the field of sarcoma represents an important step forward in this direction. It is a non-interventional study performed on a prospective cohort of 170 patients.

The primary aim of the study is the recording of signs of Grade 3 and 4 toxicity within the first three cycles (9 weeks) and documentation of dose reductions of more than 25% and of unplanned admissions within the observation period. Secondary target figures are data quality of the survey and assessment of the viability and usefulness of a mobile platform for obtaining PROs.

Discussion

The results of the study should show whether any of the geriatric screening instruments available to date can be used as a predictive tool in sarcoma. The study will also show whether the electronic collection of PROs via iPads represents a reliable and pioneering instrument for guidance of therapy.