E-MOSAIC: A Multicenter Randomized Controlled Phase III Study of Longitudinal Electronic Monitoring of Symptoms and Syndromes Associated With Advanced Cancer in Patients Receiving Anticancer Treatment in Palliative Intention
- Determine the effect of an electronic tool for monitoring symptoms and syndromes
associated with advanced cancer (E-MOSAIC) and a Longitudinal Monitoring Sheet (LoMoS)
on global quality of life (G-QOL) of patients with advanced incurable cancer receiving
palliative anticancer treatment.
- Determine if this tool affects communication between these patients and their treating
- Determine if this tool affects the symptoms and syndromes reported by these patients.
- Determine if this tool impacts symptom management performance.
- Identify factors influencing changes in G-QOL.
- Determine how patients adapt to illness and burden of treatment.
- Describe patients' decision-making preference.
OUTLINE: This is a controlled, randomized, longitudinal, multicenter study. Physicians are
stratified according to participating center. Physicians are randomized to 1 of 2 arms. All
patients allocated to a physician undergo the same intervention.
- Arm I: Patients complete a weekly symptom assessment and nutritional intake using a
Palm-based monitoring tool. Nurses record weight and Karnofsky performance status (KPS)
scores weekly. A proof of electronic transfer sheet is printed and stored.
- Arm II: Patients complete a weekly assessment comprising visual analogue scales (VAS)
of pain, fatigue, drowsiness, nausea, anxiety, depression, shortness of breath, loss of
appetite, and overall well-being; up to 3 optional symptoms selected by the patient;
and an estimated nutritional intake using an electronic tool for monitoring symptoms
and syndromes associated with advanced cancer (E-MOSAIC). Nurses record the patient's
weight, KPS score, body mass index, and assessment of current medication for pain
(i.e., morphine-equivalent daily dose), fatigue, and anorexia/cachexia syndromes
weekly. A Longitudinal Monitoring Sheet (LoMoS) is printed (comprising VAS of pain,
pain medication, fatigue, KPS, medication for fatigue [i.e., methylphenidate
hydrochloride or epoetin alfa], anorexia, weight change, nutritional intake,
medication, supplements, counseling for anorexia, VAS of individually selected
symptoms) and stored.
In both arms, patients are assessed for outcome criteria at baseline and at weeks 3 and 6
(end of study).
PROJECTED ACCRUAL: A total of 24 physicians and 192 patients will be accrued for this study.
Determine the effect of an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC) and a Longitudinal Monitoring Sheet (LoMoS) on global quality of life (G-QOL)
Until trial ends
Florian Strasser, MD, ABHPM
Kantonsspital St. Gallen
Switzerland: Ethical Committee