This is a multicenter, open-label, randomized, controlled study to test the hypothesis that ePRO monitoring added to usual care helps prolong OS or maintain and improve HRQoL in patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic drug therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
The e-PRO monitoring will concern treatment of each predefined type of cancer or characteristic symptoms of the condition. PRO-CTCAE (Patient-Reported Outcome-Common Terminology Criteria for Adverse Events) will be used as the scale for monitoring symptoms. The patient and (sub)investigator will share the monitoring results during examinations and use them to determine treatment strategies, etc. Threshold values will be predefined for a diagnosis of "severe" for individual symptoms. When it is reported that a threshold value has been exceeded, an alert notification will be sent to the study staff member assigned to the patient. The (sub)investigator who receives the notification will assess the information in the notification and take the best course of action.
Kobe University Graduate School
Kobe, Hyōgo, Japan
Overall Survival (OS)
Time frame: After enrollment to death from any cause (up to 57 months)
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score
Time frame: At enrollment and week 4,8,12,16,20 and 24 after enrollment
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) domain score
Time frame: At enrollment and week 4,8,12,16,20 and 24 after enrollment
HRQoL EQ-5D-5L index score
Time frame: At enrollment and every 4 weeks after enrollment up to 57 months
Quality-adjusted life year (QALY) score
Time frame: After enrollment to death from any cause (up to 57 months)
At-home mortality rate
Time frame: After enrollment to death from any cause (up to 57 months)
Time from last completion of drug therapy to death
Time frame: Time from last completion of drug therapy to death from any cause (up to 57 months)
Number of unscheduled hospital visits during drug therapy
Time frame: After enrollment up to 24 weeks
Relative Dose Intensity (RDI)
Time frame: After enrollment up to 24 weeks
Total number of drug regiments
Time frame: After enrollment up to 57 months
Incremental Cost-Effectiveness Ratio (ICER)
Time frame: After enrollment up to 57 months
Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)
Time frame: At enrollment and week 24 after enrollment
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