Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer

NAActive, not recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

January 26, 2021

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2027

Conditions
Breast CancerLung CancerColorectal CancerLiver CancerStomach CancerEndometrial CancerOvarian CancerSquamous Cell Carcinoma of the Head and Neck
Interventions
OTHER

e-PRO monitoring

"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."

Trial Locations (1)

650-0017

Kobe University Graduate School, Kobe

All Listed Sponsors
lead

Comprehensive Support Project for Oncology Research

OTHER