Multicenter, Open-label, Randomized Comparative Study to Verify the Usefulness of Monitoring of Electronic Patient Reported Outcome (ePRO) in Patients with Unresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors (PRO-MOTE)
- Conditions
- nresectable Advanced Cancers and Metastasized or Relapsed Solid Tumors(Breast cancer, lung cancer, stomach cancer, colon cancer, squamous cell carcinoma of the head and neck, liver cancer, endometrial cancer, ovarian cancer)
- Registration Number
- JPRN-UMIN000042447
- Lead Sponsor
- Public Health Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 500
Not provided
(1) Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors*Notes 1, 2 (2) Currently participating in a study where PRO is tracked and the results are passed on to a physician (3) The following are exclusion criteria for individual types of cancer 1) Breast cancer - Scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer - Scheduled to receive or currently receiving first regimen of anti-HER2 therapy for HER2-positive disease 2) Liver cancer - Hepatic function of Child-Pugh B/C (4) Ongoing or planned radical radiotherapy (5) Deemed otherwise unsuitable for the study by the investigator or sub-investigator *Notes: 1. If the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy. 2. Does not include endocrine therapy for breast cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) OS (2) HRQoL The global health status score on the The European Organization for Research and Treatment of Cancer QLQ-C30 (EORTC QLQ-C30) at all measurement time points to Week 24 after enrollment
- Secondary Outcome Measures
Name Time Method