Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Sol… (NCT05931445) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer
Japan500 participantsStarted 2021-01-26
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Unresectable, advanced, metastasized, or relapsed solid tumors (Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Stomach Cancer, Endometrial Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck)
. Expected to be able to undergo treatment or observation for at least 6 months at the study site
. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
. Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment (In principle, patients should be receiving pharmacotherapy on an out-patient basis.)
. Capable of using electronic device (includes cases needing some assistance)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Survival (OS)
Timeframe: After enrollment to death from any cause (up to 57 months)
2
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score
Timeframe: At enrollment and week 4,8,12,16,20 and 24 after enrollment
Trial details
NCT IDNCT05931445
SponsorComprehensive Support Project for Oncology Research
. Written consent for the study personally obtained from the subject
Exclusion criteria
. Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors\*Notes 1, 2
. Currently participating in a study where PRO is tracked and the results are passed on to a physician
. The following are exclusion criteria for individual types of cancer 1) Breast cancer
. Undergoing or scheduled to undergo radiation therapy for curative purposes
. Deemed otherwise unsuitable for the study by the investigator or sub-investigator
. 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.
. Does not include endocrine therapy for breast cancer.