Trials / Active Not Recruiting
Active Not RecruitingNCT05931445
Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer
Multicenter, Open-label, Randomized, Controlled Study to Test the Utility of Electronic Patient-reported Outcome (ePRO) Monitoring in Patients With Unresectable Advanced Cancers or Metastatic/Recurrent Solid Tumors
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Comprehensive Support Project for Oncology Research · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Breast Cancer
- Lung Cancer
- Colorectal Cancer
- Liver Cancer
- Stomach Cancer
- Endometrial Cancer
- Ovarian Cancer
- Squamous Cell Carcinoma of the Head and Neck
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-01-26
- Primary completion
- 2026-03-31
- Completion
- 2027-03-31
- First posted
- 2023-07-05
- Last updated
- 2024-04-23
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT05931445. Inclusion in this directory is not an endorsement.