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

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer; Ovarian Cancer; Squamous Cell Carcinoma of the Head and Neck; Breast Cancer; Colorectal Cancer; Stomach Cancer; Endometrial Cancer; Liver Cancer

• Registration Number: NCT05931445
• Lead Sponsor: Comprehensive Support Project for Oncology Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-26
• Status Verified: 2023-05
• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-27
• Study First Posted: 2023-07-05
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. 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)
2. Expected to be able to undergo treatment or observation for at least 6 months at the study site
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
4. 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.)
5. Capable of using electronic device (includes cases needing some assistance)
6. Aged 18 years or older at informed consent
7. Written consent for the study personally obtained from the subject

Exclusion Criteria

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. Undergoing or scheduled to undergo radiation therapy for curative purposes

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: PARALLEL

Primary Outcome Measures

Name	Time	Method
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score	At enrollment and week 4,8,12,16,20 and 24 after enrollment
Overall Survival (OS)	After enrollment to death from any cause (up to 57 months)

Secondary Outcome Measures

Name	Time	Method
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) domain score	At enrollment and week 4,8,12,16,20 and 24 after enrollment
Total number of drug regiments	After enrollment up to 57 months
HRQoL EQ-5D-5L index score	At enrollment and every 4 weeks after enrollment up to 57 months
Time from last completion of drug therapy to death	Time from last completion of drug therapy to death from any cause (up to 57 months)
At-home mortality rate	After enrollment to death from any cause (up to 57 months)
Quality-adjusted life year (QALY) score	After enrollment to death from any cause (up to 57 months)
Relative Dose Intensity (RDI)	After enrollment up to 24 weeks
Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)	At enrollment and week 24 after enrollment
Number of unscheduled hospital visits during drug therapy	After enrollment up to 24 weeks
Incremental Cost-Effectiveness Ratio (ICER)	After enrollment up to 57 months

Trial Locations

Locations (1)

Kobe University Graduate School; 🇯🇵 Kobe, Hyogo, Japan