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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stomach Cancer; Breast Cancer; Colorectal Cancer; Ovarian Cancer; Lung Cancer; Squamous Cell Carcinoma of the Head and Neck; Endometrial Cancer; Liver Cancer
• Intervention / Treatment: Other: e-PRO monitoring

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0017
      • Kobe University Graduate School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitoring group; ePRO monitoring will be conducted once weekly after study enrollment, along with standard care of treatment.	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.
No Intervention: Non-monitoring group; Standard care of treatment will be given without ePRO monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	After enrollment to death from any cause (up to 57 months)
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
HRQoL EQ-5D-5L index score	At enrollment and every 4 weeks after enrollment up to 57 months
Quality-adjusted life year (QALY) score	After enrollment to death from any cause (up to 57 months)
At-home mortality rate	After enrollment to death from any cause (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)
Number of unscheduled hospital visits during drug therapy	After enrollment up to 24 weeks
Relative Dose Intensity (RDI)	After enrollment up to 24 weeks
Total number of drug regiments	After enrollment up to 57 months
Incremental Cost-Effectiveness Ratio (ICER)	After enrollment up to 57 months
Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)	At enrollment and week 24 after enrollment

Collaborators and Investigators

• Sponsor: Comprehensive Support Project for Oncology Research
• Investigators: Principal Investigator: Hironobu Minami, Kobe University Graduate School

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Carcinoma, Squamous Cell; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Stomach Neoplasms; Endometrial Neoplasms; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: PRO-MOTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No