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

April 22, 2024 updated by: Comprehensive Support Project for Oncology Research

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: After enrollment to death from any cause (up to 57 months)
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
Time Frame: At enrollment and week 4,8,12,16,20 and 24 after enrollment
At enrollment and week 4,8,12,16,20 and 24 after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) domain score
Time Frame: At enrollment and week 4,8,12,16,20 and 24 after enrollment
At enrollment and week 4,8,12,16,20 and 24 after enrollment
HRQoL EQ-5D-5L index score
Time Frame: At enrollment and every 4 weeks after enrollment up to 57 months
At enrollment and every 4 weeks after enrollment up to 57 months
Quality-adjusted life year (QALY) score
Time Frame: After enrollment to death from any cause (up to 57 months)
After enrollment to death from any cause (up to 57 months)
At-home mortality rate
Time Frame: After enrollment to death from any cause (up to 57 months)
After enrollment to death from any cause (up to 57 months)
Time from last completion of drug therapy to death
Time Frame: Time from last completion of drug therapy to death from any cause (up to 57 months)
Time from last completion of drug therapy to death from any cause (up to 57 months)
Number of unscheduled hospital visits during drug therapy
Time Frame: After enrollment up to 24 weeks
After enrollment up to 24 weeks
Relative Dose Intensity (RDI)
Time Frame: After enrollment up to 24 weeks
After enrollment up to 24 weeks
Total number of drug regiments
Time Frame: After enrollment up to 57 months
After enrollment up to 57 months
Incremental Cost-Effectiveness Ratio (ICER)
Time Frame: After enrollment up to 57 months
After enrollment up to 57 months
Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)
Time Frame: At enrollment and week 24 after enrollment
At enrollment and week 24 after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Comprehensive Support Project for Oncology Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hironobu Minami, Kobe University Graduate School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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