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

Primary Purpose

Breast Cancer, Lung Cancer, Colorectal Cancer

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
e-PRO monitoring
Sponsored by
Comprehensive Support Project for Oncology Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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) Aged 18 years or older at informed consent 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 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 Undergoing or scheduled to undergo radiation therapy for curative purposes Deemed otherwise unsuitable for the study by the investigator or sub-investigator Notes: 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.

Sites / Locations

  • Kobe University Graduate School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Monitoring group

Non-monitoring group

Arm Description

ePRO monitoring will be conducted once weekly after study enrollment, along with standard care of treatment.

Standard care of treatment will be given without ePRO monitoring.

Outcomes

Primary Outcome Measures

Overall Survival (OS)
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score

Secondary Outcome Measures

HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) domain score
HRQoL EQ-5D-5L index score
Quality-adjusted life year (QALY) score
At-home mortality rate
Time from last completion of drug therapy to death
Number of unscheduled hospital visits during drug therapy
Relative Dose Intensity (RDI)
Total number of drug regiments
Incremental Cost-Effectiveness Ratio (ICER)
Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)

Full Information

First Posted
June 5, 2023
Last Updated
June 27, 2023
Sponsor
Comprehensive Support Project for Oncology Research
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1. Study Identification

Unique Protocol Identification Number
NCT05931445
Brief Title
Patient Reported Outcomes Study Using Electronic Monitoring System for Advanced or Metastatic Solid Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Comprehensive Support Project for Oncology Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Stomach Cancer, Endometrial Cancer, Ovarian Cancer, Squamous Cell Carcinoma of the Head and Neck

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monitoring group
Arm Type
Experimental
Arm Description
ePRO monitoring will be conducted once weekly after study enrollment, along with standard care of treatment.
Arm Title
Non-monitoring group
Arm Type
No Intervention
Arm Description
Standard care of treatment will be given without ePRO monitoring.
Intervention Type
Other
Intervention Name(s)
e-PRO monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
After enrollment to death from any cause (up to 57 months)
Title
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
Secondary Outcome Measure Information:
Title
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
Title
HRQoL EQ-5D-5L index score
Time Frame
At enrollment and every 4 weeks after enrollment up to 57 months
Title
Quality-adjusted life year (QALY) score
Time Frame
After enrollment to death from any cause (up to 57 months)
Title
At-home mortality rate
Time Frame
After enrollment to death from any cause (up to 57 months)
Title
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)
Title
Number of unscheduled hospital visits during drug therapy
Time Frame
After enrollment up to 24 weeks
Title
Relative Dose Intensity (RDI)
Time Frame
After enrollment up to 24 weeks
Title
Total number of drug regiments
Time Frame
After enrollment up to 57 months
Title
Incremental Cost-Effectiveness Ratio (ICER)
Time Frame
After enrollment up to 57 months
Title
Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)
Time Frame
At enrollment and week 24 after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) Aged 18 years or older at informed consent 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 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 Undergoing or scheduled to undergo radiation therapy for curative purposes Deemed otherwise unsuitable for the study by the investigator or sub-investigator Notes: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hironobu Minami
Organizational Affiliation
Kobe University Graduate School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kobe University Graduate School
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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