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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05931445
• Other study ID #: PRO-MOTE
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: March 31, 2027

Study information

• Verified date: May 2023
• Source: Comprehensive Support Project for Oncology Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Japan	Kobe University Graduate School	Kobe	Hyogo

Sponsors (1)

Lead Sponsor	Collaborator
Comprehensive Support Project for Oncology Research

Country where clinical trial is conducted

Japan, 

Outcome

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