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

NCT ID: NCT05931445

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2027-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monitoring group

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

Group Type: EXPERIMENTAL

e-PRO monitoring

Intervention Type: OTHER

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.

Non-monitoring group

Standard care of treatment will be given without ePRO monitoring.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comprehensive Support Project for Oncology Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hironobu Minami

Role: PRINCIPAL_INVESTIGATOR

Kobe University Graduate School

Locations

Kobe University Graduate School

Kobe, Hyōgo, Japan

Countries

Japan

Other Identifiers

PRO-MOTE

Identifier Type: -

Identifier Source: org_study_id