The Effect of ePRO on Quality of Life and Prognosis of Patients With Unresectable Metastatic Colorectal Cancer

NCT ID: NCT04684095

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-26
• Study Completion Date: 2024-06-15

Brief Summary

Bevacizumab combined with fluorouracil-based chemotherapy is the first-line standard treatment for patients with metastatic colorectal cancer (mCRC). However, some research show that the long-term survival benefit of patients in real world data is inferior to clinical trial. The reason may be related to the difference in follow-up strategy of patients in the real world. Patient-Reported Outcomes (PROs) are a kind of outcome indicators that directly measure and evaluate the disease and its consequences based on how the patient feels about his own health. In advanced cancer, quality of life (QoL) is a major treatment goal. And the electronic patient report outcome (ePRO) has become an effective method to capture the symptoms of patients, which can improve the quality of life and physical and mental health of patients. In order to observe whether ePRO can bring clinical benefits to patients with metastatic colorectal cancer, this study aimed to compare the effects of ePRO and routine follow-up on the quality of life and prognosis of patients with unresectable metastatic colorectal cancer who received first-line bevacizumab combined with chemotherapy. This is an open label, multicenter, randomized controlled prospective study of first-line bevacizumab combined with chemotherapy in patients with unretractable metastatic colorectal cancer.The aim of this study was to assess the impact of ePRO on quality of life and survival outcomes compared with routine follow-up.The study intends to start in February 2021 and end in June 2024.Patients were recruited for 12 months and followed up for 24 months.The study included a screening period (28 days before first-line treatment to 1 day before treatment) and an observation period (from the beginning of treatment to the end of the study).Day 1 (baseline) was defined as the first day of first-line bevacizumab combined with chemotherapy.About 338 patients will be enrolled in the study in China, and enrolled patients will be randomly assigned to one of the following two groups in a 1:1 ratio.

Conditions

Colorectal Cancer Metastatic; Cancer

Study Design

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

Study Groups

routine follow-up group

only according to the routine follow-up frequency to the center visit.

Group Type: NO_INTERVENTION

No interventions assigned to this group

ePRO group

ePRO group : self-evaluation in ePRO mode was accepted, and the patients were visited in the center according to the routine follow-up frequency.

Group Type: EXPERIMENTAL

electronic patient report outcome

Intervention Type: BEHAVIORAL

ePRO was conducted every two weeks in addition to routine follow-up

Interventions

electronic patient report outcome

ePRO was conducted every two weeks in addition to routine follow-up

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients must have informed consent form (ICF) signed for the study
• Patients must be ≥18 years old when signing the ICF
• Histologically or cytologically-diagnosed unresectable metastatic colorectal cancer
• Patients must receive bevacizumab combined with chemotherapy for first-line systemic treatment
• The researcher believes that the patient is capable of implementing the research protocol

Exclusion Criteria

• Patients has participated in any clinical trial in the past 4 weeks
• Patients is currently or about to participate in a clinical trial
• Patients with other malignant tumors (except carcinoma in situ)
• Patients with lung metastases only
• Patients with evidence of any serious or uncontrolled systemic disease, including but not limited to: unstable or decompensated respiratory, heart, liver or kidney disease, HIV infection, uncontrolled hypertension, diabetes, severe arrhythmia, massive hemorrhagic activity, etc
• Patients with history of alcohol or drug abuse
• According to the researcher's judgment, the possibility of inclusion is low (including inability to understand the study requirements, poor compliance, weakness, inability to ensure that the protocol can be implemented as required, etc.), or the researcher believes that other factors are not suitable for this study

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

Sponsors

Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yanqiao Zhang

Director of the hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanqiao Zhang

Role: PRINCIPAL_INVESTIGATOR

Harbin Medical University Hospital

Locations

Harbin Medical University Hospital

Harbin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanqiao Zhang, PhD

Role: CONTACT

yanqiaozhang@126.com

13845120210

Facility Contacts

Yanqiao Zhang, phD

Role: primary

Other Identifiers

EPRO-CRCQoL-1L

Identifier Type: -

Identifier Source: org_study_id