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

Harbin Medical University

Status

Enrolling

Conditions

Cancer

Colorectal Cancer Metastatic

Treatments

Behavioral: electronic patient report outcome

Study type

Interventional

Funder types

Other

Identifiers

NCT04684095

EPRO-CRCQoL-1L

Details and patient eligibility

About

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.

Enrollment

338 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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