Clinical trial NCT04684095: The Effect of ePRO on Quality of Life and Prognosis of Patients With Unresectable Metastatic Colorectal Cancer
Official title: The Effect of ePRO on Quality of Life and Prognosis of Patients With Unresectable Metastatic Colorectal Cancer Who Received Bevacizumab Combined With Chemotherapy for First Line Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer Metastatic
Cancer
Keywords: Patient-Reported Outcomes
QoL
mCRC
Bevacizumab
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Changes of quality of life (QoL) at 1 year after randomization compared with baseline
timeFrame: from randomization (day 1) up to 1 year
Secondary outcomes:
measure: 2-year survival rate
timeFrame: 2 year
measure: Absolute changes of quality of life (QoL) compared with baseline
timeFrame: from randomization (day 1) up to two year
measure: Progression-free survival (PFS)
timeFrame: 2 year
measure: Performance Status score at first disease progression
timeFrame: from randomization (day 1) up to two year
measure: Time to deterioration (TTD)
timeFrame: 2 year
measure: Patient compliance
timeFrame: 2 year
measure: Patient satisfaction
timeFrame: 2 year
Other outcomes:
measure: Accuracy of PRO to predict disease progression
timeFrame: 2 year
measure: Economic assessment for ePRO compared to regular follow-up
timeFrame: 2 year
Locations:
city: Harbin
country: China
facility: Harbin Medical University Hospital
Study officials:
affiliation: Harbin Medical University Hospital
name: Yanqiao Zhang
role: PRINCIPAL_INVESTIGATOR
References: