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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04684095
• Other study ID #: EPRO-CRCQoL-1L
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: July 2021
• Source: Harbin Medical University
• Contact: Yanqiao Zhang, PhD
• Phone: 13845120210
• Email: yanqiaozhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 338
• Est. completion date: June 15, 2024
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Behavioral:
• electronic patient report outcome
ePRO was conducted every two weeks in addition to routine follow-up

Locations

Country	Name	City	State
China	Harbin Medical University Hospital	Harbin

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accuracy of PRO to predict disease progression	To obtain a scale that can indicate disease progression of metastatic colorectal cancer and to determine the correlation coefficient between the item score of the scale and the degree of disease progression. A multi-item scale was put into this study, and the correlation between the items in the scale and disease progression was analyzed after the study.According to the correlation screening items, a scale was obtained to indicate the progression of metastatic colorectal cancer, and the correlation coefficient between the score of items in the scale and the degree of disease progression was calculated.The patient's disease progression will be determined by a combination of imaging and clinical symptoms	2 year
Other	Economic assessment for ePRO compared to regular follow-up	the index for the incremental cost-effectiveness ratio (ICUR=?C/?QALY ), ePRO group patients compared to regular follow-up group patients, each for a unit of quality adjusted life years (QALY ), the extra cost	2 year
Primary	Changes of quality of life (QoL) at 1 year after randomization compared with baseline	The European Cancer Research and Treatment Collaboration (EORTC) Core Quality of Life Questionnaire (QLQ-C30) was used to assess patients' quality of life at 1 year after randomization (day 1). Proportion of improved/stable patients was considered as prespecified main endpoint. Improvement: at least 10 points improvement in Global Health status; Deterioration: Global Health status (Items 29 and 30 standardized score in QLQ-C30) decreased by at least 10 points; Other conditions are stable. Scoring method: In order to make the scores can be compared with each other, the range method is further adopted to carry out linear transformation, the Score for the field (RS,Raw Score) is obtained by adding up the Score of the items included in each field and dividing by the number of items included, and the crude scores are converted into standardized scores within 0-100.	from randomization (day 1) up to 1 year
Secondary	2-year survival rate	The probability of survival for 2 years from randomization. The patient's death for any cause is regarded as an end-point event. The time of death was recorded as the end event time. If no death was observed during the follow-up period, the date of the last confirmed survival was used as the time of deletion	2 year
Secondary	Absolute changes of quality of life (QoL) compared with baseline	The European Cancer Research and Treatment Collaboration Quality of Life Questionnaire-Colorectal Cancer 29 (EORTC QLQ-CR29). Standardized scores within 0-100. Describe the change in score.	from randomization (day 1) up to two year
Secondary	Progression-free survival (PFS)	The time from randomization to the first occurrence of disease progression or death from all causes (whichever occurs first). If disease progression and death were not observed during follow-up, the date of the last tumor evaluation was used as the deletion time of PFS.	2 year
Secondary	Performance Status score at first disease progression	Zubrod-Eastern Cooperative Oncology Group(ECOG)-World Health Organization(WHO) was used to assess patients' performance status score for for patients with first disease progression after randomization. A minimum score of 0 is the best performance status; A maximum score of 5 is worst performance status.	from randomization (day 1) up to two year
Secondary	Time to deterioration (TTD)	The time from randomization until patients reported the first deterioration (=10 points from baseline) on each of the European Cancer Research and Treatment Collaboration (EORTC) Core Quality of Life Questionnaire(QLQ-C30) / The European Cancer Research and Treatment Collaboration Quality of Life Questionnaire-Colorectal Cancer 29 subscales (standardized scores within 0-100), and this was true for both consecutive evaluations, or for only one evaluation but death from any cause within the following 3 weeks.	2 year
Secondary	Patient compliance	Patients who submit the electronic-Patient-Reported Outcomes questionnaire as required are considered to be completed	2 year
Secondary	Patient satisfaction	Patients were followed up every 3 months for a satisfaction survey	2 year