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

July 7, 2021 updated by: Yanqiao Zhang, Harbin Medical University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
338

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Harbin, China
        • Recruiting
        • Harbin Medical University Hospital
        • Contact:
          • Yanqiao Zhang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: routine follow-up group
only according to the routine follow-up frequency to the center visit.
EXPERIMENTAL: 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.
Behavioral: electronic patient report outcome
ePRO was conducted every two weeks in addition to routine follow-up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes of quality of life (QoL) at 1 year after randomization compared with baseline
Time Frame: from randomization (day 1) up to 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
2-year survival rate
Time Frame: 2 year
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
Absolute changes of quality of life (QoL) compared with baseline
Time Frame: from randomization (day 1) up to two year
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
Progression-free survival (PFS)
Time Frame: 2 year
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
Performance Status score at first disease progression
Time Frame: from randomization (day 1) up to two year
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
Time to deterioration (TTD)
Time Frame: 2 year
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
Patient compliance
Time Frame: 2 year
Patients who submit the electronic-Patient-Reported Outcomes questionnaire as required are considered to be completed
2 year
Patient satisfaction
Time Frame: 2 year
Patients were followed up every 3 months for a satisfaction survey
2 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy of PRO to predict disease progression
Time Frame: 2 year
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
Economic assessment for ePRO compared to regular follow-up
Time Frame: 2 year
the index for the incremental cost-effectiveness ratio (ICUR=ΔC/ΔQALY ), 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harbin Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yanqiao Zhang, Harbin Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EPRO-CRCQoL-1L

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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