Colorectal Cancer MetastaticNCT04684095
The Effect of ePRO on Quality of Life and Prognosis of Patients With Unresectable Metastatic Colorectal Cancer
A study testing electronic patient report outcome in people with Colorectal Cancer Metastatic and Cancer, run by Harbin Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Cancer
- What is being tested?
- electronic patient report outcome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2021to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Harbin Medical University Hospital
Harbin
Yanqiao Zhang, phD
About this study
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
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
- Being tested
- electronic patient report outcome
- Keywords
- Patient-Reported Outcomes, QoL, mCRC, Bevacizumab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic patient report outcomeBehavioural
ePRO was conducted every two weeks in addition to routine follow-up
| Study group | Role | What they receive |
|---|---|---|
| routine follow-up group | No intervention | only according to the routine follow-up frequency to the center visit. |
| ePRO group | Experimental | ePRO group : self-evaluation in ePRO mode was accepted, and the patients were visited in the center according to the routine follow-up frequency. Receives: Behavioral: electronic patient report outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from randomization (day 1) up to 1 year
Secondary outcomes (7)
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
Measured: 2 year
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.
Measured: from randomization (day 1) up to two year
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.
Measured: 2 year
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.
Measured: from randomization (day 1) up to two year
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.
Measured: 2 year
Patient compliance
Patients who submit the electronic-Patient-Reported Outcomes questionnaire as required are considered to be completed
Measured: 2 year
Patient satisfaction
Patients were followed up every 3 months for a satisfaction survey
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start26 May 2021
- Primary completion15 Feb 2022 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqiao Zhang, Harbin Medical University
- Investigators
- Yanqiao Zhang, Principal investigator, Harbin Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684095
- Sponsor's protocol ID
- EPRO-CRCQoL-1L
- Status last verified
- Jul 2021
- First submitted
- 9 Dec 2020
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04684095
- Acronym / sponsor ID
- EPRO-CRCQoL-1L
- Conditions
- Colorectal Cancer Metastatic, Cancer
- Keywords
- Patient-Reported Outcomes, QoL, mCRC, Bevacizumab
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 15 Feb 2022 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine follow-up group | No intervention | –only according to the routine follow-up frequency to the center visit. |
| ePRO group | Experimental | Behavioral: electronic patient report outcomeePRO group : self-evaluation in ePRO mode was accepted, and the patients were visited in the center according to the routine follow-up frequency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic patient report outcomeePRO was conducted every two weeks in addition to routine follow-up | Behavioural | ePRO group |
Primary outcome
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.
7 secondary outcomes
2-year survival rate
Time frame: 2 year
Absolute changes of quality of life (QoL) compared with baseline
Time frame: from randomization (day 1) up to two year
Progression-free survival (PFS)
Time frame: 2 year
Performance Status score at first disease progression
Time frame: from randomization (day 1) up to two year
Time to deterioration (TTD)
Time frame: 2 year
Patient compliance
Time frame: 2 year
Patient satisfaction
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
Related trials for Colorectal Cancer Metastatic
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqiao Zhang principal investigator
Harbin Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic patient report outcome in people with Colorectal Cancer Metastatic and Cancer, run by Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqiao Zhang, PhD (13845120210, yanqiaozhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of quality of life (QoL) at 1 year after randomization compared with baseline (time frame: from randomization (day 1) up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.