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

• ClinicalTrials.gov Identifier: NCT04684095
• Recruitment Status: Recruiting
• First Posted: December 24, 2020
• Last Update Posted: July 9, 2021
• Sponsor: Harbin Medical University
• Information provided by (Responsible Party): Yanqiao Zhang, Harbin Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer Metastatic; Cancer	Behavioral: electronic patient report outcome	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 338 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: May 26, 2021
• Estimated Primary Completion Date: February 15, 2022
• Estimated Study Completion Date: June 15, 2024

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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. 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.
3. 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.
4. 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.
5. 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.
6. Patient compliance [ Time Frame: 2 year ]
   Patients who submit the electronic-Patient-Reported Outcomes questionnaire as required are considered to be completed
7. Patient satisfaction [ Time Frame: 2 year ]
   Patients were followed up every 3 months for a satisfaction survey

Other Outcome Measures:

1. 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. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Yanqiao Zhang, PhD; 13845120210; yanqiaozhang@126.com

Locations

China

Harbin Medical University Hospital; Recruiting

Harbin, China

Contact: Yanqiao Zhang, phD

Sponsors and Collaborators

Harbin Medical University

Investigators

• Principal Investigator: Yanqiao Zhang; Harbin Medical University Hospital

More Information

• Responsible Party: Yanqiao Zhang, Director of the hospital, Harbin Medical University
• ClinicalTrials.gov Identifier: NCT04684095
• Other Study ID Numbers: EPRO-CRCQoL-1L
• First Posted: December 24, 2020
• Last Update Posted: July 9, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yanqiao Zhang, Harbin Medical University:

Patient-Reported Outcomes; QoL; mCRC; Bevacizumab

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases