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

NCT04684095 | Unknown

• 1 other identifier: EPRO-CRCQoL-1L
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Metastatic; Cancer

Keywords

Patient-Reported Outcomes; QoL; mCRC; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 2-year survival rate

  2 year

• Absolute changes of quality of life (QoL) compared with baseline

  from randomization (day 1) up to two year

• Progression-free survival (PFS)

  2 year

• Performance Status score at first disease progression

  from randomization (day 1) up to two year

• Time to deterioration (TTD)

  2 year

Other Outcomes (2)

• Accuracy of PRO to predict disease progression

  2 year

• Economic assessment for ePRO compared to regular follow-up

  2 year

Study Arms (2)

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.

Behavioral: electronic patient report outcome

Interventions

electronic patient report outcome BEHAVIORAL

ePRO was conducted every two weeks in addition to routine follow-up

ePRO group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

Harbin Medical University Hospital

Harbin, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Yanqiao Zhang

  Harbin Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanqiao Zhang, PhD

CONTACT

13845120210; yanqiaozhang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the hospital

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 24, 2020
• Study Start: May 26, 2021
• Primary Completion: February 15, 2022
• Study Completion: June 15, 2024
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

CN (1)