ePRO for Adjuvant Therapy of Colorectal Adenocarcinoma

NCT04069455 | Unknown

• 1 other identifier: CRCCZ-ePRO2
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

It is a multi-centric randomized controlled trial. The goal of this study is to observe the improvement of QoL using ePRO to manage patients with colorectal cancer who received Oxaliplatin-based adjuvant chemotherapy.The prognosis will also be studied.

Conditions

Colorectal Carcinoma

Keywords

electronic patient reported outcomes; colorectal carcinoma; adjuvant chemotherapy; quality of life

Outcome Measures

Primary Outcomes (3)

• Global health and functional scores

  Global health and functional scores will be evaluated by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 version 3.0 (EORTC QLQ-C30) questionnaire.It comprises a two-item global health status domain and five multi-item functional domains (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning); Items were scaled and scored according to the EORTC Scoring Manual. Raw scores were transformed to a linear scale ranging from 0 to 100. For scores measuring global health status and functional domains, a higher score represents a 'better' level of status or functioning.

  6 months after surgery

• C30 symptom scores

  C30 symptom scores will be evaluated by EORTC QLQ-C30 questionnaire. It comprises three multi-item symptom domains (fatigue, pain, and nausea and vomiting); and six single-item domains for the assessment of additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and the perceived financial impact of the disease and treatment. Items were scaled and scored according to the EORTC Scoring Manual. Raw scores were transformed to a linear scale ranging from 0 to 100. A higher score for symptom domains represents a 'worse' level of symptoms.

  6 months after surgery

• CR29 scores

  CR29 scores will be evaluated by European Organization for Research and Treatment of Cancer (EORTC) questionnaire module for colorectal cancer, the QLQ-CR29. It was created with six hypothesised scales (micturition, pain, faecal incontinence, defaecation problems, anxiety and body image) and 11 single items. Raw scores were transformed to a linear scale ranging from 0 to 100.a high score for a symptom scale represents a high level of symptomatology or problems.

  6 months after surgery

Secondary Outcomes (4)

• the incidence of adverse events

  baseline, 3, 6 and 12 months after surgery

• the proportion of completed chemotherapy

  3 and 6 months after surgery

• Disease free survival

  36 months after randomized

• Overall survival

  36 months after randomized

Study Arms (2)

EPRO group

EXPERIMENTAL

Clinical usual care plus ePRO App self-management online during postoperative adjuvant chemotherapy

Other: Electronic Patients Reported Outcomes

Control group

NO INTERVENTION

Clinical usual care during postoperative adjuvant chemotherapy

Interventions

Electronic Patients Reported Outcomes OTHER

ePRO is a application which is web based and accessible from home or mobile device, for patients to complete symptom reports and receive severity-based advice

Also known as: ePRO

EPRO group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years old (inclusive), regardless of gender.
• Patients with colorectal cancer diagnosed by cytology or histopathology.
• The patient underwent radical surgery for cancer. Radical surgery is defined as routine laparotomy or laparoscopic radical surgery for the purpose of radical
• The ECOG performance status is 0 to 2 points and able to receive adjuvant chemotherapy.
• Patients must be randomized within 2 months after the surgery.
• According to the investigator's judgment, the patient has recovered from surgical side effects after radical surgery (e.g., the wound has healed fully without complications).
• Oxaliplatin regimen is planned to be used for postoperative adjuvant chemotherapy for 3 to 6 months
• The blood pregnancy test results of women of childbearing age must be negative within 7 days prior to randomization.
• The main organs function well. That is, the relevant inspection indexes within 14 days prior to enrollment meet the following requirements:
• a) Routine blood test: i. Leukocyte≥ 4.0×109/L; ii. Neutrophil count \> 1.5×109/L; iii. Blood platelet count \> 80×109/L; iv. Hemoglobin \> 90 g/L (No blood transfusion in 14 days); b) Biochemistry test: i. TBil ≤ 1.5×ULN (upper limit of normal); ii. Blood glutamic alanine aminotransferas (ALT) or serum aspartate aminotransferase (AST) ≤ 2.5×ULN; iii. Endogenous creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula); c) Cardiac doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ 50%.
• The patient has provided written informed consent prior to any study-specific procedures, and is willing and able to be present during the study and follow the study procedure during treatment and follow-up.

You may not qualify if:

• \<18 years old or \>75 years old.
• Other tumors except gastric and colorectal cancer.
• Metastasis has occurred.
• Female during pregnancy or lactation.
• A history of other malignant tumors within 5 years, except for adequately treated basal cell carcinoma or squamous cell carcinoma or carcinoma in situ.
• The patient is known to be allergic to oxaliplatin, 5-FU, folinic acid or any excipients of these products.
• Evidence of any severe or uncontrolled systemic disease, including but not limited to:
• Unstable or decompensated respiratory, cardiac, liver or kidney disease;
• HIV infection;
• Uncontrol high blood pressure, diabetes;
• Severe arrhythmia;
• Massive active bleeding.
• A history of alcohol abuse or drug abuse.
• As judged by the investigator, there is a low likelihood of enrollment (including inability to understand study requirements, poor compliance, infirmity, inability to ensure that the protocol can be followed as required, etc.), or there are other factors considered by the investigator to be unsuitable for this study.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

GuoXiang Cai

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Kefeng Ding, MD

  Second Affiliated Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lifeng Sun, MD

CONTACT

+86-571-87783583; sunlifeng@zju.edu.cn

kefeng Ding, MD

CONTACT

+86-571-87783583; Dingkefeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: September 30, 2024
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

CN (1)