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ePRO for Adjuvant Therapy of Gastric and Colorectal Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT04069455
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ding Ke-Feng, Zhejiang University

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 gastric and colorectal cancer who received Oxaliplatin-based adjuvant chemotherapy.The prognosis will also be studied.

Condition or disease Intervention/treatment Phase
Gastric Carcinoma Colorectal Carcinoma Other: Electronic Patients Reported Outcomes Not Applicable

Detailed Description:

The most of advanced gastric and colorectal carcinoma are underwent postoperative chemotherapy. Adverse events (AE) during chemotherapy disrupt treatment and impair the patients' quality of life(QoL). Under usual care, the patients are largely required to self-monitor symptoms at home. Patients can lack confidence in making decisions between obtaining clinical support or self-managing and can delay seeking medical advice, heightening the risk of symptom escalation and hospital admissions and impact the efficacy of chemotherapy finally. There is growing evidence that the utilisation of patient-reported outcome(PRO) measures can aid the timely identification of physical and psychosocial disorders, facilitate patient-doctor communication and assist decision-making. There has been a drive to develop electronic systems(ePRO) to allow remote real-time patient monitoring during cancer therapy. Positive patient benefit (including QOL and survival) was recently reported in a US trial of an online system for metastatic cancer treatment.

The trial is a prospective randomised two-arm parallel group design study with repeated measures and mixed methods. Participants (adult patients with gastric and colorectal cancer on adjuvant chemotherapy) are randomised to receive the ePRO intervention or usual care over 24 weeks of treatment. Participants in the intervention arm receive training in using the ePRO APP system to provide routine weekly adverse event reports from home. Hospital staff can access ePRO reports via APP and use the information during consultations or phone calls or message with patients. The overall target sample for the trial is N = 270. The primary outcome of is quality of life (EORTC QLQ-C30/CR29) with secondary outcomes including the proportion of completed chemotherapy, AE, DFS, OS and patient self-efficacy. Outcome data is collected at baseline, 3, 6 and 12 months. The intervention is also being evaluated via end of study interviews with patient participants and clinical staff.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: A Randomized, Multi-center, Prospective Study Evaluating e-Patient Report Outcomes (ePRO) for Adjuvant Chemotherapy in Chinese Patients With Gastric and Colorectal Cancers
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EPRO group
Clinical usual care plus ePRO App self-management online during postoperative adjuvant chemotherapy
Other: Electronic Patients Reported Outcomes
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
Other Name: ePRO

No Intervention: Control group
Clinical usual care during postoperative adjuvant chemotherapy



Primary Outcome Measures :
  1. Global health and functional scores [ Time Frame: 6 months after surgery ]
    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.

  2. C30 symptom scores [ Time Frame: 6 months after surgery ]
    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.

  3. CR29 scores [ Time Frame: 6 months after surgery ]
    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.


Secondary Outcome Measures :
  1. the incidence of adverse events [ Time Frame: baseline, 3, 6 and 12 months after surgery ]
    AE

  2. the proportion of completed chemotherapy [ Time Frame: 3 and 6 months after surgery ]
  3. Disease free survival [ Time Frame: 36 months after randomized ]
    DFS

  4. Overall survival [ Time Frame: 36 months after randomized ]
    OS



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 to 75 years old (inclusive), regardless of gender.
  2. Patients with gastric cancer or colorectal cancer diagnosed by cytology or histopathology.
  3. The patient underwent radical surgery for cancer. Radical surgery is defined as routine laparotomy or laparoscopic radical surgery for the purpose of radical
  4. The ECOG performance status is 0 to 2 points and able to receive adjuvant chemotherapy.
  5. Patients must be randomized within 2 months after the surgery.
  6. 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).
  7. Oxaliplatin regimen is planned to be used for postoperative adjuvant chemotherapy for 3 to 6 months
  8. The blood pregnancy test results of women of childbearing age must be negative within 7 days prior to randomization.
  9. 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%.

  10. 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.

Exclusion Criteria:

  1. <18 years old or >75 years old.
  2. Other tumors except gastric and colorectal cancer.
  3. Metastasis has occurred.
  4. Female during pregnancy or lactation.
  5. A history of other malignant tumors within 5 years, except for adequately treated basal cell carcinoma or squamous cell carcinoma or carcinoma in situ.
  6. The patient is known to be allergic to oxaliplatin, 5-FU, folinic acid or any excipients of these products.
  7. Evidence of any severe or uncontrolled systemic disease, including but not limited to:

    1. Unstable or decompensated respiratory, cardiac, liver or kidney disease;
    2. HIV infection;
    3. Uncontrol high blood pressure, diabetes;
    4. Severe arrhythmia;
    5. Massive active bleeding.
  8. A history of alcohol abuse or drug abuse.
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069455


Contacts
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Contact: Lifeng Sun, MD +86-571-87783583 sunlifeng@zju.edu.cn
Contact: kefeng Ding, MD +86-571-87783583 Dingkefeng@zju.edu.cn

Locations
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China
GuoXiang Cai
Shanghai, China
Contact: GuoXiang Cai, MD         
Jianmin Xu
Shanghai, China
Contact: Jianmin Xu, MD         
Sponsors and Collaborators
Zhejiang University
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Responsible Party: Ding Ke-Feng, Principal Investigator, Zhejiang University
ClinicalTrials.gov Identifier: NCT04069455    
Other Study ID Numbers: CRCCZ-ePRO2
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ding Ke-Feng, Zhejiang University:
electronic patient reported outcomes
gastric carcinoma
colorectal carcinoma
adjuvant chemotherapy
quality of life
Additional relevant MeSH terms:
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Carcinoma
Colorectal Neoplasms
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases