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Colorectal CarcinomaNCT04069455

ePRO for Adjuvant Therapy of Colorectal Adenocarcinoma

A study testing Electronic Patients Reported Outcomes in people with Colorectal Carcinoma, run by Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Carcinoma
What is being tested?
Electronic Patients Reported Outcomes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteChina
Study dates
1 Oct 2019to 30 Sep 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 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).
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  • 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:
  • 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.

Who cannot join

  • <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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Lifeng Sun, MD contact

+86-571-87783583

sunlifeng@zju.edu.cn

kefeng Ding, MD contact

+86-571-87783583

Dingkefeng@zju.edu.cn

China1 site, 1 recruiting

  • GuoXiang Cai

    Shanghai, Shanghai Municipality

    GuoXiang Cai, MD, gxcai@fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Multi-center, Prospective Study Evaluating e-Patient Report Outcomes (ePRO) for Adjuvant Chemotherapy in Chinese Patients With Colorectal Cancers

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.

Read the detailed description

The most of advanced 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 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.

Being tested
Electronic Patients Reported Outcomes
Keywords
electronic patient reported outcomes, colorectal carcinoma, adjuvant chemotherapy, quality of life
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic Patients Reported OutcomesOther

    Also called ePRO

    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

Study groups in NCT04069455
Study groupRoleWhat they receive
EPRO groupExperimentalClinical usual care plus ePRO App self-management online during postoperative adjuvant chemotherapy
Receives: Other: Electronic Patients Reported Outcomes
Control groupNo interventionClinical usual care during postoperative adjuvant chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months after surgery

  2. 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.

    Measured: 6 months after surgery

  3. 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.

    Measured: 6 months after surgery

Secondary outcomes (4)

  1. the incidence of adverse events

    AE

    Measured: baseline, 3, 6 and 12 months after surgery

  2. the proportion of completed chemotherapy

    Measured: 3 and 6 months after surgery

  3. Disease free survival

    DFS

    Measured: 36 months after randomized

  4. Overall survival

    OS

    Measured: 36 months after randomized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start1 Oct 2019
  3. Primary completion1 Oct 2021 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04069455
Sponsor's protocol ID
CRCCZ-ePRO2
Status last verified
Sep 2021
First submitted
22 Aug 2019
Last updated
17 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Electronic Patients Reported Outcomes in people with Colorectal Carcinoma, run by Zhejiang 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 11 inclusion and 14 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 17 Sep 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 Lifeng Sun, MD (+86-571-87783583, sunlifeng@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global health and functional scores (time frame: 6 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04069455.

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 17 Sep 2021.

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