Trials Sponsors Conditions Drugs Pricing

Conditions

Colorectal Carcinoma

Keywords

electronic patient reported outcomescolorectal carcinomaadjuvant chemotherapyquality 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 OutcomesOther

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Zhejiang University
Otherlead

Study Sites (1)

GuoXiang Cai

Shanghai, Shanghai Municipality, China

RECRUITING

GuoXiang Cai, MDCONTACTgxcai@fudan.edu.cn

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal 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

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

Actual (reported)

Primary Completion

October 1, 2021

Estimated (date passed)

ePRO for Adjuvant Therapy of Colorectal Adenocarcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

EPRO group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

EPRO group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations