Dataset Information

Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol.

ABSTRACT:

Introduction

An electronic Patient-Reported Outcome (ePRO) platform is needed for implementing evidence-based symptom management in outpatients with advanced cancer. We describe the overall protocol and the methodology for measuring symptom burden, to provide critical parameters needed to implement symptom management on the ePRO platform.

Methods and analysis

The study focusses on patients with advanced lung cancer, stomach cancer, oesophagus cancer, liver cancer, colorectal cancer or breast cancer. The primary outcome is the change of symptom burden. MD Anderson Symptom Inventory, and other PRO instruments (Insomnia Severity Index, Hospital Anxiety and Depression Scale, 9-item Patient Health Questionnaire and EuroQol-5 dimensions-5 levels version) were used. The secondary outcomes include feasibility of using ePRO, symptom-related quality of life, reasons for no improvement of symptoms, defining frequency of PRO assessments and cut-points, items for screening and management of comorbidity and satisfaction with ePRO platform in patients and health providers. After initial outpatient visit for baseline assessment, ePRO system will automatically send follow-up notification seven times over 4 weeks to patients. The characteristics and changing trajectory of symptoms of patients will be described. Parameters for using PROs, such as optimal time points for follow-up and cut-off point for alert will be determined. The feasibility of ePRO platform to track the changes of target symptoms in outpatients will be evaluated.

Ethics and dissemination

The study protocol and related documents were approved by the Institutional Research Board (IRB) of Peking University Cancer Hospital on 13 February 2019 (2019YJZ07). The results of this study will be disseminated through academic workshops, peer-reviewed publications and conferences.

Trial registration number

ChiCTR1900023560.

SUBMITTER: Tang L

PROVIDER: S-EPMC7682447 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol.

Tang Lili L Pang Ying Y He Yi Y Shi Qiuling Q Han Xinkun X Li Zimeng Z Zhou Chengcheng C Zhou Yuhe Y He Shuangzhi S Wang Yan Y Zhang Yening Y Song Lili L Wang Bingmei B Li Xiumin X

BMJ open 20201120 11

<h4>Introduction</h4>An electronic Patient-Reported Outcome (ePRO) platform is needed for implementing evidence-based symptom management in outpatients with advanced cancer. We describe the overall protocol and the methodology for measuring symptom burden, to provide critical parameters needed to implement symptom management on the ePRO platform.<h4>Methods and analysis</h4>The study focusses on patients with advanced lung cancer, stomach cancer, oesophagus cancer, liver cancer, colorectal cance ...[more]

PMID: 33444183

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Project description:IntroductionCancer patients experience different complications and outcomes during or after medical treatments. Electronic reporting of the outcomes by patients is a solution that facilitates communication with physicians and improve patient health status. The aim of this study was to develop a smartphone-based application for electronic reporting of outcomes by patients with prostate cancer.MethodsThe present research was conducted in 2021 in two phases. In the first phase, initially, users' requirements were identified based on reviewing the related literature, existing applications, and guidelines. Then, a questionnaire was designed and the specialists' opinions about the users' requirements were investigated. The specialties included urologists, hemato-oncologists, uro-oncologists, and radiotherapists (n = 15). In the second phase, the application was designed, and patients with prostate cancer (n = 21) and specialists (n = 10) evaluated it using the post-study system usability questionnaire (PSSUQ). Data were analyzed using descriptive statistics.ResultsThe findings of the first phase of the research showed that out of 108 data elements and functions proposed for the application, 91 items were found essential by the specialists. Data elements were categorized into the patient data, general complications of prostate cancer and side effects of drug therapy, surgery, chemotherapy, cryotherapy, radiation therapy, and hormone therapy. Necessary functions for the application included presenting a patient care summary, communication between the patient and the specialist, free text explanation for complications and sides effects, generating reports, reminder and alert, completing quality of life questionnaire, and calculating the score for the questionnaire. In the second phase of the research, the application was developed and evaluated. The mean value for user satisfaction was (5.95 ± 0.55) out of 7.ConclusionThe developed application can help to accelerate communication with the specialists. It can improve quality of care, reduce unnecessary treatment visits and side effects, and improve timely data collection for a variety of research purposes. However, further research on the cost-effectiveness and usefulness of the collected data is recommended.

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Dataset Information

Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol.

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