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
|Condition or disease||Intervention/treatment||Phase|
|Gastric Carcinoma Colorectal Carcinoma||Other: Electronic Patients Reported Outcomes||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- 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.
- 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.
- 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.
- the incidence of adverse events [ Time Frame: baseline, 3, 6 and 12 months after surgery ]AE
- the proportion of completed chemotherapy [ Time Frame: 3 and 6 months after surgery ]
- Disease free survival [ Time Frame: 36 months after randomized ]DFS
- Overall survival [ Time Frame: 36 months after randomized ]OS
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069455
|Contact: Lifeng Sun, MDfirstname.lastname@example.org|
|Contact: kefeng Ding, MD||+86-571-87783583||Dingkefeng@zju.edu.cn|
|Contact: GuoXiang Cai, MD|
|Contact: Jianmin Xu, MD|