NCT04069455

ePRO for Adjuvant Therapy of Colorectal Adenocarcinoma

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-10-01
• Completion: 2024-09-30
• First posted: 2019-08-28
• Last updated: 2021-09-17

Locations

1 site across 1 country: China