Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Colorectal Carcinoma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

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 confide...

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.

Tracking Information

NCT #
NCT04069455
Collaborators
Not Provided
Investigators
Principal Investigator: Kefeng Ding, MD Second Affiliated Hospital, Zhejiang University School of Medicine