NCT07144449

Nurse-Led Electronic Patient-Reported Outcome System to Improve Quality of Life in Chemotherapy Patients

Effect of Information-based Symptom Management on the Quality of Life of Cancer Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: CHIAO-CHI KUAN · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy often causes burdensome symptoms that affect daily life and reduce patients' quality of life. This study aims to test whether an information-based symptom management program can help cancer patients better manage their symptoms, improve self-care ability, and enhance quality of life. The program was developed by nurses and delivered through a simple electronic platform, allowing patients to report symptoms such as fever, pain, shortness of breath, nausea, diarrhea, fatigue, or anxiety. Patients in the intervention group will receive tailored self-care advice and weekly nurse follow-up calls, while the control group will receive usual care. The study will compare outcomes in symptom self-management, quality of life, and health literacy between the two groups over 12 weeks.

Detailed description

This study is a single-center, two-arm, parallel-group randomized controlled trial designed to evaluate the effectiveness of a nurse-led electronic patient-reported outcome (ePRO) system for symptom management in patients receiving chemotherapy. Participants will be randomized 1:1 into the intervention group or control group. Intervention group: Participants will use the nurse-led ePRO system to report weekly symptoms over 12 weeks. The system automatically provides tailored, evidence-based self-care advice and triggers nurse follow-up, including weekly phone calls when severe symptoms are reported.Control group: Participants will receive standard oncology care without access to the ePRO system. Symptom monitoring and management will follow routine clinical practice.Three validated tools will be used to measure outcomes at four time points (baseline, week 4, week 8, and week 12): Partners in Health (PIH) Scale - symptom self-management Functional Assessment of Cancer Therapy-General (FACT-G) - quality of life Mandarin Multidimensional Health Literacy Questionnaire (MMHLQ) - health literacy The primary outcomes are changes in self-management and quality of life, while the secondary outcome is health literacy. Statistical analyses will follow the intention-to-treat principle, and group differences over time will be evaluated using linear mixed-effects models. This trial aims to provide high-quality evidence on the effectiveness of a nurse-led, digitally delivered intervention for improving self-management, quality of life, and health literacy in patients undergoing chemotherapy.

Conditions

• Neoplasms
• Nursing Caries

Interventions

Type	Name	Description
BEHAVIORAL	Nurse-Led ePRO System	A nurse-designed electronic patient-reported outcome (ePRO) system for chemotherapy patients. Participants complete weekly symptom assessments for 12 weeks through an electronic platform. The system provides automated feedback, evidence-based self-care advice, and alerts to oncology nurses. Nurses follow up with weekly phone calls if severe symptoms are reported. This intervention is intended to improve symptom self-management, quality of life, and health literacy.
BEHAVIORAL	Usual Care	Participants will receive standard oncology care without the use of an ePRO system. Symptom monitoring and management will be provided according to routine clinical practice by the treating oncology team, typically during scheduled visits or when patients proactively report problems.

Timeline

• Start date: 2024-05-04
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: Taiwan