Nurse-Led Electronic Patient-Reported Outcome System to Improve Quality of Life in Chemotherapy Patients
NURSE-PRO
Effect of Information-based Symptom Management on the Quality of Life of Cancer Patients
2 other identifiers
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2025
CompletedFirst Submitted
Initial submission to the registry
August 19, 2025
CompletedFirst Posted
Study publicly available on registry
August 27, 2025
CompletedAugust 27, 2025
August 1, 2025
1.2 years
August 19, 2025
August 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health-Related Quality of Life
Quality of life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire. The FACT-G contains 27 items across four domains: Physical, Social/Family, Emotional, and Functional well-being. The total score ranges from 0 to 108, with higher scores indicating better quality of life.
Baseline, Week 4, Week 8, Week 12
Secondary Outcomes (2)
Self-Management
Baseline, Week 4, Week 8, Week 12
Health Literacy
Baseline, Week 4, Week 8, Week 12
Study Arms (2)
Nurse-Led ePRO System
EXPERIMENTALParticipants will use a nurse-led electronic patient-reported outcome (ePRO) system during chemotherapy. The system was designed by oncology nurses and allows patients to complete weekly symptom assessments for 12 weeks. Automated feedback and evidence-based self-care advice are provided. Alerts are triggered for severe symptoms, prompting follow-up by oncology nurses including weekly phone calls.
Usual Care
ACTIVE COMPARATORParticipants will receive standard oncology care without access to the ePRO system. Symptom monitoring and management will be provided according to routine clinical practice by the treating oncology team.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \- Adults aged 18 years or older
- Diagnosis of cancer and currently receiving chemotherapy
- Able to communicate in Mandarin Chinese
- Access to and ability to use a smartphone or tablet with internet connection
- Provide written informed consent
You may not qualify if:
- Cognitive impairment, severe psychiatric illness, or any condition that limits ability to complete questionnaires
- Physical or medical conditions judged by the treating physician to interfere with study participation
- Participation in another interventional trial that could confound study outcomes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHIAO-CHI KUANlead
Study Sites (1)
National Taiwan University Cancer Center
Taipei County, Taipei, 106, Taiwan
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Hsueh-Hsing Pan, RN, PhD
Graduate Institute of Nursing, School of Nursing, National Defense Medical Center, Taipei, Taiwan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Registered Nurse (RN)
Study Record Dates
First Submitted
August 19, 2025
First Posted
August 27, 2025
Study Start
May 4, 2024
Primary Completion
July 30, 2025
Study Completion
July 30, 2025
Last Updated
August 27, 2025
Record last verified: 2025-08