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NCT Number: NCT07144449

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

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.

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Key information

Conditions

Neoplasms Nursing Caries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Cancer Center

Taipei County, Taipei, 106, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Nurse-Led ePRO System

Behavioral

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.

Usual Care

Behavioral

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.

Primary outcomes

  1. Health-Related Quality of Life

    Time frame: Baseline, Week 4, Week 8, Week 12

    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.

Secondary outcomes

  1. Self-Management

    Time frame: Baseline, Week 4, Week 8, Week 12

    Symptom self-management will be evaluated using the Partners in Health (PIH) Scale. The PIH consists of 12 items scored on a 9-point Likert scale. The total score ranges from 0 to 96, with higher scores indicating better self-management ability.

  2. Health Literacy

    Time frame: Baseline, Week 4, Week 8, Week 12

    The MMHLQ includes 20 items rated on a 4-point Likert scale. The total score ranges from 20 to 80, with higher scores indicating better health literacy.

Sponsors and collaborators

Lead sponsor

CHIAO-CHI KUAN

Other

Registry information

Official study title

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

Acronym: NURSE-PRO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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