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

CHIAO-CHI KUAN

Status: Completed

Conditions: Neoplasms; Nursing Caries

Treatments: Behavioral: Nurse-Led ePRO System; Behavioral: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07144449

NTUCCS-112-23 (Other Grant/Funding Number)

202304084RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Nurse-Led ePRO System

Experimental group

Description:

Participants 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.

Treatment:

Behavioral: Nurse-Led ePRO System

Usual Care

Active Comparator group

Description:

Participants 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.

Treatment:

Behavioral: Usual Care