Effect of Information-based Symptom Management on the Quality of Life of Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Health-Related Quality of Life
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nurse-Led ePRO System
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.
Intervention: Nurse-Led ePRO System (Behavioral)
Usual Care
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.
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
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
- Self-Management(Baseline, Week 4, Week 8, Week 12)
- Health Literacy(Baseline, Week 4, Week 8, Week 12)
Investigators
CHIAO-CHI KUAN
Registered Nurse (RN)
National Taiwan University