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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-04

Study Completion Date

2025-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nurse-led Care Program for Cancer Patients in Chemotherapy Day Center

NCT02228200

Breast Neoplasms Colorectal Neoplasms

COMPLETED NA

The Effectiveness of Nurse Navigators in Cancer Care

NCT05537870

Neoplasms Nurse-Patient Relations Psychiatric Disorder

COMPLETED NA

The Effects of Multi-Psycho-Oncology Care Courses

NCT05776680

Cancer Psychological Oncology +1 more

RECRUITING NA

Effects of Mobile Game on Life Quality of Cancer Patients

NCT03205969

Breast Cancer

COMPLETED NA

Improving Care After Chemotherapy

NCT01944137

Non-small Cell Lung Cancer Colorectal Cancer Breast Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms Nursing Caries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to either the intervention group (nurse-led ePRO system) or control group (usual care).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Nurse-Led ePRO System

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No