Effects of a Nursing-led Communication Support Program Using Mobile Health Information on Physical and Mental Status in Breast Cancer Patients Undergoing Concurrent Chemotherapy: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Quality of Life (EORTC QLQ-C30)
Study Overview
Brief Summary
Breast cancer is the most common malignant tumor among women. Side effects from initial chemotherapy include sleep disorders, anxiety, depression, and reduced quality of life. Mental health distress is also a major issue in cancer care. This study integrates mobile health information with a nurse-led communication support plan, aiming to improve patients' physical and mental outcomes during chemotherapy.
Detailed Description
The objective of this study is to explore the effects of a nursing-led communication support program using mobile health information on physical and mental state in breast cancer patients undergoing initial chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •breast cancer initial chemotherapy
Exclusion Criteria
- •Patients whose cancer has recurred without undergoing the first course of chemotherapy
Arms & Interventions
Nursing routine treatment
Nursing routine treatment
Intervention: Nursing routine treatment (Other)
nursing-led communication
nursing-led communication support
Intervention: nursing-led communication support (Other)
Outcomes
Primary Outcomes
Quality of Life (EORTC QLQ-C30)
Time Frame: Baseline, 1 month, and 2 months after enrollment
Quality of life was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Scores were transformed to a 0-100 scale according to the EORTC scoring manual. Higher scores indicate better functioning and global quality of life, whereas higher symptom scores indicate greater symptom burden. Measurements were obtained at baseline, 1 month, and 2 months after enrollment.
Secondary Outcomes
- Anxiety and Depression(Baseline, 1 month, and 2 months after enrollment)
Investigators
Mei Man
Student
National Defense Medical Center, Taiwan