Application of Intelligent Care Systems in Radiation Therapy: Enhancing Patient Safety and Reducing Anxiety Through System Optimization and Real-Time Blood Data Monitoring
ICS-RT
1 other identifier
interventional
100
1 country
1
Brief Summary
This study aims to evaluate the impact of an intelligent care system on radiation therapy patients, focusing on real-time blood data monitoring, optimized patient education, and internal alert systems. The goal is to enhance patient safety, improve treatment adherence, and reduce anxiety by integrating an alert function into the hospital's existing system. Key interventions include: Real-time blood monitoring alerts: Healthcare providers will receive automatic notifications of abnormal blood test results to ensure timely intervention. Optimized patient education materials: Clearer guidance will help patients proactively communicate blood test needs and manage their health during radiation therapy. Internal reminders: Visual signs and alerts in treatment areas will reinforce patient awareness and engagement. The study will compare patients receiving these interventions with those under standard care, assessing treatment compliance, anxiety levels, and clinical outcomes over a 12-month period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedStudy Start
First participant enrolled
February 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 20, 2025
February 1, 2025
10 months
February 12, 2025
February 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Patient Anxiety Levels During Radiation Therapy
The study will measure changes in patient anxiety levels before and after the intervention using the Brief Symptom Rating Scale-5 (BSRS-5). The BSRS-5 is a validated psychological assessment tool designed to screen for psychological distress, including anxiety, depression, hostility, interpersonal sensitivity, and insomnia. Scale Range: The BSRS-5 consists of five items, each scored from 0 (not at all) to 4 (extremely severe). Minimum Score: 0 (indicating no psychological distress). Maximum Score: 20 (indicating severe psychological distress). Interpretation: Higher scores indicate worse psychological distress. Outcome Goal: A decrease in BSRS-5 scores in the intervention group compared to the control group will indicate reduced anxiety and improved psychological well-being.
Baseline (before radiation therapy) and 3 weeks after treatment initiation
Treatment Adherence Rate During Radiation Therapy
The study will track patient compliance with the prescribed radiation therapy regimen. Compliance will be measured through attendance records, completion of scheduled treatment sessions, and physician assessments. The intelligent care system is expected to improve adherence by increasing patient engagement and awareness through automated alerts and improved educational materials. A higher completion rate in the intervention group compared to the control group will indicate improved treatment adherence.
Throughout the entire course of radiation therapy (typically 4-6 weeks)
Secondary Outcomes (3)
Change in Blood Cell Counts During Radiation Therapy
Weekly from baseline (Week 0) until treatment completion (approximately 4 to 6 weeks).
Patient Understanding of Self-Care and Blood Test Needs
Pre-treatment and after 3 weeks of treatment
Patient Satisfaction with the Intelligent Care System
At Week 6 (end of radiation therapy treatment, typically 4 to 6 weeks after initiation).
Study Arms (2)
Intelligent Care System Group (Intervention Group)
EXPERIMENTALParticipants in this group will receive an optimized intelligent care system designed to enhance patient safety, improve treatment adherence, and reduce anxiety during radiation therapy. This system includes real-time blood data monitoring alerts, enhanced patient education materials, and internal warning reminders.
Standard Care Group (Control Group)
NO INTERVENTIONParticipants in this group will receive standard care without the optimized intelligent care system interventions. They will continue their treatment following existing clinical practices without additional automated monitoring or enhanced education strategies.
Interventions
Description: An alert function will be integrated into the hospital's electronic system, allowing healthcare providers to view real-time blood test results of radiation therapy patients. The system will notify both medical staff and patients of abnormal results, prompting timely intervention. Mode of Delivery: Hospital Information System (HIS) Integration Purpose: Improve treatment safety by reducing delays in managing abnormal blood counts.
Description: Optimized educational pamphlets and multimedia resources will be provided to patients, including clear self-care instructions and guidance on reporting blood test needs during radiation therapy. Mode of Delivery: Printed materials, multimedia resources, verbal education by medical staff Purpose: Improve patient understanding and engagement in their treatment process.
Description: Physical reminder signs will be placed in high-traffic patient areas (e.g., check-in counters, treatment rooms) to prompt patients to report discomfort or abnormal symptoms, especially related to blood test needs. Mode of Delivery: Visual reminders placed within the radiation oncology department Purpose: Increase patient awareness and adherence to treatment safety protocols.
Eligibility Criteria
You may qualify if:
- Patients undergoing radiation therapy combined with chemotherapy.
- Age ≥ 18 years.
- Ability to understand and comply with the study protocol.
- Willing to participate in the study and provide informed consent.
You may not qualify if:
- Patients with severe cognitive impairment or intellectual disability, affecting their ability to understand or follow study procedures.
- Patients unwilling to complete study questionnaires.
- Any mental health condition (e.g., major depressive disorder, severe anxiety disorder) that could interfere with participation.
- Patients with conditions requiring immediate intervention that would make study participation impractical.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung Shan Medical University
Taichung, Taiwan, 403, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not be informed of the specific intervention details, but healthcare providers and researchers will be aware of the group assignments.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2025
First Posted
February 19, 2025
Study Start
February 20, 2025
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
February 20, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share