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Clinical Trial NCT06833801 (ICS-RT) for Radiation Therapy, Chemoradiotherapy, Anxiety, Adherence is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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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) 100
Clinical Trial NCT06833801 (ICS-RT) is an interventional study for Radiation Therapy, Chemoradiotherapy, Anxiety, Adherence and is currently not yet recruiting. Enrollment is planned to begin on February 20, 2025 and continue until the study accrues 100 participants. Led by Chung Shan Medical University, this study is expected to complete by December 31, 2025. The latest data from ClinicalTrials.gov was last updated on February 20, 2025.
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 alert...
Show MoreDetailed Description
Background & Rationale Cancer patients undergoing radiation therapy often experience changes in blood cell counts, particularly when combined with chemotherapy, affecting treatment safety and completion rates. Lack of real-time monitoring and patient engagement can lead to delays or complications in treatment. This study integrates an intelligent care system into clinical practice to enhance patient monitoring and e...Show More
Official Title
Application of Intelligent Care Systems in Radiation Therapy: Enhancing Patient Safety and Reducing Anxiety Through System Optimization, Enhanced Education Strategies, and Real-Time Blood Data Monitoring
Conditions
Radiation TherapyChemoradiotherapyAnxietyAdherenceOther Study IDs
- ICS-RT
- 2025-A-031
NCT ID Number
Start Date (Actual)
2025-02-20
Last Update Posted
2025-02-20
Completion Date (Estimated)
2025-12-31
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Radiation Therapy
Intelligent Care System
Real-Time Blood Data Monitoring
Patient Safety
Oncology Treatment Compliance
Cancer Treatment Anxiety
Clinical Decision Support System
Health Education in Radiation Oncology
Automated Blood Test Alerts
Supportive Care in Cancer Patients
Intelligent Care System
Real-Time Blood Data Monitoring
Patient Safety
Oncology Treatment Compliance
Cancer Treatment Anxiety
Clinical Decision Support System
Health Education in Radiation Oncology
Automated Blood Test Alerts
Supportive Care in Cancer Patients
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalIntelligent Care System Group (Intervention Group) Participants 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. | Real-Time Blood Data Monitoring System (Device/Software Integration) 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 manag...Show More Enhanced Patient Education Materials (Behavioral/Educational Intervention) 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. Internal Warning Signs and Alerts (Behavioral Intervention) 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. |
No InterventionStandard Care Group (Control Group) Participants 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in Blood Cell Counts During Radiation Therapy | This study will evaluate how often abnormal blood cell counts (White Blood Cell \[WBC\], Hemoglobin \[Hb\], and Platelet \[PLT\] levels) are detected and addressed using the real-time blood data monitoring system. The system provides timely alerts for abnormal values, enabling healthcare providers to intervene promptly.
Assessment Tool: Electronic medical records of routine blood test results. Outcome Goal: The intervention group is expected to have fewer missed abnormal results and faster clinical response times compared to the control group, indicating improved patient safety. | Weekly from baseline (Week 0) until treatment completion (approximately 4 to 6 weeks). |
Patient Understanding of Self-Care and Blood Test Needs | Assess patient awareness and knowledge of self-care practices and the importance of blood test monitoring during radiation therapy. Patients will receive optimized educational materials, and their understanding will be evaluated through a self-reported questionnaire. A higher score in the intervention group compared to the control group will indicate improved patient education and awareness. | Pre-treatment and after 3 weeks of treatment |
Patient Satisfaction with the Intelligent Care System | Measure patient satisfaction regarding the new real-time blood monitoring alerts and enhanced educational materials provided as part of the intelligent care system. A patient-reported satisfaction survey will be conducted to evaluate the perceived usefulness and acceptability of the system.
Assessment Tool: Patient-reported satisfaction survey. Outcome Goal: Higher satisfaction scores in the intervention group compared to the control group, indicating greater patient acceptance and perceived benefits of the system. | At Week 6 (end of radiation therapy treatment, typically 4 to 6 weeks after initiation). |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
Chung Shan Medical UniversityStudy Central Contact
Contact: Yueh-Chun Lee, MD-PhD, +886937355888, [email protected]
1 Study Locations in 1 Countries
Taiwan
Chung Shan Medical University, Taichung, Taiwan, 403, Taiwan
Yueh-Chun Lee, Contact, 0937355888, [email protected]