Radiation TherapyICS-RTNCT06833801
Application of Intelligent Care Systems in Radiation Therapy: Enhancing Patient Safety and Reducing Anxiety Through System Optimization and Real-Time Blood Data Monitoring
A study testing Real-Time Blood Data Monitoring System (Device/Software Integration), Enhanced Patient Education Materials (Behavioral/Educational Intervention) and Internal Warning Signs and Alerts (Behavioral Intervention) in people with Radiation Therapy and Chemoradiotherapy, run by Chung Shan Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation Therapy, Chemoradiotherapy, Anxiety
- What is being tested?
- Real-Time Blood Data Monitoring System (Device/Software Integration), Enhanced Patient Education Materials (Behavioral/Educational Intervention) and Internal Warning Signs and Alerts (Behavioral Intervention)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chung Shan Medical University
Taichung, Taiwan, 403
Yueh-Chun Lee, 0937355888, lee.yuehchun@gmail.com
About this study
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
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:
Read more
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.
Read the detailed 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 education, reducing treatment interruptions and improving outcomes.
Study Objectives
System Optimization: Develop an automated blood data monitoring system that alerts medical staff and patients about abnormal results.
Patient Education Enhancement: Improve educational materials to guide patients on self-care and timely communication with healthcare providers.
Internal Warning Implementation: Install reminder signs in treatment areas to increase awareness and compliance.
Study Design
Type: Interventional (Clinical Trial) Design: Randomized, parallel assignment
Groups:
Intervention Group: Receives real-time monitoring alerts, enhanced education materials, and internal warning systems.
Control Group: Receives standard care without system enhancements. Primary Outcomes: Anxiety reduction (measured by BSRS-5) and treatment adherence rates.
Secondary Outcomes: Blood data changes, patient understanding of self-care, and clinical treatment outcomes.
Expected Impact By combining real-time data monitoring with patient education and engagement, this study aims to create a safer, more informed treatment experience, reducing patient anxiety and enhancing overall treatment success.
- Conditions
- Radiation Therapy, Chemoradiotherapy, Anxiety, Adherence
- Being tested
- Real-Time Blood Data Monitoring System (Device/Software Integration), Enhanced Patient Education Materials (Behavioral/Educational Intervention), Internal Warning Signs and Alerts (Behavioral Intervention)
- 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
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Blood Data Monitoring System (Device/Software Integration)Device
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.
Enhanced Patient Education Materials (Behavioral/Educational Intervention)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intelligent Care System Group (Intervention Group) | Experimental | 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. Receives: Device: Real-Time Blood Data Monitoring System (Device/Software Integration); Behavioral: Enhanced Patient Education Materials (Behavioral/Educational Intervention); Behavioral: Internal Warning Signs and Alerts (Behavioral Intervention) |
| Standard Care Group (Control Group) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Throughout the entire course of radiation therapy (typically 4-6 weeks)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: At Week 6 (end of radiation therapy treatment, typically 4 to 6 weeks after initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study involves two parallel groups: Intervention Group - Receives real-time blood monitoring alerts, enhanced patient education materials, and internal warning reminders. Control Group - Receives standard care without system enhancements.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833801
- Sponsor's protocol ID
- 2025-A-031
- Acronym
- ICS-RT
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06833801
- Acronym / sponsor ID
- ICS-RT / 2025-A-031
- Conditions
- Radiation Therapy, Chemoradiotherapy, Anxiety, Adherence
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 education, reducing treatment interruptions and improving outcomes.
Study Objectives
System Optimization: Develop an automated blood data monitoring system that alerts medical staff and patients about abnormal results.
Patient Education Enhancement: Improve educational materials to guide patients on self-care and timely communication with healthcare providers.
Internal Warning Implementation: Install reminder signs in treatment areas to increase awareness and compliance.
Study Design
Type: Interventional (Clinical Trial) Design: Randomized, parallel assignment
Groups:
Intervention Group: Receives real-time monitoring alerts, enhanced education materials, and internal warning systems.
Control Group: Receives standard care without system enhancements. Primary Outcomes: Anxiety reduction (measured by BSRS-5) and treatment adherence rates.
Secondary Outcomes: Blood data changes, patient understanding of self-care, and clinical treatment outcomes.
Expected Impact By combining real-time data monitoring with patient education and engagement, this study aims to create a safer, more informed treatment experience, reducing patient anxiety and enhancing overall treatment success.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study involves two parallel groups: Intervention Group - Receives real-time blood monitoring alerts, enhanced patient education materials, and internal warning reminders. Control Group - Receives standard care without system enhancements.
| Arm | Type | Receives |
|---|---|---|
| Intelligent Care System Group (Intervention Group) | Experimental | Device: Real-Time Blood Data Monitoring System (Device/Software Integration), Behavioral: Enhanced Patient Education Materials (Behavioral/Educational Intervention), Behavioral: Internal Warning Signs and Alerts (Behavioral Intervention)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. |
| Standard Care Group (Control Group) | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 managing abnormal blood counts. | Device | Intelligent Care System Group (Intervention Group) |
| 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. | Behavioural | Intelligent Care System Group (Intervention Group) |
| 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. | Behavioural | Intelligent Care System Group (Intervention Group) |
Primary outcome
Change in Patient Anxiety Levels During Radiation Therapy
Time frame: Baseline (before radiation therapy) and 3 weeks after treatment initiation
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.
Treatment Adherence Rate During Radiation Therapy
Time frame: Throughout the entire course of radiation therapy (typically 4-6 weeks)
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.
3 secondary outcomes
Change in Blood Cell Counts During Radiation Therapy
Time frame: Weekly from baseline (Week 0) until treatment completion (approximately 4 to 6 weeks).
Patient Understanding of Self-Care and Blood Test Needs
Time frame: Pre-treatment and after 3 weeks of treatment
Patient Satisfaction with the Intelligent Care System
Time frame: At Week 6 (end of radiation therapy treatment, typically 4 to 6 weeks after initiation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Blood Data Monitoring System (Device/Software Integration), Enhanced Patient Education Materials (Behavioral/Educational Intervention) and Internal Warning Signs and Alerts (Behavioral Intervention) in people with Radiation Therapy and Chemoradiotherapy, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yueh-Chun Lee, MD-PhD (+886937355888, lee.yuehchun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Anxiety Levels During Radiation Therapy (time frame: Baseline (before radiation therapy) and 3 weeks after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.