Application of Intelligent Care Systems in Radiation Therapy: Enhancing Patient Safety and Reducing Anxiety Through System Optimization and Real-Time Blood Data Monitoring

NCT ID: NCT06833801

Last Updated: 2025-02-20

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-20

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Radiation Therapy Chemoradiotherapy Anxiety Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants will not be informed of the specific intervention details, but healthcare providers and researchers will be aware of the group assignments.

Study Groups

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Intelligent 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.

Group Type EXPERIMENTAL

Real-Time Blood Data Monitoring System (Device/Software Integration)

Intervention Type 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)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

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.

Standard 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chung Shan Medical University

Taichung, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Yueh-Chun Lee, MD-PhD

Role: CONTACT

+886937355888

Facility Contacts

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Yueh-Chun Lee

Role: primary

0937355888

Other Identifiers

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2025-A-031

Identifier Type: -

Identifier Source: org_study_id

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