Clinical trial NCT06833801: Application of Intelligent Care Systems in Radiation Therapy: Enhancing Patient Safety and Reducing Anxiety Through System Optimization and Real-Time Blood Data Monitoring
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Automated Blood Test Alerts
Supportive Care in Cancer Patients
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Patient Anxiety Levels During Radiation Therapy
timeFrame: Baseline (before radiation therapy) and 3 weeks after treatment initiation
measure: Treatment Adherence Rate During Radiation Therapy
timeFrame: Throughout the entire course of radiation therapy (typically 4-6 weeks)
Secondary outcomes:
measure: Change in Blood Cell Counts During Radiation Therapy
timeFrame: Weekly from baseline (Week 0) until treatment completion (approximately 4 to 6 weeks).
measure: Patient Understanding of Self-Care and Blood Test Needs
timeFrame: Pre-treatment and after 3 weeks of treatment
measure: Patient Satisfaction with the Intelligent Care System
timeFrame: At Week 6 (end of radiation therapy treatment, typically 4 to 6 weeks after initiation).
Other outcomes:
Locations:
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University
Study officials:
References: