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临床试验/NCT06833801
NCT06833801尚未招募不适用

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

Chung Shan Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Change in Patient Anxiety Levels During Radiation Therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Real-Time Blood Data Monitoring System (Device/Software Integration) (Device)

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.

干预措施: Enhanced Patient Education Materials (Behavioral/Educational Intervention) (Behavioral)

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.

干预措施: Internal Warning Signs and Alerts (Behavioral Intervention) (Behavioral)

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.

结局指标

主要结局

Change in Patient Anxiety Levels During Radiation Therapy

时间窗: 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

时间窗: 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.

次要结局

  • 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).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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