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Artificial Intelligence-based Dietary Care System (AI DC-system)

2026年6月3日 更新者：National Taiwan University Hospital

Effectiveness of An Artificial Intelligence-based Dietary Care System for Distress From Altered Bowel Function and Quality of Life in Rectal Cancer Patients With Low Anterior Resection Syndrome

Patients with rectal cancer complicated by low anterior resection syndrome who undergo anal-preserving surgery may experience severe distress in daily life due to changes in bowel function, thus requiring significant post-discharge care support from healthcare professionals. This study is a multicenter, non-blinded randomized controlled trial. One hundred patients with rectal cancer complicated by low anterior resection syndrome are planned to be randomly assigned in a 1:1 ratio from the colorectal surgery outpatient clinics of National Taiwan University Hospital, its Cancer Center, and its Yunlin Branch. They will be divided into a control group receiving routine dietary education and an experimental group receiving both routine dietary education and the use of an artificial intelligence-based dietary care system application. The artificial intelligence-based dietary care system application will be used for approximately six months. Three questionnaires will be administered at one month post-surgery (before intervention), three months post-surgery, and six months post-surgery. The questionnaires will include: a demographic data sheet, a low anterior resection syndrome score, distress inventory from altered bowel functioning, and the European Organization for Research and Treatment of Cancer QLQ-30 Scale, to verify the effectiveness of the artificial intelligence-based dietary care system application in improving bowel disturbance and quality of life in patients with rectal cancer complicated by low anterior resection syndrome.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 台湾
      • Taipei、台湾、10617
        • National Taiwn University, College of Medicine
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age ≥18 years.
  • Clear consciousness with ability to communicate in Mandarin or Taiwanese.
  • Histopathological confirmation of rectal adenocarcinoma.
  • Undergoing radical rectal resection or such surgery combined with temporary stoma closure.

Exclusion Criteria:

  • Diagnosis of other intestinal disorders, including intestinal tumors, bloating, obstruction, ulcerative colitis, or irritable bowel syndrome.
  • Inability to access the internet.
  • Inability to use a smartphone.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：卫生服务研究
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Artificial Intelligence-based Dietary Care System
Care program will conduct by Artificial Intelligence-based Dietary Care System.
设备：Artificial Intelligence-based Dietary Care System
  1. Large language model-based communication for patient interaction, system guidance, analytic feedback, dietary recommendations, and referral information.
  2. AI-driven image analysis using regional convolutional neural networks, linked to a database of over 100,000 meals and national dietary reference standards, enabling estimation of food types, portions, and nutrient intake.
  3. Bowel movement tracking interface for recording time, frequency, and stool characteristics.
有源比较器：Routine care
Routine dietary education during hospitalization is provided via hospital-developed electronic materials accessible through QR code scanning.
其他：Routine Care
Content covers postoperative dietary progression, nutritional supplementation, intake principles, and food avoidance. The postoperative regimen typically advances through four stages-clear liquid, low-residue semi-liquid, low-residue soft, and regular diet-with most patients resuming normal intake within one month. Guidance emphasizes high-protein, high-calorie foods, small frequent meals, and balanced nutrition, while advising avoidance of gas-producing, odorous, coarse-fiber, greasy, spicy, pickled, and dairy products.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
大体时间：Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
This 30-item instrument assesses cancer-related QoL across global health, five functional domains (physical, role, cognitive, emotional, and social), and nine symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulty) [22, 23]. Higher scores for functioning and global health indicate better QoL, whereas higher symptom scores denote greater symptom burden.
Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

次要结果测量

结果测量
措施说明
大体时间
Distress Inventory for Altered Bowel Functioning (DI-ABF)
大体时间：Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
Developed by Lu et al., the 16-item DI-ABF measures distress arising from altered bowel functioning across three domains: daily life, emotional regulation, and social functioning, with higher scores reflecting greater distress. Cut point 9.5 divided to be no bowel-related distress (0-9.5) and bowel-related distress (>9.5).
Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

其他结果措施

结果测量
措施说明
大体时间
Low Anterior Resection Syndrome (LARS) Score
大体时间：Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
Developed by Emmertsen and Laurberg [21], this tool evaluates five aspects of bowel dysfunction: flatus incontinence, fecal incontinence, bowel frequency, clustering, and urgency. Scores range from 0 to 42, with higher scores indicating more severe symptoms. Severity is categorized as no LARS (0-20), minor LARS (21-29), and major LARS (30-42).
Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Taiwan University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年6月3日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年6月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 202603195RIND

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

For privacy protection considerations, no individual praticipant data will be shared.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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