Artificial Intelligence-based Dietary Care System

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Другое 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, pi

Первичные конечные точки

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [Срок оценки: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.]

Вторичные конечные точки (1)

• Distress Inventory for Altered Bowel Functioning (DI-ABF) [Срок оценки: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Тайвань · 1 центр

• National Taiwn University, College of Medicine — Taipei

Идентификаторы

NCT: NCT07637565 · 202603195RIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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