Artificial Intelligence-based Dietary Care System

NCT07637565 | Not Yet Recruiting DMC

• 1 other identifier: 202603195RIND
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

AI Care Device

Outcome Measures

Primary Outcomes (1)

• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  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.

Secondary Outcomes (1)

• Distress Inventory for Altered Bowel Functioning (DI-ABF)

  Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

Other Outcomes (1)

• Low Anterior Resection Syndrome (LARS) Score

  Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

Study Arms (2)

Artificial Intelligence-based Dietary Care System

EXPERIMENTAL

Care program will conduct by Artificial Intelligence-based Dietary Care System.

Device: Artificial Intelligence-based Dietary Care System

Routine care

ACTIVE COMPARATOR

Routine dietary education during hospitalization is provided via hospital-developed electronic materials accessible through QR code scanning.

Other: Routine Care

Interventions

Routine Care OTHER

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.

Routine care

Artificial Intelligence-based Dietary Care System DEVICE

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.

Artificial Intelligence-based Dietary Care System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwn University, College of Medicine

Taipei, 10617, Taiwan

Location

Central Study Contacts

Ling-Chun Lu, PhD

CONTACT

886-2-33665589; lulingchun@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)