AI Care Device
Conditions
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.
Interventions
DEVICEArtificial 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.
OTHERRoutine 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). |
Countries
Taiwan
Contacts
CONTACTLing-Chun Lu, PhD
Outcome results
None listed