AI Care DeviceAI DC-systemNCT07637565
Artificial Intelligence-based Dietary Care System
A study testing Artificial Intelligence-based Dietary Care System and Routine Care in people with AI Care Device, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AI Care Device
- What is being tested?
- Artificial Intelligence-based Dietary Care System and Routine Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Taiwn University, College of Medicine
Taipei, 10617
Ling-Chun Lu, PhD, 886-2-33665589, lulingchun@ntu.edu.tw
About this study
Official title: 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.
- Conditions
- AI Care Device
- Being tested
- Artificial Intelligence-based Dietary Care System, Routine Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-based Dietary Care SystemDevice
- Large language model-based communication for patient interaction, system guidance, analytic feedback, dietary recommendations, and referral information.
- 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.
- Bowel movement tracking interface for recording time, frequency, and stool characteristics.
Routine CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Artificial Intelligence-based Dietary Care System | Experimental | Care program will conduct by Artificial Intelligence-based Dietary Care System. Receives: 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. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI Care DeviceStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637565
- Sponsor's protocol ID
- 202603195RIND
- Acronym
- AI DC-system
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For privacy protection considerations, no individual praticipant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07637565
- Acronym / sponsor ID
- AI DC-system / 202603195RIND
- Conditions
- AI Care Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence-based Dietary Care System | Experimental | Device: Artificial Intelligence-based Dietary Care SystemCare program will conduct by Artificial Intelligence-based Dietary Care System. |
| Routine care | Active comparator | Other: Routine CareRoutine dietary education during hospitalization is provided via hospital-developed electronic materials accessible through QR code scanning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence-based Dietary Care System1. 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. | Device | Artificial Intelligence-based Dietary Care System |
| Routine CareContent 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. | Other | Routine care |
Primary outcome
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: 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.
1 secondary outcome
Distress Inventory for Altered Bowel Functioning (DI-ABF)
Time frame: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No. For privacy protection considerations, no individual praticipant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-based Dietary Care System and Routine Care in people with AI Care Device, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling-Chun Lu, PhD (886-2-33665589, lulingchun@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (time frame: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.