Knowledge-enhanced Digital Intervention to Prevent Low Anterior Resection Syndrome

National Cancer Center (NCC)

Status: Not yet enrolling

Conditions: Rectal Neoplasm

Treatments: Other: Mobile app; Other: standard

Study type: Interventional

Funder types: Other

Identifiers

NCT07041515

NCC2025-0022

Details and patient eligibility

About

Low anterior resection syndrome refers to changes in bowel habits such as frequent defecation, urgent defecation, and fecal incontinence, which result in decreased bowel function. It occurs very commonly after surgery for colorectal cancer, especially rectal cancer, and symptoms appear severely immediately after surgery, followed by a recovery process. It is known that symptoms improve significantly after one year of surgery, but in some patients, symptoms persist, which significantly affects the quality of life and causes social problems.

There is no established treatment method for low anterior resection syndrome, and accurate evaluation and customized treatment are required according to the patient's surgical or radiotherapy treatment content and symptoms. It is also important to monitor the change in symptoms during the treatment process, and a customized step-by-step treatment strategy for such patients is required. However, such a customized step-by-step treatment strategy for such patients is very complex, and there are no clear guidelines to date, and the research design for some clinical trials has been recently reported.

The purpose of this study was to develop an app-based Patient-Reported Outcome (PRO) standardized questionnaire for patients after rectal cancer surgery to systematically collect and monitor symptom information, establish a multidisciplinary management plan tailored to patients, and provide education and treatment to improve the quality of life of rectal cancer survivors. A management program utilizing a research device (app) can reduce the incidence of Major LARS after rectal cancer surgery compared to standard treatment.

Enrollment: 320 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 20-70 years
2. Patients scheduled for anal-sparing rectal resection or stomy repair diagnosed with rectal cancer (within 15 cm from Anal Verge)
3. Patients with an expected survival period of 1 year or more
4. Patients or their primary caregivers use smartphones (apps)
5. Patients who are aware of their own status and can provide consent for this study

Exclusion criteria

1. If you are receiving chemotherapy or radiotherapy at the time of consent
2. If you are scheduled for major colectomy such as total colectomy or partial colectomy in addition to rectal resection
3. If you cannot be contacted by phone
4. If you cannot read and understand Korean
5. If you cannot provide consent based on clear and sufficient information

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 2 patient groups

comparator

Active Comparator group

Description:

Subjects classified as control group will receive educational materials.

Treatment:

Other: standard

mobile app

Experimental group

Description:

Subjects in the experimental group and pilot phase will install the management program app on their mobile phones and use it directly for 6 months.

Treatment:

Other: Mobile app