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NOT YET RECRUITING
NCT07463690
NA

Construction and Evaluation of a Flipped Discharge Model for Stomates With Colorectal Cancer

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This multicenter randomized controlled trial aims to develop and evaluate the effectiveness of a "Flipped Discharge" intervention for colorectal cancer patients with a new intestinal stoma. Guided by the Response to Transition Theory, the model addresses the care gap during the vulnerable post-discharge period by shifting critical support from the hospital to the patient's home. Approximately 200 eligible patients will be randomized into either the intervention or standard care control group. The core "Flipped Discharge" intervention occurs on the third day post-discharge, delivered either as an in-home visit by a specialist stoma nurse (via an "Internet + Nursing Service" platform) or as an intensive, standardized video follow-up with mailed instructional materials. The study's primary outcome is the incidence of stoma-related complications. Secondary outcomes include quality of life, self-care ability, self-efficacy, stoma adaptation, discharge readiness, healthcare costs, and satisfaction. The trial will also explore the mechanisms by which the intervention affects patient outcomes, ultimately seeking to provide evidence for a feasible, patient-centered model to improve care continuity.

Official title: Construction and Empirical Study of a "Flipped" Discharge Model for Colorectal Cancer Patients With Stoma Based on Response Transformation Theory Research

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-03-10

Completion Date

2027-12-30

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

Response to Transition Theory-based Flipped Discharge Model

This is a structured, multi-component continuing care intervention initiated after hospital discharge for colorectal cancer patients with an intestinal stoma. Based on the Response to Transition Theory, it aims to support patients' adaptation during the critical early post-discharge period. The core intervention is a standardized assessment and education session conducted around the third day post-discharge. This is delivered flexibly based on patient location: either an in-home visit by a certified enterostomal therapist via a hospital-approved "Internet + Nursing Service" platform, or a standardized, intensive video follow-up (≥30 minutes) coupled with a mailed stoma care kit for those outside the service area. The intervention is complemented by protocol-driven telephone follow-ups on days 1-2 and at 1 week to reinforce education, provide psychological support, and address individual concerns.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China