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

NCT07463690 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2027-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463690 on ClinicalTrials.gov