Clinical trial · Interventional
Construction and Evaluation of a Flipped Discharge Model for Stomates With Colorectal Cancer
Construction and Empirical Study of a "Flipped" Discharge Model for Colorectal Cancer Patients With Stoma Based on Response Transformation Theory Research
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Response to Transition Theory-based Flipped Discharge Model | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flipped Discharge Model Group
- description
- Participants receive the "Flipped Discharge" intervention based on Response to Transition Theory. This includes standardized post-discharge telephone follow-ups on days 1-2. The core intervention occurs around day 3 (±1 day), delivered either via an in-home visit by a certified stoma nurse through the hospital's "Internet + Nursing Service" platform or, for eligible patients outside the service area, a standardized intensive video follow-up (≥30 min) with a mailed stoma care kit. Additional telephone support is provided at 1 week. All interventions follow a central protocol and are conducted by trained, certified stoma care specialists.
- interventionNames
- Behavioral: Response to Transition Theory-based Flipped Discharge Model
- type
- NO_INTERVENTION
- label
- Standard Care Group
- description
- Participants receive routine post-discharge care and follow-up as per the current standard practice at their respective hospital centers. This typically includes conventional discharge education and scheduled follow-up contacts (e.g., phone calls) conducted by hospital staff according to local protocols, without the structured, early in-home or intensive video intervention provided to the intervention group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically diagnosed colorectal cancer patients undergoing their first radical surgery with either abdominoperineal resection (Miles) plus permanent colostomy or sphincter-preserving anterior resection (Dixon) plus temporary ileostomy. 2. Aged 18 years or older. 3. Possess at least elementary school education and are able to read, communicate, and understand questionnaire content. Voluntarily participate and provide written informed consent. 4. Postoperative condition is stable without major complications, and patient is conscious. 5. Meets standard hospital discharge criteria with normally functioning stoma. Exclusion Criteria: 1. History of psychiatric disorders or severe cognitive impairment. 2. Diagnosis with other concurrent malignancies.
References
Publications (0)
Data not yet available