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

NCT07463690 | Not Yet Recruiting

• 2 other identifiers: G2025-208-01A2025001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Colorectal Cancer; Stoma

Outcome Measures

Primary Outcomes (1)

• Incidence of stoma and peristomal skin complications

  The occurrence of complications related to the intestinal stoma and the surrounding skin will be assessed using a standardized Stoma Complication Assessment Form. This form evaluates six major items: changes in peristomal skin, degree of stoma prolapse, presence of parastomal hernia, degree of stoma stenosis, degree of stoma retraction, and degree of stoma mucocutaneous separation. Each item has specific criteria and a scoring system, with a higher total score indicating a greater number and severity of complications.

  From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.

Secondary Outcomes (10)

• Level of adaptation to the stoma

  From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.

• Level of stoma-related self-efficacy

  From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.

• Readiness for hospital discharge

  Assessed at the core intervention point (approximately 3 days post-discharge).

• Disease-specific quality of life

  From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.

• Self-care ability for stoma management

  From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.

Study Arms (2)

Flipped Discharge Model Group

EXPERIMENTAL

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.

Behavioral: Response to Transition Theory-based Flipped Discharge Model

Standard Care Group

NO INTERVENTION

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.

Interventions

Response to Transition Theory-based Flipped Discharge Model BEHAVIORAL

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.

Flipped Discharge Model Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Aged 18 years or older.
• Possess at least elementary school education and are able to read, communicate, and understand questionnaire content. Voluntarily participate and provide written informed consent.
• Postoperative condition is stable without major complications, and patient is conscious.
• Meets standard hospital discharge criteria with normally functioning stoma.

You may not qualify if:

• History of psychiatric disorders or severe cognitive impairment.
• Diagnosis with other concurrent malignancies.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Luo Baojia

CONTACT

15989044977; luobj@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief nurse

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: March 11, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)