Construction and Evaluation of a Flipped Discharge Model for Stomates With Colorectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of psychiatric disorders or severe cognitive impairment.
Diagnosis with other concurrent malignancies.
Trial design
Design model
Parallel
Treatments tested in this trial
Response to Transition Theory-based Flipped Discharge Model
BehavioralThis 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Flipped Discharge Model GroupExperimental treatment 1 intervention
Group B: Standard Care GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.Secondary outcomes
1
Level of adaptation to the stoma
Measured using the Chinese version of the Ostomy Adjustment Scale (OAS) . The scale consists of 34 items rated on a 6-point Likert scale, with total scores ranging from 34 to 204. A higher total score indicates better psychological and social adaptation to living with a stoma.
Time frame
From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.2
Level of stoma-related self-efficacy
Measured using the Chinese version of the Stoma Self-Efficacy Scale (SSES) . This 22-item scale assesses patients' confidence in managing their stoma (stoma efficacy) and in social situations (social self-efficacy) using a 5-point Likert scale. Total scores range from 22 to 110. A higher score indicates greater self-efficacy.
Time frame
From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.3
Readiness for hospital discharge
Measured using the Chinese version of the Readiness for Hospital Discharge Scale (RHDS) . This 12-item scale assesses a patient's self-perceived preparedness for discharge across three dimensions: personal status, coping ability, and expected support. Each item is scored on a 0-10 scale, with total scores ranging from 0 to 120. A higher total score indicates better readiness for discharge.
Time frame
Assessed at the core intervention point (approximately 3 days post-discharge).4
Disease-specific quality of life
Measured using the Chinese version of the Stoma Quality of Life Scale (Stoma-QOL-C) . This 20-item scale evaluates the impact of the stoma on various life domains over the past month across four dimensions (e.g., sleep, social relationships). Each item is scored on a 4-point Likert scale (1 = always, 4 = never), with total scores ranging from 20 to 80. A higher total score indicates better stoma-specific quality of life.
Time frame
From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.Sponsors and contacts
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Sun Yat-sen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Sponsor institution
Source ClinicalTrials.gov
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