Colorectal CancerNCT07463690
Construction and Evaluation of a Flipped Discharge Model for Stomates With Colorectal Cancer
A study testing Response to Transition Theory-based Flipped Discharge Model in people with Colorectal Cancer and Stoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Stoma
- What is being tested?
- Response to Transition Theory-based Flipped Discharge Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of psychiatric disorders or severe cognitive impairment.
- Diagnosis with other concurrent malignancies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Luo Baojia, 15989044977, luobj@sysucc.org.cn
About this study
Official title: Construction and Empirical Study of a "Flipped" Discharge Model for Colorectal Cancer Patients With Stoma Based on Response Transformation Theory Research
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.
Read the detailed description
This study aims to develop and test a "Flipped Discharge" model for colorectal cancer patients with an intestinal stoma (ostomy) based on the Response to Transition Theory. After stoma surgery, patients often face significant physical, psychological, and social challenges during the vulnerable early post-discharge period. Current care models, characterized by shorter hospital stays and limited follow-up support, may leave patients unprepared for self-care, potentially leading to complications, reduced quality of life, and increased hospital readmissions. The proposed "Flipped Discharge" model shifts essential post-discharge assessments and education from the hospital to the patient's home or via enhanced remote support, aiming to provide continuous, specialized care during this critical transition. In this multi-center study, approximately 200 eligible patients will be randomly assigned to either an intervention group receiving the "Flipped Discharge" protocol or a control group receiving standard care. The intervention includes early telephone follow-ups and a core intervention around the third day after discharge, delivered either through an in-home visit by a specialized stoma nurse within an established "Internet + Nursing Service" network or a standardized intensive video follow-up with mailed instructional materials for patients outside the service coverage area. The study will measure outcomes including stoma-related complications (primary outcome), patient quality of life, self-care ability, self-efficacy, adaptation to the stoma, readiness for discharge, healthcare costs, and satisfaction. The research also seeks to understand how factors like self-efficacy influence quality of life, with the ultimate goal of determining if this model is effective and feasible in improving care continuity and patient outcomes, thereby providing evidence for a new patient-centered care model suited to the current healthcare context.
- Conditions
- Colorectal Cancer, Stoma
- Being tested
- Response to Transition Theory-based Flipped Discharge Model
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Response to Transition Theory-based Flipped Discharge ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Assessed at the core intervention point (approximately 3 days post-discharge).
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.
Measured: 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
Measured using the Chinese version of the Stoma Self-Care Scale - Early Stage version (SSCS-early) . This 10-item scale specifically assesses a patient's skill in independently changing the stoma appliance. Each item is scored on a 5-point Likert scale (1 = very unskilled, 5 = very skilled), with total scores ranging from 10 to 50. A higher score indicates greater self-care ability.
Measured: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.
Length of Hospital Stay
Measured as the average length of the index hospital admission in days.
Measured: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Healthcare Costs
Includes total medical costs during the study period, covering Western and traditional Chinese medicine, stoma center fees, and supplies. Measured in RMB.
Measured: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Intervention Implementation Costs
The direct costs of implementing the "Flipped Discharge" intervention (e.g., provider travel expenses, personnel time) will be quantified separately. Measured in RMB.
Measured: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Hospital Readmission Rate
The rate of hospital readmission during the follow-up period. Measured as a percentage (%) .
Measured: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Patient Trust and Perceived Support
Assessed using a self-developed questionnaire evaluating the nurse-patient relationship. The tool includes two subscales: Trust subscale: Scores range from X to Y, with higher scores indicating greater patient trust in the nurse-patient relationship. Support subscale: Scores range from X to Y, with higher scores indicating greater perceived support from the stoma nurse. Each item is rated on a Likert scale (e.g., 1 = not at all to 5 = completely), and subscale scores are calculated by summing the individual item scores.
Measured: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start10 Mar 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luo BaoJia, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463690
- Sponsor's protocol ID
- G2025-208-01
- Other IDs
- A2025001
- Status last verified
- Dec 2025
- First submitted
- 29 Dec 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Empirical Study of a "Flipped" Discharge Model for Colorectal Cancer Patients With Stoma Based on Response Transformation Theory Research
- ClinicalTrials.gov ID
- NCT07463690
- Acronym / sponsor ID
- G2025-208-01
- Conditions
- Colorectal Cancer, Stoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to develop and test a "Flipped Discharge" model for colorectal cancer patients with an intestinal stoma (ostomy) based on the Response to Transition Theory. After stoma surgery, patients often face significant physical, psychological, and social challenges during the vulnerable early post-discharge period. Current care models, characterized by shorter hospital stays and limited follow-up support, may leave patients unprepared for self-care, potentially leading to complications, reduced quality of life, and increased hospital readmissions. The proposed "Flipped Discharge" model shifts essential post-discharge assessments and education from the hospital to the patient's home or via enhanced remote support, aiming to provide continuous, specialized care during this critical transition. In this multi-center study, approximately 200 eligible patients will be randomly assigned to either an intervention group receiving the "Flipped Discharge" protocol or a control group receiving standard care. The intervention includes early telephone follow-ups and a core intervention around the third day after discharge, delivered either through an in-home visit by a specialized stoma nurse within an established "Internet + Nursing Service" network or a standardized intensive video follow-up with mailed instructional materials for patients outside the service coverage area. The study will measure outcomes including stoma-related complications (primary outcome), patient quality of life, self-care ability, self-efficacy, adaptation to the stoma, readiness for discharge, healthcare costs, and satisfaction. The research also seeks to understand how factors like self-efficacy influence quality of life, with the ultimate goal of determining if this model is effective and feasible in improving care continuity and patient outcomes, thereby providing evidence for a new patient-centered care model suited to the current healthcare context.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flipped Discharge Model Group | Experimental | Behavioral: Response to Transition Theory-based Flipped Discharge ModelParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- History of psychiatric disorders or severe cognitive impairment.
- Diagnosis with other concurrent malignancies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Response to Transition Theory-based Flipped Discharge ModelThis 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. | Behavioural | Flipped Discharge Model Group |
Primary outcome
Incidence of stoma and peristomal skin 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.
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.
10 secondary outcomes
Level of adaptation to the 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.
Level of stoma-related 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.
Readiness for hospital discharge
Time frame: Assessed at the core intervention point (approximately 3 days post-discharge).
Disease-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.
Self-care ability for stoma management
Time frame: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.
Length of Hospital Stay
Time frame: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Healthcare Costs
Time frame: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Intervention Implementation Costs
Time frame: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Hospital Readmission Rate
Time frame: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).
Patient Trust and Perceived Support
Time frame: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Response to Transition Theory-based Flipped Discharge Model in people with Colorectal Cancer and Stoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luo Baojia (15989044977, luobj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stoma and peristomal skin 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.