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Набор скоро начнётся NCT07463690

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

Без фазы С лечением Colorectal Cancer Stoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Response to Transition Theory-based Flipped Discharge Model.
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Stoma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Construction and Empirical Study of a "Flipped" Discharge Model for Colorectal Cancer Patients With Stoma Based on Response Transformation Theory Research

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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 certi

Первичные конечные точки

  • Incidence of stoma and peristomal skin complications [Срок оценки: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.]
Вторичные конечные точки (10)
  • Level of adaptation to the stoma [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Assessed at the core intervention point (approximately 3 days post-discharge).]
  • Disease-specific quality of life [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).]
  • Healthcare Costs [Срок оценки: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).]
  • Intervention Implementation Costs [Срок оценки: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).]
  • Hospital Readmission Rate [Срок оценки: From hospital admission for the index surgery through the follow-up period (e.g., 1 month postoperatively).]
  • Patient Trust and Perceived Support [Срок оценки: From the initiation of the intervention (post-discharge) up to 1 month postoperatively, or as defined by the primary study endpoint period.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Китай · 1 центр
  • Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07463690 · G2025-208-01 · A2025001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗