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Идёт набор NCT05990946

Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer

Без фазы С лечением Lung Neoplasms, Non-Small Cell Lung Cancer Postoperative Complications Patient Reported Outcome Measures Telerehabilitation

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: ePRO based Remote Symptom Management provide by a mobile phone app.
Кому может быть актуально
Состояния в реестре: Lung Neoplasms, Non-Small Cell Lung Cancer, Postoperative Complications, Patient Reported Outcome Measures, Telerehabilitation. Базовые параметры: 18 лет — 75 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 →

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Официальное название

A Prospective, Randomized, Controlled Study to Evaluate the Impact of Remote Symptom Management Via Smartphone App Based on Electronic Patient-Reported Outcomes on Rehabilitation Exercise Adherence After Minimally Invasive Surgery in Lung Cancer Patients

Обзор

Brief Summary: This randomized controlled trial aims to evaluate whether active remote symptom monitoring and management via a smartphone app utilizing electronic patient-reported outcomes (ePRO) can improve adherence to prescribed outpatient pulmonary rehabilitation exercises among postsurgical lung cancer patients. Eligible patients will use the app for perioperative care and be randomized to an intervention group receiving ePRO-based symptom monitoring with clinician feedback or a control group receiving ePRO without feedback. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. If proven effective, the app-enabled remote rehabilitation model can be scaled up to enhance recovery for more postoperative patients. Due to slower-than-expected recruitment, an interim analysis was introduced through a protocol amendment. The amendment was approved by the Ethics Committee before conducting the analysis, and the plan was incorporated into the updated study record. The interim review evaluated feasibility and informed the addition of mean weekly exercise duration as a co-primary endpoint with adjusted statistical thresholds.

Подробное описание

Adherence to postoperative pulmonary rehabilitation exercises is crucial but challenging to address in lung cancer patients after hospital discharge. Pain, fatigue, cough and other symptoms may hinder adherence. This study will enroll 224 patients undergoing Video-assisted thoracic surgery (VATS) for lung Cancer. All patients will use a smartphone app for perioperative care and periodic PRO measurement. Before discharge, patients will be randomized 1:1 to an intervention group or control group. The intervention group will complete ePRO symptom severity scores on the PSA-Lung Scale questionnaire on discharge and post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance. The control group will complete ePRO without clinician alerts. The primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. Secondary outcomes include postoperative complications, hospital readmissions, symptom changes, exercise participation rate, and patient satisfaction. If proven effective, this innovative rehabilitation model can be scaled up to enhance recovery for more postoperative patients.

Due to slower-than-expected recruitment, the study protocol was amended to introduce one interim analysis. The protocol amendment was reviewed and approved by the Ethics Committee before the analysis was conducted. The interim analysis was performed using aggregated, de-identified data by an independent monitoring group, without disclosing any individual-level unblinded outcomes to investigators. Based on the interim findings, mean weekly exercise duration was added as a co-primary endpoint alongside 1-month adherence. Statistical thresholds for interim testing were adjusted using an O'Brien-Fleming alpha-spending approach (interim p \< 0.006).

Вмешательства

  • Устройство ePRO based Remote Symptom Management provide by a mobile phone app
    Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management. This is facilitated through the "Shuyu" mobile application, which serves as the platform for monitoring symptoms and communication.

Первичные конечные точки

  • Rehabilitation exercise adherence rate over 1 month after discharge [Срок оценки: From the day of discharge to 30 days after discharge]
  • Mean weekly exercise duration over 1 month after discharge [Срок оценки: From discharge to 30 days after discharge.]
Вторичные конечные точки (4)
  • Post-discharge pulmonary complication rate [Срок оценки: From the day of discharge to 30 days after discharge]
  • 30-day hospital readmission rate [Срок оценки: From the day of discharge to 30 days after discharge]
  • Changes in symptom severity scores from discharge to 30 days [Срок оценки: From the day of discharge to 30 days after discharge]
  • Patient satisfaction scores [Срок оценки: From the day of discharge to 30 days after discharge]

Критерии участия

Критерии включения

  • Age 18-75 years old
  • Undergoing minimally invasive lung cancer resection
  • Able to use smartphones and complete electronic questionnaires
  • Signed informed consent

Критерии исключения

  • conversions to open thoracotomy during surgery
  • ECOG score > 1
  • Received neoadjuvant therapy
  • Previous lung resection surgery
  • Unable to exercise due to physical limitations
  • Continuous systemic corticosteroid use within 1 month before enrollment
  • Unresolved toxicity above Grade 1 from previous treatments
  • Significant comorbidities or medical history

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Китай · 1 центр
  • No.2 Sunwen East Rd. — Zhongshan

Публикации

  • Yang X, Zhang Q, Ye C, Cheng Y, Wu J, Liang Y, Su J. Factors Influencing Symptom Severity at Discharge after Lobectomy and Sublobar Resection Through Video-assisted Thoracoscopic Surgery. Interdiscip Cardiovasc Thorac Surg. 2025 Aug 5;40(8):ivaf170. doi: 10.1093/icvts/ivaf170. PMID 40811025
  • Su J, Ye C, Zhang Q, Liang Y, Wu J, Liang G, Cheng Y, Yang X. Impact of Remote Symptom Management on Exercise Adherence After Video-Assisted Thoracic Surgery for Lung Cancer in a Tertiary Hospital in China: Protocol for a Prospective Randomized Controlled Trial. JMIR Res Protoc. 2025 Jan 1;14:e60420. doi: 10.2196/60420. PMID 39610048

Идентификаторы

NCT: NCT05990946 · K2022-285

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗