Implementing Surgery School Prehabilitation Using Telehealth

Официальное название

Implementing Tele-prehabilitation Education Into Cancer Care Pathways

Обзор

The physiological challenge of major surgery has been likened to running a marathon. In both cases, preparation is critical. Yet, many patients undergo major surgery without understanding the potential consequences. The STTARRS trial aims to test the effect of an education program delivered via telehealth in people preparing for lung or major abdominal cancer surgery , compared with usual care on the development of a respiratory complications after surgery. The secondary aims will be to determine the effect of the online education program for people preparing for lung or major abdominal cancer surgery compared to usual care on the following outcomes; acute hospital length of stay, surgical recovery, physical function and activity, self-efficacy, behaviour change, symptoms, health-related quality of life, number of days alive and out of hospital and health service usage and survival. This trial includes one sub-study. The sub-study will recruit eligible people preparing for lung cancer surgery. In the sub-study, 35 participants will receive an individualised inspiratory muscle training and walking program delivered and monitored by telehealth in addition to the main STTARRS trial intervention before surgery.

Вмешательства

• Поведенческое Tele-prehabilitation education session: Surgery School
  Online telehealth education program using videos and a live clinician facilitator
• Поведенческое Individualised Inspiratory Muscle Training and Walking Program
  An individualised inspiratory muscle training and walking program delivered by a Physiotherapist using telehealth.
• Другое Usual Care
  Usual care alone. Usual care will be reviewed every four months during the trial and site leads will be asked to provide information about any changes to usual hospital and medical care at their site.

Первичные конечные точки

• Post operative Pulmonary Complication (PPC) [Срок оценки: Daily for up to 7 days post operatively or until hospital discharge.]

Вторичные конечные точки (12)

• Diagnosis of pneumonia [Срок оценки: Daily up to postoperative day 7 or until hospital discharge]
• Postoperative complications [Срок оценки: Postoperative day 3,5,10 unless discharge prior and 30 days post operative.]
• Number of days alive and out of hospital [Срок оценки: 30 days, 6 months and 12 months post operative]
• Maximal Inspiratory Pressure (MIP) [Срок оценки: Baseline and preoperatively at centres participating in the inspiratory muscle training sub study]
• Physical activity levels - subjective [Срок оценки: Baseline, Preoperatively, 30 days post operative]
• Physical activity levels - objective [Срок оценки: Baseline, Preoperatively, 30 days post operative]
• Video and Surgery School Session Attendance (Intervention group only) [Срок оценки: Preoperative timepoint]
• Access to video outside the Surgery School Session (Intervention group only) [Срок оценки: Preoperative timepoint]
• Symptoms: electronic Edmonton Symptom Assessment System-revised ((e)ESAS-r) [Срок оценки: Baseline (and repeated every 4 weeks for participants having treatment before surgery), Preoperative, Postoperative: 30 days.]
• Behaviour Change [Срок оценки: Preoperative timepoint, at hospital discharge (+3 days)]
• Self-efficacy: Patient Activation Measure [Срок оценки: Baseline, preoperative timepoint, 30 days and 6 months postoperative.]
• Treatment Burden: Multimorbidity Treatment Burden Questionnaire (MTBQ) [Срок оценки: Baseline, preoperative timepoint, 30 days postoperative]

Критерии участия

Критерии включения

• Preparing for lung cancer (open or video assisted) or major abdominal cancer surgery (e.g. upper GI, hepatobiliary or colorectal, open or video assisted).
• Provide consent
• Have primary treating surgeon approval
• Proficient in English to understand testing, video interventions as well as outcome assessments.

Критерии исключения

• Concurrent, actively treated other malignancy or history of other malignancy treated within the past year.
• Severe or unstable psychiatric, cognitive or substance abuse disorders, such that precludes informed consent or interferes with cooperation with trial requirements or current inpatients.
• Current inpatients or incarcerated
• Surgery date booked <7 days from consent

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

Австралия · 9 центров

• John Hunter Hospital — New Lambton Heights
• Calvary Mater Newcastle — Waratah
• Gold Coast University Hospital — Southport
• Princess Alexandra Hospital — Woolloongabba
• North West Regional Hospital — Burnie
• Launceston General Hospital — Launceston
• Austin Health — Heidelberg
• Royal Melbourne Hospital — Melbourne
• … и ещё 1 центр

Идентификаторы

NCT: NCT06631872 · 4.4 11/12/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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