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.
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.
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
Parallel
Tele-prehabilitation education session: Surgery School
BehavioralOnline telehealth education program using videos and a live clinician facilitator
Individualised Inspiratory Muscle Training and Walking Program
BehavioralAn individualised inspiratory muscle training and walking program delivered by a Physiotherapist using telehealth.
Usual Care
Other interventionUsual 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.
Post operative Pulmonary Complication (PPC)
Post operative pulmonary complications (PPC) will be assessed using the Melbourne Group Score (MGS). The MGS is an eight-item checklist. Minimum score 0, Maximum score 8. Participants are identifying as having a PPC if they score four or more in a 24-hour period.
Diagnosis of pneumonia
Diagnosis of pneumonia (Y/N) classified according the centre for disease control definition.
Postoperative complications
Complications after surgery will be defined as any deviation from the normal postoperative course and classified according to the Clavien-Dindo classification. from Grade I through GradeV. Higher classifications indicating complications that require more complex interventions.
Number of days alive and out of hospital
DAoH-30, DAoH-180, DAoH-365 (days alive and out of hospital 30, 180, 365 days post operatively): a patient centric metric and composite outcome that integrates several clinically important outcomes: hospital length of stay, re-admission or discharge to a destination other than origin (usually home) as well as survival. Higher numbers indicate a greater time alive and out of hospital post operatively.
Maximal Inspiratory Pressure (MIP)
Maximal Inspiratory Pressure (cm H2O) will be assessed using a small handheld device using 3 tests of inspiratory muscle strength recording the highest value. Undertaken at centres participating in the sub study.
Sex
After consent, participants' demographic data will be extracted from their medical record. Sex will be recorded as a categorical variable with categories: female, male, other.
Date of birth
After consent, participants' demographic data will be extracted from their medical record, including date of birth (years).
Height
After consent, participants' demographic data will be extracted from their medical record, including height (cm).
Weight
After consent, participants' demographic data will be extracted from their medical record, including weight (kg).
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University of Melbourne
Lead sponsor
Peter MacCallum Cancer Centre, Australia
Collaborator
