Implementing Surgery School Prehabilitation Using Telehealth
STTARRS
Implementing Tele-prehabilitation Education Into Cancer Care Pathways
1 other identifier
interventional
515
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedStudy Start
First participant enrolled
January 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
August 27, 2025
October 1, 2024
2.4 years
September 15, 2024
August 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Daily for up to 7 days post operatively or until hospital discharge.
Secondary Outcomes (32)
Diagnosis of pneumonia
Daily up to postoperative day 7 or until hospital discharge
Postoperative complications
Postoperative day 3,5,10 unless discharge prior and 30 days post operative.
Number of days alive and out of hospital
30 days, 6 months and 12 months post operative
Maximal Inspiratory Pressure (MIP)
Baseline and preoperatively at centres participating in the inspiratory muscle training sub study
Physical activity levels - subjective
Baseline, Preoperatively, 30 days post operative
- +27 more secondary outcomes
Other Outcomes (16)
Sex
Baseline
Date of birth
Baseline
Height
Baseline
- +13 more other outcomes
Study Arms (4)
Tele-prehabilitation intervention (Intervention Group)
EXPERIMENTALThe Teleprehabilitaiton intervention (also known as Surgery School) is a one-off group based education session delivered online. Video presentations of 8-10 key prehabilitation education areas will be facilitated by a live clinician facilitator who will introduce the educational content and answer any questions. All standardised video presentations during the session will be made available to participants through an online password-protected video repository hosted on a video platform after the session and will be available until their surgery.
Usual care alone (Control Group)
ACTIVE COMPARATORParticipants allocated to the control group will receive usual care according to their health care team, which may consist of advice on smoking cessation, reduction of alcohol intake, nutritional counselling and medical optimisation in preoperative anaesthetic clinic visits. Participants will be asked to maintain their normal daily activities.
Sub-study: Tele-prehabilitation and inspiratory muscle training program
EXPERIMENTALEligible participants awaiting lung cancer surgery that have been randomised into the intervention arm will be re-randomised to receive either the STTARRS (larger trial) intervention or the STTARRS intervention PLUS an individualised inspiratory muscle training and walking program delivered by a physiotherapist using telehealth in the lead up to their lung cancer surgery. The inspiratory muscle training program includes an inspiratory muscle training explanatory video and an individually prescribed dosage and resistance for inspiratory muscle training and walking program, delivered via telehealth.
Sub-study: Tele-prehabilitation intervention
ACTIVE COMPARATORThe Teleprehabilitaiton intervention (also known as Surgery School) is a one-off group based education session delivered online. Video presentations of 8-10 key prehabilitation education areas will be facilitated by a live clinician facilitator who will introduce the educational content and answer any questions. All standardised video presentations during the session will be made available to participants through an online password-protected video repository hosted on a video platform after the session and will be available until their surgery.
Interventions
Online telehealth education program using videos and a live clinician facilitator
An individualised inspiratory muscle training and walking program delivered by a Physiotherapist using telehealth.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Melbournelead
- Peter MacCallum Cancer Centre, Australiacollaborator
Study Sites (6)
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
Fiona Stanley Hospital
Perth, Western Australia, 6845, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
Linda Denehy, B AppSc (Physio), PhD
University of Melbourne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2024
First Posted
October 8, 2024
Study Start
January 22, 2025
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
August 27, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share