Implementing Surgery School Prehabilitation Using Telehealth

NCT ID: NCT06631872

Last Updated: 2025-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-22

Study Completion Date

2028-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a two-arm, multicentre, comparative, assessor-blinded, randomised, controlled, hybrid (Type 1; examining both efficacy and feasibility) superiority trial that includes one sub-study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tele-prehabilitation intervention (Intervention Group)

The 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.

Group Type EXPERIMENTAL

Tele-prehabilitation education session: Surgery School

Intervention Type BEHAVIORAL

Online telehealth education program using videos and a live clinician facilitator

Usual care alone (Control Group)

Participants 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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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.

Sub-study: Tele-prehabilitation and inspiratory muscle training program

Eligible 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.

Group Type EXPERIMENTAL

Tele-prehabilitation education session: Surgery School

Intervention Type BEHAVIORAL

Online telehealth education program using videos and a live clinician facilitator

Individualised Inspiratory Muscle Training and Walking Program

Intervention Type BEHAVIORAL

An individualised inspiratory muscle training and walking program delivered by a Physiotherapist using telehealth.

Sub-study: Tele-prehabilitation intervention

The 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.

Group Type ACTIVE_COMPARATOR

Tele-prehabilitation education session: Surgery School

Intervention Type BEHAVIORAL

Online telehealth education program using videos and a live clinician facilitator

Interventions

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Tele-prehabilitation education session: Surgery School

Online telehealth education program using videos and a live clinician facilitator

Intervention Type BEHAVIORAL

Individualised Inspiratory Muscle Training and Walking Program

An individualised inspiratory muscle training and walking program delivered by a Physiotherapist using telehealth.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peter MacCallum Cancer Centre, Australia

OTHER

Sponsor Role collaborator

University of Melbourne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Denehy, B AppSc (Physio), PhD

Role: PRINCIPAL_INVESTIGATOR

University of Melbourne

Locations

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John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Site Status RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Site Status RECRUITING

Launceston General Hospital

Launceston, Tasmania, Australia

Site Status NOT_YET_RECRUITING

Austin Health

Heidelberg, Victoria, Australia

Site Status RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Fiona Stanley Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Linda Denehy, B AppSc (Physio), PhD

Role: CONTACT

+61 3 8344 6428

Jamie Waterland, B Physio(Hons), PhD

Role: CONTACT

+61 3 8559 8223

Facility Contacts

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Jennifer Mackney, PhD

Role: primary

Claire Hackett, BPHTY

Role: primary

Ianthe Boden, PhD

Role: primary

Sue Berney, PhD

Role: primary

Leonie Shaw, BAppSc(Phy)

Role: primary

Vinicius Cavalheri, PhD

Role: primary

Other Identifiers

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4.2 19/02/2025

Identifier Type: -

Identifier Source: org_study_id

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