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Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer SurgerySTTARRSNCT06631872

Implementing Surgery School Prehabilitation Using Telehealth

A study testing Tele-prehabilitation education session: Surgery School and Individualised Inspiratory Muscle Training and Walking Program in people with Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery, run by University of Melbourne at 9 sites in Australia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tele-prehabilitation education session: Surgery School and Individualised Inspiratory Muscle Training and Walking Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
515 participants
Where
9 sitesAustralia
Study dates
22 Jan 2025to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Linda Denehy, B AppSc (Physio), PhD contact

+61 3 8344 6428

l.denehy@unimelb.edu.au

Jamie Waterland, B Physio(Hons), PhD contact

+61 3 8559 8223

jamie.waterland@unimelb.edu.au

9 sites in 1 country

Australia9 sites, 9 recruiting
  • North West Regional Hospital

    Burnie, Tasmania, 7320

    Ianthe Boden, PhD, ianthe.boden@utas.edu.au

    Not yet recruiting
  • Austin Health

    Heidelberg, Victoria, 3084

    Sue Berney, PhD, sue.berney@austin.org.au

    Recruiting
  • Launceston General Hospital

    Launceston, Tasmania, 7250

    Ianthe Boden, PhD, ianthe.boden@ths.tas.gov.au

    Recruiting
  • Royal Melbourne Hospital

    Melbourne, Victoria, 3050

    Leonie Shaw, BAppSc(Phy), leonie.shaw@mh.org.au

    Recruiting
  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

    Jennifer Mackney, PhD, jennifer.mackney@health.nsw.gov.au

    Recruiting
  • Fiona Stanley Hospital

    Perth, Western Australia, 6845

    Vinicius Cavalheri, PhD, vinicius.cavalheri@curtin.edu.au

    Recruiting
  • Gold Coast University Hospital

    Southport, Queensland, 4215

    Hayley Edwards, Hayley.Edwards4@health.qld.gov.au

    Recruiting
  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

    Jennifer Mackney, PhD, jennifer.mackney@health.nsw.gov.au

    Recruiting
  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Claire Hackett, BPHTY, claire.hackett@health.qld.gov.au

    Recruiting

Other trials in Australia

About this study

Official title: Implementing Tele-prehabilitation Education Into Cancer Care Pathways

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.

Read more

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.

Being tested
Tele-prehabilitation education session: Surgery School, Individualised Inspiratory Muscle Training and Walking Program, Usual Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-prehabilitation education session: Surgery SchoolBehavioural

    Online telehealth education program using videos and a live clinician facilitator

  • Individualised Inspiratory Muscle Training and Walking ProgramBehavioural

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

  • Usual CareOther

    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.

Study groups in NCT06631872
Study groupRoleWhat they receive
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 7 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.
Receives: Behavioral: Tele-prehabilitation education session: Surgery School
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.
Receives: Other: Usual Care
Sub-study: Tele-prehabilitation and inspiratory muscle training programExperimentalEligible 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.
Receives: Behavioral: Tele-prehabilitation education session: Surgery School; Behavioral: Individualised Inspiratory Muscle Training and Walking Program
Sub-study: Tele-prehabilitation interventionActive comparatorThe Teleprehabilitaiton intervention (also known as Surgery School) is a one-off group based education session delivered online. Video presentations of 7 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.
Receives: Behavioral: Tele-prehabilitation education session: Surgery School

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Daily for up to 7 days post operatively or until hospital discharge.

Secondary outcomes (32)
  1. Diagnosis of pneumonia

    Diagnosis of pneumonia (Y/N) classified according the centre for disease control definition.

    Measured: Daily up to postoperative day 7 or until hospital discharge

  2. 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.

    Measured: Postoperative day 3,5,10 unless discharge prior and 30 days post operative.

  3. 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.

    Measured: 30 days, 6 months and 12 months post operative

  4. 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.

    Measured: Baseline and preoperatively at centres participating in the inspiratory muscle training sub study

  5. Physical activity levels - subjective

    Physical activity levels will be documented subjectively using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF is a questionnaire used internationally to obtain comparable estimates of physical activity. The questionnaire comprises seven questions related to physical activity at different levels of intensity and sitting time. Results will be reported in categories (low activity levels, moderate activity levels or high activity levels) and a continuous variable (MET minutes a week). Higher METs or categories indicate higher levels of physical activity.

    Measured: Baseline, Preoperatively, 30 days post operative

  6. Physical activity levels - objective

    Physical activity levels will be collected objectively using wearable monitors, such as fitbits for three days at baseline, three days after the intervention and at 30 days postoperatively. Physical activity variables will include the total number of daily steps, daily minutes of moderate to vigorous physical activity (MVPA), peak 1-minute cadence (the highest single minute of steps recorded), and peak 30-minute cadence (the average steps/min for the highest non-consecutive 30 minutes in a day). A minimum of 8 hours over 3 days is considered valid wear time for physical activity data. Values are described using mean +/- standard deviation and mean difference (MD) with 95% confidence intervals (95% CI).

    Measured: Baseline, Preoperatively, 30 days post operative

  7. Video and Surgery School Session Attendance (Intervention group only)

    Attendance at Surgery School session, length of time attended the Surgery School session and number of questions asked during Surgery School session.

    Measured: Preoperative timepoint

  8. Access to video outside the Surgery School Session (Intervention group only)

    The number of times the videos are accessed outside of the Surgery School session, site, day of week, time of day will be collected. Number of questions asked during Surgery School session.

    Measured: Preoperative timepoint

  9. Symptoms: electronic Edmonton Symptom Assessment System-revised ((e)ESAS-r)

    The electronic Edmonton Symptom Assessment System-revised ((e)ESAS-r) is a 10-item assessment tool for self-reporting symptom intensity via electronic platforms for digital use. The (e)ESAS-r allows participants to rate the severity of common symptoms as well as the opportunity to rate 'other problems' as nominated by the participant on a scale from 0 to 10 with higher score indicating higher severity of symptoms

    Measured: Baseline (and repeated every 4 weeks for participants having treatment before surgery), Preoperative, Postoperative: 30 days.

  10. Behaviour Change

    Behaviour change will be measured using a bespoke questionnaire: STTARRS behaviour change questionnaire (SBCQ) developed to assess patient action related to information (a) contained within the videos and surgery school session (intervention group) and (b) for usual care participants information provided to them through educational materials. This patient reported experience measure will measure responses to questions on a 5-point Likert scale (strongly disagree to strongly agree). Results will be presented descriptively. Higher responses on the likert scales indicates a higher agreement.

    Measured: Preoperative timepoint, at hospital discharge (+3 days)

  11. Self-efficacy: Patient Activation Measure

    Patient Activation Measure (PAM) is a questionnaire assessing three key domains: knowledge, skills, confidence to understand self-management ability. The PAM is a 13-item survey scored on a 100 point scale, with 4 activation levels validated for across time measures and used world-wide. PAM Levels 1 and 2 indicate lower patient activation, while PAM levels 3 and 4 indicate higher patient activation.

    Measured: Baseline, preoperative timepoint, 30 days and 6 months postoperative.

  12. Treatment Burden: Multimorbidity Treatment Burden Questionnaire (MTBQ)

    Multimorbidity Treatment Burden Questionnaire (MTBQ) is a 13 item questionnaire that assesses the perception of the effort required to self-manage their medical conditions and the impact that this has on their wellbeing. The MTBQ has demonstrated good content and construct validity, reliability and responsiveness. The MTBQ is scored from 0-100 with higher scores indicating higher treatment burden which fall into four categories: no burden (score 0), low burden (score <10), medium burden (10-22) and high burden (>=22).

    Measured: Baseline, preoperative timepoint, 30 days postoperative

  13. Viewer perceptions of the intervention (intervention group only)

    Viewer perceptions of the intervention including perceived personal relevance will be assessed using a previously published questionnaire. The questionnaire includes questions on four domains: helpfulness, believability, novelty, and relevance of information. A total of 7 questions all rate on 0-6 Likert scales from strongly disagree to strongly agree, with higher score indicating stronger agreement and an additional yes/no question asked regarding whether participants intend to change any behaviours.

    Measured: Preoperative timepoint

  14. Feasibility of the teleprehabilitation program: Proportion of eligible patients participating

    Portion of eligible patients participating will be collected and reported as a percentage of all patients eligible for the trial.

    Measured: Time Frame: Through study recruitment, up to 2.5 years

  15. Feasibility of the teleprehabilitation program: Representativeness

    Representativeness relative to a wider group of eligible patients presented descriptively

    Measured: Time Frame: Through study recruitment, up to 2.5 years

  16. Feasibility of the teleprehabilitation program: Referral rates

    Actual teleprehabilitation referral rates as a % of total eligible to be referred

    Measured: Time Frame: Through study recruitment, up to 2.5 years

  17. Feasibility of the teleprehabilitation program: reasons for declining

    Reasons for declining will be reported descriptively.

    Measured: Time Frame: Through study recruitment, up to 2.5 years

  18. Acceptability

    Participants will be asked to complete a survey regarding trial acceptability. The survey questions will be based upon the Theoretical Framework of Acceptability. The framework comprises seven domains designed to assess acceptability elements: perceived effectiveness, self-efficacy, affective attitude, ethicality burden, intervention coherence and opportunity costs.

    Measured: Preoperative timepoint, at hospital discharge (+3 days), 30 days post operative

  19. Fidelity (treatment delivery): Tele-prehabilitation education session duration

    Treatment delivery: using duration of education session provided (minutes).

    Measured: Through study data collection, up to 2.5 years

  20. Fidelity (treatment delivery): Number of videos accessed

    Treatment delivery: total number of videos accessed, presented descriptively and also by video title.

    Measured: Through study data collection, up to 2.5 years

  21. Fidelity (treatment delivery): Number of video views

    Treatment delivery: using number of videos viewed, results presented descriptively .

    Measured: Through study data collection, up to 2.5 years

  22. Fidelity (treatment delivery): Telehealth implementation process concordance with implementation protocol.

    Treatment delivery (centre level): using process concordance with implementation protocol.

    Measured: Through study data collection, up to 2.5 years

  23. Fidelity (treatment delivery): viewing time

    Treatment delivery: using the time of participant viewing (minutes).

    Measured: Through study data collection, up to 2.5 years

  24. Fidelity (treatment receipt): participant attendance at telehealth meeting

    Treatment receipt: % of participants who attend a session once booked in

    Measured: Through study data collection, up to 2.5 years

  25. Fidelity (treatment receipt): number of questions

    Treatment receipt: the number of questions per session will be recorded.

    Measured: Through study data collection, up to 2.5 years

  26. Fidelity (treatment receipt): participant retention at follow up

    Treatment receipt: the number of participants attending follow up will be recorded (% of total participants).

    Measured: Through study data collection, up to 2.5 years

  27. Participant satisfaction: Australian Hospital Experience Question Set (AHPEQS)

    The Australian Hospital Patient Experience Question Set (AHPEQS) is a 12-item questionnaire (ten core items and two sub-items) used to measure patient satisfaction with recent treatment. Questions are measured on responses from always to never or didn't apply. Results will be reported descriptively with positive responses indicating greater satisfaction with recent treatment.

    Measured: 30 days post operative

  28. Health related quality of life: EORTC QLQ-C30

    European Organisation for the Research and Treatment of Cancer (EORTC QLQ- C30) core questionnaire is a measure composed of five multi-item domains (physical, role, emotional, cognitive function and social functioning). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status / quality of life represents a high quality of life but a high score for a symptom scale / item represents a high level of symptomatology / problems. The EORTC QLQ-C30 Summary score will also be reported and is calculated from the mean of 13 of the 15 QLQ-C30 scale, with higher score indicating a higher quality of life. This tool has established validity and reliability in cancer.

    Measured: Baseline, Preoperative, 30 days, 6 months and 12 months post operative

  29. Postoperative Quality of Recovery: Postoperative Quality of Recovery Score (PostopQRS)

    The Postoperative Quality of Recovery Score (PostopQRS) is a multidimensional recovery assessment tool that is a verbal questionnaire. It has proven patient user acceptance and has been validated to be performed either face to face or over the telephone. The core domains include physiologic, nociceptive, functional, cognitive and emotional recovery and satisfaction with care, that is designed for use over multiple timepoints. The PostopQRS provides objective assessment of post-operative recovery, analysing the core domains of recovery, namely physiologic, nociceptive, functional, cognitive and emotional recovery compared to a unique individual preoperative baseline score. Recovery is then scored for each domain, and patients must recover in all tests within the domain to be scored as recovered. "All domains" recovery implies recovery in all of the five recovery domains.

    Measured: Preoperative timepoint, 3 days and 6 days postoperatively (if not discharged prior), 30 days and 6 months postoperative

  30. Length of hospital stay

    Length of hospital stay will be documented from the medical records by a blinded assessor at each centre.

    Measured: at hospital discharge

  31. Health service use and costs

    Captured in following ways:

    (i) hospital services and the use of health care services outside of hospital. (ii) Patients will be surveyed on their use of health services outside the hospital at 6 and 12 months postop follow-up using a questionnaire. (iii) Cost of program delivery

    Measured: at hospital discharge, 30 days, 6 and 12 months post operative

  32. Exploratory Outcomes

    Teleprehabilitation is an intervention suitable for patients of low to moderately high perioperative risk levels, however subgroup analyses based on risk provide the opportunity to explore if teleprehabilitation offers additional benefits to patients of increasing risk level. Surgical procedure: Differences in PPC rates between the two surgical groups (abdominal and lung) and between those receiving or not receiving neo-adjuvant therapy before abdominal cancer surgery will be explored.

    Measured: through study completion, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start22 Jan 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
515 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06631872
Sponsor's protocol ID
4.4 11/12/2025
Acronym
STTARRS
Status last verified
May 2026
First submitted
15 Sep 2024
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tele-prehabilitation education session: Surgery School and Individualised Inspiratory Muscle Training and Walking Program in people with Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery, run by University of Melbourne at 9 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Linda Denehy, B AppSc (Physio), PhD (+61 3 8344 6428, l.denehy@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post operative Pulmonary Complication (PPC) (time frame: Daily for up to 7 days post operatively or until hospital discharge.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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