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.
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
- Conditions the study is for
- Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery
- What is being tested?
- Tele-prehabilitation education session: Surgery School and Individualised Inspiratory Muscle Training and Walking Program
- Type of treatment
- Lifestyle or therapy programme
- 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.
9 sites in 1 country
Australia9 sites, 9 recruiting
- Not yet recruiting
North West Regional Hospital
Burnie, Tasmania, 7320
Ianthe Boden, PhD, ianthe.boden@utas.edu.au
- 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
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.
- Conditions
- Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer 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 group | Role | What they receive |
|---|---|---|
| Tele-prehabilitation intervention (Intervention Group) | Experimental | The 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 comparator | 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. Receives: Other: Usual Care |
| Sub-study: Tele-prehabilitation and inspiratory muscle training program | Experimental | 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. Receives: Behavioral: Tele-prehabilitation education session: Surgery School; Behavioral: Individualised Inspiratory Muscle Training and Walking Program |
| Sub-study: Tele-prehabilitation intervention | Active comparator | The 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.
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)
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
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.
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
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
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
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
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
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
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.
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)
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.
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
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
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
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
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
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
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
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
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
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
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
Fidelity (treatment delivery): viewing time
Treatment delivery: using the time of participant viewing (minutes).
Measured: Through study data collection, up to 2.5 years
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
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
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
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
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
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
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
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
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.
- First posted8 Oct 2024
- Study start22 Jan 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Responsible party
- Sponsor
- Investigators
- Linda Denehy, B AppSc (Physio), PhD, Principal investigator, University of Melbourne
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Tele-prehabilitation Education Into Cancer Care Pathways
- ClinicalTrials.gov ID
- NCT06631872
- Acronym / sponsor ID
- STTARRS / 4.4 11/12/2025
- Conditions
- Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 515 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Peter MacCallum Cancer Centre, Australia
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tele-prehabilitation intervention (Intervention Group) | Experimental | Behavioral: Tele-prehabilitation education session: Surgery SchoolThe 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. |
| Usual care alone (Control Group) | Active comparator | Other: Usual CareParticipants 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 | Experimental | Behavioral: Tele-prehabilitation education session: Surgery School, Behavioral: Individualised Inspiratory Muscle Training and Walking ProgramEligible 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 comparator | Behavioral: Tele-prehabilitation education session: Surgery SchoolThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-prehabilitation education session: Surgery SchoolOnline telehealth education program using videos and a live clinician facilitator | Behavioural | Sub-study: Tele-prehabilitation and inspiratory muscle training program, Sub-study: Tele-prehabilitation intervention, Tele-prehabilitation intervention (Intervention Group) |
| Individualised Inspiratory Muscle Training and Walking ProgramAn individualised inspiratory muscle training and walking program delivered by a Physiotherapist using telehealth. | Behavioural | Sub-study: Tele-prehabilitation and inspiratory muscle training program |
| Usual CareUsual 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. | Other | Usual care alone (Control Group) |
Primary outcome
Post operative Pulmonary Complication (PPC)
Time frame: Daily for up to 7 days post operatively or until hospital discharge.
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.
32 secondary outcomes
Diagnosis of pneumonia
Time frame: Daily up to postoperative day 7 or until hospital discharge
Postoperative complications
Time frame: Postoperative day 3,5,10 unless discharge prior and 30 days post operative.
Number of days alive and out of hospital
Time frame: 30 days, 6 months and 12 months post operative
Maximal Inspiratory Pressure (MIP)
Time frame: Baseline and preoperatively at centres participating in the inspiratory muscle training sub study
Physical activity levels - subjective
Time frame: Baseline, Preoperatively, 30 days post operative
Physical activity levels - objective
Time frame: Baseline, Preoperatively, 30 days post operative
Video and Surgery School Session Attendance (Intervention group only)
Time frame: Preoperative timepoint
Access to video outside the Surgery School Session (Intervention group only)
Time frame: Preoperative timepoint
Symptoms: electronic Edmonton Symptom Assessment System-revised ((e)ESAS-r)
Time frame: Baseline (and repeated every 4 weeks for participants having treatment before surgery), Preoperative, Postoperative: 30 days.
Behaviour Change
Time frame: Preoperative timepoint, at hospital discharge (+3 days)
Self-efficacy: Patient Activation Measure
Time frame: Baseline, preoperative timepoint, 30 days and 6 months postoperative.
Treatment Burden: Multimorbidity Treatment Burden Questionnaire (MTBQ)
Time frame: Baseline, preoperative timepoint, 30 days postoperative
Viewer perceptions of the intervention (intervention group only)
Time frame: Preoperative timepoint
Feasibility of the teleprehabilitation program: Proportion of eligible patients participating
Time frame: Time Frame: Through study recruitment, up to 2.5 years
Feasibility of the teleprehabilitation program: Representativeness
Time frame: Time Frame: Through study recruitment, up to 2.5 years
Feasibility of the teleprehabilitation program: Referral rates
Time frame: Time Frame: Through study recruitment, up to 2.5 years
Feasibility of the teleprehabilitation program: reasons for declining
Time frame: Time Frame: Through study recruitment, up to 2.5 years
Acceptability
Time frame: Preoperative timepoint, at hospital discharge (+3 days), 30 days post operative
Fidelity (treatment delivery): Tele-prehabilitation education session duration
Time frame: Through study data collection, up to 2.5 years
Fidelity (treatment delivery): Number of videos accessed
Time frame: Through study data collection, up to 2.5 years
Fidelity (treatment delivery): Number of video views
Time frame: Through study data collection, up to 2.5 years
Fidelity (treatment delivery): Telehealth implementation process concordance with implementation protocol.
Time frame: Through study data collection, up to 2.5 years
Fidelity (treatment delivery): viewing time
Time frame: Through study data collection, up to 2.5 years
Fidelity (treatment receipt): participant attendance at telehealth meeting
Time frame: Through study data collection, up to 2.5 years
Fidelity (treatment receipt): number of questions
Time frame: Through study data collection, up to 2.5 years
Fidelity (treatment receipt): participant retention at follow up
Time frame: Through study data collection, up to 2.5 years
Participant satisfaction: Australian Hospital Experience Question Set (AHPEQS)
Time frame: 30 days post operative
Health related quality of life: EORTC QLQ-C30
Time frame: Baseline, Preoperative, 30 days, 6 months and 12 months post operative
Postoperative Quality of Recovery: Postoperative Quality of Recovery Score (PostopQRS)
Time frame: Preoperative timepoint, 3 days and 6 days postoperatively (if not discharged prior), 30 days and 6 months postoperative
Length of hospital stay
Time frame: at hospital discharge
Health service use and costs
Time frame: at hospital discharge, 30 days, 6 and 12 months post operative
Exploratory Outcomes
Time frame: through study completion, up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Denehy, B AppSc (Physio), PhD principal investigator
University of Melbourne
9 sites in 1 country: see every site and its status.
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.