An interventional study of Tele-prehabilitation education session: Surgery School and Individualised Inspiratory Muscle Training and Walking Program in Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery, sponsored by University of Melbourne. Recruiting at 9 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University of Melbourne · Not applicable, Interventional, and Supportive care
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.
University of Melbourne is the lead sponsor of 84 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Tele-prehabilitation education session: Surgery School
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.
Other: Usual Care
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.
Behavioral: Tele-prehabilitation education session: Surgery School · Behavioral: Individualised Inspiratory Muscle Training and Walking Program
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.
Behavioral: Tele-prehabilitation education session: Surgery School
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.
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.
Time frame: Daily for up to 7 days post operatively or until hospital discharge.
Diagnosis of pneumonia
Diagnosis of pneumonia (Y/N) classified according the centre for disease control definition.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: Through study data collection, up to 2.5 years
Fidelity (treatment delivery): viewing time
Treatment delivery: using the time of participant viewing (minutes).
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: through study completion, up to 3 years
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.
Time frame: Baseline
Date of birth
After consent, participants' demographic data will be extracted from their medical record, including date of birth (years).
Time frame: Baseline
Height
After consent, participants' demographic data will be extracted from their medical record, including height (cm).
Time frame: Baseline
Weight
After consent, participants' demographic data will be extracted from their medical record, including weight (kg).
Time frame: Baseline
Primary language spoken
After consent, participants' demographic data will be extracted from their medical record, including primary language spoken (name of).
Time frame: Baseline
Proposed surgery
After consent, participants' clinical data will be extracted from their medical record, including proposed surgery (category of abdominal cancer or lung cancer surgery) and description of surgery.
Time frame: Baseline
Medical history
After consent, participants' clinical data will be extracted from their medical record, including medical conditions.
Time frame: Baseline
Social history: live alone
After consent, participants' social data will be extracted from their medical record, including living situation, living alone (yes/no).
Time frame: Baseline
Social history: partner
After consent, participants' social data will be extracted from their medical record, including living situation, if they have a partner (yes/no).
Time frame: Baseline
Work status
After consent, participants' demographic data will be extracted from their medical record, including work status.
Time frame: Baseline
Postcode
After consent, participants' demographic data will be extracted from their medical record, including postcode (zip code).
Time frame: Baseline
American Society of Anaesthesiologists (ASA) score
The American Society of Anaesthesiologists (ASA) score is a longstanding score that includes a subjective assessment of a patient's overall health according to five classes; (i) Patient is a completely healthy fit patient, (ii) Patient has mild systemic disease, (iii) Patient has severe systematic disease that is not incapacitating, (iii) Patient has severe systemic disease that is not incapacitating, (iv) Patient has incapacitating disease that is a constant threat to life or (v) A moribund patient who is not expected to live 24 hours with or without surgery. A higher category indicates higher risk.
Time frame: Baseline
Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score
The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score is a valid tool for determining a patient's risk score for developing postoperative pulmonary complications. A higher score indicates higher risk of postoperative pulmonary complications and is classified as: low risk \<26, intermediate risk: 26-44, and high risk : \>=45.
Time frame: Baseline
Frailty
Frailty is a multidimensional geriatric syndrome characterised by a decline of physical and cognitive reserves that leads to increased vulnerability. It will be measured using the modified Reported Edmonton Frail Scale. The scale is a questionnaire with 13 items with a total score of 0 to 18. Scores are converted into the following categories: (0-5) not frail, (6-7) apparently vulnerable, (8-9) mild frailty, (10-11) moderate frailty and (12-18) severe frailty.
Time frame: Baseline
Survival
Patients will be followed to assess if they are alive at 12 months post operatively.
Time frame: 12 months post operative
Surgical and anaesthetic information
Intraoperative details of surgical procedure, type of anaesthesia and reversal agent
Time frame: at hospital discharge
Plan to share: No
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University of Melbourne