Implementing Surgery School Prehabilitation Using Telehealth (STTARRS)

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.

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 Overview

• Status: Recruiting
• Conditions: Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery
• Intervention / Treatment: Behavioral: Tele-prehabilitation education session: Surgery School; Other: Usual Care; Behavioral: Individualised Inspiratory Muscle Training and Walking Program

• Study Type: Interventional
• Enrollment (Estimated): 515
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda Denehy, B AppSc (Physio), PhD; Phone Number: +61 3 8344 6428; Email: l.denehy@unimelb.edu.au
• Study Contact Backup: Name: Jamie Waterland, B Physio(Hons), PhD; Phone Number: +61 3 8559 8223; Email: jamie.waterland@unimelb.edu.au

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • Recruiting
      • John Hunter Hospital
      • Contact: Jennifer Mackney, PhD; Email: jennifer.mackney@health.nsw.gov.au
    • Waratah, New South Wales, Australia, 2298
      • Recruiting
      • Calvary Mater Newcastle
      • Contact: Jennifer Mackney, PhD; Email: jennifer.mackney@health.nsw.gov.au
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Recruiting
      • Gold Coast University Hospital
      • Contact: Hayley Edwards; Email: Hayley.Edwards4@health.qld.gov.au
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
      • Contact: Claire Hackett, BPHTY; Email: claire.hackett@health.qld.gov.au
  • Tasmania
    • Burnie, Tasmania, Australia, 7320
      • Not yet recruiting
      • North West Regional Hospital
      • Contact: Ianthe Boden, PhD; Email: ianthe.boden@utas.edu.au
    • Launceston, Tasmania, Australia, 7250
      • Recruiting
      • Launceston General Hospital
      • Contact: Ianthe Boden, PhD; Email: ianthe.boden@ths.tas.gov.au
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Recruiting
      • Austin Health
      • Contact: Sue Berney, PhD; Email: sue.berney@austin.org.au
    • Melbourne, Victoria, Australia, 3050
      • Recruiting
      • Royal Melbourne Hospital
      • Contact: Leonie Shaw, BAppSc(Phy); Email: leonie.shaw@mh.org.au
  • Western Australia
    • Perth, Western Australia, Australia, 6845
      • Recruiting
      • Fiona Stanley Hospital
      • Contact: Vinicius Cavalheri, PhD; Email: vinicius.cavalheri@curtin.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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.	Behavioral: Tele-prehabilitation education session: Surgery School; Online telehealth education program using videos and a live clinician facilitator; Behavioral: Individualised Inspiratory Muscle Training and Walking Program; An individualised inspiratory muscle training and walking program delivered by a Physiotherapist using telehealth.
Experimental: 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 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
Active Comparator: 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative Pulmonary Complication (PPC)	Post operative pulmonary complications (PPC) will be assessed using the Melbourne Group Score (MGS). The MGS is an eight-item checklist. Minimum score 0, Maximum score 8. Participants are identifying as having a PPC if they score four or more in a 24-hour period.	Daily for up to 7 days post operatively or until hospital discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of pneumonia	Diagnosis of pneumonia (Y/N) classified according the centre for disease control definition.	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.	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.	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.	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.	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).	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.	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.	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	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.	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.	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).	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.	Preoperative timepoint
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.	Preoperative timepoint, at hospital discharge (+3 days), 30 days post operative
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.	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.	Baseline, Preoperative, 30 days, 6 months and 12 months post operative
Length of hospital stay	Length of hospital stay will be documented from the medical records by a blinded assessor at each centre.	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	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.	through study completion, up to 3 years
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: 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: 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: 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: Through study recruitment, up to 2.5 years
Fidelity (treatment delivery): Tele-prehabilitation education session duration	Treatment delivery: using duration of education session provided (minutes).	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.	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 .	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.	Through study data collection, up to 2.5 years
Fidelity (treatment delivery): viewing time	Treatment delivery: using the time of participant viewing (minutes).	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.	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).	Through study data collection, up to 2.5 years
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.	Preoperative timepoint, 3 days and 6 days postoperatively (if not discharged prior), 30 days and 6 months postoperative
Fidelity (treatment receipt): participant attendance at telehealth meeting	Treatment receipt: % of participants who attend a session once booked in	Through study data collection, up to 2.5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
Date of birth	After consent, participants' demographic data will be extracted from their medical record, including date of birth (years).	Baseline
Height	After consent, participants' demographic data will be extracted from their medical record, including height (cm).	Baseline
Weight	After consent, participants' demographic data will be extracted from their medical record, including weight (kg).	Baseline
Primary language spoken	After consent, participants' demographic data will be extracted from their medical record, including primary language spoken (name of).	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.	Baseline
Medical history	After consent, participants' clinical data will be extracted from their medical record, including medical conditions.	Baseline
Social history: live alone	After consent, participants' social data will be extracted from their medical record, including living situation, living alone (yes/no).	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).	Baseline
Work status	After consent, participants' demographic data will be extracted from their medical record, including work status.	Baseline
Postcode	After consent, participants' demographic data will be extracted from their medical record, including postcode (zip code).	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.	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.	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.	Baseline
Survival	Patients will be followed to assess if they are alive at 12 months post operatively.	12 months post operative
Surgical and anaesthetic information	Intraoperative details of surgical procedure, type of anaesthesia and reversal agent	at hospital discharge

Collaborators and Investigators

• Sponsor: University of Melbourne
• Collaborators: Peter MacCallum Cancer Centre, Australia
• Investigators: Principal Investigator: Linda Denehy, B AppSc (Physio), PhD, University of Melbourne

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: September 15, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 4.4 11/12/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No