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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06631872




Registration number
NCT06631872
Ethics application status
Date submitted
15/09/2024
Date registered
8/10/2024

Titles & IDs
Public title
Implementing Surgery School Prehabilitation Using Telehealth
Scientific title
Implementing Tele-prehabilitation Education Into Cancer Care Pathways
Secondary ID [1] 0 0
3.0 31/07/2024
Universal Trial Number (UTN)
Trial acronym
STTARRS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Colorectal Cancer 0 0
Oesophageal Cancer 0 0
Pancreas Cancer 0 0
Gastric Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Tele-prehabilitation education session: Surgery School
BEHAVIORAL - Individualised Inspiratory Muscle Training and Walking Program
Other interventions - Usual Care

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 8-10 key prehabilitation education areas will be facilitated by a live clinician facilitator who will introduce the educational content and answer any questions. All standardised video presentations during the session will be made available to participants through an online password-protected video repository hosted on a video platform after the session and will be available until their surgery.

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.

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.

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 8-10 key prehabilitation education areas will be facilitated by a live clinician facilitator who will introduce the educational content and answer any questions. All standardised video presentations during the session will be made available to participants through an online password-protected video repository hosted on a video platform after the session and will be available until their surgery.


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.

Other interventions: Usual Care
Usual care alone. Usual care will be reviewed every four months during the trial and site leads will be asked to provide information about any changes to usual hospital and medical care at their site.
Intervention code [1] 0 0
BEHAVIORAL
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post operative Pulmonary Complication (PPC)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Daily for up to 7 days post operatively or until hospital discharge.
Secondary outcome [1] 0 0
Diagnosis of pneumonia
Assessment method [1] 0 0
Diagnosis of pneumonia (Y/N) classified according the centre for disease control definition.
Timepoint [1] 0 0
Daily up to postoperative day 7 or until hospital discharge
Secondary outcome [2] 0 0
Postoperative complications
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Postoperative day 3,5,10 unless discharge prior and 30 days post operative.
Secondary outcome [3] 0 0
Number of days alive and out of hospital
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
30 days, 6 months and 12 months post operative
Secondary outcome [4] 0 0
Maximal Inspiratory Pressure (MIP)
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Baseline and preoperatively at centres participating in the inspiratory muscle training sub study
Secondary outcome [5] 0 0
Physical activity levels - subjective
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Baseline, Preoperatively, 30 days post operative
Secondary outcome [6] 0 0
Physical activity levels - objective
Assessment method [6] 0 0
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).
Timepoint [6] 0 0
Baseline, Preoperatively, 30 days post operative
Secondary outcome [7] 0 0
Video and Surgery School Session Attendance (Intervention group only)
Assessment method [7] 0 0
Attendance at Surgery School session, length of time attended the Surgery School session and number of questions asked during Surgery School session.
Timepoint [7] 0 0
Preoperative timepoint
Secondary outcome [8] 0 0
Access to video outside the Surgery School Session (Intervention group only)
Assessment method [8] 0 0
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.
Timepoint [8] 0 0
Preoperative timepoint
Secondary outcome [9] 0 0
Symptoms: electronic Edmonton Symptom Assessment System-revised ((e)ESAS-r)
Assessment method [9] 0 0
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
Timepoint [9] 0 0
Baseline (and repeated every 4 weeks for participants having treatment before surgery), Preoperative, Postoperative: 30 days.
Secondary outcome [10] 0 0
Behaviour Change
Assessment method [10] 0 0
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.
Timepoint [10] 0 0
Preoperative timepoint, at hospital discharge (+3 days)
Secondary outcome [11] 0 0
Self-efficacy: Patient Activation Measure
Assessment method [11] 0 0
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.
Timepoint [11] 0 0
Baseline, preoperative timepoint, 30 days and 6 months postoperative.
Secondary outcome [12] 0 0
Treatment Burden: Multimorbidity Treatment Burden Questionnaire (MTBQ)
Assessment method [12] 0 0
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).
Timepoint [12] 0 0
Baseline, preoperative timepoint, 30 days postoperative
Secondary outcome [13] 0 0
Viewer perceptions of the intervention (intervention group only)
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Preoperative timepoint
Secondary outcome [14] 0 0
Feasibility of the teleprehabilitation program: Proportion of eligible patients participating
Assessment method [14] 0 0
Portion of eligible patients participating will be collected and reported as a percentage of all patients eligible for the trial.
Timepoint [14] 0 0
Time Frame: Through study recruitment, up to 2 years
Secondary outcome [15] 0 0
Feasibility of the teleprehabilitation program: Representativeness
Assessment method [15] 0 0
Representativeness relative to a wider group of eligible patients presented descriptively
Timepoint [15] 0 0
Time Frame: Through study recruitment, up to 2 years
Secondary outcome [16] 0 0
Feasibility of the teleprehabilitation program: Referral rates
Assessment method [16] 0 0
Actual teleprehabilitation referral rates as a % of total eligible to be referred
Timepoint [16] 0 0
Time Frame: Through study recruitment, up to 2 years
Secondary outcome [17] 0 0
Feasibility of the teleprehabilitation program: reasons for declining
Assessment method [17] 0 0
Reasons for declining will be reported descriptively.
Timepoint [17] 0 0
Time Frame: Through study recruitment, up to 2 years
Secondary outcome [18] 0 0
Acceptability
Assessment method [18] 0 0
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.
Timepoint [18] 0 0
Preoperative timepoint, at hospital discharge (+3 days), 30 days post operative
Secondary outcome [19] 0 0
Fidelity (treatment delivery): Tele-prehabilitation education session duration
Assessment method [19] 0 0
Treatment delivery: using duration of education session provided (minutes).
Timepoint [19] 0 0
Through study data collection, up to 2 years
Secondary outcome [20] 0 0
Fidelity (treatment delivery): Number of videos accessed
Assessment method [20] 0 0
Treatment delivery: total number of videos accessed, presented descriptively and also by video title.
Timepoint [20] 0 0
Through study data collection, up to 2 years
Secondary outcome [21] 0 0
Fidelity (treatment delivery): Number of video views
Assessment method [21] 0 0
Treatment delivery: using number of videos viewed, results presented descriptively .
Timepoint [21] 0 0
Through study data collection, up to 2 years
Secondary outcome [22] 0 0
Fidelity (treatment delivery): Telehealth implementation process concordance with implementation protocol.
Assessment method [22] 0 0
Treatment delivery (centre level): using process concordance with implementation protocol.
Timepoint [22] 0 0
Through study data collection, up to 2 years
Secondary outcome [23] 0 0
Fidelity (treatment delivery): viewing time
Assessment method [23] 0 0
Treatment delivery: using the time of participant viewing (minutes).
Timepoint [23] 0 0
Through study data collection, up to 2 years
Secondary outcome [24] 0 0
Fidelity (treatment receipt): participant attendance at telehealth zoom meeting
Assessment method [24] 0 0
Treatment receipt: % of participants who attend a session once booked in
Timepoint [24] 0 0
Through study data collection, up to 2 years
Secondary outcome [25] 0 0
Fidelity (treatment receipt): number of questions
Assessment method [25] 0 0
Treatment receipt: the number of questions per session will be recorded.
Timepoint [25] 0 0
Through study data collection, up to 2 years
Secondary outcome [26] 0 0
Fidelity (treatment receipt): participant retention at follow up
Assessment method [26] 0 0
Treatment receipt: the number of participants attending follow up will be recorded (% of total participants).
Timepoint [26] 0 0
Through study data collection, up to 2 years
Secondary outcome [27] 0 0
Participant satisfaction: Australian Hospital Experience Question Set (AHPEQS)
Assessment method [27] 0 0
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.
Timepoint [27] 0 0
30 days post operative
Secondary outcome [28] 0 0
Health related quality of life: EORTC QLQ-C30
Assessment method [28] 0 0
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.
Timepoint [28] 0 0
Baseline, Preoperative, 30 days, 6 months and 12 months post operative
Secondary outcome [29] 0 0
Postoperative Quality of Recovery: Postoperative Quality of Recovery Score (PostopQRS)
Assessment method [29] 0 0
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.
Timepoint [29] 0 0
Preoperative timepoint, 3 days postoperatively, hospital discharge (if greater than 2 days after postoperative day 3 review), 30 days and 6 months postoperative
Secondary outcome [30] 0 0
Length of hospital stay
Assessment method [30] 0 0
Length of hospital stay will be documented from the medical records by a blinded assessor at each centre.
Timepoint [30] 0 0
at hospital discharge
Secondary outcome [31] 0 0
Health service use and costs
Assessment method [31] 0 0
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
Timepoint [31] 0 0
at hospital discharge, 30 days, 6 and 12 months post operative
Secondary outcome [32] 0 0
Exploratory Outcomes
Assessment method [32] 0 0
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.
Timepoint [32] 0 0
through study completion, up to 3 years

Eligibility
Key inclusion criteria
* Preparing for lung cancer (open or video assisted) or major abdominal cancer surgery (upper GI, hepatobiliary and 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Concurrent, actively treated other malignancy of 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
545
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [6] 0 0
Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
7250 - Launceston
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3050 - Melbourne
Recruitment postcode(s) [6] 0 0
6845 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Linda Denehy, B AppSc (Physio), PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Linda Denehy, B AppSc (Physio), PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 8344 6428
Email 0 0
l.denehy@unimelb.edu.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06631872