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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)
Timepoint [1] 0 0
Daily for up to 7 days post operatively or until hospital discharge.
Secondary outcome [1] 0 0
Diagnosis of pneumonia
Timepoint [1] 0 0
Daily up to postoperative day 7 or until hospital discharge
Secondary outcome [2] 0 0
Postoperative complications
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
Timepoint [3] 0 0
30 days, 6 months and 12 months post operative
Secondary outcome [4] 0 0
Maximal Inspiratory Pressure (MIP)
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
Timepoint [5] 0 0
Baseline, Preoperatively, 30 days post operative
Secondary outcome [6] 0 0
Physical activity levels - objective
Timepoint [6] 0 0
Baseline, Preoperatively, 30 days post operative
Secondary outcome [7] 0 0
Video and Surgery School Session Attendance (Intervention group only)
Timepoint [7] 0 0
Preoperative timepoint
Secondary outcome [8] 0 0
Access to video outside the Surgery School Session (Intervention group only)
Timepoint [8] 0 0
Preoperative timepoint
Secondary outcome [9] 0 0
Symptoms: electronic Edmonton Symptom Assessment System-revised ((e)ESAS-r)
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
Timepoint [10] 0 0
Preoperative timepoint, at hospital discharge (+3 days)
Secondary outcome [11] 0 0
Self-efficacy: Patient Activation Measure
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)
Timepoint [12] 0 0
Baseline, preoperative timepoint, 30 days postoperative
Secondary outcome [13] 0 0
Viewer perceptions of the intervention (intervention group only)
Timepoint [13] 0 0
Preoperative timepoint
Secondary outcome [14] 0 0
Feasibility of the teleprehabilitation program: Proportion of eligible patients participating
Timepoint [14] 0 0
Time Frame: Through study recruitment, up to 2 years
Secondary outcome [15] 0 0
Feasibility of the teleprehabilitation program: Representativeness
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
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
Timepoint [17] 0 0
Time Frame: Through study recruitment, up to 2 years
Secondary outcome [18] 0 0
Acceptability
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
Timepoint [19] 0 0
Through study data collection, up to 2 years
Secondary outcome [20] 0 0
Fidelity (treatment delivery): Number of videos accessed
Timepoint [20] 0 0
Through study data collection, up to 2 years
Secondary outcome [21] 0 0
Fidelity (treatment delivery): Number of video views
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.
Timepoint [22] 0 0
Through study data collection, up to 2 years
Secondary outcome [23] 0 0
Fidelity (treatment delivery): viewing time
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
Timepoint [24] 0 0
Through study data collection, up to 2 years
Secondary outcome [25] 0 0
Fidelity (treatment receipt): number of questions
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
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)
Timepoint [27] 0 0
30 days post operative
Secondary outcome [28] 0 0
Health related quality of life: EORTC QLQ-C30
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)
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
Timepoint [30] 0 0
at hospital discharge
Secondary outcome [31] 0 0
Health service use and costs
Timepoint [31] 0 0
at hospital discharge, 30 days, 6 and 12 months post operative
Secondary outcome [32] 0 0
Exploratory Outcomes
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
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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
Fax 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
Fax 0 0
Email 0 0
l.denehy@unimelb.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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