Trial Title:
Implementing Surgery School Prehabilitation Using Telehealth
NCT ID:
NCT06631872
Condition:
Lung Cancer
Colorectal Cancer
Oesophageal Cancer
Pancreas Cancer
Gastric Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Tele-prehabilitation education session: Surgery School
Description:
Online telehealth education program using videos and a live clinician facilitator
Arm group label:
Sub-study: Tele-prehabilitation and inspiratory muscle training program
Arm group label:
Sub-study: Tele-prehabilitation intervention
Arm group label:
Tele-prehabilitation intervention (Intervention Group)
Intervention type:
Behavioral
Intervention name:
Individualised Inspiratory Muscle Training and Walking Program
Description:
An individualised inspiratory muscle training and walking program delivered by a
Physiotherapist using telehealth.
Arm group label:
Sub-study: Tele-prehabilitation and inspiratory muscle training program
Intervention type:
Other
Intervention name:
Usual Care
Description:
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.
Arm group label:
Usual care alone (Control Group)
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.
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, 65 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.
Criteria for eligibility:
Criteria:
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.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
John Hunter Hospital
Address:
City:
New Lambton Heights
Zip:
2305
Country:
Australia
Contact:
Last name:
Jennifer Mackney, PhD
Email:
jennifer.mackney@health.nsw.gov.au
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Contact:
Last name:
Claire Hackett, BPHTY
Email:
claire.hackett@health.qld.gov.au
Facility:
Name:
Launceston General Hospital
Address:
City:
Launceston
Zip:
7250
Country:
Australia
Contact:
Last name:
Ianthe Boden, PhD
Email:
ianthe.boden@ths.tas.gov.au
Facility:
Name:
Austin Health
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Contact:
Last name:
Sue Berney, PhD
Email:
sue.berney@austin.org.au
Facility:
Name:
Royal Melbourne Hospital
Address:
City:
Melbourne
Zip:
3050
Country:
Australia
Contact:
Last name:
Leonie Shaw, BAppSc(Phy)
Email:
leonie.shaw@mh.org.au
Facility:
Name:
Fiona Stanley Hospital
Address:
City:
Perth
Zip:
6845
Country:
Australia
Contact:
Last name:
Vinicius Cavalheri, PhD
Email:
vinicius.cavalheri@curtin.edu.au
Start date:
October 2024
Completion date:
October 2027
Lead sponsor:
Agency:
University of Melbourne
Agency class:
Other
Collaborator:
Agency:
Peter MacCallum Cancer Centre, Australia
Agency class:
Other
Source:
University of Melbourne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06631872
