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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06716437




Registration number
NCT06716437
Ethics application status
Date submitted
25/11/2024
Date registered
4/12/2024

Titles & IDs
Public title
Prehabilitation for Patients Undergoing Lung Cancer Surgery
Scientific title
Digitally Enabled Prehabilitation in a Community-based Setting for Patients Undergoing Lung Cancer Surgery
Secondary ID [1] 0 0
30930
Universal Trial Number (UTN)
Trial acronym
DIGI-Lung
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Prehabilitation

Experimental: Prehabilitation arm - Patients will receive the prehabilitation program


BEHAVIORAL: Prehabilitation
Patients will undergo a physiotherapy-led digitally-enabled prehabilitation program before lung resection surgery.

The intervention will be delivered through a mobile app and supported by tele-health and will consist of:

i) watching six educational videos embedded on the app on relevant topics to prepare for surgery, such as the importance of physical fitness, breathing exercises after surgery, and pain management.

ii) a physical activity coaching program to increase daily activity with feedback iii) a home-based, unsupervised exercise program consisting of 10 whole body strengthening exercises delivered in a video format iv) an inspiratory muscle training program using a hand-held device to be performed twice daily.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of the intervention
Timepoint [1] 0 0
From enrollment to the end of the study approximately one week after surgery
Primary outcome [2] 0 0
App usability and acceptability
Timepoint [2] 0 0
Within one week before surgery
Secondary outcome [1] 0 0
Safety of the intervention
Timepoint [1] 0 0
From enrollment to the end of the program before surgery
Secondary outcome [2] 0 0
Inspiratory Muscle Strength
Timepoint [2] 0 0
Within one week before surgery
Secondary outcome [3] 0 0
Diaphragmatic excursion and thickness
Timepoint [3] 0 0
Within one week before surgery
Secondary outcome [4] 0 0
Lung function
Timepoint [4] 0 0
Within one week before surgery
Secondary outcome [5] 0 0
Self-efficacy
Timepoint [5] 0 0
Within one week before surgery
Secondary outcome [6] 0 0
Participant satisfaction
Timepoint [6] 0 0
Within one week before surgery
Secondary outcome [7] 0 0
Health Related Quality of Life
Timepoint [7] 0 0
Within one week before surgery
Secondary outcome [8] 0 0
Recovery from surgery
Timepoint [8] 0 0
Within one week before surgery

Eligibility
Key inclusion criteria
* Diagnosis of lung cancer and scheduled for lung resection surgery
* Ability to understand and speak English to follow instructions and complete the intended assessments.
* Age = 18 years at the point of baseline screening
* Provide written informed consent for the trial
* Sufficient digital literacy to use a smartphone and mobile app
* No contraindications for exercise
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Other cancer diagnoses than lung cancer
* Surgery scheduled in less than one week
* Unstable psychiatric, cognitive or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The University of Melbourne, Department of Physiotherapy - Parkville
Recruitment postcode(s) [1] 0 0
3010 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Melbourne Health
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
St Vincent's Hospital Melbourne
Address [2] 0 0
Country [2] 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, 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
Lara Edbrooke, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 3 90354213
Fax 0 0
Email 0 0
[email protected]
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/NCT06716437