Lung Cancer (NSCLC)DIGI-LungNCT06716437
Prehabilitation for Patients Undergoing Lung Cancer Surgery
A study testing Prehabilitation in people with Lung Cancer (NSCLC), run by University of Melbourne at 1 site in Australia.
Trial summary
Major surgery has been linked to running a marathon as in both represent large endeavours where the body will experience an increase in demands to supply the necessary energy. It has been alledged that, as one would train to prepare for a marathon, the same should be applied to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Prehabilitation
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
The University of Melbourne, Department of Physiotherapy
Parkville, Victoria, 3010
Lara Edbrooke, PhD, +61 3 9035 4213, larae@unimelb.edu.au
Raquel Sebio Garcia, PhD, +34 679336288
About this study
Official title: Digitally Enabled Prehabilitation in a Community-based Setting for Patients Undergoing Lung Cancer Surgery
Major surgery has been linked to running a marathon as in both represent large endeavours where the body will experience an increase in demands to supply the necessary energy. It has been alledged that, as one would train to prepare for a marathon, the same should be applied to surgery. The process of getting ready and/or fitter for surgery is frequently referred to as prehabilitation and it usually involves interventions on improving nutrition and diet, getting fit and improve emotional wellness. Prehabilitation can improve the recovery after surgery and reduce the time spent in hospital afterwards. This research seeks to determine whether a home based program of increased physical activity and breathing training can improve patients' physical and respiratory function in preparation for lung cancer surgery.
Read the detailed description
Patients with lung cancer who are scheduled to undergo lung resection surgery will be provided with a digitally-enabled, remotely-monitored prehablitation program. The intervention will consist of the following components: i) general education; ii) inspiratory muscle training; iii) physical activity coaching; and iv) home-based exercise training. The program will be supported with a mobile app and weekly telehealth sessions with one experienced physiotherapist. Participants will be assessed at baseline and at the end of the intervention, prior to surgery. Participants will be contacted and scheduled to undergo face-to-face assessments on lung function, respiratory muscle strength, and functional capacity both at baseline and after the prehabilitation program.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Prehabilitation
- Keywords
- Prehabilitation, Inspiratory Muscle Training, Exercise Therapy, Lung Cancer, Telehealth
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
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:
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation arm | Experimental | Patients will receive the prehabilitation program Receives: Behavioral: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention
Feasibility of the intervention determined by enrolment rate (number of patients who accept participation in the trial vs. number of eligible patients)
Measured: From enrollment to the end of the study approximately one week after surgery
App usability and acceptability
The app usability will be measured with a questionnaire (the mHealth App Usability Questionnaire). The questionnaire consists of 21 items on a likert scale ranging from 1 (disagree) to 7 (agree) assessing different domains of a mHealth app. A median of 4.5 out of 7 across all domains will be considered as high usability and acceptability.
Measured: Within one week before surgery
Secondary outcomes (8)
Safety of the intervention
Adverse events, defined as any unexpected, undesirable event, such as injury, fall, and discomfort related to prehabilitation program will be recorded weekly through telehealth. They will be classified according to the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.
Measured: From enrollment to the end of the program before surgery
Inspiratory Muscle Strength
Maximal inspiratory pressure (MIP) registered at the mouth will be recorded using a specific device (BHC RP Check, Bird Health Care Australia).
Measured: Within one week before surgery
Diaphragmatic excursion and thickness
Diaphragmatic excurssion will be measured with through Point of Care Ultrasound (POCUS) both at normal breathing and maximal inspiration. Diaphragmatic thickness will also be measured.
Measured: Within one week before surgery
Lung function
Lung function parameters including forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1) will be collected during a forced spirometry test. The tests will be conducted according to the international recommendations from the ATS/ERS.
Measured: Within one week before surgery
Self-efficacy
Patient's perception of self-efficacy will be measured using a validated questionnaire (General Self-Efficacy Scale). The scale is 10-item each one measured on a likert-scale from 1 to 4. Total scores range from 10 to 40 with higher scores indicating higher self-efficacy.
Measured: Within one week before surgery
Participant satisfaction
Participants' satisfaction with the intervention will be measured through the Australian Hospital Patient Experience Question Set (AHPEQS). The AHPEQS is a 12-item questionnaire with each question assessed on a likert-scale which measures the satisfaction with a healthcare intervention. There is no scoring for this scale.
Measured: Within one week before surgery
Health Related Quality of Life
Heaht-related quality of life will be assessed using a validated questionnaire specific to cancer patients from the European Organization of Research in Cancer Treatment (EORTC QLQ C30). The questionnaire will be self-administered and consists of 30 questions on several domains of physical functioning, emotional functioning and cancer-related symptoms. Two main subscales are obtained from the questionnaire (one in function, one in symptoms) plus one item on global health. The score ranges from 0 to 100 with higher scores representing higher self-reported quality of life or higher symptom burden.
Measured: Within one week before surgery
Recovery from surgery
Self-reported recovery from surgery will be measured using a validated questionnaire (the Quality of Recovery Questionnaire - QoR15).
Measured: Within one week before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start24 Jan 2025
- Primary completion30 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Melbourne Health, St Vincent's Hospital Melbourne
- Responsible party
- Sponsor
- Investigators
- Linda Denehy, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716437
- Sponsor's protocol ID
- 30930
- Acronym
- DIGI-Lung
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be considered upon reasonable request made to the principal investigator
Publications
Waterland JL, Ismail H, Amin B, Granger CL, Denehy L, Riedel B. Patient acceptance of prehabilitation for major surgery: an exploratory survey. Support Care Cancer. 2021 Feb;29(2):779-785. doi: 10.1007/s00520-020-05547-1. Epub 2020 May 28.
PubMed 32462351Whish-Wilson GA, Edbrooke L, Cavalheri V, Denehy L, Seller D, Granger CL, Parry SM. Physiotherapy and Exercise Management of People Undergoing Surgery for Lung Cancer: A Survey of Current Practice across Australia and New Zealand. J Clin Med. 2023 Mar 9;12(6):2146. doi: 10.3390/jcm12062146.
PubMed 36983146Kunadharaju R, Saradna A, Ray A, Yu H, Ji W, Zafron M, Mador MJ. Post-Operative Outcomes of Pre-Thoracic Surgery Respiratory Muscle Training vs Aerobic Exercise Training: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil. 2023 May;104(5):790-798. doi: 10.1016/j.apmr.2022.10.015. Epub 2022 Dec 17.
PubMed 36539175Ferreira V, Lawson C, Ekmekjian T, Carli F, Scheede-Bergdahl C, Chevalier S. Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. Support Care Cancer. 2021 Oct;29(10):5597-5610. doi: 10.1007/s00520-021-06161-5. Epub 2021 Mar 25.
PubMed 33768372Sebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional and postoperative outcomes after preoperative exercise training in patients with lung cancer: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):486-97. doi: 10.1093/icvts/ivw152. Epub 2016 May 25.
PubMed 27226400Cavalheri V, Granger CL. Exercise training as part of lung cancer therapy. Respirology. 2020 Nov;25 Suppl 2:80-87. doi: 10.1111/resp.13869. Epub 2020 Jun 1.
PubMed 32567236Cavalheri V, Granger C. Preoperative exercise training for patients with non-small cell lung cancer. Cochrane Database Syst Rev. 2017 Jun 7;6(6):CD012020. doi: 10.1002/14651858.CD012020.pub2.
PubMed 28589547
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitally Enabled Prehabilitation in a Community-based Setting for Patients Undergoing Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT06716437
- Acronym / sponsor ID
- DIGI-Lung / 30930
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- Prehabilitation, Inspiratory Muscle Training, Exercise Therapy, Lung Cancer, Telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Melbourne Health, St Vincent's Hospital Melbourne
- Study start
- 24 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major surgery has been linked to running a marathon as in both represent large endeavours where the body will experience an increase in demands to supply the necessary energy. It has been alledged that, as one would train to prepare for a marathon, the same should be applied to surgery. The process of getting ready and/or fitter for surgery is frequently referred to as prehabilitation and it usually involves interventions on improving nutrition and diet, getting fit and improve emotional wellness. Prehabilitation can improve the recovery after surgery and reduce the time spent in hospital afterwards. This research seeks to determine whether a home based program of increased physical activity and breathing training can improve patients' physical and respiratory function in preparation for lung cancer surgery.
Detailed description
Patients with lung cancer who are scheduled to undergo lung resection surgery will be provided with a digitally-enabled, remotely-monitored prehablitation program. The intervention will consist of the following components: i) general education; ii) inspiratory muscle training; iii) physical activity coaching; and iv) home-based exercise training. The program will be supported with a mobile app and weekly telehealth sessions with one experienced physiotherapist. Participants will be assessed at baseline and at the end of the intervention, prior to surgery. Participants will be contacted and scheduled to undergo face-to-face assessments on lung function, respiratory muscle strength, and functional capacity both at baseline and after the prehabilitation program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation arm | Experimental | Behavioral: PrehabilitationPatients will receive the prehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationPatients 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. | Behavioural | Prehabilitation arm |
Primary outcome
Feasibility of the intervention
Time frame: From enrollment to the end of the study approximately one week after surgery
Feasibility of the intervention determined by enrolment rate (number of patients who accept participation in the trial vs. number of eligible patients)
App usability and acceptability
Time frame: Within one week before surgery
The app usability will be measured with a questionnaire (the mHealth App Usability Questionnaire). The questionnaire consists of 21 items on a likert scale ranging from 1 (disagree) to 7 (agree) assessing different domains of a mHealth app. A median of 4.5 out of 7 across all domains will be considered as high usability and acceptability.
8 secondary outcomes
Safety of the intervention
Time frame: From enrollment to the end of the program before surgery
Inspiratory Muscle Strength
Time frame: Within one week before surgery
Diaphragmatic excursion and thickness
Time frame: Within one week before surgery
Lung function
Time frame: Within one week before surgery
Self-efficacy
Time frame: Within one week before surgery
Participant satisfaction
Time frame: Within one week before surgery
Health Related Quality of Life
Time frame: Within one week before surgery
Recovery from surgery
Time frame: Within one week before surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Background: PubMed 32462351Waterland JL, Ismail H, Amin B, Granger CL, Denehy L, Riedel B. Patient acceptance of prehabilitation for major surgery: an exploratory survey. Support Care Cancer. 2021 Feb;29(2):779-785. doi: 10.1007/s00520-020-05547-1. Epub 2020 May 28.
- Background: PubMed 36983146Whish-Wilson GA, Edbrooke L, Cavalheri V, Denehy L, Seller D, Granger CL, Parry SM. Physiotherapy and Exercise Management of People Undergoing Surgery for Lung Cancer: A Survey of Current Practice across Australia and New Zealand. J Clin Med. 2023 Mar 9;12(6):2146. doi: 10.3390/jcm12062146.
- Background: PubMed 36539175Kunadharaju R, Saradna A, Ray A, Yu H, Ji W, Zafron M, Mador MJ. Post-Operative Outcomes of Pre-Thoracic Surgery Respiratory Muscle Training vs Aerobic Exercise Training: A Systematic Review and Network Meta-analysis. Arch Phys Med Rehabil. 2023 May;104(5):790-798. doi: 10.1016/j.apmr.2022.10.015. Epub 2022 Dec 17.
- Background: PubMed 33768372Ferreira V, Lawson C, Ekmekjian T, Carli F, Scheede-Bergdahl C, Chevalier S. Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. Support Care Cancer. 2021 Oct;29(10):5597-5610. doi: 10.1007/s00520-021-06161-5. Epub 2021 Mar 25.
- Background: PubMed 27226400Sebio Garcia R, Yanez Brage MI, Gimenez Moolhuyzen E, Granger CL, Denehy L. Functional and postoperative outcomes after preoperative exercise training in patients with lung cancer: a systematic review and meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Sep;23(3):486-97. doi: 10.1093/icvts/ivw152. Epub 2016 May 25.
- Background: PubMed 32567236Cavalheri V, Granger CL. Exercise training as part of lung cancer therapy. Respirology. 2020 Nov;25 Suppl 2:80-87. doi: 10.1111/resp.13869. Epub 2020 Jun 1.
- Background: PubMed 28589547Cavalheri V, Granger C. Preoperative exercise training for patients with non-small cell lung cancer. Cochrane Database Syst Rev. 2017 Jun 7;6(6):CD012020. doi: 10.1002/14651858.CD012020.pub2.
- Individual participant dataSharing planned: Undecided. Data sharing will be considered upon reasonable request made to the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Linda Denehy, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Lung Cancer (NSCLC), run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lara Edbrooke, PhD (+61 3 90354213, larae@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: From enrollment to the end of the study approximately one week after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06716437, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.