Prehabilitation for Patients Undergoing Lung Cancer Surgery

NCT06716437 | Recruiting DMC

• 1 other identifier: 30930
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lung Cancer (NSCLC)

Keywords

Prehabilitation; Inspiratory Muscle Training; Exercise Therapy; Lung Cancer; Telehealth

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Within one week before surgery

Secondary Outcomes (8)

• Safety of the intervention

  From enrollment to the end of the program before surgery

• Inspiratory Muscle Strength

  Within one week before surgery

• Diaphragmatic excursion and thickness

  Within one week before surgery

• Lung function

  Within one week before surgery

• Self-efficacy

  Within one week before surgery

Study Arms (1)

Prehabilitation arm

EXPERIMENTAL

Patients will receive the prehabilitation program

Behavioral: Prehabilitation

Interventions

Prehabilitation BEHAVIORAL

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.

Prehabilitation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Melbourne: lead
• Melbourne Health: collaborator
• St Vincent's Hospital Melbourne: collaborator

Study Sites (1)

The University of Melbourne, Department of Physiotherapy

Parkville, Victoria, 3010, Australia

RECRUITING

Related Publications (7)

• 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.

  PMID: 32462351 BACKGROUND

• Whish-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.

  PMID: 36983146 BACKGROUND

• Kunadharaju 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.

  PMID: 36539175 BACKGROUND

• Ferreira 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.

  PMID: 33768372 BACKGROUND

• Sebio 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.

  PMID: 27226400 BACKGROUND

• Cavalheri 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.

  PMID: 32567236 BACKGROUND

• Cavalheri 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.

  PMID: 28589547 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Linda Denehy, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Edbrooke, PhD

CONTACT

+61 3 90354213; larae@unimelb.edu.au

Raquel Sebio Gracia, PhD

CONTACT

+ 34 679336288; raquel.sebiogarcia@unimelb.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 4, 2024
• Study Start: January 24, 2025
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 22, 2025

Record last verified: 2024-11

Locations

AU (1)