Prehabilitation for Patients Undergoing Lung Cancer Surgery

Not Applicable

Recruiting

• Conditions: Lung Cancer (NSCLC)

• Registration Number: NCT06716437
• Lead Sponsor: University of Melbourne

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.

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-28
• Study First Posted: 2024-12-04
• Study Start: 2025-01-24
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	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	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.

Secondary Outcome Measures

Name	Time	Method
Safety of the intervention	From enrollment to the end of the program before surgery	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.
Inspiratory Muscle Strength	Within one week before surgery	Maximal inspiratory pressure (MIP) registered at the mouth will be recorded using a specific device (BHC RP Check, Bird Health Care Australia).
Diaphragmatic excursion and thickness	Within one week before surgery	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.
Lung function	Within one week before surgery	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.
Self-efficacy	Within one week before surgery	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.
Participant satisfaction	Within one week before surgery	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.
Health Related Quality of Life	Within one week before surgery	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.
Recovery from surgery	Within one week before surgery	Self-reported recovery from surgery will be measured using a validated questionnaire (the Quality of Recovery Questionnaire - QoR15).

Trial Locations

Locations (1)

The University of Melbourne, Department of Physiotherapy; 🇦🇺 Parkville, Victoria, Australia