Prehabilitation for Patients Undergoing Lung Cancer Surgery
ConditionLung Cancer (NSCLC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Melbourne
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Prehabilitation
BehavioralPatients 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Prehabilitation armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
From enrollment to the end of the study approximately one week after surgery2
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.
Time frame
Within one week before surgerySecondary outcomes
1
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.
Time frame
From enrollment to the end of the program before surgery2
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).
Time frame
Within one week before surgery3
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.
Time frame
Within one week before surgery4
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.
Time frame
Within one week before surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Melbourne
Lead sponsor
Melbourne Health
Collaborator
St Vincent's Hospital Melbourne
Collaborator
Source ClinicalTrials.gov