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Trial registered on ANZCTR


Registration number
ACTRN12622001001785
Ethics application status
Approved
Date submitted
8/07/2022
Date registered
15/07/2022
Date last updated
15/07/2022
Date data sharing statement initially provided
15/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical Activity and Lung cancer Screening (PALS): a feasibility randomised controlled trial of exercise and physical activity in lung cancer screening.
Scientific title
Physical Activity and Lung cancer Screening (PALS): a feasibility randomised controlled trial of exercise and physical activity in lung cancer screening.
Secondary ID [1] 307517 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This is a substudy of the International Lung Screen Trial NCT02871856.

Health condition
Health condition(s) or problem(s) studied:
lung cancer screening
 326947 0
Condition category
Condition code
Cancer 324135 324135 0 0
Lung - Non small cell
Cancer 324136 324136 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Home based exercise program (in addition to written material and usual care) individualised to the person (their ability and safety to perform the exercises). The program will be conducted remotely medical staff and physiotherapists trained in the intervention protocol. The program will run for 8 weeks and participants will be encouraged to exercise at home unsupervised. The program consists of weekly video-conferencing and/or telephone call support for up to 30 minutes (choice up to participant) for 8 weeks. The home program will consist of;
a. Initial education session about symptom assessment and self-management including overcoming barriers to exercise will be included as part of the first remote exercise program session via telehealth or telephone.
b. Resistance training: comprised of 5 simple functional resistance exercises using gravity or body weight. These will be individualised to the participants ability. There will be a mix of upper body and lower body exercises. Examples include squats, static wall squats, sit-to-stands, calf raises, stair climbing, wall push-ups, shoulder presses and bicep curls. The aim will be to complete each exercise 8-15 times (repetitions) in 2 – 3 sets, depending on the individual participant (this will be assessed during the first session). If the participant has access to exercise equipment at home, such as light hand-held weights (< 5 kg) or theraband, we can utilise this equipment in their program should they wish too.
c. Aerobic exercise: comprised of a moderate intensity walking program as defined by a modified Borg score of 3 to 4 for shortness of breath, or targeting a heart rate of 65 to 76% estimated maximum heart rate.
d. Weekly progress review and goal setting, aiming to meet the Australian guideline recommendation for 150 to 300 minutes of moderate intensity physical activity (or 75 to 150 minutes of vigorous intensity physical activity) in addition to at least 2 days of muscle strengthening activities. The total number and duration of unsupervised resistance training and aerobic sessions will be determined after discussion with the participant. Demonstration of exercises will be provided either at the time of the assessment via telehealth or via email with provision of written and pictorial demonstrations. Adherence will be monitored by participant self-reporting and attendance checklists.

The intervention will be conducted independent to lung cancer screening scans, however baseline assessments will be scheduled at the same time as screening scans if feasible to minimise inconvenience to participant.
Intervention code [1] 323980 0
Lifestyle
Intervention code [2] 323997 0
Prevention
Comparator / control treatment
1. Usual care: No intervention, Participant will continue with pre-existing medical, nursing and allied health care.
2. Written material: Australia’s physical activity and sedentary behavior guidelines by the Department of Health will be provided to participants in person at the time of their enrollment. Use of the written material will be assessed at the 9 week assessment.

Comparison arms will run independent to lung cancer screening scans, however baseline assessments will be scheduled at the same time as screening scans if feasible to minimise inconvenience to participant.
Control group
Active

Outcomes
Primary outcome [1] 331947 0
1. Feasibility, assessed by proportion of home-based exercise sessions completed and recorded during weekly review sessions, of an 8-week multi-modal exercise program targeted at improving health related quality of life and physical activity levels of participants of lung cancer screening.
Timepoint [1] 331947 0
At 9 weeks from enrollment, following intervention completion.
Primary outcome [2] 331968 0
2. Safety of an 8-week multi-modal exercise program targeted at improving health related quality of life and physical activity levels of participants of lung cancer screening. Safety will be assessed by the number of adverse events occurring during or within 60 minutes following the intervention. Serious adverse events are defined as any adverse event related to the study that resulted in death or is life threatening, requiring hospitalisation, causing disability or incapacity. Minor adverse events were those that are directly caused by exercise such as: a minor fall (not resulting in a serious adverse event), new or progressive pain, transient neurological deficits, transient altered mental status, palpitations or progressive fatigue. Adverse events will be recorded by participant self reporting in accordance with Common Terminology Criteria for Adverse Events (CTCAE5.0).
Timepoint [2] 331968 0
At each weekly review during the intervention and at 9 weeks from enrollment, following intervention completion.
Primary outcome [3] 332000 0
Feasibility, assessed by the proportion of participants enrolled in the study when offered, of an 8-week multi-modal exercise program targeted at improving health related quality of life and physical activity levels of participants of lung cancer screening.
Timepoint [3] 332000 0
At 9 weeks from enrollment, following intervention completion.
Secondary outcome [1] 411691 0
Physical activity levels assessed by International Physical Activity Questionnaire.
Timepoint [1] 411691 0
9 weeks post commencement of intervention and 6 months post commencement of intervention.
Secondary outcome [2] 411765 0
Exercise capacity measured by 6 minute walk distance.
Timepoint [2] 411765 0
9 weeks post commencement of intervention and 6 months post commencement of intervention.
Secondary outcome [3] 411766 0
Isometric hand grip muscle strength measured using a dynamometer.
Timepoint [3] 411766 0
9 weeks post commencement of intervention and 6 months post commencement of intervention.
Secondary outcome [4] 411767 0
Body composition (muscle mass, fat mass), assessed by "InBody 770" Body Composition Analyser.
Timepoint [4] 411767 0
9 weeks post commencement of intervention and 6 months post commencement of intervention.
Secondary outcome [5] 411768 0
Mental well being assessed using the Hospital Anxiety and Depression Scale
Timepoint [5] 411768 0
9 weeks post commencement of intervention and 6 months post commencement of intervention.
Secondary outcome [6] 411871 0
Overall health and wellbeing assessed via 36-Item Short Form Health Survey.
Timepoint [6] 411871 0
9 weeks post commencement of intervention and 6 months post commencement of intervention.
Secondary outcome [7] 411872 0
Health related quality of life assessed by EuroQol five dimensions questionnaire
Timepoint [7] 411872 0
9 weeks post commencement of intervention and 6 months post commencement of intervention.
Secondary outcome [8] 411873 0
Physical activity levels assessed by step count using an electronic pedometer for a 10-day period
Timepoint [8] 411873 0
9 weeks post commencement of intervention and 6 months post commencement of intervention.

Eligibility
Key inclusion criteria
People already enrolled in the International Lung Screening Trial (ILST, NCT02871856. ) at the Royal Melbourne Hospital.

To be eligible for the program patients must be:
- Women or men age 55 to 80 years at the time of recruitment to the ILST.
- Current or former smokers. A former smoker is defined as one who has stopped smoking for one or more years.
- An estimated 6-year lung cancer risk of greater than or equal to 1.51% based on the PLCOm2012 risk prediction model or greater than or equal to 30 pack-years smoking history (pack-year is defined as number of pack of cigarettes smoked per day multiply by the number of years smoked. If a participant stopped smoking for 6 months or more and then restarted smoking again, the time will be subtracted from the total duration of smoking in 0.5 year increments)
- ECOG performance status 0 or 1

Capable of providing, informed consent for screening procedures (low dose spiral CT)
Minimum age
55 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to ambulate 100m independently +/- aid
Unable to safety complete the home-based components of the intervention.
Co-morbidity or medical status preventing exercise, for example acute uncontrolled cardiovascular or respiratory issues
Have a diagnosis of lung cancer

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation via computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/05/2022
Date of last participant enrolment
Anticipated
30/11/2022
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
75
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22778 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 38059 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 311798 0
Charities/Societies/Foundations
Name [1] 311798 0
Royal Melbourne Hospital Foundation
Country [1] 311798 0
Australia
Primary sponsor type
Individual
Name
Asha Bonney
Address
Respiratory and Sleep Department, Royal Melbourne Hospital
300 Grattan Street Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 313265 0
Individual
Name [1] 313265 0
Renee Manser
Address [1] 313265 0
Respiratory and Sleep Department, Royal Melbourne Hospital
300 Grattan Street Parkville VIC 3050
Country [1] 313265 0
Australia
Secondary sponsor category [2] 313267 0
Individual
Name [2] 313267 0
Catherine Granger
Address [2] 313267 0
Department of Physiotherapy,
Royal Melbourne Hospital
300 Grattan Street Parkville VIC 3050
Country [2] 313267 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311241 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 311241 0
Office of Research
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 311241 0
Australia
Date submitted for ethics approval [1] 311241 0
Approval date [1] 311241 0
19/07/2021
Ethics approval number [1] 311241 0
HREC/74684/MH-2021

Summary
Brief summary
Lung cancer is the largest cause of cancer related death in the world. Low dose computed tomography (LDCT) is a scan that reduces deaths from lung cancer by detecting early disease, which is currently being investigated as a screening program for current or former smokers as part of the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital. Physical activity is a potentially modifiable risk factor for the development of lung cancer. Therefore, the purpose of this study is to see if it is feasible to implement an exercise program as part of lung cancer screening to modify an individual’s risk profile.

Who is it for?
You may be eligible for this study if you are aged 55 to 80 years, are already enrolled in the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital (NCT02871856), and are a current or former smoker estimated to be at a high risk of lung cancer.

Study details
Participants will be randomised (i.e. allocated by chance) to either the intervention group, which will receive a home-based exercise program, or to a control group that will not receive the exercise program. The home-based exercise program will involve an 8 week unsupervised program consisting of education, aerobic exercise, and resistance training, with weekly progress reviews and goal setting. Weekly progress reviews and goal settings involves a telehealth or telephone consultation of up to 30 minutes per week. Targets for aerobic exercise over the week will range up to 300 minutes per week divided over multiple sessions. Resistance training will be up to two 30 minute sessions per week. Participants allocated to the exercise program will also receive written materials describing Australia’s physical activity and sedentary behaviour guidelines, and will continue to receive usual care, defined as their current medical, nursing and allied health support. Participants in the control group will receive usual care and access to the written materials only. 9 weeks after commencing the intervention or control treatments, all participants will be assessed for feasibility of the intervention by adherence to exercise sessions, as well as for safety of the intervention by number of adverse events occurring during or within 60 minutes following the intervention. Participants will also be assessed for any changes in known contributors to lung cancer risk, including physical activity levels, exercise capacity, muscle strength, body composition, and overall health and wellbeing at 9 weeks and 6 months after commencing the intervention or control treatments.

It is hoped that this study may show that the addition of a home-based exercise program to lung cancer screening is feasible, safe, and is able to improve the lung cancer risk profile of current or former smokers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120426 0
Dr Asha Bonney
Address 120426 0
Respiratory and Sleep Department, Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country 120426 0
Australia
Phone 120426 0
+61 493427708
Fax 120426 0
Email 120426 0
[email protected]
Contact person for public queries
Name 120427 0
Asha Bonney
Address 120427 0
Respiratory and Sleep Department, Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country 120427 0
Australia
Phone 120427 0
+61 493427708
Fax 120427 0
Email 120427 0
[email protected]
Contact person for scientific queries
Name 120428 0
Asha Bonney
Address 120428 0
Respiratory and Sleep Department, Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country 120428 0
Australia
Phone 120428 0
+61 493427708
Fax 120428 0
Email 120428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified, raw, line-by-line data for each participant will be made available on a case-by-case basis at the discretion of the principal investigator.
When will data be available (start and end dates)?
Following completion of the study and publication of results with no end date determined.
Available to whom?
De-identified, raw, line-by-line data for each participant will be made available on a case-by-case basis at the discretion of the principal investigator.
Available for what types of analyses?
De-identified, raw, line-by-line data for each participant will be made available on a case-by-case basis at the discretion of the principal investigator.
How or where can data be obtained?
De-identified, raw, line-by-line data for each participant will be made available on a case-by-case basis at the discretion of the principal investigator (email: [email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16575Statistical analysis plan  [email protected]
16576Study protocol  [email protected]
16577Ethical approval  [email protected]
16578Informed consent form  [email protected]



Results publications and other study-related documents

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