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Trial registered on ANZCTR


Registration number
ACTRN12618002019280
Ethics application status
Approved
Date submitted
11/12/2018
Date registered
17/12/2018
Date last updated
17/12/2018
Date data sharing statement initially provided
17/12/2018
Date results information initially provided
17/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A physical activity program for women living with metastatic breast cancer
Scientific title
A physical activity program for women living with metastatic breast cancer; a randomised feasibility study
Secondary ID [1] 296857 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic breast cancer 310764 0
Condition category
Condition code
Cancer 309452 309452 0 0
Breast
Physical Medicine / Rehabilitation 309473 309473 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprised an 8-week program of 16 exercise sessions conducted in the participant’s home or a local park, supervised by an exercise specialist. An unsupervised walking program was also prescribed for the duration of the 8-week intervention.

Each supervised session consisted of a 10-15 min brisk walk followed by 30-40 min of resistance training. The short walk was monitored via a pedometer and Borg’s rating of perceived exertion (RPE), with a target zone of 11-13 to reflect a moderate intensity. The resistance exercises included chest press, horizontal row, upright row, bicep curl, calf raises, lunges and either sit-to-stands or squats. Each exercise was individualised based on training experience and baseline strength. Upper body exercises were delivered using a Smart Stick™ and Smart Toner® and the lower body exercises used body weight resistance, with the addition of hand weights as required. Each resistance exercise involved 2 sets of 10-12 repetitions, with one-minute recovery between each set. Resistance training was performed at a moderate intensity. The volume and intensity of each exercise was recorded in an exercise diary by the trainer at each session.

The unsupervised walking program was conducted in the same manner as the supervised walk, with steps counted using a pedometer and a target RPE of 11-13. Women were asked to walk on days they were not seeing their trainer and encouraged to increase the number of steps taken each week by 10%. The number of steps taken during each walk was recorded in a diary maintained by the participant.
Intervention code [1] 313136 0
Lifestyle
Intervention code [2] 313151 0
Rehabilitation
Comparator / control treatment
The control group was asked to maintain their habitual level of physical activity, and no advice on exercise or physical activity was provided.
Control group
Active

Outcomes
Primary outcome [1] 308407 0
Recruitment rate determined by the percentage of eligible patients who enrolled
Timepoint [1] 308407 0
Last patient first visit
Primary outcome [2] 308408 0
Retention calculated as the percentage of participants who completed the final study visit (16 weeks after commencing the intervention)
Timepoint [2] 308408 0
Last patient last visit
Primary outcome [3] 308409 0
Adherence calculated by the number of attended sessions divided by the number of expected sessions
Timepoint [3] 308409 0
Last patient last visit
Secondary outcome [1] 354884 0
Fatigue assessed using FACIT-Fatigue
Timepoint [1] 354884 0
Baseline, 8 weeks and 16 weeks after the commencement of intervention
Secondary outcome [2] 354885 0
Quality of Life assessed using EORTC-QLQ C30
Timepoint [2] 354885 0
Baseline, 8 weeks and 16 weeks after the commencement of intervention
Secondary outcome [3] 354886 0
Cardiovascular fitness assessed using Modified Canadian Aerobic Fitness Test (mCAFT)
Timepoint [3] 354886 0
Baseline, 8 weeks and 16 weeks after the commencement of intervention
Secondary outcome [4] 354887 0
Lower limb strength assessed using back-leg dynamometry
Timepoint [4] 354887 0
Baseline, 8 weeks and 16 weeks after the commencement of intervention
Secondary outcome [5] 354888 0
Upper strength assessed using hand dynamometry
Timepoint [5] 354888 0
Baseline, 8 weeks and 16 weeks after the commencement of intervention
Secondary outcome [6] 354889 0
Physical activity assessed using International Physical Activity Questionnaire
Timepoint [6] 354889 0
Baseline, 8 weeks and 16 weeks after the commencement of intervention
Secondary outcome [7] 354890 0
Daily physical activity energy expenditure assessed using ActiHeart
Timepoint [7] 354890 0
Baseline, 8 weeks and 16 weeks after the commencement of intervention

Eligibility
Key inclusion criteria
i. stage IV breast cancer
ii. living in the community
iii. mentally competent to follow instructions
iv. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
v. oncologist-expected survival of at least 4 months
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
i. individuals participating in regular physical activity, determined as “high” activity by the International Physical Activity Questionnaire (IPAQ)
ii. inability to communicate in English
iii. experiencing pain or other neuromuscular or musculoskeletal symptoms that limit physical activity.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization was performed using a computer-generated random numbers list by an individual external to the study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Given the exploratory nature of the study, sample size was established based on available funding and resources. Measures of feasibility and safety were determined using descriptive statistics. The unadjusted mean change from baseline in physical activity, physical performance and patient-reported outcomes were compared between the two groups using descriptive statistics. Glass’s delta was used to calculate the effect size of the intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12704 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 12705 0
Westmead Hospital - Westmead
Recruitment hospital [3] 12706 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 12707 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 25126 0
2050 - Camperdown
Recruitment postcode(s) [2] 25127 0
2145 - Westmead
Recruitment postcode(s) [3] 25128 0
2747 - Kingswood
Recruitment postcode(s) [4] 25129 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 301429 0
Charities/Societies/Foundations
Name [1] 301429 0
National Breast Cancer Foundation
Address [1] 301429 0
9/10 Barrack St, Sydney NSW 2000
Country [1] 301429 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
75 East Street
Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 301109 0
None
Name [1] 301109 0
Address [1] 301109 0
Country [1] 301109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302163 0
Sydney Local Health District
Ethics committee address [1] 302163 0
Suite 210A, RPAH Medical Centre
100 Carillon Ave
NEWTOWN NSW 2042
Ethics committee country [1] 302163 0
Australia
Date submitted for ethics approval [1] 302163 0
14/12/2011
Approval date [1] 302163 0
07/02/2012
Ethics approval number [1] 302163 0
HREC/11/RPAH/543

Summary
Brief summary
The purpose of this study is to determine if physical activity can be safely prescribed for women with metastatic breast cancer.

Who is it for?

You may be eligible for this study if you are an adult female who has been diagnosed with metastatic breast cancer.

Study details

Participants in this study will be randomly allocated to one of two treatment groups:
1) Group one will continue with their usual care and be monitored by researchers over a period of 4 months.
2) Group two will take part in an 8-week physical activity program consisting of 2 supervised sessions per week plus a walking program.
All participants will also complete a few fitness assessments and questionnaires.

Physical activity may be beneficial for improving quality of life and symptom burden. This study will examine whether a supervised physical activity program is safe and feasible for women living with metastatic breast cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89342 0
Prof Sharon Kilbreath
Address 89342 0
The University of Sydney
75 East Street
Lidcombe NSW 1825
Country 89342 0
Australia
Phone 89342 0
+61 2 9351 9272
Fax 89342 0
Email 89342 0
sharon.kilbreath@sydney.edu.au
Contact person for public queries
Name 89343 0
Dr Jasmine Yee
Address 89343 0
The University of Sydney
75 East Street
Lidcombe NSW 1825
Country 89343 0
Australia
Phone 89343 0
+61 2 9351 9256
Fax 89343 0
Email 89343 0
jasmine.yee@sydney.edu.au
Contact person for scientific queries
Name 89344 0
Dr Jasmine Yee
Address 89344 0
The University of Sydney
75 East Street
Lidcombe NSW 1825
Country 89344 0
Australia
Phone 89344 0
+61 2 9351 9256
Fax 89344 0
Email 89344 0
jasmine.yee@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval only covers use of the data by the identified research team
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary