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Trial registered on ANZCTR


Registration number
ACTRN12617001577303
Ethics application status
Approved
Date submitted
13/11/2017
Date registered
24/11/2017
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
BRAin Cancer and Exercise (BRACE) Study.
Scientific title
A Phase II trial evaluating exercise for patients with brain cancer - determining the feasibility and safety of an 18-week individualised exercise program .
Secondary ID [1] 293324 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BRACE (BRAin Cancer and Exercise) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Cancer 305416 0
Condition category
Condition code
Cancer 304696 304696 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise intervention will span a total of 18-weeks and will involve individualised exercise prescription of aerobic-and resistance-based exercise at moderate-intensity with a goal of 150 minutes per week including 2-3 sessions of resistance exercise.

Although the target dose of exercise (150 minutes of moderate intensity activity) will be the same for all participants, the structure of the intervention, including the type, intensity and duration will be individualised according to each participant’s interests, fitness, presence of treatment-related side effects and co-morbidities.

An accredited exercise physiologist (AEP) will prescribe and monitor exercise type, duration and frequency on a weekly basis and modify prescription according to presentation of symptoms and by adhering to the exercise principle of gradual progression. AEPs will complete a study logbook to record details about the exercise prescribed, exercise completed and presence of adverse events. The delivery of the intervention will involve a minimum of one AEP supervised session (approximately 60 minute duration) per week for the first 8 weeks, and one AEP supervised sessions (approximate duration of 30 minutes) per fortnight for weeks 9-18. Supervised AEP sessions will take place at Aspire fitness and rehabilitation (at Woolloongabba). Unsupervised exercise session will be conducted at the convenient to the participant (e.g. local park, at home). Additional support by way of additional supervised sessions and/or telephone contact will occur when needed (as determined by the AEP) or when desired (as determined by the participant). The AEP will speak to the participant (either in person during supervised sessions or over the telephone) at least once per week. The participant will be provided with printed (or emailed) copies of their exercise prescription including instructions.
Intervention code [1] 299581 0
Rehabilitation
Intervention code [2] 299586 0
Behaviour
Intervention code [3] 299604 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303906 0
Feasibility
Feasibility will be assessed by:
(i) Participant recruitment (#consent / #invited and eligible, x 100%),
(ii) Participant retention (#completed follow-up testing /#completed baseline testing x100%),
(iii) Adherence (#completed exercise sessions / #scheduled exercise sessions, x100%), and
(iv) Compliance (prescribed program [exercise dose prescribed which will take into account exercise type, intensity and duration of each session] compared with completed exercise dose each week). This will be recorded by the accredited exercise physiologist (AEP).

The exercise intervention will be deemed as ‘feasible’ when each of the above factors have a pre-defined acceptability rate of 75% or above.
Timepoint [1] 303906 0
The AEP will record the weekly exercise prescription (type, duration, intensity) in the study logbook, from which adherence and compliance will be determined.
Primary outcome [2] 303907 0
Safety
Safety will be assessed by the number and severity of exercise-related adverse events.
Adverse events will be categorised using the CTCAE (Common Terminology Criteria for Adverse Events version 4.0) criteria and will then be categorised according to grade (1-5 using CTC definitions), as well as categorised according to whether they were related to the exercise intervention by the AEP in consultation with the participant. Additionally, whether the adverse event resulted in an interruption to the intervention and if the intervention was modified (e.g. adjustment to prescribed exercises or temporarily or permanently ceased participation in the intervention) will be recorded.

The study will be deemed safe if the proportion of participants reporting grade 3-5 intervention-related adverse events (as measured by the standard CTCAE version 4) is less than 10%.

Examples of adverse events could include (but are not limited to): fall, sprain, fracture, injury, episode of low blood sugar, strain, pull, tear of muscle or bone, or any other adverse events the participant considers as being a direct result of the exercise intervention.
Timepoint [2] 303907 0
As standard protocol, AEPs will routinely ask the participant during each contact (face to face or over the phone) if they had experienced any adverse events since the previous face to face or over the phone contact. This will occur for the duration of the exercise program (18-weeks).
Secondary outcome [1] 340416 0
Changes in Quality of Life (General and cancer specific) scores - assessed using Functional Assessment of Cancer Therapy-Brain (FACT-Br v4).
Timepoint [1] 340416 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [2] 340417 0
Changes in Fatigue assessed using Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-Fatigue scale).
Timepoint [2] 340417 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [3] 340418 0
Changes Anxiety assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Timepoint [3] 340418 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [4] 340419 0
Self-reported leisure time activity using the Godin Leisure-Time Exercise Questionnaire.
Timepoint [4] 340419 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [5] 340420 0
Fitness will be assessed using the 6 minute walk test.
Timepoint [5] 340420 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [6] 340421 0
Strength assessed using hand-grip strength dynamometery.
Timepoint [6] 340421 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [7] 340422 0
Lower extremity physical performance status assessed using the Short Physical Performance Battery (SPPB) - a composite assessment.
Timepoint [7] 340422 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [8] 340663 0
Changes Depression assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire.
Timepoint [8] 340663 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [9] 340664 0
Upper body strength assessed via 10 repetition maximum.
Timepoint [9] 340664 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [10] 340665 0
Lower body strength assessed via 10 repetition maximum.
Timepoint [10] 340665 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.
Secondary outcome [11] 340666 0
Balance assessed using single leg balance.
Timepoint [11] 340666 0
Assessed at baseline, mid intervention (9 week), end of intervention (18 week) and at 6-month follow up.

Eligibility
Key inclusion criteria
1. People with a diagnosis of primary or recurrent malignant brain tumour (i.e. brain cancer e.g. gliomas (astrocytomas, glioblastomas, oligodendrogliomas, ependymomas and mixed cell type gliomas)). Patients with recurrent brain cancer are eligible if they have been continuously disease-free for at least 2 years after definitive primary treatment. .
2. Age 18 years or older
3. Eastern Cooperative Oncology Group (ECOG) status 0-2.
4. Willing and able to comply with all study requirements, including the exercise intervention, timing and/or nature of required assessments.
5. Sufficiently fluent in English to fully participate in data collection requirements and comprehend intervention requirements.
6. Anticipated survival of a minimum of 12 months, as assessed by the treating clinician (e.g. medical oncologist, radiation oncologist, or surgeon).
7. If radiotherapy was received, they are between 12 and 26 weeks post-radiotherapy (receipt of oral chemotherapy during this period is allowed).
8. Signed written informed consent.
9. Deemed suitable to participate in the study by treating clinician.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of secondary brain cancer, or brain cancer recurrence within the first two years of definitive primary treatment.
2. Diagnosis of central nervous system lymphoma.
3. History of another malignancy within 2 years prior to registration. Patients with a history of other malignancies are eligible if they have been continuously disease-free for at least 2 years after definitive primary treatment. Patients with a diagnosis of basal cell carcinoma and squamous cell carcinomas and pre-malignant carcinomas (e.g. in situ) are also eligible.
4. Concurrent illness, including severe infection or unstable angina that may jeopardise the ability of the patient to undergo the exercise intervention outlined in this protocol with reasonable safety.
5. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol, as determined by their treating clinician.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A sample size of 30 has been recommended for feasibility studies (Lancaster et al., 2004, Moore et al., 2011.).

The feasibility of the intervention will be assessed by computing retention, adherence and compliance rates and deemed acceptable when at or above 75%. The intervention will also be considered safe if adverse events (grade 3-5) are less than 10%. Secondary outcomes will be tracked over time (T1-T4) and analysed using repeated measures regression (e.g. generalised estimating equation modeling). We will also explore trajectories of outcomes and categorise participants according to trajectories (e.g. improvers, no change, decliners). As exploratory analyses, we will explore whether patient, diagnosis, treatment and/or intervention compliance was associated with outcomes over time.

Lancaster G, Dodd S, Williamson P. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Practice. 2004;10:307-12.
Moore C, Carter R, Nietert P, Stewart P. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011; 4(5):332-7.

Recruitment
Recruitment status
Recruiting
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)
QLD
Recruitment hospital [1] 9378 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [2] 9576 0
The Newro Foundation - Auchenflower
Recruitment postcode(s) [1] 18069 0
4066 - Auchenflower
Recruitment postcode(s) [2] 18332 0
4066 - Auchenflower

Funding & Sponsors
Funding source category [1] 297949 0
Charities/Societies/Foundations
Name [1] 297949 0
Haematology & Oncology Clinics of Australia Research Centre Ltd (Trading as Icon Cancer Foundation)
Address [1] 297949 0
Level 1, 22 Cordelia Street
South Brisbane
QLD 4101
Country [1] 297949 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Haematology & Oncology Clinics of Australia Research Centre Ltd (Trading as Icon Cancer Foundation)
Address
Level 1, 22 Cordelia St
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 297087 0
None
Name [1] 297087 0
Address [1] 297087 0
Country [1] 297087 0
Other collaborator category [1] 279794 0
University
Name [1] 279794 0
Queensland University of Technology
Address [1] 279794 0
Institute of Health and Biomedical Innovation
Queensland University of Technology.
60 Musk Avenue, Kelvin Grove
QLD 4059 Australia
Country [1] 279794 0
Australia
Other collaborator category [2] 279795 0
Charities/Societies/Foundations
Name [2] 279795 0
Newro Foundation
Address [2] 279795 0
Level 10, Evan Thomson Building
Wesley Hospital
24 Chasely Street
AUCHENFLOWER, QLD 4066
Country [2] 279795 0
Australia
Other collaborator category [3] 279796 0
Other
Name [3] 279796 0
Aspire fitness and rehabilitation
Address [3] 279796 0
8 Trafalgar street
Woolloongabba
QLD 4102
Country [3] 279796 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298993 0
Bellberry Limited
Ethics committee address [1] 298993 0
129 Glen Osmond Road, Eastwood South Australia 5063
Ethics committee country [1] 298993 0
Australia
Date submitted for ethics approval [1] 298993 0
18/08/2017
Approval date [1] 298993 0
23/10/2017
Ethics approval number [1] 298993 0
2017-06-481
Ethics committee name [2] 299013 0
Queensland University of Technology - Office of Research Ethics & Integrity
Ethics committee address [2] 299013 0
Research Ethics Advisory Team, Office of Research Ethics & Integrity
Level 4, 88 Musk Avenue
Kelvin Grove QLD, 4059
Ethics committee country [2] 299013 0
Australia
Date submitted for ethics approval [2] 299013 0
26/10/2017
Approval date [2] 299013 0
09/11/2017
Ethics approval number [2] 299013 0
1700001009

Summary
Brief summary
The aim of this study is to determine the suitability and safety of an 18-week exercise program for people with brain cancer and to test whether the program improves quality of life, well-being and physical health.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and have a diagnosis of primary malignant brain tumour (i.e. brain cancer).


Study details
During the 18-week intervention, Accredited Exercise Physiologists (AEP) will prescribe weekly exercise that will be individualised according to the your interests, fitness, presence of treatment-related side effects and co-morbidities. The exercise program will include aerobic (cardiovascular) exercise, and resistance (strength) based exercise. The AEP will prescribe and monitor exercise type, duration and frequency every week and modify prescription according to symptoms and gradually progress the exercise prescription. You may choose to do all exercise sessions under the supervision of an AEP at Aspire Fitness and Rehabilitation (at Woolloongabba, Brisbane) or have some exercise sessions supervised and other unsupervised (at home or another convenient location). Assessments (questionnaires and physical assessments) will be conducted at baseline, the middle (week 9), the end of the of the program (week 18) and 6 months later.

We hypothesise that participants will feasibly and safely participate in an 18-week individualised exercise intervention.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78926 0
Dr John Bashford
Address 78926 0
Icon Cancer Foundation
Level 1, 22 Cordelia St
South Brisbane QLD 4101
Country 78926 0
Australia
Phone 78926 0
+617 3138 6472
Fax 78926 0
Email 78926 0
carolina.sandler@qut.edu.au
Contact person for public queries
Name 78927 0
Dr Carolina Sandler
Address 78927 0
Institute of Health and Biomedical Innovation
60 Musk Avenue, Kelvin Grove
Queensland University of Technology QLD 4059
Country 78927 0
Australia
Phone 78927 0
+617 3138 6472
Fax 78927 0
Email 78927 0
carolina.sandler@qut.edu.au
Contact person for scientific queries
Name 78928 0
Dr Carolina Sandler
Address 78928 0
Institute of Health and Biomedical Innovation
60 Musk Avenue, Kelvin Grove
Queensland University of Technology QLD 4059
Country 78928 0
Australia
Phone 78928 0
+617 3138 6472
Fax 78928 0
Email 78928 0
carolina.sandler@qut.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
to be discussed with study team
What supporting documents are/will be available?
Informed consent form
Summary results
No Results