Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000547448
Ethics application status
Approved
Date submitted
21/04/2016
Date registered
28/04/2016
Date last updated
3/07/2019
Date data sharing statement initially provided
3/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
S.A.F.E. Study: Safety And Feasibility of Exercise for women with breast cancer
Scientific title
S.A.F.E. Study: Safety And Feasibility of Exercise for women with breast cancer
Secondary ID [1] 284982 0
Nil
Universal Trial Number (UTN)
NA
Trial acronym
S.A.F.E. Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage II+ Breast Cancer
 292484 0
Breast Cancer treatment-related sequelae 292486 0
Condition category
Condition code
Cancer 292795 292795 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: The exercise intervention will involve a minimum prescription of 150 minutes of moderate intensity aerobic- and resistance-exercise each week, with the type, intensity and duration per session individualised according to patient’s interests, fitness, presence of treatment-related side effects and co-morbidities. That is, while each woman’s exercise program will be individualised, total exercise dose prescribed per week will be at least 150 minutes of moderate-intensity exercise each week. For example, patient #1 may accumulate the required exercise dose by walking 3 days/week for 30 minutes and undertaking resistance-based exercise (using machine weights) for 30 minutes on an additional 2 days/week. Patient #2 may exercise (including walking, stationary cycling and resistance-based exercise using hand weights) twice daily for 10-15 minutes.
In line with exercise promoted within breast cancer rehabilitation models, the intervention will encourage women to exercise in both a supervised and unsupervised setting.
However, given the patient population to be studied, and that safety is a primary outcome of interest, unsupervised sessions will be introduced slowly. Participants will receive a workbook that includes information relating to the exercise program and a logbook to record details about the exercise sessions, as well as presentation of adverse events. All women will perform the supervised sessions at their homes (or another location as specified as convenient for the participant (e.g., local gymnasium) under the supervision of a trained Accredited Exercise Physiologist (AEP).
The study is a randomised wait-list study with a two-group design. The wait-list control group will be provided with a modified intervention; that is, the exercise program will be delivered with less face-to-face contact with the AEP (that is, 5 sessions instead of 20 sessions). However, the dose of exercise prescribed will be identical in both groups (150 minutes of moderate-intensity exercise/ week). Group 1 (immediate-intervention group) will attend 20 sessions with an AEP over the 12 weeks (2 sessions per week for the first 8 weeks and 1 session per week for the final 4 weeks). Group 2 (wait-list control) will attend 5 sessions with an AEP over 12 weeks (the five sessions will be scheduled taking into consideration AEP clinical judgement and participant preference). All participants will also complete unsupervised sessions throughout the 12 weeks under the guidance of the AEP.
Intervention code [1] 289813 0
Lifestyle
Intervention code [2] 294589 0
Treatment: Other
Comparator / control treatment
There will be a wait-list control group who wait 12 weeks prior to participating in the exercise intervention. Following the assessment at 12 weeks post-baseline the wait-list control group will commence the exercise intervention. As with the immediate-intervention group they will complete 150 minutes of moderate-intensity exercise/ week; however they will only attend 5 supervised sessions with an accredited exercise physiologist (AEP). These sessions will be scheduled taking into consideration AEP clinical judgment and participant preference, with a focus on ensuring safety and feasibility of meeting the exercise goal.
Control group
Active

Outcomes
Primary outcome [1] 292648 0
Safety
The exercise intervention will be deemed as ‘safe’ when there is:
(i) no worsening of current treatment-related side effects,
(ii) no increase in medication(s) prescribed for chronic disease(s), and
(iii) absence of exercise-related adverse event whereby the participant could not participate in the intervention for two or more weeks.
Timepoint [1] 292648 0
12 and 24 weeks following commencement of intervention period.
Primary outcome [2] 298107 0
Feasibility:
The exercise intervention will be deemed as ‘feasible’ when each of the following factors have a pre-defined acceptability rate of 75% or above:
(i) participant recruitment (#consent/#invited and eligible, x 100%),
(ii) participant retention (#completed baseline testing/#completed follow-up 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 as measured by METS] compared with completed exercise dose/METS each week). Subjectively reported via logbooks.
Timepoint [2] 298107 0
12 and 24 weeks following commencement of the intervention period.
Secondary outcome [1] 309414 0
Aerobic fitness (6 minute walk test)
Timepoint [1] 309414 0
12 and 24 weeks following the commencement of the intervention period
Secondary outcome [2] 323196 0
Body composition (bioelectrical impedance)
Timepoint [2] 323196 0
12 and 24 weeks following the commencement of the intervention period.
Secondary outcome [3] 323197 0
Quality of life (FACT-B+4)
Timepoint [3] 323197 0
12 and 24 weeks following the commencement of the intervention period

Eligibility
Key inclusion criteria
Women aged 18 years or older (i.e., adults who are able to provide informed consent); reside or work in greater Brisbane (i.e., living within a 60 kilometre radius of the CBD); diagnosed with breast cancer stage II+; treated at one of the referring hospitals. The residence criterion will allow for the Accredited Exercise Physiologist (AEP) to travel to participants’ homes for intervention sessions. All participants must be undergoing or have completed treatment within the past 24 months, with the exception of hormone therapy. Additionally, women will be assessed on a range of factors to determine their disease burden; eligible participants must currently not meet national physical activity level recommendations (<150 minutes of weekly physical activity) PLUS meet one or more of the following criteria: confirmed clinical diagnosis of: (i) at least one co-morbidity or chronic disease (hypertension, hypercholesterolemia, overweight or obese [body mass index>25], classified as osteopenic or has osteoporosis, type II diabetes), or (ii) at least one chronic breast cancer treatment sequelae (lymphoedema, upper-body morbidity, neuropathy, fatigue, arthralgia). We will also accept self-report of moderate to severe in intensity treatment sequelae, even in the absence of a clinical diagnosis. This self-report criterion is necessary since treatment-sequelae are not routinely screened, detected and recorded by follow-up care (Cheville et al. 2012). Our self-report measures are ones that we have included our prospective cohort studies.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Currently meeting the current exercise recommendations (i.e., sufficiently active); stage I disease; planning to become pregnant during the study; plans for additional surgery (e.g., reconstructive) during the study period; unable to consent.

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)
Strategy 1: Breast care nurses (BCNs) at one public and two private Brisbane hospitals will review medical records of women diagnosed 0-36 months prior. BCNs will hand-deliver whenever possible (during standard clinical follow-up appointments; e.g., at the standard 12-, 18- and 24-month follow-up), or send, a basic information pack about the study, requesting consent for researchers to contact them. Information on this process will be collected. BCNs will stress the targeting of the study to women potentially doing less well, i.e., even if they are not feeling well and/or have little history of exercise, that this intervention is designed specifically for them. Researchers will contact potentially eligible women, ascertain interest in participating in the study, administer eligibility screening, gain consent and commence data collection and intervention.
Strategy 2: We will also seek eligible participants via the National Breast Cancer Foundation register4, a national online database where the public can sign up to receive information about breast cancer research projects that require participants. Register4 aims to speed up the research process by bringing together researchers and willing and potentially eligible participants. At this stage, there is no fee for researchers to use Register4. It is estimated that 1400 Queensland women with breast cancer are registered with this database, all completed a characteristics survey.
Strategy 3: Media/social announcements will be placed in various locations about the aims of the trial and encouraging women to contact the study team if eligible. CIA has used this type of recruitment strategy in the past, with success. Advertisements about the study will be placed in local media as well as in breast cancer-specific newsletters (e.g., Breast Cancer Network Australia).
Recruitment brochures will be professionally designed, and developed under the guidance of CIC Young, in collaboration with women affected by breast cancer, and specifically address common concerns that may hinder women from enrolment; for example feeling too ill, too fatigued, or too much in pain to exercise, or being concerned that exercise may result in more symptoms, or being too busy to fit exercise into ones daily life. Our previous exercise trials that have required recruitment of women with specific criteria (e.g., women lymphoedema after breast cancer) have demonstrated that strategy 1, 2 and 3 contribute to 45%, 50% and 5% of the sample recruited. Due to the nature of this trial and the high level of interest and involvement of our AI clinicians, here we anticipate recruitment rates of 60%, 35% and 5% from strategies 1-3, respectively.
Following recruitment, central randomisation by computer will occur.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation: Participants will be randomly assigned to either the immediate intervention or wait-list control group with a 1:1 allocation as per a computer generated randomisation schedule stratified by treatment time period (i.e., during treatment or post-treatment)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Modified wait-list control trial: the active treatment group will receive the intervention for 12 weeks following the baseline assessment, During this period the wait-list control group will receive no intervention. At 12 weeks both groups will complete an assessment of primary and secondary outcomes. Following this the active treatment group will receive no further intervention, while the wait-list control group receive a modified intervention (i.e., the exercise volume will be identical to the original intervention; however, it will be delivered via a less supervised model of care). Both groups will complete the same assessments 12 weeks later (i.e., 24 weeks after the baseline assessment).
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2016
Actual
2/05/2016
Date of last participant enrolment
Anticipated
31/08/2017
Actual
25/08/2017
Date of last data collection
Anticipated
Actual
12/02/2018
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2718 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 5657 0
Holy Spirit Northside - Chermside
Recruitment hospital [3] 5658 0
Mater Private Hospital - South Brisbane
Recruitment postcode(s) [1] 13145 0
4101 - South Brisbane
Recruitment postcode(s) [2] 13146 0
4032 - Chermside
Recruitment postcode(s) [3] 13148 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 289597 0
University
Name [1] 289597 0
Queensland University of Technology
Country [1] 289597 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
School of Public Health, Institute of Health and Biomedical Innovation, Queensland University of Technology
Victoria Park Road, Kelvin Grove QLD 4059 Australia
Country
Australia
Secondary sponsor category [1] 292278 0
None
Name [1] 292278 0
Address [1] 292278 0
Country [1] 292278 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291332 0
Mater Health Services Research Ethics
Ethics committee address [1] 291332 0
Ethics committee country [1] 291332 0
Australia
Date submitted for ethics approval [1] 291332 0
14/07/2014
Approval date [1] 291332 0
19/04/2016
Ethics approval number [1] 291332 0
HREC/14/MHS/155
Ethics committee name [2] 294877 0
St Vincent’s Health and Aged Care Human Research and Ethics Committee
Ethics committee address [2] 294877 0
Ethics committee country [2] 294877 0
Australia
Date submitted for ethics approval [2] 294877 0
01/12/2015
Approval date [2] 294877 0
08/04/2016
Ethics approval number [2] 294877 0
HREC 15/19

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49926 0
Dr Sandi Hayes
Address 49926 0
School of Public Health and Social Work, Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 49926 0
Australia
Phone 49926 0
(+617) 3138 9645
Fax 49926 0
Email 49926 0
[email protected]
Contact person for public queries
Name 49927 0
Rosa Spence
Address 49927 0
School of Public Health and Social Work, Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 49927 0
Australia
Phone 49927 0
(+617) 3138 3016
Fax 49927 0
(+617) 3138 3130
Email 49927 0
[email protected]
Contact person for scientific queries
Name 49928 0
Rosa Spence
Address 49928 0
School of Public Health and Social Work, Queensland University of Technology
Victoria Park Road
Kelvin Grove QLD 4059
Country 49928 0
Australia
Phone 49928 0
(+617) 3138 3016
Fax 49928 0
(+617) 3138 3130
Email 49928 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?
All individual participant data, deidentified – dependent variables and patient characteristics
When will data be available (start and end dates)?
Following the publication of outcome data (safety, feasibility, and effect) through to December 2033 (end of study +15 years).
Available to whom?
Researchers conducting meta-analyses that are to be submitted to peer-review. Requestors must provide a methodologically sound proposal and agree to a data access agreement.
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
Proposals should be directed to [email protected].
Data will be made available as deidientified files to be transferred via secure file transfer protocol.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Randomised, Comparative, Effectiveness Trial Evaluating Low-versus High-Level Supervision of an Exercise Intervention for Women with Breast Cancer: The SAFE Trial.2022https://dx.doi.org/10.3390/cancers14061528
EmbaseA cost-consequences analysis of the SAFE trial: a comparative, effectiveness trial evaluating high- versus low-supervision of an exercise intervention for women with breast cancer.2023https://dx.doi.org/10.1007/s12282-022-01418-1
N.B. These documents automatically identified may not have been verified by the study sponsor.