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Trial registered on ANZCTR


Registration number
ACTRN12620001133921
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
30/10/2020
Date last updated
30/10/2020
Date data sharing statement initially provided
30/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Sleep, Cancer and Rest (SleepCare) Trial: A Randomised, Controlled Trial of Four Treatments for Sleep during Chemotherapy
Scientific title
A Randomised, Controlled, 6-week, Parallel-group, Superiority Trial to Compare the Efficacy of Sleep Hygiene, Cognitive Behavioural Therapy, Bright Light Therapy and Their Combination on Insomnia Symptoms during Chemotherapy for Breast Cancer: The Sleep, Cancer and Rest (SleepCare) Trial
Secondary ID [1] 302152 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poor sleep 318797 0
breast cancer 319174 0
Condition category
Condition code
Cancer 316813 316813 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions will be therapist-assisted with self-directed/automated components. A trained member of the research team will interact with participants in person (if appropriate) or via phone, at the initiation of the intervention (t1) to personalise aspects of delivery, and via phone (or in person if participants are at clinic for another appointment and prefer to meet in person) at mid-point through the intervention (t2).
All intervention conditions were devised with the primary goal of minimising participant burden and optimising intervention efficacy. As participants will already be going through an intensive cancer treatment regimen (chemotherapy), the design of the intervention was carefully considered such that the effort and time associated with each intervention component are outweighed by the anticipated benefits.
For example, the initial consultation if conducted in-person, will be scheduled around participants’ existing medical appointments to reduce burden of time and travel. All other aspects of the intervention can be completed in the comfort of participants’ own homes, at their leisure. Similarly, the light glasses are comfortable, easy to wear, and are not likely to disrupt participant’s usual morning routines. Wearing the light glasses for 20 minutes per day with glasses fixed at 1500 lux will not impair participants’ ability to move around and undertake any domestic or work-related responsibilities such as preparing and consuming food, household cleaning, reading, writing or typing.
Furthermore, the intervention has been designed to be economical from the perspective of the healthcare system, it is simple for clinicians to deliver and entails relatively low financial expense and burden of time. Taken together, the proposed interventions, if shown to be effective, have the potential to be sustainably integrated within routine oncology care.

Arm 1 - Cognitive Behavioural Therapy (CBT) Intervention
Eligible participants randomised to the CBT and CBT+BLT conditions will receive an abbreviated online-based, resource-orientated variant of cognitive behavioural therapy for insomnia and sleep. The intervention will consist of an initial CBT consult (conducted in-person or via phone; about 60-75-minutes), one phone call (about 30-minutes) and a series of 12 biweekly self-administered emails (about 15-30-minutes). All email content is standardised. The initial CBT consult will be structured but personalised to emphasise aspects most relevant based on individuals' needs and goals. Following the initial CBT consult, participants will then subsequently engage in activities or materials by distance in a self-guided manner (i.e., by reading emails and applying recommended strategies). The primary themes targeted within the proposed adaptation of CBT include behavioural (i.e. timing, conditioning) and psychological (i.e. anxiety, rumination, stress, depression) causes of sleep disturbance and strategies for sleeping with symptoms common to cancer and its associated treatments (i.e. pain, nausea, hot flushes). Broadly, the CBT intervention groups will receive sleep strategies with the following core components:
-- general information and skills for better sleep (e.g., sleep hygiene, relaxation and mindfulness exercises, dealing with night-time worries);
-- fostering healthy attitudes and expectations about sleep following cancer diagnosis and during oncology treatment;
-- managing sleep challenges specific to cancer patients (e.g., physical discomfort, pain, daytime consequences of poor sleep);
-- identifying and managing symptoms of insomnia (e.g., self-monitoring, stimulus control, sleep scheduling, bed restriction).

The adapted intervention materials were modelled on the core components described in ‘Cognitive Behavioural Treatment of Insomnia Session by Session Guide’ (Perlis, Jungquist, Smith & Posner, 2005). These core components have been demonstrated to improve sleep and are well-suited for use within an abridged intervention time frame (Johnson et al., 2016). Each email will address a unique theme. The total duration of this intervention is 6 weeks.

Arm 2 - Bright Light Therapy (BLT) Intervention
Participants allocated to the CBT+BLT and BLT conditions will be provided a pair of Luminette(registered) light therapy glasses. The BLT intervention will consist of an initial consultation (conducted in-person or via phone; about 30-45 minutes), one phone call (about 30-minutes) and daily use of the Luminette(registered) light glasses for 20 minutes at their habitual wake time for the six-week duration of the intervention. The initial consultation will follow a structured program but be personalised by the interventionist to individuals' needs and goals, for example taking into typical wake times and daily routines in the scheduling of light glass use. Additionally, participants will receive a brief email each week that will include reminders to promote intervention adherence as well as basic strategies to promote positive sleep habits. Participants will be provided specific instructions during the initial consultation to address both Light Therapy (e.g., seeking bright light upon waking and during the day) and Dark Therapy (e.g., avoiding electronic devices an hour before bedtime, using Nightshift mode), which will be personalised according to their individual routine. Specifically, the initial consultation session will have three objectives: (1) assess participant’s current sleep-wake patterns to inform individualised timing of light glasses; (2) discuss light therapy applications and functions to promote more effective integration in daily use; and, (3) collaboratively identify and problem-solve any foreseeable difficulties concerning adherence to light therapy protocol. Additionally, pertinent information will be provided to participants in the form of a brief Light Therapy Participant Guide, including how/when to use the light glasses, as well as a summary of key Light/Dark Therapy strategies and safety information. Participants will also receive a Luminette(registered) guide for further detailed information regarding their light glasses. Additionally, participants in the BLT alone condition will receive basic sleep hygiene and education information (beyond light/dark therapy) to match what is delivered in SHE (described below). This email content will be standardised so it is the same for all participants. The total duration of this intervention is 6 weeks.

Arm 3 - Combined (CBT+BLT) Intervention
Participants in this condition will receive both CBT and BLT interventions simultaneously as detailed above.

Arm 4 - Sleep Hygiene and Education (SHE) Intervention
The Sleep Hygiene and Education intervention group will receive similar time and attention relative to CBT and BLT interventions. Participants will receive one initial consultation covering sleep education and basic sleep hygiene (conducted in-person or via phone; about 30 minutes), a midpoint phone call (about 15 minutes) and weekly emails (about 10 minutes). The initial consultation will follow a structured program, but will be personalised by the interventionist depending on individuals' needs and goals. For example, although all aspects of good sleep hygiene are encouraged, a plan and suggestions will incorporate indivdiuals' daily routines and changes that they are willing and able to commit to. For example, one person may be willing to use caffeine only in the morning but not remove a television from the bedroom. Email modules will review positive sleep hygiene practices and general sleep education materials:
-- Purpose and benefits of sleep
-- Stages of sleep
-- Processes that influence sleep (homeostatic and circadian)
-- Sleep disorders (dyssomnias, parasomnias and circadian disruption)
-- Tips to modulate light exposure in the evening to improve sleep
-- Tips to better regulate temperature overnight to improve sleep
-- Guidelines regarding physical activity and its timing to optimise sleep
-- Noise reduction techniques to improve sleep
-- Tips on the timing and content of food consumption to improve sleep
-- Tips on the timing and quantity of caffeine consumption to improve sleep
-- Tips on the timing and quantity of alcohol consumption to improve sleep
-- Tips for selecting mattress and bedding to improve sleep

This email content will be standardised so it is the same for all participants. The total duration of this intervention is 6 weeks.
Intervention code [1] 318454 0
Behaviour
Intervention code [2] 318669 0
Treatment: Other
Comparator / control treatment
All four arms will be compared to each other. The reference comparator is Arm 4 - Sleep Hygiene and Education.
Control group
Active

Outcomes
Primary outcome [1] 324925 0
Insomnia Severity Index
Timepoint [1] 324925 0
The first primary outcome is assessed at multiple time points, including baseline (t0), 3 weeks post-intervention commencement (t2) and 6 weeks post-intervention commencement (t3) with the linear slope of change across these time points being the primary timepoint.
Primary outcome [2] 324926 0
PROMIS Fatigue symptoms (computer adaptive test)
Timepoint [2] 324926 0
The second primary outcome is assessed at multiple time points, including baseline (t0), 3 weeks post-intervention commencement (t2) and 6 weeks post-intervention commencement (t3) with the linear slope of change across these time points being the primary timepoint.
Secondary outcome [1] 386234 0
PROMIS Health-Related Quality of Life / Health Utility Score
Timepoint [1] 386234 0
This secondary outcome is assessed at multiple time points, including baseline (t0), 3 weeks post-intervention commencement (t2) and 6 weeks post-intervention commencement (t3) with the linear slope of change across these time points being the secondary timepoint.
Secondary outcome [2] 386235 0
Actigraphy - Rest Activity Rhythms
Timepoint [2] 386235 0
This secondary outcome is assessed daily for two weeks from four to 6 weeks post-intervention commencement (t3). The average rest activity rhythm calculated on the daily data from this two-week period will be the secondary timepoint for this secondary outcome.
Secondary outcome [3] 386236 0
PROMIS sleep-related impairment computer adaptive test
Timepoint [3] 386236 0
This secondary outcome is assessed at multiple time points, including baseline (t0), 3 weeks post-intervention commencement (t2) and 6 weeks post-intervention commencement (t3) with the linear slope of change across these time points being the secondary timepoint.
Secondary outcome [4] 387233 0
Total QALYs for health economic analyses will utilise the PROMIS health utility scores (PROPr).
Timepoint [4] 387233 0
Total QALYs will be calculated using an area-under-the-curve approach from PROPr scores at baseline (t0), 3 weeks post-intervention commencement (t2), 6 weeks post-intervention commencement (t3), 3-month follow-up (t4), and 6-month follow-up (t5) and assuming a linear time-trend between time-points.

Eligibility
Key inclusion criteria
(a) Breast cancer diagnosis;
(b) Age greater than or equal to 18 years;
(c) Receiving oral or intravenous cytotoxic chemotherapy, with at least 6 weeks of chemotherapy treatment anticipated at the time of enrolment;
(d) Able to read and write in English;
(e) Able to provide informed consent;
(f) Have regular access to email and internet.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) History of suffering migraines;
(b) Severe psychiatric disorder including substance use disorders;
(c) Male;
(d) Daily use of sleep medications or herbal sleep aids for the previous two weeks or ongoing/planned daily use during the trial;
(e) Brain metastasis with daily steroid use;
(f) Significant symptoms of the following sleep disorders based on The Structured Clinical Interview for Sleep Disorders (SCISD-R; Taylor, Kelly, Kohut, & Song, 2017): narcolepsy, sleep apnoea, periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disorders.

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)
The randomisation scheme will be generated and set up in REDCap. To randomise a participant, an authorized research staff member will login to REDCap, enter eligibility and stratification data on the participant and will receive the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomised into group using a complete randomisation scheme generated in advance. Specifically, variable block sizes (4 or 8) will be used. Random seeds will be generated to assure allocation concealment and pre-guessing of the allocation sequence at the end of each block. Randomisation will be stratified by site (Peter MacCallum Cancer Centre, Monash Health), cancer stage (less than or equal to 3, equal to 4) and screening ISI (less than or equal to 7, greater than or equal to 8).
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
Based on previous studies, data from our previous sleep trial in women with breast cancer treated with chemotherapy (Bean et al, 2020), and clinical judgement, we set the minimally important difference (MID) for the insomnia severity index at 3 and for the PROMIS Fatigue at 4 (Yost, Eton, Garcia & Cella, 2011). These represent approximately half a standard deviation on both measures in our SleepWell trial or a between group Cohen’s d of approximately 0.50. For the insomnia severity index, a 3-point change also is about half a “category” shift based on common cut offs. In addition to representing a minimally important difference, previous trials demonstrate that these or larger magnitude changes may be expected.
Following recommendations for analysing longitudinal data from randomised controlled trials, we plan to use so-called “constrained longitudinal data analysis” (Coffman, Edelman, Woolson, 2016; Twisk, Bosman, Hoekstra, et al, 2018) and to adjust for stratification factors used in randomisation (Kahan & Morris, 2011; Kahan & Morris, 2012). In addition, we anticipate dropout throughout the trial due to illness and burden from other cancer treatment including chemotherapy. Appropriate power analysis for constrained longitudinal analyses (Coffman, Edelman, Woolson, 2016; Twisk, Bosman, Hoekstra, et al, 2018) adjusted for stratification factors and with missing data is not readily calculated using fixed formula. Therefore, a Monte Carlo study was conducted in Mplus using MplusAutomation (Muthen & Muthen, 2002; Hallquist & Wiley, 2018). Extensive details and code to reproduce the Monte Carlo study is publicly available at: https://github.com/behavioralmedicinelab/SleepCarePlanning. This trial is powered to detect a main effect of BLT and main effect of CBT for the primary outcomes, insomnia severity index and fatigue symptoms at alpha = .05, assuming the minimally important differences previously noted (3 for insomnia severity index and 4 for fatigue symptoms) and little to no interaction between conditions, given that they operate on very different mechanisms. In our previous SleepWell trial, over a quarter of participants had metastatic cancer resulting in high attrition rates. We estimated that there would be 35% missing data by the post intervention assessment, a very conservative estimate. The BLT x CBT interaction (the combination sleep treatment) is an exploratory aim of this trial and the trial is not powered for this.
Tests for the primary trial aims (main effect of BLT and CBT on ISI and Fatigue) will be adjusted for multiple comparisons using a false discovery rate to control for type 1 error (Benjamin & Hochberg, 1995; Verhoeven, Simonsen & McIntyre, 2005), with FDR set at 0.05. While this method is less conservative than other methods, it has been used previously in sleep research (Maccora, Manousakis & Anderson., 2018; Lee et al., 2015).
Randomising N = 210 participants will provide = 80% power for the main effect of BLT and CBT on the insomnia severity index and fatigue symptoms (Aims 1 and 2) under the conditions specified based on results from the Monte Carlo simulation study.

Statistical Analysis Plan

Data Cleaning
All descriptive and inferential statistics will be computed using R (R Core Team, 2018). Preliminary analysis will be conducted to screen for outliers and skew within the data set. Where applicable, data abnormalities will undergo appropriate transformations or will be winsorized to their respective group’s next highest non-outlier value, in accordance with Field’s (2013) recommendations. For Actigraphy data, prior to analysis all off-wrist intervals (omissions in activity data) will be excluded. Any 24 hr periods containing less than 75% data will be excluded from analysis.

Baseline Characteristics
A thorough descriptive profile of baseline characteristics for each intervention condition and the overall sample will be presented as a table. Discrete variables will be summarised by frequencies and percentages, while continuous variables will be represented using mean (SD) and median (IQR). These descriptive analyses will facilitate evaluation of the external validity and generalisability of the findings.

Primary Intervention Effects (Aims 1 and 2)
To assess the intervention-dependent changes on each primary outcome (Aim 1 & 2) an intention-to-treat analysis will be conducted in R and Mplus using MplusAutomation (Hallquist & Wiley, 2018). Primary analyses will match those used in the Monte Carlo simulation study for power analysis and are available online: https://github.com/behavioralmedicinelab/SleepCarePlanning.
Latent growth models (LGMs) will be estimated with an intercept and a linear slope with loadings constrained to 0, 0.5, and 1.0 for times t0, t2, and t3, respectively. The means and variances of the intercept and slope factors will be freely estimated (corresponding to random effects in linear mixed models) and the intercept and slope covariance will be estimated. The residual variance will be constrained to equality across time and residuals assumed uncorrelated, corresponding to an independent, homogenous residual structure. Intercepts of indicators will be constrained to 0 to allow estimation of the latent random intercept mean.
There are three stratification factors: site (Peter MacCallum Cancer Centre, Monash Health), cancer stage (less than or equal to 3, equal to 4) and insomnia severity index at screening (less than or equal to 7, greater than or equal to 8). These factors will be crossed creating eight groups. Dummy codes will be created for each strata. These dummy codes will be included as covariates to adjust for their effect on the random intercept, following recommendations that stratification factors be adjusted for in analyses of randomised controlled trials (Kahan & Morris, 2011; Kahan & Morris, 2012).
Intervention effects will be evaluated by creating dummy codes for BLT, CBT, and the BLT x CBT interaction. These will be entered as predictors of the random intercept and slope. However, intervention factors will be constrained to 0 for the random intercept, to implement so-called “constrained longitudinal data analysis” (Coffman, Edelman, Woolson, 2016; Twisk, Bosman, Hoekstra, et al, 2018), which studies show provides a more accurate estimate of intervention effects from randomised controlled trials with repeated measures. To calculate the overall main effects, estimates will be averaged across conditions to average out the interaction (for non-primary analyses, the interaction and simple effects will be tested). We anticipate missing data and dropout over time. Missing data will be addressed using full information maximum likelihood estimation (Enders & Bandalos, 2001).
An alpha level of .05 will be used to assign significance. All comparisons will be made using a false discovery rate to control for type 1 error (Benjamin & Hochberg, 1995; Verhoeven, Simonsen & McIntyre, 2005). While this method is less conservative than other methods, it has been used previously in sleep research (Maccora, Manousakis & Anderson., 2018; Lee et al., 2015).
For each outcome measure, a Cohen’s d effect size at 6 weeks post-intervention commencement (t3) will be computed as well as a “within” standardised mean difference based on the change from baseline (t0) to 6 weeks post-intervention commencement (t3). To assess comparative treatment effects, post hoc pairwise comparisons of each condition’s computed effect size will be conducted on all primary outcomes.
In the event normality cannot be assumed for an outcome variable, as can occur with sleep measures (Carney et al., 2012), bootstrapping will be employed for significance testing and calculation of confidence intervals (Field, 2013).

Economic Evaluation
Overseen by AI Mortimer, cost-effectiveness and cost-utility analyses will be conducted to summarise health gains, health care costs and productivity gains associated with (i) replacing SHE with CBT+BLT, CBT alone or BLT alone, (ii) adding CBT to BLT alone, and (iii) adding BLT to CBT alone. Analyses will be conducted from a societal perspective and will be limited to costs and consequences within the trial period.
Health gains will be captured by primary clinical outcomes (ISI at t3 and t4; PROMIS Fatigue at t3 and t4) and total quality adjusted life-years (QALYs) from baseline to trial-end. Total QALYs to trial-end will be calculated using an area-under-the-curve approach based on PROPr utility scores at t0, t2, t3, t4, and t5 and assuming a linear time-trend between time-points. Intervention effects with respect to QALYs will be estimated using one-part generalized linear models (GLM) specifying appropriate variance and link functions, controlling for strata variables and PROPr utility scores at baseline (t0). Intervention effects with respect to the primary clinical outcomes will be estimated as for the main effectiveness analysis (described above).
Total cost per patient from baseline to trial-end will be calculated as the sum of intervention costs (i.e. direct cost of SHE, CBT, BLT or CBT+BLT), cost of ‘related’ health service utilisation (e.g. prescription and OTC medicines for sleep problems, anxiety, low mood and depression; visits to primary, specialist and allied health care providers for sleep problems, anxiety, low mood and depression) and productivity gains (e.g. use of paid and unpaid home help; change in employment status hours; paid and unpaid sick leave). Patient-level estimates of intervention costs will be based on administrative records and fidelity analysis regarding delivery of intervention components and adherence data regarding receipt of intervention components. Patient-level estimates of the cost of ‘related’ health service utilisation will be based on patient self-report at t3 (for the period t0 to t3), t4 (for the period t3 to t4), and t5 (for the period t4 to t5). Patient-level estimates of productivity gains will be based on patient self-report at t3, t4, and t5 with respect to use of paid and unpaid home help, paid and unpaid sick leave and hours of paid employment. Intervention effects with respect to total cost will be estimated using one-part GLM models with gamma variance function and a log link (rather than transformed OLS or two-part models), controlling for strata variables.
Results will be expressed as (1) cost per point improvement on the primary clinical outcomes (ISI at t3, t4, t5; PROMIS Fatigue at t3, t4, and t5), and (2) cost per QALY gained to t5. We will summarise sampling error and parameter uncertainty using the bootstrap acceptability to calculate confidence intervals and generate cost-effectiveness acceptability curves.


Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment hospital [1] 17341 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 17342 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 17343 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 31069 0
3000 - Melbourne
Recruitment postcode(s) [2] 31070 0
3165 - East Bentleigh
Recruitment postcode(s) [3] 31071 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 306579 0
University
Name [1] 306579 0
Monash University
Address [1] 306579 0
18 Innovation Walk,
Clayton campus, VIC 3800 Australia
Country [1] 306579 0
Australia
Funding source category [2] 306580 0
Government body
Name [2] 306580 0
National Health and Medical Research Council
Address [2] 306580 0
National Health & Medical Research Council
GPO Box 1421
Canberra, ACT, 2601
Country [2] 306580 0
Australia
Primary sponsor type
University
Name
Monash University
Address
18 Innovation Walk,
Clayton campus, VIC 3800 Australia
Country
Australia
Secondary sponsor category [1] 307105 0
None
Name [1] 307105 0
Address [1] 307105 0
Country [1] 307105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306763 0
Peter MacCallum Cancer Centre Human Research Ethics Committee [EC00235]
Ethics committee address [1] 306763 0
305 Grattan St, Melbourne VIC 3000
Ethics committee country [1] 306763 0
Australia
Date submitted for ethics approval [1] 306763 0
04/11/2019
Approval date [1] 306763 0
10/09/2020
Ethics approval number [1] 306763 0
HREC/55622/PMCC

Summary
Brief summary
The purpose of this study is to examine several treatments for poor sleep and fatigue during chemotherapy for breast cancer.

Who is it for?
You may be eligible for this study if you are aged 18 years or older with diagnosis of breast cancer and will be receiving chemotherapy treatment for at least 6 weeks at the start of the study.

Study details
Participants in this study are randomly allocated (by chance) to one of four groups for 6 weeks of:
1. Cognitive behavioural therapy. Cognitive behavioural therapy is a short-term therapy technique that focuses on changing ways of thinking and behavioural patterns to improve sleep; or
2. Light therapy. Light therapy manages someone’s exposure to light, particularly in the morning and evening, to help support energy levels during the day and improve sleep overnight; or
3. Combination of treatments 1 & 2; or
4. Sleep hygiene and education therapy. Sleep hygiene and education therapy refers to a set of strategies about your behaviours and your sleep environment that support healthy sleep.

Participants will be expected to complete some assessments. Assessments will include structured interviews in person or over the telephone (~ 1 hour) to assess eligibility and identify whether you have any current sleep disorders, wearing a wrist-watch like device to track your activity and sleep for the first and last two weeks of the intervention, and questionnaires you complete online or with us over the phone.

If effective, results from this study will identify which treatments most improve sleep and fatigue during chemotherapy and may be used to guide routine treatments offered to women undergoing chemotherapy for breast cancer in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104938 0
Dr Joshua F. Wiley
Address 104938 0
Monash University
Room 510, 18 Innovation Walk,
Clayton campus, VIC 3800 Australia
Country 104938 0
Australia
Phone 104938 0
+61399059598
Fax 104938 0
Email 104938 0
joshua.wiley@monash.edu
Contact person for public queries
Name 104939 0
Dr Joshua F. Wiley
Address 104939 0
Monash University
Room 510, 18 Innovation Walk,
Clayton campus, VIC 3800 Australia
Country 104939 0
Australia
Phone 104939 0
+61399059598
Fax 104939 0
Email 104939 0
joshua.wiley@monash.edu
Contact person for scientific queries
Name 104940 0
Dr Joshua F. Wiley
Address 104940 0
Monash University
Room 510, 18 Innovation Walk,
Clayton campus, VIC 3800 Australia
Country 104940 0
Australia
Phone 104940 0
+61399059598
Fax 104940 0
Email 104940 0
joshua.wiley@monash.edu

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 collected during the trial will be shared. With the following exceptions/redactions:
- contact information will not be shared
- every effort will be made to de-identify data and reduce possibility of re-identification, including: collapsing rare categories (eg date of birth converted into age categories; study dates converted to month/year)
- raw accelerometry data
When will data be available (start and end dates)?
Data will be available publicly seven years after completion of the final publication with no planned end date.
Available to whom?
General public.
Available for what types of analyses?
Any analyses.
How or where can data be obtained?
Seven years after the final publication of the current study, the data and documentation will be shared publicly via Monash Bridges (currently powered by figshare located at: https://bridges.monash.edu/), Monash University’s data repository.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Analytic code
How or where can supporting documents be obtained?
Type [1] 8971 0
Study protocol
Citation [1] 8971 0
Link [1] 8971 0
Email [1] 8971 0
Other [1] 8971 0
Will be available after the trial has commenced.
Attachment [1] 8971 0
Type [2] 8972 0
Statistical analysis plan
Citation [2] 8972 0
Link [2] 8972 0
Email [2] 8972 0
Other [2] 8972 0
Will be available after the trial has commenced.
Attachment [2] 8972 0
Type [3] 8973 0
Informed consent form
Citation [3] 8973 0
Link [3] 8973 0
Email [3] 8973 0
Other [3] 8973 0
See attached.
Type [4] 8974 0
Ethical approval
Citation [4] 8974 0
Link [4] 8974 0
Email [4] 8974 0
Other [4] 8974 0
See attached.
Type [5] 8975 0
Analytic code
Citation [5] 8975 0
Link [5] 8975 0
Email [5] 8975 0
Other [5] 8975 0
Will be available after primary outcomes have been analyzed.
Attachment [5] 8975 0
Summary results
No Results