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Trial registered on ANZCTR


Registration number
ACTRN12616000187448
Ethics application status
Approved
Date submitted
9/02/2016
Date registered
12/02/2016
Date last updated
1/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Bright light therapy to improve sleep and quality of life in children with acute lymphoblastic leukaemia
Scientific title
Does bright light therapy improve sleep, reduce fatigue and improve quality of life in children (3-9 years old) with acute lymphoblastic leukaemia during maintenance therapy
Secondary ID [1] 288502 0
Nil Known
Universal Trial Number (UTN)
U1111-1179-3707
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukaemia 297572 0
Sleep Disorders 297573 0
Fatigue 297574 0
Quality of Life 297575 0
Condition category
Condition code
Cancer 297768 297768 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The participants (children 3-9 years of age with Acute Lymphoblastic Leukaemia) will be randomly assigned to the treatment group. They will wear a Feel Bright Light Visor (Physicians Engineered Products, Maine, USA) for 30 minutes as soon as awakening in the morning, for the 84 days of the second cycle of maintenance treatment. This device delivers 8,000 lux of light in the wavelength range of 460 nm to 550 nm. In addition to the light visor, the children will be asked to wear a small device attached to their clothing at the same time (HOBO Pendant (Registered Trademark) 8K Temperature/Light Data Logger (Onset Computer Corporation, Bourne, MA, USA), which measures light intensity and will be used to assess compliance.
Intervention code [1] 293867 0
Treatment: Devices
Comparator / control treatment
Children 3-9 years of age with Acute Lymphoblastic Leukaemia) will be randomly assigned to the control group. They will have no light therapy intervention and will also be studied during the the 84 days of the second cycle of maintenance treatment.
Control group
Active

Outcomes
Primary outcome [1] 297296 0
Composite outcome of sleep quantity and quality, using a combination of actigraphy, sleep diary and the Tayside Children’s Sleep Questionnaire.
Timepoint [1] 297296 0
Comparing the five days before light therapy to the last five days of the second cycle of maintenance treatment
Primary outcome [2] 297297 0
Quality of life using the PedsQL - Cancer module and the Mood and Feelings Questionnaire
Timepoint [2] 297297 0
Comparing the five days before light therapy to the last five days of the second cycle of maintenance treatment
Primary outcome [3] 297298 0
Daytime sleepiness using the Modified Epworth Sleepiness Scale
Timepoint [3] 297298 0
Comparing the five days before light therapy to the last five days of the second cycle of maintenance treatment
Secondary outcome [1] 320651 0
Parental stress using the Parenting Stress Index – short form
Timepoint [1] 320651 0
Comparing the five days before light therapy to the last five days of the second cycle of maintenance treatment
Secondary outcome [2] 320652 0
Composite outcome of sleep quantity and quality, using a combination of actigraphy, sleep diary and the Tayside Children’s Sleep Questionnaire.
Timepoint [2] 320652 0
Six months after completion of 84 days of light therapy
Secondary outcome [3] 320679 0
Fatigue using the Peds QL Multidimensional Fatigue Scale (Primary outcome)
Timepoint [3] 320679 0
Comparing the five days before light therapy to the last five days of the second cycle of maintenance treatment
Secondary outcome [4] 320680 0
Family quality of life using the Peds QL Family Impact Module
Timepoint [4] 320680 0
Comparing the five days before light therapy to the last five days of the second cycle of maintenance treatment
Secondary outcome [5] 320681 0
Quality of life using the PedsQL - Cancer module and the Mood and Feelings Questionnaire
Timepoint [5] 320681 0
Six months after completion of 84 days of light therapy
Secondary outcome [6] 320682 0
Daytime sleepiness using the Modified Epworth Sleepiness Scale
Timepoint [6] 320682 0
Six months after completion of 84 days of light therapy
Secondary outcome [7] 320683 0
Fatigue using the Peds QL Multidimensional Fatigue Scale
Timepoint [7] 320683 0
Six months after completion of 84 days of light therapy
Secondary outcome [8] 320684 0
Family quality of life using the Peds QL Family Impact Module
Timepoint [8] 320684 0
Six months after completion of 84 days of light therapy
Secondary outcome [9] 320685 0
Parental Stress using the Parenting Stress Index – short form
Timepoint [9] 320685 0
Six months after completion of 84 days of light therapy

Eligibility
Key inclusion criteria
Children 3 to 9 years of age
Undergoing maintenance treatment for acute lymphoblastic leukaemia
White cell count less than 50,000 cells per microliter
Favourable cytogenetics, i.e. no extreme hypodiploidy with < 44 chromosomes/cell; MLL gene rearrangement; Philadelphia chromosome positivity; Internal amplification of chromosome 21
No cerebrospinal disease
Minimum age
3 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who are blind
Have a history of diagnosed retinal problems
On photo-sensitive medication, such as azole anti-fungal medication (risk of photosensitivity
On medications which alter/induce sleep
On psychotropic medications
Non-English speaking and/or non-English speaking parents
Have pre-existing developmental disabilities
Have epilepsy or migraines
Wear tinted glasses
Are in foster care or with documented protective services involvement.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our primary aim is to determine whether light therapy significantly improves the quality of life in children with ALL Based on the number of children meeting the study criteria in 2016 from both MMC and RCH, and an 86% participation rate in our pilot study, we expect to recruit 80 children over the three years of the project from both sites. As there are no previous studies of light therapy in children with cancer upon which to base a power calculation, we have based our power calculation on a study that investigated the change in quality of life in children with ALL when being administered dexamethasone compared to no dexamethasone (Pound CM, et al. Corticosteroids, behavior, and quality of life in children treated for acute lymphoblastic leukemia; a multicentered trial. J Pediatr Hematol Oncol 2012;34:517-23). A mean difference in the pain and hurt scale of the PedsQL_cancer module of -17.4, SD 26.9 between the on-dexamethasone and off-dexamethasone time-points was significant (p<0.001). Using these data, our sample size of 40 children per group, will allow the detection of a significant difference between the light therapy and comparison groups with a power of 83% and alpha level of 0.05.
In this study, the effect of light therapy on sleep parameters (sleep pattern, total sleep time, sleep onset latency, wake after sleep onset), and scores from the Tayside Children’s Sleep Questionnaire, Epworth Sleepiness Scale, PedsQL-Cancer module, PedsQl-Fatigue module, Mood and Feelings Questionnaire, PedsQL-Family Impact module and the Parenting Stress Index will be analysed using linear mixed model analyses to allow for random effects over repeated observations. Group and time will be entered as fixed effects. Age and SES will be entered as covariates. Subject code will be used as the random factor. When there is a significant interaction between group and time in the mixed model analyses, post-hoc one-way-ANOVAs with Bonferroni adjustments will be used. Separate analysis at six month follow-up will compare sleep parameters and questionnaire scores between the groups using Student’s T-tests with Bonferroni correction to account for multiple tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2016
Actual
8/06/2016
Date of last participant enrolment
Anticipated
1/03/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5249 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 7416 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 12717 0
3168 - Clayton
Recruitment postcode(s) [2] 15218 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 292856 0
Other
Name [1] 292856 0
The Ritchie Centre, Hudson Institute of Medical Research
Country [1] 292856 0
Australia
Funding source category [2] 295484 0
Charities/Societies/Foundations
Name [2] 295484 0
Children's Cancer Foundation
Country [2] 295484 0
Australia
Primary sponsor type
Individual
Name
Lisa Walter
Address
The Ritchie Centre,
Hudson Institute of Medical Research
27-31 Wright St,
Clayton
Victoria 3168
Country
Australia
Secondary sponsor category [1] 291599 0
None
Name [1] 291599 0
Address [1] 291599 0
Country [1] 291599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294356 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 294356 0
Ethics committee country [1] 294356 0
Australia
Date submitted for ethics approval [1] 294356 0
04/02/2016
Approval date [1] 294356 0
15/02/2016
Ethics approval number [1] 294356 0
16047A
Ethics committee name [2] 296813 0
Royal Children's Hospital, Research Ethics and Governance
Ethics committee address [2] 296813 0
Ethics committee country [2] 296813 0
Australia
Date submitted for ethics approval [2] 296813 0
21/12/2016
Approval date [2] 296813 0
Ethics approval number [2] 296813 0

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

Contacts
Principal investigator
Name 63402 0
Dr Lisa Walter
Address 63402 0
The Ritchie Centre
Hudson Institute of Medical Research
27-31 Wright St
Clayton
Victoria 3168
Country 63402 0
Australia
Phone 63402 0
+61 385722834
Fax 63402 0
+61 395946811
Email 63402 0
[email protected]
Contact person for public queries
Name 63403 0
Lisa Walter
Address 63403 0
The Ritchie Centre
Hudson Institute of Medical Research
27-31 Wright St
Clayton
Victoria 3168
Country 63403 0
Australia
Phone 63403 0
+61 385722834
Fax 63403 0
+61 395946811
Email 63403 0
[email protected]
Contact person for scientific queries
Name 63404 0
Lisa Walter
Address 63404 0
The Ritchie Centre
Hudson Institute of Medical Research
27-31 Wright St
Clayton
Victoria 3168
Country 63404 0
Australia
Phone 63404 0
+61 385722834
Fax 63404 0
+61 395946811
Email 63404 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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