MedPath

Bright light therapy to improve sleep and quality of life in children with acute lymphoblastic leukaemia

Not Applicable
Recruiting
Conditions
Acute Lymphoblastic Leukaemia
Sleep Disorders
Fatigue
Quality of Life
Cancer - Children's - Leukaemia & Lymphoma
Registration Number
ACTRN12616000187448
Lead Sponsor
isa Walter
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
80
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

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

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Composite outcome of sleep quantity and quality, using a combination of actigraphy, sleep diary and the Tayside Children’s Sleep Questionnaire.<br><br>[Comparing the five days before light therapy to the last five days of the second cycle of maintenance treatment];Quality of life using the PedsQL - Cancer module and the Mood and Feelings Questionnaire[Comparing the five days before light therapy to the last five days of the second cycle of maintenance treatment];Daytime sleepiness using the Modified Epworth Sleepiness Scale [Comparing the five days before light therapy to the last five days of the second cycle of maintenance treatment]
Secondary Outcome Measures
NameTimeMethod
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