RecruitingACTRN12616000187448

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

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

Sponsor

Lisa Walter

Enrollment

80 participants

Start Date

Jun 8, 2016

Study Type

Interventional

Conditions

Quality of Life Fatigue Acute Lymphoblastic Leukaemia Sleep Disorders

Summary

The primary purpose of this study is to evaluate the efficacy of bright light therapy for improving sleep and quality of life in children undergoing treatment for acute lymphoblastic leukaemia. Who is it for? You may be eligible to participate in this study if you are aged 3 to 9 years of age, and undergoing maintenance treatment for acute lymphoblastic leukaemia. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive either bright light therapy or standard leukaemia care with no bright light therapy. Participants allocated to the bright light therapy group will be asked to wear a bright light visor for 30 minutes immediately after waking up each morning for the 84 days of the second maintenance treatment cycle. To assess sleep, fatigue, mood, and quality of life measures, researchers will use a combination of home-based assessment of sleep (actigraphy), a detailed sleep diary and questionnaires. The questionnaires will be completed by both the child and the parents at the beginning and the end of the light therapy, and six months after therapy, and will take approximately 30 minutes to complete at each time point. It is hoped that bright light therapy will provide a cost-effective method of improving sleep and quality of life for children undergoing treatment for acute lymphoblastic leukaemia who are a group at risk of development of potentially long-term sleep problems, increased psychological distress, poor treatment resilience and low quality of life.

Eligibility

Sex: Both males and femalesMin Age: 3 YearssMax Age: 9 Yearss

Inclusion Criteria5

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 Criteria10

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.

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Interventions

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.