None listed
Conditions
Brief 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.
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 att
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.
Sponsors
Lisa Walter
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
3 Years to 9 Years
Healthy volunteers
No
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.
Outcome results
None listed