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

Plain Language Summary

Simplified for easier understanding

This study tests whether bright light therapy can improve sleep and quality of life for children aged 3 to 9 who are being treated for acute lymphoblastic leukaemia (ALL). Children with ALL often have disrupted sleep, which affects their mood and recovery. Those in the treatment group will wear a light-up visor for 30 minutes each morning for about 12 weeks. Sleep, mood, fatigue, and quality of life are measured before, during, and after the therapy. You may be eligible if: - Your child is between 3 and 9 years old - Your child is currently in the maintenance phase of ALL treatment - Your child's white cell count is below 50,000 cells per microlitre - Your child has favourable test results (cytogenetics) You may NOT be eligible if: - Your child is blind or has diagnosed eye or retinal problems - Your child is on light-sensitive medications (e.g. certain antifungal drugs) - Your child takes medications that affect sleep - Your child has epilepsy or migraines - Your child has a developmental disability - Your child is in foster care - You or your child do not speak English Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.