Clinical trial · Interventional
Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy
Feasibility, Acceptability, and Effectiveness of a Sleep Hygiene and Relaxation Intervention to Improve Sleep and Fatigue for Children Receiving Maintenance Chemotherapy for Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot randomized controlled trial examined the feasibility, acceptability and effectiveness of an intervention to improve sleep quality and decrease fatigue levels in children with a diagnosis of ALL, during maintenance treatment. Families were randomized to usual care or the intervention. The intervention included a sleep hygiene and relaxation education session with a nurse practitioner, literature for home, two story books, and a follow-up phone call. Self-reported measures were used in addition to actigraphy to measure children's quality and quantity of sleep.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Fatigue | — | UNRESOLVED | — |
| Sleep | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sleep Hygiene and Relaxation Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual care
- type
- EXPERIMENTAL
- label
- Sleep Hygiene and Relaxation Education
- interventionNames
- Behavioral: Sleep Hygiene and Relaxation Education
Primary outcomes (1)
- measure
- Feasibility and acceptability of intervention (The Evaluation of Sleep Tips form)
- timeFrame
- Weeks 1-4, post-intervention
- description
- The Evaluation of Sleep Tips form will use open-ended questions to ask parents about factors that promoted or prevented implementing the sleep hygiene and relaxation interventions, and which components of the intervention they implemented and in what frequency.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 10 Years
Show eligibility criteria text
Inclusion Criteria: * Child aged 4-10 with a diagnosis of precursor acute B lymphoblastic leukemia (B ALL) in maintenance phase of therapy beyond 3rd course (protocol AALL0331) * Child and parent able to understand and read English * Child is within one year of age-appropriate grade in school Exclusion Criteria: * Child who is receiving palliative care * Child with diagnosis of depression * Child who has been prescribed medications for insomnia * Child who has a physician-diagnosed sleep disorder (e.g. narcolepsy, restless legs syndrome) * Child who has received radiation therapy * Child has potential sleep disordered breathing (measured by Children's Sleep Habits Questionnaire)
References
Publications (1)
- RESULTZupanec S, Jones H, McRae L, Papaconstantinou E, Weston J, Stremler R. A Sleep Hygiene and Relaxation Intervention for Children With Acute Lymphoblastic Leukemia: A Pilot Randomized Controlled Trial. Cancer Nurs. 2017 Nov/Dec;40(6):488-496. doi: 10.1097/NCC.0000000000000457. PMID 27922922