WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy

Trial Title: WASPE Sleep Adjustment for Children Aged 0-4 Years Undergoing Radiation Therapy

NCT ID: NCT06443632

Condition: Pediatric Cancer

Conditions: Keywords:
Pediatric cancer
Radiotherapy
Sleep adjustment

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Sleep Adjustment
Description: (1) Establishing a sleep schedule with early bedtime and wake-up times; (2) Establishing a consistent bedtime routine based on the child's preferences, such as wearing a sleep sack, providing soothing touch before sleep, offering a pacifier, using white noise, or playing sleep-inducing music; (3) Setting a fixed afternoon radiotherapy time each day and familiarizing the child with the radiotherapy environment beforehand; (4) Engaging the child in stimulating activities like watching videos, playing with toys, snacking, or outdoor activities to keep them awake from morning until 2 PM before radiotherapy; (5) Ensuring the child reaches deep sleep; (6) Completing the radiotherapy plan.
Arm group label: Sleep Adjustment

Summary: In China, pediatric tumors are the second leading cause of death in children. Radiotherapy is critical to the treatment of pediatric cancer, with about one-third of patients requiring it and nearly 50% for certain cancers, but young age and immature cognitive abilities pose challenges for precise positioning, leading to reliance on sedatives such as propofol or chloral hydrate, which pose health risks. Radiotherapy technicians are exploring new methods such as psychological interventions, but these methods are challenging for children aged 0-4, who account for a high proportion of pediatric cancer cases in China. Therefore, new methods for children aged 0-4 are urgently needed.

Detailed description: Approximately 400,000 children and adolescents globally and 22,000 children in China are diagnosed with malignancies each year, with pediatric tumors being the second leading cause of death in children. Radiotherapy is crucial for pediatric cancer treatment, with about one-third of patients requiring it and nearly 50% for certain cancers, but young age and immature cognitive abilities pose challenges for precise positioning and irradiation, leading to reliance on sedatives like propofol or chloral hydrate, which carry health risks. A retrospective study found a 5.8% incidence of cardiopulmonary complications with propofol-only anesthesia during pediatric radiotherapy, and guidelines and studies indicate that anesthetics pose rare but serious risks and may impact neurological development and learning abilities, highlighting the need to reduce sedative use to minimize side effects and improve long-term quality of life for pediatric cancer patients. Radiotherapy technicians are exploring new methods like psychological interventions, as shown by Sonja et al.'s study where psychological intervention significantly reduced the need for sedation anesthesia in children undergoing radiotherapy, with better outcomes observed in girls. A 2023 multicenter study found that audiovisual-assisted radiotherapy (AVATAR) effectively reduced sedative use and improved quality of life and anxiety in 3-10-year-old children, with significant QoL improvements for children aged 5-7 and their parents. However, the application of these methods is challenging for children aged 0-4, who account for the highest proportion (30.59%) of newly diagnosed pediatric cancer cases in China. Therefore, new methods for children aged 0-4 years are urgently needed. Our center's prospective study (Oct 2021 - Oct 2022) with 28 children aged 0-4 found that the WASPE method combined with optical surface monitoring systems (OSMS) effectively guided young children to complete radiotherapy with reduced sedative use, with 69% of parents preferring the sleep adjustment method. Based on promising findings, our study will randomize 0-4-year-old radiotherapy patients into sleep adjustment or conventional sedation groups to compare radiotherapy completion rates, efficiency, accuracy, quality of life (assessed via PedsQL™), immune function indicators and growth hormone levels, and safety.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patient of any gender, aged 0-4 years - Pathologically confirmed diagnosis of pediatric malignant solid tumors (including Wilms tumor, neuroblastoma, rhabdomyosarcoma, hepatoblastoma, germ cell tumors, etc.). - The child's parents can cooperate with the implementation of the sleep training plan. - Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. - Expected survival of the patient ≥3 months. - Normal major organ function (within 14 days before enrollment) - Growth and immune function are within acceptable ranges as determined by the investigator. - The patient's parents must provide informed consent for the study before participation and voluntarily sign the informed consent form. Exclusion Criteria: - Primary or metastatic lesions that cannot undergo radiotherapy (as determined by the investigator). - Children who can independently maintain position fixation. - Children with clinical signs of central nervous system dysfunction. - Children with sleep disorders. - Children with severe growth retardation or immune function impairment. - Other significant medical conditions that may impact the study (e.g., severe cardiopulmonary diseases). The decision is at the discretion of the investigator. - Severe or uncontrolled infections. - Allergy to sedatives. - The investigator deems the patient unsuitable for participation in this clinical study for other reasons.

Gender: All

Minimum age: N/A

Maximum age: 4 Years

Healthy volunteers: No

Locations:

Facility:
Name: Department of Radiation Oncology, Shandong Cancer Hospital and Institute

Address:
City: Jinan
Zip: 0531
Country: China

Status: Recruiting

Contact:
Last name: Jinbo Yue, doctor

Phone: 0531-67626442
Email: yuejinbo@hotmail.com

Start date: June 1, 2024

Completion date: November 1, 2025

Lead sponsor:
Agency: Shandong Cancer Hospital and Institute
Agency class: Other

Source: Shandong Cancer Hospital and Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06443632