NCT05428176

A High Intensity Electronic Health Intervention for the Reduction of Learning Disparities in Childhood Cancer Survivors

Leveraging Digital Health Solutions to Reduce Learning and Functional Disparities in Children With Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Accepted

Summary

This clinical trial evaluates a high intensity electronic health (eHealth) intervention program for reducing learning disparities in children with cancer. Most children with leukemia and lymphoblastic lymphoma can be cured due to advancements in diagnosis and treatment. However, because treatments for these conditions target the central nervous system, these children are at increased risk for developing neurocognitive late effects (problems with attention, thinking, learning, and remembering). Fortunately, many survivors do well, but some children continue to struggle with learning and have academic difficulties after their cancer treatments. The purpose of this research study is to see whether providing parents with educational knowledge and parenting tips using videoconferencing and a special website better helps their cancer survivor child in learning and school achievement compared to typical services.

Detailed description

PRIMARY OBJECTIVE: I. Determine the effectiveness of high intensity program (HIP)-eHealth on pediatric cancer survivors' learning and school-related outcomes up to 12 months post-enrollment. SECONDARY OBJECTIVES: I. Determine the effectiveness of HIP-eHealth on parental efficacy up to 12 months post-enrollment. II. Examine the extent to which parents' self-reported efficacy and/or children's use of online learning activities correlates with the children's school functioning. III. Examine differences in HIP-eHealth uptake and effects across socio-demographic groups. OUTLINE: PRE-STUDY: Parent-child dyads attend 4 intervention sessions over 10 weeks and provide feedback in support of intervention refinement. Parent-child dyads are randomized to 1 of 2 arms. ARM I: Patients and parents undergo high intensity eHealth intervention through the interactive website and via videoconferencing for 30-50 minutes once every 3 to 4 weeks for up to 5 sessions over 6 months. Patients and parents also receive usual care. After 6 months, parents attend booster sessions at months 7, 9, and 11. ARM II: Patients and parents receive usual care.

Conditions

• Acute Leukemia
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Lymphoblastic Lymphoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Internet-Based Intervention	Undergo eHealth intervention
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-02-16
• Primary completion: 2026-05-12
• Completion: 2027-06-30
• First posted: 2022-06-22
• Last updated: 2026-04-15

Locations

4 sites across 1 country: United States