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

NCT05428176 | Active Not Recruiting DMC

• 3 other identifiers: 22057NCI-2022-04695P30CA033572
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Lymphoblastic Lymphoma; Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• Child's improvement in academic functioning

  Measured using the Wechsler Individual Achievement Test (WIAT) Numerical Operations (NO) subset. The WIAT NO score at 1 year will be compared between treatment arms using the Generalized Estimating Equation (GEE), adjusting for baseline values and accounting for correlations among patients within a study site. An indicator variable for treatment arm will be included in the model, its significance tested, and a 95% confidence interval constructed.

  At baseline and 1 year

Secondary Outcomes (9)

• Objective academic performance (Child)

  Up to 5 years

• Attention performance (Child)

  Up to 5 years

• Parent-reported functioning of child (Child)

  Up to 5 years

• Use of learning strategies (Child)

  Up to 5 years

• Mean of item scores from the Student Intrinsic Motivation to Learn questionnaire

  Baseline, time 2, time 3

Study Arms (2)

Arm I (high intensity e-Health program)

EXPERIMENTAL

Patients and parents receive the 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.

Other: Best Practice; Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (usual care)

ACTIVE COMPARATOR

Patients and parents receive usual care.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual care

Arm I (high intensity e-Health program); Arm II (usual care)

Internet-Based Intervention OTHER

Undergo eHealth intervention

Arm I (high intensity e-Health program)

Quality-of-Life Assessment OTHER

Ancillary studies

Arm I (high intensity e-Health program); Arm II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (high intensity e-Health program); Arm II (usual care)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant and/or legally authorized representative
• Assent, when appropriate, will be obtained per institutional guidelines
• Primary participating parent/caregiver is English- or Spanish-speaking (any race/ethnicity)
• Child is aged 6-12 years (yr.) (for the website usability pre-study, child is age 8 - 12 yrs.)
• Child understands English (but can be bilingual)
• Child treated for acute leukemia (e.g., acute lymphoblastic leukemia, acute myelogenous leukemia) or lymphoblastic lymphoma
• Child is in cancer remission and has completed cancer therapies, including maintenance treatment
• Primary participating parent/caregiver has daily contact with the child
• Child is enrolled in school

You may not qualify if:

• Recent or current participation in a behavioral intervention study with a similar focus
• History of major psychiatric condition (e.g., psychosis) in parent or child
• Severe neurodevelopmental disorder in the child (e.g., down syndrome, intellectual disability)
• Child has previously used the IXL online learning program extensively and unwilling to regularly use it again
• Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Childrens Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

University of Calif San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sunita K Patel

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Neuropsychologists blinded to arm assignment
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 22, 2022
• Study Start: February 16, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

US (4)