Acute Myeloid Leukemia Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)
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)

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

342

Study ID:

NCT05428176

Recruitment Status:

Recruiting

Sponsor:

City of Hope Medical Center

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There is 1 Location for this study

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City of Hope Medical Center
Duarte California, 91010, United States More Info
Sunita K. Patel
Contact
626-218-6062
[email protected]
Sunita K. Patel
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

342

Study ID:

NCT05428176

Recruitment Status:

Recruiting

Sponsor:


City of Hope Medical Center

How clear is this clinincal trial information?

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