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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; Acute Leukemia
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Best Practice; Other: Internet-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 342
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center
    • Los Angeles, California, United States, 90027
      • Childrens Hospital of Los Angeles
    • San Diego, California, United States, 92123
      • Rady Children's Hospital San Diego
    • San Francisco, California, United States, 94115
      • University of Calif San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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, 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (high intensity e-Health program); 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: Quality-of-Life Assessment; Ancillary studies; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care; Other: Internet-Based Intervention; Undergo eHealth intervention
Active Comparator: Arm II (usual care); Patients and parents receive usual care.	Other: Quality-of-Life Assessment; Ancillary studies; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective academic performance (Child)	Assessed by WIAT reading and math scores, grades from school report cards, IXL diagnostic scores in math and English language arts (high intensity program e-health group only). The GEE will also be used to compare the effects of high intensity program e-Health intervention and low intensity program on this outcome. Non-normally distributed measurements will be transformed to achieve normality. If this is not possible, they will be dichotomized, and GEE for binary outcomes will be used for analysis. Potential modification of the treatment effect by covariates (e.g., child's age, parent's language, sex/gender, race/ethnicity, time since diagnosis) will be explored by including the two-way interaction of treatment by covariate. Will also perform subgroup analysis by estimating the within-subgroup intervention effects and constructing the 95% confidence intervals in groups defined by the covariates, e.g. sex/gender (men, women) and language (English, Spanish).	Up to 5 years
Attention performance (Child)	Assessed with Conners Parent Report Attention and Hyperactivity subscales. The GEE will also be used to compare the effects of high intensity program e-Health intervention and low intensity program on this outcome. Non-normally distributed measurements will be transformed to achieve normality. If this is not possible, they will be dichotomized, and GEE for binary outcomes will be used for analysis. Potential modification of the treatment effect by covariates (e.g., child's age, parent's language, sex/gender, race/ethnicity, time since diagnosis) will be explored by including the two-way interaction of treatment by covariate. Will also perform subgroup analysis by estimating the within-subgroup intervention effects and constructing the 95% confidence intervals in groups defined by the covariates, e.g. sex/gender (men, women) and language (English, Spanish).	Up to 5 years
Parent-reported functioning of child (Child)	Assessed by Pediatric Quality of Life Inventory Psychosocial Functioning: School, Emotional, Social domains. The GEE will also be used to compare the effects of high intensity program e-Health intervention and low intensity program on this outcome. Non-normally distributed measurements will be transformed to achieve normality. If this is not possible, they will be dichotomized, and GEE for binary outcomes will be used for analysis. Potential modification of the treatment effect by covariates (e.g., child's age, parent's language, sex/gender, race/ethnicity, time since diagnosis) will be explored by including the two-way interaction of treatment by covariate. Will also perform subgroup analysis by estimating the within-subgroup intervention effects and constructing the 95% confidence intervals in groups defined by the covariates, e.g. sex/gender (men, women) and language (English, Spanish).	Up to 5 years
Use of learning strategies (Child)	Assessed with School Motivation and Learning Strategies Inventory study strategies subscale, student self-regulatory strategy use scale. The GEE will also be used to compare the effects of high intensity program e-Health intervention and low intensity program on this outcome. Non-normally distributed measurements will be transformed to achieve normality. If this is not possible, they will be dichotomized, and GEE for binary outcomes will be used for analysis. Potential modification of the treatment effect by covariates (e.g., child's age, parent's language, sex/gender, race/ethnicity, time since diagnosis) will be explored by including the two-way interaction of treatment by covariate. Will also perform subgroup analysis by estimating the within-subgroup intervention effects and constructing the 95% confidence intervals in groups defined by the covariates, e.g. sex/gender (men, women) and language (English, Spanish).	Up to 5 years
Mean of item scores from the Student Intrinsic Motivation to Learn questionnaire	Student Intrinsic Motivation to Learn Questionnaire measuring motivation for academic learning	Baseline, time 2, time 3
Mean of item scores from the Student Academic Self-efficacy questionnaire	.Student Academic Self-efficacy measures self-confidence	Baseline, time 2, time 3
Knowledge of pro-learning parenting (Parents)	Assessed with Parent Beliefs and Behaviors Questionnaire (PBQ-R3) knowledge scale. GEE models using one indicator variable of time will be used to examine the efficacy of the high intensity program eHealth intervention compared to low intensity program on these scores, adjusting for baseline measurements and study site, and accounting for within-site and within-individual correlations. Other parent-related covariates that are imbalanced at baseline will be included in the model. The efficacy of the intervention will be assessed by testing the significance of the interaction of treatment-by-time indicator.	Up to 5 years
Frequency of pro-learning behaviors (Parents)	Assessed with PBQ-R3 parenting behaviors scale, and weekly time spent with the child in pro-learning behaviors and activities. GEE models using one indicator variable of time will be used to examine the efficacy of the high intensity program eHealth intervention compared to low intensity program on these scores, adjusting for baseline measurements and study site, and accounting for within-site and within-individual correlations. Other parent-related covariates that are imbalanced at baseline will be included in the model. The efficacy of the intervention will be assessed by testing the significance of the interaction of treatment-by-time indicator.	Up to 5 years
Parenting pro-learning efficacy (Parents)	Assessed with PBQ-R3 efficacy scale. GEE models using one indicator variable of time will be used to examine the efficacy of the high intensity program eHealth intervention compared to low intensity program on these scores, adjusting for baseline measurements and study site, and accounting for within-site and within-individual correlations. Other parent-related covariates that are imbalanced at baseline will be included in the model. The efficacy of the intervention will be assessed by testing the significance of the interaction of treatment-by-time indicator.	At baseline, 6 months, 1 year

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sunita K Patel, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Myeloid; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Guidelines as Topic; Quality Assurance, Health Care; Practice Guidelines as Topic
• Other Study ID Numbers: 22057 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2022-04695 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No