Electronic Health Intervention for Childhood Leukemia

Not currently recruiting at 3 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Psychiatric condition, Neurodevelopmental disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new electronic health program designed to help children who have survived leukemia or lymphoblastic lymphoma perform better in school. Cancer treatment often affects the brain, leading to learning challenges for these children. The study aims to determine if providing parents with educational tools through videoconferencing and a special website can improve their child's learning compared to usual care. It is suitable for children aged 6-12 who are in remission, have completed cancer treatment, and are experiencing school difficulties. As an unphased trial, this study offers families a unique opportunity to access innovative educational support tools that could significantly enhance their child's learning experience.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on educational support rather than medical treatment, so you may not need to change your medications.

What prior data suggests that this eHealth intervention is safe for children with cancer?

Research shows that telehealth programs, such as the high-intensity electronic health (eHealth) program under study, are generally safe for children. A review of telehealth treatments for children with cancer found them to be well-tolerated. Most children adjust well to these programs, with no reports of serious side effects.

This trial uses an interactive website and video calls for educational support, making physical harm unlikely. The goal is to help children with cancer improve their school performance. Involving parents adds extra safety and support for the child.

Overall, research suggests this eHealth program is a safe way to assist children with learning challenges related to cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to support children with leukemia and their families through a high intensity electronic health intervention. Unlike standard care, which typically involves in-person visits and treatments, this approach integrates digital tools like an interactive website and videoconferencing to provide ongoing support and education. This method aims to enhance the care experience by offering more accessible, flexible, and personalized interactions, potentially empowering families and improving the overall management of the child's health. Additionally, the use of technology could lead to more consistent follow-ups and engagement, which might improve outcomes over time.

What evidence suggests that this eHealth intervention is effective for reducing learning disparities in children with leukemia?

Research shows that digital health programs can help children with cancer learn better. Studies have found that these programs can boost school performance and improve thinking and learning skills. In this trial, participants in Arm I will receive a high-intensity eHealth intervention, providing parents with tools and advice to support their children's school success through videoconferencing and interactive websites. Early results suggest that involving parents in these methods can enhance children's learning. While data collection on this specific program's effectiveness continues, similar methods have shown positive results in other contexts. ^{1 3 4 6 7}

Who Is on the Research Team?

Sunita K. Patel

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking parents of children aged 6-12 who have been treated for acute leukemia or lymphoblastic lymphoma, are in remission, and enrolled in school. The child should understand English and be able to comply with study procedures. Children with severe neurodevelopmental disorders or extensive prior use of the IXL program, as well as those involved in similar studies, cannot participate.

Inclusion Criteria

Child is enrolled in school

Child understands English (but can be bilingual)

My child is between 6-12 years old.

Exclusion Criteria

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)

Severe neurodevelopmental disorder in the child (e.g., down syndrome)

My child has used IXL before and doesn't want to use it again.

Timeline for a Trial Participant

Pre-study

Parent-child dyads attend 4 intervention sessions over 10 weeks and provide feedback in support of intervention refinement.

10 weeks

4 visits (in-person or virtual)

Treatment

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.

6 months

5 sessions (virtual)

Booster Sessions

Parents attend booster sessions at months 7, 9, and 11.

3 months

3 sessions (virtual)

Follow-up

Participants are monitored for learning and school-related outcomes up to 12 months post-enrollment.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Electronic Health Intervention

Trial Overview The trial tests an eHealth intervention aimed at reducing learning disparities in childhood cancer survivors. It involves providing educational resources and parenting tips through videoconferencing and a website to see if this improves learning outcomes compared to usual care.

How Is the Trial Designed?

Group I: Arm I (high intensity e-Health program) Experimental Treatment 4 Interventions

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.

Group II: Arm II (usual care) Active Control 3 Interventions

Patients and parents receive usual care.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A Web-based system in Brazil has successfully provided health information and services for childhood cancer, managing records for approximately 3,200 patients across 30 hospitals.

Doctors from the Neuroblastoma Cooperative Group positively evaluated the system for its ease of online access and effective data validation, demonstrating its potential for remote pediatric cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based patient records and treatment guidelines in paediatric oncology. Hira, AY., Lopes, TT., de Mello, AN., et al.[2007]

In a study of pediatric patients with acute lymphoblastic leukemia, adherence rates to oral medications were found to be 85% for 6-mercaptopurine and 81% for methotrexate, indicating that many patients are not fully adhering to their treatment.

Adherence was particularly lower among patients aged 12 years and older, suggesting that targeted interventions are needed for this age group to improve medication adherence during maintenance therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Oral Medications During Maintenance Therapy Among Children and Adolescents With Acute Lymphoblastic Leukemia: A Medication Refill Analysis. Wu, YP., Stenehjem, DD., Linder, LA., et al.[2021]

Routine symptom screening in pediatric cancer care can enhance communication between patients and healthcare providers, potentially improving quality of life and even survival rates, as suggested by evidence from adult oncology.

Automating the reporting of adverse events through electronic health records (EHRs) could improve accuracy and reduce the workload for healthcare providers, which is crucial for managing both symptom and nonsymptom toxicities in pediatric cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving symptom control and reducing toxicities for pediatric patients with hematological malignancies. Sung, L., Miller, TP., Phillips, R.[2021]

Out of 9,000 patient safety reports analyzed from 2012 to 2017, 36% identified usability issues related to electronic health records (EHRs) that contributed to medication events, highlighting significant safety concerns in pediatric care.

Among the usability issues, the most frequent problems were related to system feedback and visual display, with improper dosing being the most common medication error, indicating critical areas for improvement in EHR design to enhance safety for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Electronic Health Record Usability And Safety Challenges In Pediatric Settings. Ratwani, RM., Savage, E., Will, A., et al.[2019]

In a study of 181 pediatric patients with acute lymphoblastic leukemia, the incidence of healthcare-associated adverse events was found to be 51.8 per 1000 patient-days, affecting 81.2% of patients during the induction phase, with most events being severe or higher in severity.

Infectious processes were the most common severe adverse events, accounting for 30.5%, and 80.2% of these adverse events led to hospital readmissions, highlighting the need for improved safety measures to reduce preventable and ameliorable adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence, severity, and preventability of adverse events during the induction of patients with acute lymphoblastic leukemia in a tertiary care pediatric hospital in Mexico. Vázquez-Cornejo, E., Morales-Ríos, O., Hernández-Pliego, G., et al.[2022]

A panel of national experts identified six specific adverse events (AEs) that are 'definitely reduced by health information technology (HIT)', including adverse drug events related to digoxin and IV heparin, indicating that HIT can significantly improve patient safety in these areas.

This study highlights the importance of understanding how HIT can impact patient outcomes, which is crucial for justifying federal investments in health technology and guiding future research on its effectiveness in reducing inpatient AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert panel evaluation of health information technology effects on adverse events. Abramson, EL., Kern, LM., Brenner, S., et al.[2019]

The study demonstrated that collecting weekly electronic patient-reported outcome measures (ePROMs) from 70 pediatric cancer patients and their caregivers is feasible, with 69% completing the assessments over 8 weeks.

While distress and cancer-related quality of life improved over time, nearly half of the participants still reported high distress levels by the end of the study, indicating a need for ongoing assessment and timely interventions to address persistent symptoms and improve overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Weekly Electronic Patient- and Proxy-Reported Outcome Measures in Pediatric Oncology. Skrabal Ross, X., Condon, P., Yates, P., et al.[2023]

A computable phenotype algorithm developed using electronic health record (EHR) data accurately identifies pediatric patients with leukemia and lymphoma who received chemotherapy, achieving 100% sensitivity and 99% specificity during evaluation.

The algorithm demonstrated consistent performance across multiple institutions, indicating it is a reliable tool for cohort identification in clinical studies involving pediatric hematologic malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a computable phenotype to identify pediatric patients with leukemia and lymphoma treated with chemotherapy using electronic health record data. Phillips, CA., Razzaghi, H., Aglio, T., et al.[2020]

The mHealth supportive care intervention significantly reduced anxiety and uncertainty in illness among parents of children with acute lymphoblastic leukemia (ALL), with notable improvements in social function and knowledge about ALL and caregiving.

In a study involving 101 parents, those using the mHealth intervention reported greater satisfaction and a decreased need for additional knowledge compared to those receiving standard health education alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Supportive Care Intervention for Parents of Children With Acute Lymphoblastic Leukemia: Quasi-Experimental Pre- and Postdesign Study. Wang, J., Howell, D., Shen, N., et al.[2020]

A study of 7,728 children with acute lymphoblastic leukemia (ALL) using electronic health records revealed that while most health systems generally align with the Children's Oncology Group (COG) recommended milestones for lumbar punctures, none had complete data for all procedures across all patients.

The research highlights the importance of using large-scale aggregate EHR data to evaluate real-world adherence to clinical guidelines, which can help improve treatment protocols for pediatric ALL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aligning EHR Data for Pediatric Leukemia With Standard Protocol Therapy. Wood, NM., Davis, S., Lewing, K., et al.[2022]

A systematic review of 21 studies involving 1506 participants found that eHealth and mHealth interventions are feasible and acceptable for youth undergoing cancer treatment and survivors, indicating a positive reception among this population.

While there is mixed evidence regarding the efficacy of these digital interventions in improving emotional distress, health behaviors, and neurocognitive functioning, they hold potential for enhancing mental and physical health outcomes in young cancer patients and survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eHealth and mHealth interventions in pediatric cancer: A systematic review of interventions across the cancer continuum. Ramsey, WA., Heidelberg, RE., Gilbert, AM., et al.[2020]

Adverse event (AE) reporting in pediatric acute myeloid leukemia trials often underestimates the actual rates, with sensitivity for many AEs being less than 50%, indicating a need for improved reporting methods.

Using external electronic data sources, like Pediatric Health Information System (PHIS) billing and microbiology data, significantly enhances the accuracy of AE detection, particularly for specific toxicities such as viridans group streptococcal bacteremia, which showed high sensitivity and positive predictive value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. Miller, TP., Li, Y., Kavcic, M., et al.[2020]

Citations

1. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05428176

High Intensity Electronic Health Intervention for the ... This clinical trial evaluates a high intensity electronic health (eHealth) intervention program for reducing learning disparities in children with cancer.

2. withpower.com withpower.com/trial/electronic-health-intervention-for-childhood-leukemia-f629b

Electronic Health Intervention for Childhood Leukemia This clinical trial evaluates a high intensity electronic health (eHealth) intervention program for reducing learning disparities in children with cancer.

3. ancora.ai ancora.ai/en/details/NCT05428176

A High Intensity Electronic Health Intervention for the ... This clinical trial evaluates a high intensity electronic health (eHealth) intervention program for reducing learning disparities in children with cancer.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03178617

NCT03178617 | High-Intensity Parent Intervention Program ... This randomized clinical trial studies how well a high-intensity intervention parenting program works in improving learning and school functioning in Latino ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10276316/

The Electronic Surviving Cancer Competently Intervention ... eSCCIP is an innovative digital health intervention for parents and caregivers of children with cancer, delivered through a combination of self-guided web- ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/347800

A High Intensity Electronic Health Intervention for the Reduction ... This clinical trial evaluates a high intensity electronic health (eHealth) intervention program for reducing learning disparities in children with cancer.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11040188/

A Systematic Review of Telehealth-Based Pediatric Cancer ... This systematic review aimed to examine telehealth-based rehabilitation interventions aimed at preventing, maintaining, or improving disability in pediatric ...