332 Participants Needed

Electronic Health Intervention for Childhood Leukemia

Recruiting at 3 trial locations
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the High Intensity Electronic Health Intervention for childhood leukemia?

Research on eHealth (electronic health) and mHealth (mobile health) interventions in pediatric cancer shows that these technologies can improve communication between patients and healthcare providers, reduce distress, and enhance quality of life. Although specific data on the High Intensity Electronic Health Intervention for childhood leukemia is not available, similar interventions have shown promise in improving care for pediatric cancer patients.12345

Is the Electronic Health Intervention for Childhood Leukemia safe for humans?

The research articles do not provide specific safety data for the Electronic Health Intervention for Childhood Leukemia or similar interventions. They focus on adverse events related to chemotherapy and electronic health record usability, not on the safety of the electronic health intervention itself.26789

How is the High Intensity Electronic Health Intervention treatment for childhood leukemia different from other treatments?

The High Intensity Electronic Health Intervention is unique because it uses electronic health records (EHR) and web-based systems to enhance treatment protocols and patient management, offering remote access and data validation, which is not a standard feature in traditional treatments for childhood leukemia.25101112

Research Team

SK

Sunita K. Patel

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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.
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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)
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
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Timeline

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

Treatment Details

Interventions

  • High Intensity Electronic Health Intervention
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (high intensity e-Health program)Experimental Treatment4 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 Control3 Interventions
Patients and parents receive usual care.

Find a Clinic Near You

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+

Findings from Research

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

References

eHealth and mHealth interventions in pediatric cancer: A systematic review of interventions across the cancer continuum. [2020]
Development and evaluation of a computable phenotype to identify pediatric patients with leukemia and lymphoma treated with chemotherapy using electronic health record data. [2020]
Improving symptom control and reducing toxicities for pediatric patients with hematological malignancies. [2021]
Feasibility of Weekly Electronic Patient- and Proxy-Reported Outcome Measures in Pediatric Oncology. [2023]
Adherence to Oral Medications During Maintenance Therapy Among Children and Adolescents With Acute Lymphoblastic Leukemia: A Medication Refill Analysis. [2021]
Incidence, severity, and preventability of adverse events during the induction of patients with acute lymphoblastic leukemia in a tertiary care pediatric hospital in Mexico. [2022]
Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. [2020]
Expert panel evaluation of health information technology effects on adverse events. [2019]
Identifying Electronic Health Record Usability And Safety Challenges In Pediatric Settings. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Aligning EHR Data for Pediatric Leukemia With Standard Protocol Therapy. [2022]
Web-based patient records and treatment guidelines in paediatric oncology. [2007]
mHealth Supportive Care Intervention for Parents of Children With Acute Lymphoblastic Leukemia: Quasi-Experimental Pre- and Postdesign Study. [2020]