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

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

332 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{2 5 10 11 12}

Research Team

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.

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

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 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.

Participant Groups

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+

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.

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

eHealth and mHealth interventions in pediatric cancer: A systematic review of interventions across the cancer continuum. [2020]

2. United States 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Improving symptom control and reducing toxicities for pediatric patients with hematological malignancies. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Weekly Electronic Patient- and Proxy-Reported Outcome Measures in Pediatric Oncology. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Adherence to Oral Medications During Maintenance Therapy Among Children and Adolescents With Acute Lymphoblastic Leukemia: A Medication Refill Analysis. [2021]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Expert panel evaluation of health information technology effects on adverse events. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Identifying Electronic Health Record Usability And Safety Challenges In Pediatric Settings. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Aligning EHR Data for Pediatric Leukemia With Standard Protocol Therapy. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Web-based patient records and treatment guidelines in paediatric oncology. [2007]

12. Canada pubmed.ncbi.nlm.nih.gov

mHealth Supportive Care Intervention for Parents of Children With Acute Lymphoblastic Leukemia: Quasi-Experimental Pre- and Postdesign Study. [2020]