Leveraging Digital Health Solutions to Reduce Learning and Functional Disparities in Children With Cancer
Overview
- Phase
- N/A
- Intervention
- Best Practice
- Conditions
- Acute Leukemia
- Sponsor
- City of Hope Medical Center
- Enrollment
- 342
- Locations
- 8
- Primary Endpoint
- Child's improvement in academic functioning
- Status
- Active, Not Recruiting
- Last Updated
- 17 days ago
Overview
Brief 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.
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.
Investigators
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, 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)
Arms & Interventions
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.
Intervention: Best Practice
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.
Intervention: Internet-Based Intervention
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.
Intervention: Quality-of-Life Assessment
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.
Intervention: Questionnaire Administration
Arm II (usual care)
Patients and parents receive usual care.
Intervention: Best Practice
Arm II (usual care)
Patients and parents receive usual care.
Intervention: Quality-of-Life Assessment
Arm II (usual care)
Patients and parents receive usual care.
Intervention: Questionnaire Administration
Outcomes
Primary Outcomes
Child's improvement in academic functioning
Time Frame: At baseline and 1 year
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.
Secondary Outcomes
- Parenting pro-learning efficacy (Parents)(At baseline, 6 months, 1 year)
- Objective academic performance (Child)(Up to 5 years)
- Mean of item scores from the Student Intrinsic Motivation to Learn questionnaire(Baseline, time 2, time 3)
- Attention performance (Child)(Up to 5 years)
- Parent-reported functioning of child (Child)(Up to 5 years)
- Knowledge of pro-learning parenting (Parents)(Up to 5 years)
- Frequency of pro-learning behaviors (Parents)(Up to 5 years)
- Use of learning strategies (Child)(Up to 5 years)
- Mean of item scores from the Student Academic Self-efficacy questionnaire(Baseline, time 2, time 3)