Clinical trial NCT05428176: A High Intensity Electronic Health Intervention for the Reduction of Learning Disparities in Childhood Cancer Survivors
Official title: Leveraging Digital Health Solutions to Reduce Learning and Functional Disparities in Children With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Leukemia
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Lymphoblastic Lymphoma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-06-22
Enrollment: 332
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Child's improvement in academic functioning
timeFrame: At baseline and 1 year
Secondary outcomes:
measure: Objective academic performance (Child)
timeFrame: Up to 5 years
measure: Attention performance (Child)
timeFrame: Up to 5 years
measure: Parent-reported functioning of child (Child)
timeFrame: Up to 5 years
measure: Use of learning strategies (Child)
timeFrame: Up to 5 years
measure: Mean of item scores from the Student Intrinsic Motivation to Learn questionnaire
timeFrame: Baseline, time 2, time 3
measure: Mean of item scores from the Student Academic Self-efficacy questionnaire
timeFrame: Baseline, time 2, time 3
measure: Knowledge of pro-learning parenting (Parents)
timeFrame: Up to 5 years
measure: Frequency of pro-learning behaviors (Parents)
timeFrame: Up to 5 years
measure: Parenting pro-learning efficacy (Parents)
timeFrame: At baseline, 6 months, 1 year
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Los Angeles
country: United States
facility: Childrens Hospital of Los Angeles
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: San Francisco
country: United States
facility: University of Calif San Francisco
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Sunita K Patel
role: PRINCIPAL_INVESTIGATOR
References: