Acute LeukemiaNCT05428176
A High Intensity Electronic Health Intervention for the Reduction of Learning Disparities in Childhood Cancer Survivors
A study testing Best Practice, Internet-Based Intervention and Quality-of-Life Assessment in people with Acute Leukemia and Acute Lymphoblastic Leukemia, run by City of Hope Medical Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
- What is being tested?
- Best Practice, Internet-Based Intervention and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Sep 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
City of Hope Medical Center
Duarte, California, 91010
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
Rady Children's Hospital San Diego
San Diego, California, 92123
University of Calif San Francisco
San Francisco, California, 94115
About this study
Official title: Leveraging Digital Health Solutions to Reduce Learning and Functional Disparities in Children With Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoblastic Lymphoma
- Being tested
- Best Practice, Internet-Based Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Receive usual care
Internet-Based InterventionOther
Undergo eHealth intervention
Quality-of-Life AssessmentOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (high intensity e-Health program) | Experimental | 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. Receives: Other: Best Practice; Other: Internet-Based Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (usual care) | Active comparator | Patients and parents receive usual care. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's improvement in academic functioning
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.
Measured: At baseline and 1 year
Secondary outcomes (9)
Objective academic performance (Child)
Assessed by WIAT reading and math scores, grades from school report cards, IXL diagnostic scores in math and English language arts (high intensity program e-health group only). The GEE will also be used to compare the effects of high intensity program e-Health intervention and low intensity program on this outcome. Non-normally distributed measurements will be transformed to achieve normality. If this is not possible, they will be dichotomized, and GEE for binary outcomes will be used for analysis. Potential modification of the treatment effect by covariates (e.g., child's age, parent's language, sex/gender, race/ethnicity, time since diagnosis) will be explored by including the two-way interaction of treatment by covariate. Will also perform subgroup analysis by estimating the within-subgroup intervention effects and constructing the 95% confidence intervals in groups defined by the covariates, e.g. sex/gender (men, women) and language (English, Spanish).
Measured: Up to 5 years
Attention performance (Child)
Assessed with Conners Parent Report Attention and Hyperactivity subscales. The GEE will also be used to compare the effects of high intensity program e-Health intervention and low intensity program on this outcome. Non-normally distributed measurements will be transformed to achieve normality. If this is not possible, they will be dichotomized, and GEE for binary outcomes will be used for analysis. Potential modification of the treatment effect by covariates (e.g., child's age, parent's language, sex/gender, race/ethnicity, time since diagnosis) will be explored by including the two-way interaction of treatment by covariate. Will also perform subgroup analysis by estimating the within-subgroup intervention effects and constructing the 95% confidence intervals in groups defined by the covariates, e.g. sex/gender (men, women) and language (English, Spanish).
Measured: Up to 5 years
Parent-reported functioning of child (Child)
Assessed by Pediatric Quality of Life Inventory Psychosocial Functioning: School, Emotional, Social domains. The GEE will also be used to compare the effects of high intensity program e-Health intervention and low intensity program on this outcome. Non-normally distributed measurements will be transformed to achieve normality. If this is not possible, they will be dichotomized, and GEE for binary outcomes will be used for analysis. Potential modification of the treatment effect by covariates (e.g., child's age, parent's language, sex/gender, race/ethnicity, time since diagnosis) will be explored by including the two-way interaction of treatment by covariate. Will also perform subgroup analysis by estimating the within-subgroup intervention effects and constructing the 95% confidence intervals in groups defined by the covariates, e.g. sex/gender (men, women) and language (English, Spanish).
Measured: Up to 5 years
Use of learning strategies (Child)
Assessed with School Motivation and Learning Strategies Inventory study strategies subscale, student self-regulatory strategy use scale. The GEE will also be used to compare the effects of high intensity program e-Health intervention and low intensity program on this outcome. Non-normally distributed measurements will be transformed to achieve normality. If this is not possible, they will be dichotomized, and GEE for binary outcomes will be used for analysis. Potential modification of the treatment effect by covariates (e.g., child's age, parent's language, sex/gender, race/ethnicity, time since diagnosis) will be explored by including the two-way interaction of treatment by covariate. Will also perform subgroup analysis by estimating the within-subgroup intervention effects and constructing the 95% confidence intervals in groups defined by the covariates, e.g. sex/gender (men, women) and language (English, Spanish).
Measured: Up to 5 years
Mean of item scores from the Student Intrinsic Motivation to Learn questionnaire
Student Intrinsic Motivation to Learn Questionnaire measuring motivation for academic learning
Measured: Baseline, time 2, time 3
Mean of item scores from the Student Academic Self-efficacy questionnaire
.Student Academic Self-efficacy measures self-confidence
Measured: Baseline, time 2, time 3
Knowledge of pro-learning parenting (Parents)
Assessed with Parent Beliefs and Behaviors Questionnaire (PBQ-R3) knowledge scale. GEE models using one indicator variable of time will be used to examine the efficacy of the high intensity program eHealth intervention compared to low intensity program on these scores, adjusting for baseline measurements and study site, and accounting for within-site and within-individual correlations. Other parent-related covariates that are imbalanced at baseline will be included in the model. The efficacy of the intervention will be assessed by testing the significance of the interaction of treatment-by-time indicator.
Measured: Up to 5 years
Frequency of pro-learning behaviors (Parents)
Assessed with PBQ-R3 parenting behaviors scale, and weekly time spent with the child in pro-learning behaviors and activities. GEE models using one indicator variable of time will be used to examine the efficacy of the high intensity program eHealth intervention compared to low intensity program on these scores, adjusting for baseline measurements and study site, and accounting for within-site and within-individual correlations. Other parent-related covariates that are imbalanced at baseline will be included in the model. The efficacy of the intervention will be assessed by testing the significance of the interaction of treatment-by-time indicator.
Measured: Up to 5 years
Parenting pro-learning efficacy (Parents)
Assessed with PBQ-R3 efficacy scale. GEE models using one indicator variable of time will be used to examine the efficacy of the high intensity program eHealth intervention compared to low intensity program on these scores, adjusting for baseline measurements and study site, and accounting for within-site and within-individual correlations. Other parent-related covariates that are imbalanced at baseline will be included in the model. The efficacy of the intervention will be assessed by testing the significance of the interaction of treatment-by-time indicator.
Measured: At baseline, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start10 Sep 2022
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sunita K Patel, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428176
- Sponsor's protocol ID
- 22057
- Other IDs
- NCI-2022-04695, 22057, P30CA033572
- Status last verified
- Aug 2026
- First submitted
- 10 Jun 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Digital Health Solutions to Reduce Learning and Functional Disparities in Children With Cancer
- ClinicalTrials.gov ID
- NCT05428176
- Acronym / sponsor ID
- 22057
- Conditions
- Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoblastic Lymphoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 332 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (high intensity e-Health program) | Experimental | Other: Best Practice, Other: Internet-Based Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
| Arm II (usual care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients and parents receive usual care. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Documented informed consent of the participant and/or legally authorized representative
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeReceive usual care | Other | Arm I (high intensity e-Health program), Arm II (usual care) |
| Internet-Based InterventionUndergo eHealth intervention | Other | Arm I (high intensity e-Health program) |
| Quality-of-Life AssessmentAncillary studies | Other | Arm I (high intensity e-Health program), Arm II (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (high intensity e-Health program), Arm II (usual care) |
Primary outcome
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.
9 secondary outcomes
Objective academic performance (Child)
Time frame: Up to 5 years
Attention performance (Child)
Time frame: Up to 5 years
Parent-reported functioning of child (Child)
Time frame: Up to 5 years
Use of learning strategies (Child)
Time frame: Up to 5 years
Mean of item scores from the Student Intrinsic Motivation to Learn questionnaire
Time frame: Baseline, time 2, time 3
Mean of item scores from the Student Academic Self-efficacy questionnaire
Time frame: Baseline, time 2, time 3
Knowledge of pro-learning parenting (Parents)
Time frame: Up to 5 years
Frequency of pro-learning behaviors (Parents)
Time frame: Up to 5 years
Parenting pro-learning efficacy (Parents)
Time frame: At baseline, 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunita K Patel principal investigator
City of Hope Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Internet-Based Intervention and Quality-of-Life Assessment in people with Acute Leukemia and Acute Lymphoblastic Leukemia, run by City of Hope Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's improvement in academic functioning (time frame: At baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.