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A High Intensity Electronic Health Intervention for the Reduction of Learning Disparities in Childhood Cancer Survivors

Primary Purpose

Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Best Practice

Internet-Based Intervention

Quality-of-Life Assessment

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Acute Leukemia

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)
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)

Sites / Locations

City of Hope Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (high intensity e-Health program)

Arm II (usual care)

Arm Description

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.

Patients and parents receive usual care.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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).

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).

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).

Mean of item scores from the Student Intrinsic Motivation to Learn questionnaire

Student Intrinsic Motivation to Learn Questionnaire measuring motivation for academic learning

Mean of item scores from the Student Academic Self-efficacy questionnaire

.Student Academic Self-efficacy measures self-confidence

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.

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.

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.

Full Information

NCT ID

NCT05428176

First Posted

June 10, 2022

Last Updated

May 23, 2023

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05428176

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 16, 2023 (Actual)

Primary Completion Date

June 30, 2027 (Anticipated)

Study Completion Date

June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphoblastic Lymphoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Masking Description

Neuropsychologists blinded to arm assignment

Allocation

Randomized

Enrollment

332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I (high intensity e-Health program)

Arm Type

Experimental

Arm Description

Arm Title

Arm II (usual care)

Arm Type

Active Comparator

Arm Description

Patients and parents receive usual care.

Intervention Type

Other

Intervention Name(s)

Best Practice

Intervention Description

Receive usual care

Intervention Type

Other

Intervention Name(s)

Internet-Based Intervention

Intervention Description

Undergo eHealth intervention

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Child's improvement in academic functioning

Description

Time Frame

At baseline and 1 year

Secondary Outcome Measure Information:

Title

Objective academic performance (Child)

Description

Time Frame

Up to 5 years

Title

Attention performance (Child)

Description

Time Frame

Up to 5 years

Title

Parent-reported functioning of child (Child)

Description

Time Frame

Up to 5 years

Title

Use of learning strategies (Child)

Description

Time Frame

Up to 5 years

Title

Mean of item scores from the Student Intrinsic Motivation to Learn questionnaire

Description

Student Intrinsic Motivation to Learn Questionnaire measuring motivation for academic learning

Time Frame

Baseline, time 2, time 3

Title

Mean of item scores from the Student Academic Self-efficacy questionnaire

Description

.Student Academic Self-efficacy measures self-confidence

Time Frame

Baseline, time 2, time 3

Title

Knowledge of pro-learning parenting (Parents)

Description

Time Frame

Up to 5 years

Title

Frequency of pro-learning behaviors (Parents)

Description

Time Frame

Up to 5 years

Title

Parenting pro-learning efficacy (Parents)

Description

Time Frame

At baseline, 6 months, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

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) 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sunita K Patel

Organizational Affiliation

City of Hope Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sunita K. Patel

Phone

626-218-6062

spatel@coh.org

First Name & Middle Initial & Last Name & Degree

Sunita K. Patel

12. IPD Sharing Statement

Learn more about this trial

A High Intensity Electronic Health Intervention for the Reduction of Learning Disparities in Childhood Cancer Survivors

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