Leveraging Digital Health Solutions to Reduce Learning and Functional Disparities in Children With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 332
- 试验地点
- 4
- 主要终点
- Child's improvement in academic functioning
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 支持治疗
- 盲法
- 单盲 (医护人员)
盲法说明
Neuropsychologists blinded to arm assignment
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 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
排除标准
- 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)
研究组 & 干预措施
Arm II (usual care)
Patients and parents receive usual care.
干预措施: Quality-of-Life Assessment (Other)
Arm II (usual care)
Patients and parents receive usual care.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Internet-Based Intervention (Other)
Arm II (usual care)
Patients and parents receive usual care.
干预措施: Best Practice (Other)
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.
干预措施: Questionnaire Administration (Other)
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.
干预措施: Best Practice (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Child's improvement in academic functioning
时间窗: 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.
次要结局
- 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)
研究者
研究点 (4)
标识符
- NCT 编号
- NCT05428176
- 其他研究编号
- 22057, NCI-2022-04695, 22057, P30CA033572
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (9个月后)
- 研究完成日期
- (9个月后)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否