City of Hope Medical Center
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.
Acute Leukemia
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Lymphoblastic Lymphoma
Best Practice
Internet-Based Intervention
Quality-of-Life Assessment
Questionnaire Administration
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 332 participants |
| Masking : | SINGLE |
| Masking Description : | Neuropsychologists blinded to arm assignment |
| Primary Purpose : | SUPPORTIVE_CARE |
| Official Title : | Leveraging Digital Health Solutions to Reduce Learning and Functional Disparities in Children With Cancer |
| Actual Study Start Date : | 2023-02-16 |
| Estimated Primary Completion Date : | 2027-06-30 |
| Estimated Study Completion Date : | 2027-06-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 6 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
City of Hope Medical Center
Duarte, California, United States, 91010
RECRUITING
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
RECRUITING
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
RECRUITING
University of Calif San Francisco
San Francisco, California, United States, 94115