Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00971 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 17139 | Other Identifier | City of Hope Medical Center | |
| RSG-17-023-01-CPPB | Other Grant/Funding Number | ACS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
This randomized clinical trial studies how well a high-intensity intervention parenting program works in improving learning and school functioning in Latino children with acute leukemia or lymphoblastic lymphoma. A high-intensity intervention program may help doctors to see whether training parents or caregivers in specific parenting skills and "pro-learning" behaviors will result in better learning and school outcomes for Latino children with acute leukemia or lymphoblastic lymphoma. It is not yet known if a high-intensity intervention program is more beneficial than a standard of care lower intensity parenting intervention.
PRIMARY OBJECTIVES:
I. Determine the effectiveness of an enhanced parenting intervention, high-intensity intervention program (HIP), on pediatric cancer survivors' learning and school health-related quality of life (HRQOL) outcomes up to 12 months post enrollment.
II. Determine the effectiveness of HIP on the "pro-learning" efficacy of parents of pediatric cancer survivors up to 12 months post enrollment.
III. Examine the extent to which the parent's increases in personal efficacy and use of "pro-learning" behaviors correlate with the child's school HRQOL and academic performance.
IV. Obtain preliminary data on the relationships between family stress and the Val66Met polymorphism of brain-derived neurotrophic factor (BDNF) with neurocognitive and health-related quality of life (HRQOL) outcomes in Latino children treated with CNS-directed therapies for cancer.
V. Conduct preliminary analysis on the interaction between family stress and the BDNF Met polymorphism when predicting cognitive and HRQOL outcomes in Latino children treated for cancer.
EXPLORATORY OBJECTIVES:
I. Explore the associations between neurocognitive performance and polymorphisms in candidate genes previously reported to explain cognitive variability in childhood cancer survivors (e.g., the catechol-O-methyltransferase Val158Met polymorphism and the nitric oxide synthase [NOS3] 894T allele) or involved in the stress response (e.g., the Serotonin transporter rs25531 and the Glucocorticoid receptor rs6190).
OUTLINE: Parents or caregivers are randomized to 1 of 2 arms.
ARM I: Parents or caregivers attend standard of care lower intensity intervention program (LIP) consisting of a meeting to review results of a neurocognitive evaluation and to discuss recommendations for optimal learning and school performance for 1 session.
ARM II: Parents or caregivers attend HIP consisting of individual parental skill training sessions with a bilingual therapist over 60-90 minutes every 2 weeks for a total of 8 sessions.
After study enrollment, patients are followed up for 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard of care LIP) | Active Comparator | Parents or caregivers attend standard of care LIP consisting of a meeting to review results of a neurocognitive evaluation and to discuss recommendations for optimal learning and school performance for 1 session. |
|
| Arm II (HIP) | Experimental | Parents or caregivers attend HIP consisting of individual parental skill training sessions with a bilingual therapist over 60-90 minutes every 2 weeks for a total of 8 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Attend standard of care LIP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in child's health-related quality of life school functioning | Measured by the parent-reported Pediatric Quality of Life Inventory school domain. | Baseline up to 12 months |
| Change in parental efficacy | Measured by the Efficacy scale from the Parent Knowledge, Beliefs and Behaviors Questionnaire-3rd Revision (PBQ-R3). | Baseline up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective academic performance (Child) | Measured by WIAT: reading and math scores and classroom grades from school report cards. | Up to 12 months |
| Attention performance (Child) | Measured by the Conners Parent Report Attention subscale. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sunita Patel | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| Children's Hospital Los Angeles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Educational Intervention | Other | Attend HIP |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Up to 12 months |
| Frequency of pro-learning behaviors (Parent) | Measured by PBQ-R3 Behaviors Scale. | Up to 12 months |
| Frequency of pro-learning behaviors (Parent) | Measured by the Parents' weekly time spent with child in pro-learning behaviors and activities. | Up to 12 months |
| Knowledge of pro-learning parenting (Parent) | Measured by PBQ-R3 Knowledge scale. | Up to 12 months |
| Children's scores on other neurocognitive tests as assessed by learning, memory, and processing speed | Up to 12 months |
| Parental reports of their children's HRQOL as measured by the PedsQL parent proxy questionnaire | Up to 12 months |
| Los Angeles |
| California |
| 90027 |
| United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
Not provided
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
Not provided
Not provided