Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R03CA130731 | U.S. NIH Grant/Contract | View source | |
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-07250 |
Not provided
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
Not provided
Not provided
RATIONALE: An educational and skills training program for the parent of a childhood cancer survivor with neurobehavioral dysfunction may help improve the child's school performance, thinking ability, and behavior.
PURPOSE: This randomized clinical trial is studying an educational and skills training program for parents of childhood cancer survivors who have neurobehavioral dysfunction.
OBJECTIVES:
OUTLINE: Parent and child participants are randomized to 1 of 2 intervention arms.
Phone support/assistance is provided by the therapist within 2-3 days following each training session to provide additional problem-solving assistance and teaching support to the parents while they are implementing the knowledge and strategies learned during the training sessions and to measure study adherence and behavioral implementation between the sessions. After completion of the training sessions, continued phone support/assistance is provided by the therapist every 2 weeks for up to 6 months to provide ongoing support and problem-solving and teaching assistance as needed and to promote ongoing maintenance of the trained parenting practices with a greater degree of independence. "Booster" in-person sessions may also occur if determined to be needed by both the therapist and parent.
Parent and child participants in both arms complete battery testing and questionnaires at baseline, 3 months, and 6 months. Battery testing includes the Wechsler Individual Achievement Test (WIAT-II) and the WISC-IV Working Memory Index and Children's Memory Scale (CMS) subtests. Questionnaires include parent, teacher, and child [self-report] questionnaires (BASC-II, BRIEF, and SMALSI); Parent Behaviors Questionnaire-Revised; Parent Knowledge and Efficacy Questionnaire; and Parent's Treatment Barriers and Satisfaction Questionnaire.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (parent intervention program and usual care) | Experimental | Child participants and their families may access multidisciplinary psychosocial services (i.e., usual care). Parents also receive 8 weekly face-to-face training sessions (75-90 minutes each) with a therapist over approximately 2-3 months. Phone support/assistance is provided by the therapist within 2-3 days following each training session and then every 2 weeks for up to 6 months after completion of the training sessions. |
|
| Arm II (wait-list/usual care control [UCC]) | Active Comparator | Child participants and their families undergo usual care as in arm I and are placed on a wait-list. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Parents receive face-to-face training sessions with a therapist over approximately 2-3 months. Phone support/assistance is provided by the therapist within 2-3 days following each training session and then every 2 weeks for up to 6 months after completion of the training sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| WIAT-II-Reading, Mathematics, and Writing composite scores as measured at baseline and 6 months (child participant) | ||
| Knowledge, efficacy, and self-report of pro-learning behaviors as measured by the PKEQ and PBQ-R at baseline, 3 months, and 6 months (parent participant) |
| Measure | Description | Time Frame |
|---|---|---|
| Parent, teacher, and self-report measures as measured by the BRIEF, BASC-II, and SMALSI at baseline, 3 months, and 6 months (child participant) | ||
| Performance on attention and memory tests as measured by the CMS and WISC-IV subtests at baseline and 6 months (child participant) |
Not provided
DISEASE CHARACTERISTICS:
Childhood cancer survivor who received CNS-directed therapy (i.e., intrathecal chemotherapy and/or cranial radiotherapy) for leukemia or non-Hodgkin lymphoma
Enrolled in school and demonstrates a deficit (operationalized as at least one standard deviation below the age expected mean) on at least one objective test of attention or memory on baseline cognitive assessment screening AND has evidence of problems in learning and adaptive functioning
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sunita Patel, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| psychosocial assessment and care | Procedure | Child participants and their families may access multidisciplinary psychosocial services (i.e., usual care). |
|
| Parenting stress as measured by the PSI at baseline, 3 months, and 6 months (parent participant) |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D002051 | Burkitt Lymphoma |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| 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 |
| D007945 | Leukemia, Lymphoid |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
Not provided
Not provided