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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00713505 |
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.
Condition | Intervention |
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Cancer Survivor Cognitive/Functional Effects Leukemia Long-term Effects Secondary to Cancer Therapy in Children Lymphoma Psychosocial Effects of Cancer and Its Treatment |
Other: educational intervention Procedure: psychosocial assessment and care |
Study Type: | Interventional |
Study Design: | Randomized, Active Control |
Official Title: | A Behavioral Intervention Trial for Parents of Childhood Cancer Survivors With Neurobehavioral Late Effects |
Estimated Enrollment: | 56 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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. |
Other: educational intervention
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.
Procedure: psychosocial assessment and care
Child participants and their families may access multidisciplinary psychosocial services (i.e., usual care).
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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.
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Procedure: psychosocial assessment and care
Child participants and their families may access multidisciplinary psychosocial services (i.e., usual care).
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OBJECTIVES:
OUTLINE: Parent and child participants are randomized to 1 of 2 intervention arms.
Ages Eligible for Study: | 6 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Sunita Patel, PhD 800 826-4673, ext. 68426 |
Principal Investigator: | Sunita Patel, PhD | Beckman Research Institute |
Study ID Numbers: | CDR0000598114, CHNMC-07250 |
Study First Received: | July 10, 2008 |
Last Updated: | July 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00713505 History of Changes |
Health Authority: | Unspecified |
psychosocial effects of cancer and its treatment long-term effects secondary to cancer therapy in children cancer survivor cognitive/functional effects childhood acute lymphoblastic leukemia childhood acute myeloid leukemia in remission childhood anaplastic large cell lymphoma |
childhood large cell lymphoma childhood lymphoblastic lymphoma childhood small noncleaved cell lymphoma childhood nasal type extranodal NK/T-cell lymphoma childhood grade III lymphomatoid granulomatosis childhood chronic myelogenous leukemia |
Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Small Non-cleaved Cell Lymphoma Leukemia, Myeloid, Acute Lymphoblastic Lymphoma Acute Myeloid Leukemia, Childhood Lymphatic Diseases |
Leukemia Acute Myelocytic Leukemia Lymphoma, T-Cell Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasm Metastasis Lymphoma, Large-Cell, Anaplastic Chronic Myelogenous Leukemia Anaplastic Large Cell Lymphoma Lymphoma, Large-cell Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
Lymphatic Diseases Leukemia Neoplastic Processes Neoplasms Pathologic Processes Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Neoplasm Metastasis Lymphoproliferative Disorders Lymphoma |