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High-Intensity Parent Intervention Program in Improving Learning and School Functioning in Latino Children With Acute Leukemia or Lymphoblastic Lymphoma

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ClinicalTrials.gov Identifier: NCT03178617
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Caregiver Childhood Acute Lymphoblastic Leukemia Childhood Acute Myeloid Leukemia Childhood Lymphoblastic Lymphoma Acute Leukemia Parent Other: Educational Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:

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.

SECONDARY 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Learning and School Functioning in Latino Children With Cancer
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Active Comparator: Arm I (standard of care LIP)
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.
Other: Educational Intervention
Attend standard of care LIP
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (HIP)
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.
Other: Educational Intervention
Attend HIP
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in child's health-related quality of life school functioning [ Time Frame: Baseline up to 12 months ]
    Measured by the parent-reported Pediatric Quality of Life Inventory school domain.

  2. Change in parental efficacy [ Time Frame: Baseline up to 12 months ]
    Measured by the Efficacy scale from the Parent Knowledge, Beliefs and Behaviors Questionnaire-3rd Revision (PBQ-R3).

  3. Children's neurocognitive functioning as measured by performance scores on Conner's Computerized Test [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Objective academic performance (Child) [ Time Frame: Up to 12 months ]
    Measured by WIAT: reading and math scores and classroom grades from school report cards.

  2. Attention performance (Child) [ Time Frame: Up to 12 months ]
    Measured by the Conners Parent Report Attention subscale.

  3. Frequency of pro-learning behaviors (Parent) [ Time Frame: Up to 12 months ]
    Measured by PBQ-R3 Behaviors Scale.

  4. Frequency of pro-learning behaviors (Parent) [ Time Frame: Up to 12 months ]
    Measured by the Parents' weekly time spent with child in pro-learning behaviors and activities.

  5. Knowledge of pro-learning parenting (Parent) [ Time Frame: Up to 12 months ]
    Measured by PBQ-R3 Knowledge scale.

  6. Children's scores on other neurocognitive tests as assessed by learning, memory, and processing speed [ Time Frame: Up to 12 months ]
  7. Parental reports of their children's HRQOL as measured by the PedsQL parent proxy questionnaire [ Time Frame: Up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • PARENT/CAREGIVER: Adult primary caregiver of children treated for leukemia or lymphoblastic lymphoma (LL) and daily contact with the child
  • PARENT/CAREGIVER: One or both parents self-identify as Hispanic/Latino and the primary participating parent/caregiver is monolingual or bilingual Spanish speaking
  • CHILD: Children treated for acute leukemia (e.g. acute lymphoblastic leukemia [ALL], acute myeloid leukemia [AML]), LL, or other types of leukemia (if treated intensively) aged 5-12 years and their parents/caregivers
  • CHILD: Child has completed cancer treatment and is up to 10 years post-treatment
  • CHILD: Child understands English and is enrolled in school (but can be bilingual)

Exclusion Criteria:

  • History of major psychiatric condition (e.g. psychosis) in parent or child; severe neurodevelopmental disorder in child (e.g. Down's syndrome)
  • Recent or current participation in educational/behavioral intervention study with similar focus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178617


Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Sunita K. Patel    626-218-6062    spatel@coh.org   
Principal Investigator: Sunita K. Patel         
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Kathleen Ingman, PhD    323-361-4179    KIngman@chla.usc.edu   
Principal Investigator: Kathleen Ingman, PhD         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Van T. Huynh    714-509-8481    vahuynh@choc.org   
Contact: Heather Huszti    714-509-8481    HHuszti@choc.org   
Principal Investigator: Van T. Huynh         
Principal Investigator: Heather Huszti         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sunita Patel City of Hope Medical Center

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03178617     History of Changes
Other Study ID Numbers: 17139
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 )
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid