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A Behavioral Intervention Trial for Parents of Childhood Cancer Survivors With Neurobehavioral Late Effects

6 Years
16 Years
Not Enrolling
Cancer Survivor, Cognitive/Functional Effects, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children, Lymphoma, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

A Behavioral Intervention Trial for Parents of Childhood Cancer Survivors With Neurobehavioral Late Effects


- To determine the feasibility of implementing an educational and skills training
intervention for parents of a childhood cancer survivor with neurobehavioral
dysfunction using face-to-face training sessions and phone assistance.

- To pilot test and collect preliminarily data on the indirect therapeutic impact of the
parent training intervention on the child's academic, cognitive, and behavioral

- To pilot test and collect preliminary outcomes of the parent training intervention on
parents of a childhood cancer survivor with neurobehavioral dysfunction.

OUTLINE: Parent and child participants are randomized to 1 of 2 intervention arms.

- Arm I (parent intervention program and usual care): In addition to medical care, 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. The training sessions
include integration and didactic review of a parent's role as a behavioral and
emotional support system for the child's school success; a parent's role as a monitor
and motivator for school performance; a parent's role as an intervener and teacher of
effective learning and study strategies; and a parent's role as a child advocate and
accessor of educational and community resources. Parents are instructed to engage in ≥
30 minutes of cognitive and academic activities with their child ≥ 4 days a week. The
therapist will observe the parent (in the home or clinic) apply knowledge and
techniques learned in the parent training sessions directly with the child at least
once after the 4th parent-therapist session to provide feedback to the parent and child
and to assess which parents may require more intense training and support. The sessions
may be videotaped by the parent and provided to the therapist for review and follow up.

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.

- Arm II (wait-list/usual care control [UCC]): Child participants and their families
undergo usual care as in arm I and are placed on a wait-list.

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

Inclusion Criteria


- Childhood cancer survivor who received CNS-directed therapy (i.e., intrathecal
chemotherapy and/or cranial radiotherapy) for leukemia or non-Hodgkin lymphoma

- In remission AND completed treatment ≥ 3 months ago

- No brain tumors

- 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

- Parent, teacher, or self-report of problems as measured by a T-score of ≥ 60 on
the BRIEF or BASC or below average academic achievement scores

- Able to be tested in English using standardized cognitive and academic
achievement tools


- Primary participating parent or caregiver fluent in English and lives with the child

- No known history of a major psychiatric condition (i.e., psychosis) that precludes
study participation (child or participating parent or caregiver)

- No history of child developmental disability prior to cancer diagnosis


- See Disease Characteristics

Type of Study:


Study Design:

Allocation: Randomized

Outcome Measure:

WIAT-II-Reading, Mathematics, and Writing composite scores as measured at baseline and 6 months (child participant)

Safety Issue:


Principal Investigator

Sunita Patel, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

March 2010

Related Keywords:

  • Cancer Survivor
  • Cognitive/Functional Effects
  • Leukemia
  • Long-term Effects Secondary to Cancer Therapy in Children
  • Lymphoma
  • Psychosocial Effects of Cancer and Its Treatment
  • 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
  • Leukemia
  • Lymphoma



City of Hope Comprehensive Cancer Center Duarte, California  91010