Educational and Skills Training Program for Parents of Childhood Cancer Survivors Who Have Neurobehavioral Dysfunction

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Leukemia; Cancer Survivor; Cognitive/Functional Effects; Long-term Effects Secondary to Cancer Therapy in Children; Psychosocial Effects of Cancer and Its Treatment
• Intervention / Treatment: Other: educational intervention; Procedure: psychosocial assessment and care

Detailed Description

OBJECTIVES:

• 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 functioning.
• 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 Questionnaire.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010-3000
      • City of Hope Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (parent intervention program and usual 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. 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).
Active Comparator: 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.	Procedure: psychosocial assessment and care; Child participants and their families may access multidisciplinary psychosocial services (i.e., usual care).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)

Secondary Outcome Measures

Outcome Measure
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)
Parenting stress as measured by the PSI at baseline, 3 months, and 6 months (parent participant)

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sunita Patel, PhD, City of Hope Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: July 10, 2008
• First Submitted That Met QC Criteria: July 10, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Estimate): October 13, 2010
• Last Update Submitted That Met QC Criteria: October 11, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: cancer survivor; childhood acute myeloid leukemia in remission; childhood chronic myelogenous leukemia; cognitive/functional effects; long-term effects secondary to cancer therapy in children; psychosocial effects of cancer and its treatment; childhood grade III lymphomatoid granulomatosis; childhood acute lymphoblastic leukemia; childhood nasal type extranodal NK/T-cell lymphoma; childhood anaplastic large cell lymphoma; childhood large cell lymphoma; childhood lymphoblastic lymphoma; childhood small noncleaved cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Leukemia
• Other Study ID Numbers: CDR0000598114; P30CA033572 (U.S. NIH Grant/Contract); R03CA130731 (U.S. NIH Grant/Contract); CHNMC-07250