Cancer SurvivorNCT00713505
Educational and Skills Training Program for Parents of Childhood Cancer Survivors Who Have Neurobehavioral Dysfunction
A study testing educational intervention and psychosocial assessment and care in people with Cancer Survivor and Cognitive/Functional Effects, run by City of Hope Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Cancer Survivor, Cognitive/Functional Effects, Leukemia
- What is being tested?
- educational intervention and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer Survivor, Cognitive/Functional Effects, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children, Lymphoma, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- educational intervention, psychosocial assessment and care
- Keywords
- 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
- Medical subject headings
- Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Large-Cell, Anaplastic, Dendritic Cell Sarcoma, Interdigitating, Burkitt Lymphoma, Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
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.
psychosocial assessment and careProcedure or surgery
Child participants and their families may access multidisciplinary psychosocial services (i.e., usual care).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: educational intervention; Procedure: psychosocial assessment and care |
| 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. Receives: Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (3)
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Sunita Patel, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713505
- Sponsor's protocol ID
- CDR0000598114
- Other IDs
- R03CA130731, P30CA033572, CHNMC-07250
- Status last verified
- Oct 2010
- First submitted
- 10 Jul 2008
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral Intervention Trial for Parents of Childhood Cancer Survivors With Neurobehavioral Late Effects
- ClinicalTrials.gov ID
- NCT00713505
- Acronym / sponsor ID
- CDR0000598114
- Conditions
- Cancer Survivor, Cognitive/Functional Effects, Leukemia, Long-term Effects Secondary to Cancer Therapy in Children, Lymphoma, Psychosocial Effects of Cancer and Its Treatment
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (parent intervention program and usual care) | Experimental | Other: educational intervention, Procedure: psychosocial assessment and careChild 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 | Procedure: psychosocial assessment and careChild participants and their families undergo usual care as in arm I and are placed on a wait-list. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational interventionParents 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. | Other | Arm I (parent intervention program and usual care) |
| psychosocial assessment and careChild participants and their families may access multidisciplinary psychosocial services (i.e., usual care). | Procedure or surgery | Arm I (parent intervention program and usual care), Arm II (wait-list/usual care control [UCC]) |
Primary outcome
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)
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunita Patel, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention and psychosocial assessment and care in people with Cancer Survivor and Cognitive/Functional Effects, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WIAT-II-Reading, Mathematics, and Writing composite scores as measured at baseline and 6 months (child participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.