Study Summary
This trial will study how effective a single session intervention is in improving psychological and neurocognitive functioning in children with neurofibromatosis.
Eligible Conditions
- Neurofibromatosis Type 1
- Mental Health Disorder
- Neurocognitive Impairment
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: Baseline, 3 months, 6 months
7 months
Satisfaction with intervention
Month 6
Change in intellectual function
Change in neurocognitive function
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
50 Total Participants · 2 Treatment Groups
Primary Treatment: Intervention · No Placebo Group · N/A
Intervention
Behavioral
Experimental Group · 1 Intervention: OPTIMAL-SSI · Intervention Types: BehavioralControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months, 6 months
Who is running the clinical trial?
Virginia Commonwealth UniversityLead Sponsor
624 Previous Clinical Trials
355,744 Total Patients Enrolled
Jennifer M Rohan, PhDPrincipal InvestigatorVirginia Commonwealth University
Eligibility Criteria
Age 6 - 16 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Parent/caregiver must be actively involved in the patient's care and able to complete study-related questionnaires at baseline, 3-, and 6-months; and the exit interview at 7-months.
References
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- Rohan, Jennifer M., Dennis Drotar, Melissa Alderfer, Crista Wetherington Donewar, Linda Ewing, Ernest R. Katz, and Anna Muriel. 2013. “Electronic Monitoring of Medication Adherence in Early Maintenance Phase Treatment for Pediatric Leukemia and Lymphoma: Identifying Patterns of Nonadherence”. Journal of Pediatric Psychology. Oxford University Press (OUP). doi:10.1093/jpepsy/jst093.
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- Pui, Ching-Hon, Charles G. Mullighan, William E. Evans, and Mary V. Relling. 2012. “Pediatric Acute Lymphoblastic Leukemia: Where Are We Going and How Do We Get There?”. Blood. American Society of Hematology. doi:10.1182/blood-2012-05-378943.
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- Buchanan, Natasha D., Rebecca Block, Ashley Wilder Smith, and Eric Tai. 2014. “Psychosocial Barriers and Facilitators to Clinical Trial Enrollment and Adherence for Adolescents with Cancer”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2014-0122i.
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- Pai ALH, Drotar D, Kodish E. Correspondence between objective and subjective reports of adherence among adolescents with acute lymphoblastic leukemia. Child Health Care. 2008.
- Pui CH, Mullighan CG, Evans WE, Relling MV. Pediatric acute lymphoblastic leukemia: where are we going and how do we get there? Blood. 2012 Aug 9;120(6):1165-74. doi: 10.1182/blood-2012-05-378943. Epub 2012 Jun 22.
- Butow P, Palmer S, Pai A, Goodenough B, Luckett T, King M. Review of adherence-related issues in adolescents and young adults with cancer. J Clin Oncol. 2010 Nov 10;28(32):4800-9. doi: 10.1200/JCO.2009.22.2802. Epub 2010 Mar 8.
- Kondryn HJ, Edmondson CL, Hill J, Eden TO. Treatment non-adherence in teenage and young adult patients with cancer. Lancet Oncol. 2011 Jan;12(1):100-8. doi: 10.1016/S1470-2045(10)70069-3. Epub 2010 Jun 26.
- Pritchard MT, Butow PN, Stevens MM, Duley JA. Understanding medication adherence in pediatric acute lymphoblastic leukemia: a review. J Pediatr Hematol Oncol. 2006 Dec;28(12):816-23. doi: 10.1097/01.mph.0000243666.79303.45.
- Bhatia S. Disparities in cancer outcomes: lessons learned from children with cancer. Pediatr Blood Cancer. 2011 Jun;56(6):994-1002. doi: 10.1002/pbc.23078. Epub 2011 Feb 15.
- Wiener L, Kazak AE, Noll RB, Patenaude AF, Kupst MJ. Standards for the Psychosocial Care of Children With Cancer and Their Families: An Introduction to the Special Issue. Pediatr Blood Cancer. 2015 Dec;62 Suppl 5(Suppl 5):S419-24. doi: 10.1002/pbc.25675. Epub 2015 Sep 23.
- Buchanan ND, Block R, Smith AW, Tai E. Psychosocial barriers and facilitators to clinical trial enrollment and adherence for adolescents with cancer. Pediatrics. 2014 Jun;133 Suppl 3(Suppl 3):S123-30. doi: 10.1542/peds.2014-0122I.
- 2022. "Intervention Effectiveness on the Neurocognitive Functioning of Children and Adolescents With Neurofibromatosis Type 1". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05377008.
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Conditions
Cancer Related
Treatments