Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
1 other identifier
observational
120
1 country
2
Brief Summary
The purpose of this study is to find out about the quality of life and health in patients who had retinoblastoma in one eye (unilateral retinoblastoma), who either received treatment with chemotherapy injected directly into an artery leading to the eye (intra-arterial chemotherapy) or removal of the eye (enucleation). By quality of life, the investigators mean how the participants are feeling about being satisfied with things in their life, including, physical health, emotional health, and their ability to carry out daily activities. The investigators want to see if either treatment option would affect quality of life differently. The investigators hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2018
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 31, 2018
CompletedFirst Submitted
Initial submission to the registry
September 4, 2018
CompletedFirst Posted
Study publicly available on registry
September 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
September 3, 2025
September 1, 2025
7.9 years
September 4, 2018
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
social-emotional health
as measured by Behavior Assessment System for Children, 3rd edition, (BASC™-3;as measured by the BASC-3) Surveys have been normed on a representative sample that closely matches United States census population characteristics; T scores and percentiles in relation to general norms are calculated for each scale. The BASC-3 uses a T score metric where 50 is the mean for the population norm and the standard deviation is 10.
2 years
behavioral health
as measured by Behavior Assessment System for Children, 3rd edition, (BASC™-3; The following four T Scores will be analyzed for these BASC-3 summary scores (1) Externalizing Problems, (2) Internalizing Problems, (3) Behavior Symptoms Index and (4) Adaptive Skills. The "at-risk" category applies to any individual who scores 2 SD above the mean of 50, while "clinically significant" risk refers to those who score 3 SD above the mean. Additional scores are also provided which may be used to identify risk for more specific behavioral or emotional areas of concern.
2 year
compare HRQoL
as measured by the Patient Reported Outcomes Measurement Information System (PROMIS®) PROMIS measures use a T-score metric where 50 is the mean for the reference population and 10 is the standard deviation of that population. Higher scores correspond to a higher degree of symptom burden (for those items measuring symptoms) or a higher level of functioning (for physical functioning items)
2 years
Study Arms (2)
retinoblastoma survivors treated with enucleation
MSK will contact all families of 1-year survivors of unilateral retinoblastoma treated with enucleation or intra-arterial chemotherapy at MSK and TCH between 2006 or later for completion of validated questionnaires integrating the BASC-3 and PROMIS surveys. The survey may be administered in-person during clinic or by mail, based upon participant preference.
retinoblastoma survivors treated with intra-arteria chemo
MSK will contact all families of 1-year survivors of unilateral retinoblastoma treated with enucleation or intra-arterial chemotherapy at MSK and TCH between 2006 or later for completion of validated questionnaires integrating the BASC-3 and PROMIS surveys. The survey may be administered in-person during clinic or by mail, based upon participant preference.
Interventions
A comprehensive questionnaire, incorporating the BASC-3 and PROMIS measures, will be administered to parents of participants ages 8-17. The BASC-3 and PROMIS scales each have a parent and child version; these scales will be used to measure the secondary objective of parent and patient concordance rates for all participants ages 8 and older.
A comprehensive questionnaire, incorporating the BASC-3 and PROMIS measures, will be administered to parents of participants ages 8-17. The BASC-3 and PROMIS scales each have a parent and child version; these scales will be used to measure the secondary objective of parent and patient concordance rates for all participants ages 8 and older.
Eligibility Criteria
Eligible survivors of unilateral retinoblastoma will be identified via the MSK and TCH databases and offered participation in the study.
You may qualify if:
- Ability to speak and understand English or Spanish
- Diagnosis of unilateral retinoblastoma at any age, confirmed by the enrolling institution
- Treatment of retinoblastoma between 2006 or later
- Patients must between the age of 8-17 years old
- At least 1 year since completion of all cancer-directed therapy
- Treatment with enucleation of the affected eye or intra-arterial chemotherapy
- Parent of patient:
- Ability to speak and understand English or Spanish
- Ability to confirm that he or she is the parent of a child treated for unilateral retinoblastoma who meets the eligibility criteria listed above
- Ability to provide informed consent
You may not qualify if:
- Patients, or parents of patients, treated with both enucleation and intra-arterial chemotherapy are not eligible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Texas Children's Hospital (Data Collection)
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Cimini, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2018
First Posted
September 7, 2018
Study Start
August 31, 2018
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
September 3, 2025
Record last verified: 2025-09