Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma

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.

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Key information

Conditions

Survivors of Unilateral Retinoblastoma Behavior Personal Satisfaction Psychological Well-Being

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients, or parents of patients, treated with both enucleation and intra-arterial chemotherapy are not eligible

Treatment and study plan

BASC-3 survey

Behavioral

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.

PROMIS survey

Behavioral

Primary outcomes

social-emotional health

Time frame: 2 years

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.
behavioral health

Time frame: 2 year

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.
compare HRQoL

Time frame: 2 years

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)

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2026
Study completion: 2026
First posted: Sep 7, 2018
Registry last updated: Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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