Survivors of Unilateral RetinoblastomaNCT03662776

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

An observational study of Survivors of Unilateral Retinoblastoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 8 to 17 years
Conditions the study is for: Survivors of Unilateral Retinoblastoma
What is being tested?: BASC-3 survey and PROMIS survey
Type of treatment: Lifestyle or therapy programme
How many people: 120 participants
Where: 2 sitesUnited States
Study dates: 31 Aug 2018to Aug 2027
Phase: Observational

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 8 to 17 years
All sexes
No healthy volunteers
Child

Study population: Eligible survivors of unilateral retinoblastoma will be identified via the MSK and TCH databases and offered participation in the study.

Who may be able to join

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

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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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

Texas Children's Hospital (Data Collection)
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Other trials in United States

About this study

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.

Conditions: Survivors of Unilateral Retinoblastoma
Being tested: BASC-3 survey, PROMIS survey
Keywords: Quality of Life, physical health, emotional health, 18-397
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BASC-3 surveyBehavioural
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 surveyBehavioural
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.

Study groups in NCT03662776
Study group	Role	What they receive
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. Receives: Behavioral: BASC-3 survey; Behavioral: PROMIS survey
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. Receives: Behavioral: BASC-3 survey; Behavioral: PROMIS survey

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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)
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 2018Aug 2027

First posted7 Sep 2018
Study start31 Aug 2018
Primary completionAug 2027 (estimated)
Study completionAug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Survivors of Unilateral RetinoblastomaStudies of the same condition, open and under way.
More trials run by Memorial Sloan Kettering Cancer 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: Observational
Observational model: Case crossover
Time perspective: Prospective
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03662776
Sponsor's protocol ID: 18-397
Status last verified: Sep 2026
First submitted: 4 Sep 2018
Last updated: 8 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Studying Health Outcomes After Treatment in Patients With Retinoblastoma
Retinoblastoma, Cancer Survivor

All Survivors of Unilateral Retinoblastoma trials