Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BASC-3 survey, PROMIS survey.
- Who it may be relevant to
- Registry conditions: Survivors of Unilateral Retinoblastoma. Basic parameters: 8 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Behavioral BASC-3 survey
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. - Behavioral PROMIS survey
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.
Primary outcome measures
- social-emotional health [Time frame: 2 years]
- behavioral health [Time frame: 2 year]
- compare HRQoL [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
United States · 2 centers
- Memorial Sloan Kettering Cancer Center — New York
- Texas Children's Hospital (Data Collection) — Houston
Identifiers
NCT: NCT03662776 · 18-397