Survivors of Unilateral Retinoblastoma Clinical Trial
Official title:
Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
| Verified date | September 2023 |
| Source | Memorial Sloan Kettering Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Enrolling by invitation |
| Enrollment | 120 |
| Est. completion date | August 2024 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 8 Years to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas Children's Hospital (Data Collection) | Houston | Texas |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |