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

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ClinicalTrials.gov Identifier: NCT03662776
Recruitment Status : Enrolling by invitation
First Posted : September 7, 2018
Last Update Posted : February 8, 2023
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment
Survivors of Unilateral Retinoblastoma Behavioral: BASC-3 survey Behavioral: PROMIS survey

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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)


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible survivors of unilateral retinoblastoma will be identified via the MSK and TCH databases and offered participation in the study.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662776


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
Texas Children's Hospital (Data Collection)
Houston, Texas, United States, 77030
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Laura Cimini, PhD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03662776    
Other Study ID Numbers: 18-397
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: February 8, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Quality of Life
physical health
emotional health
18-397
Additional relevant MeSH terms:
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Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
 Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases, Hereditary
Eye Diseases
Retinal Diseases