Quality of Life in Children Cured of Retinoblastoma

• Conditions: Retinoblastoma

• Registration Number: NCT00278031
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The aim of the study is to assess the quality of life of children who have been cured of retinoblastoma - a malignant eye tumor. The study is questionnaire-based, and uses standardized quality of life assessment tools.

Detailed Description

Retinoblastoma is the most common eye tumor of children. It can present in one eye (unilateral) or in both eyes (bilateral). The bilateral form is always hereditary.

Retinoblastoma is a highly curable tumor. Using a combination of surgery, chemotherapy, radiation and local treatment modalities to the eye, over 98% of patients are cured. This means that most children diagnosed with retinoblastoma will become long-term survivors.

The use of surgery (taking out one eye), chemotherapy, and radiation may be associated with long term side-effects, some of which may have significant impact on the quality of life of the child. In addition, in case where the disease is hereditary, additional psychological issues arise.

The aim of our study is to assess, in a comprehensive and standardized fashion, the long term quality of life in children who were treated for retinoblastoma, and who are currently alive and well.

The assessment will include the use of questionnaires that assess quality of life, as well as participation in age-appropriate activities.

Each child, and his/her parent, will be interviewed and the questionnaires completed. The process will take about one hour for each child. No risk or discomfort to the child is involved.

Study Timeline

• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-17
• Study First Posted: 2006-01-18
• Study Start: 2006-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-01
• Last Update Posted: 2016-10-04
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Past treatment for retinoblastoma

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in quality of life	Baseline and 5 years

Trial Locations

Locations (1)

Hadassah Medical Organization, Jerusalem, Israel; 🇮🇱 Jerusalem, Israel