Quality of Life in Children Cured of Retinoblastoma

October 1, 2016 updated by: Michael Weintraub, Hadassah Medical Organization
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Organization, Jerusalem, Israel
        • Principal Investigator:
          • Michael Weintraub, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Long term survivors of childhood retinoblastoma

Description

Inclusion Criteria:

  • Past treatment for retinoblastoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in quality of life
Time Frame: Baseline and 5 years
Baseline and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Collaborators

Israel Cancer Association

Investigators

  • Principal Investigator: Michael Weintraub, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 18, 2006

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 1, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qolrb-HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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