Quality of Life in Children Cured of Retinoblastoma
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Purpose
| Condition |
|---|
|
Retinoblastoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Quality of Life in Children Cured of Retinoblastoma |
- Change in quality of life [ Time Frame: Baseline and 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Past treatment for retinoblastoma
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00278031
| Contact: Michael Weintraub, MD | 972-2-6777408 | michaelw@hadassah.org.il |
| Israel | |
| Hadassah Medical Organization, Jerusalem, Israel | Recruiting |
| Jerusalem, Israel, 91120 | |
| Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il | |
| Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il | |
| Principal Investigator: Michael Weintraub, MD | |
| Principal Investigator: | Michael Weintraub, MD | Hadassah Medical Organization |
More Information
| Responsible Party: | Michael Weintraub, DIrector, Pediatric Hematology Oncology, Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00278031 History of Changes |
| Other Study ID Numbers: | qolrb-HMO-CTIL |
| Study First Received: | January 17, 2006 |
| Last Updated: | March 17, 2015 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Hadassah Medical Organization:
|
Retinoblastoma Quality of life |
Additional relevant MeSH terms:
|
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 Retinal Diseases |
ClinicalTrials.gov processed this record on September 29, 2016