Quality of Life in Children Cured of Retinoblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Israel Cancer Association
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00278031
First received: January 17, 2006
Last updated: June 22, 2011
Last verified: August 2009
  Purpose

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.


Condition
Retinoblastoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Quality of Life in Children Cured of Retinoblastoma

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 35
Study Start Date: March 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Long term survivors of childhood retinoblastoma

Criteria

Inclusion Criteria:

  • Past treatment for retinoblastoma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278031

Contacts
Contact: Michael Weintraub, MD 972-2-6777408 michaelw@hadassah.org.il

Locations
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         
Sponsors and Collaborators
Hadassah Medical Organization
Israel Cancer Association
Investigators
Principal Investigator: Michael Weintraub, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Michael Weintraub, Director. Pediatric Hematology-Oncology, Hadassah University Hospital
ClinicalTrials.gov Identifier: NCT00278031     History of Changes
Other Study ID Numbers: qolrb-HMO-CTIL
Study First Received: January 17, 2006
Last Updated: June 22, 2011
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 August 21, 2014