Abstract

The Collaborative Ocular Melanoma Study (COMS) is a set of randomized clinical trials sponsored by the National Eye Institute and designed to evaluate the role of radiotherapy in the treatment of choroidal melanoma. The primary COMS trial will determine whether enucleation or radiotherapy without enucleation provides patients with the longest remaining lifespan. The two treatment approaches under investigation, enucleation versus radiation therapy, are likely to have different psychological and physiological effects on the patients receiving them. In addition to consideration of any survival difference between treatment approaches, the impact of the treatments on the patient's quality of life will be an important consideration in determining the best form of therapy. The COMS does not currently incorporate measures of the disease impact on quality of life, with the exception of an assessment of visual acuity. The purpose of the proposed study is to address the issues of quality of life and the psychological and physical impact of treatment in patients with choroidal melanoma using the existing framework of the COMS. Specifically, the study will: 1. estimate baseline quality of life and its changes over time in choroidal melanoma patients from enrollment into the COMS, with follow-up for 5 years; 2. compare baseline quality of life and its changes over time in patients randomized to receive radiotherapy versus enucleation; 3. and compare quality of life cross-sectionally according to treatment assignment in patients previously enrolled in the COMS. To achieve these aims, a health-related quality of life instrument, the SF-36 Health Survey, and a visual functioning assessment instrument, the Activities of Daily Vision Scale, will be incorporated into the patient evaluations performed at baseline and during follow-up for the COMS. This study will provide valuable information about the how patients with choroidal melanoma experience the disease and its treatment. Future patients will benefit from these results, which will help them balance the trade-offs between quantity and quality of life related to choice of treatment for this disease.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY010207-09
Application #
6649374
Study Section
Vision Research and Training Committee (VSN)
Program Officer
Kurinij, Natalie
Project Start
1994-08-01
Project End
2004-07-31
Budget Start
2003-08-01
Budget End
2004-07-31
Support Year
9
Fiscal Year
2003
Total Cost
$88,098
Indirect Cost

  Institution

Name
Johns Hopkins University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218