QUALITY OF LIFE--THE COLLABORATIVE OCULAR MELANOMA STUDY

生活质量——眼部黑色素瘤合作研究

• 批准号: 6649374
• 负责人: B. M MELIA
• 金额: $ 8.81万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-08-01 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6649374
• 关键词: behavioral /social science research tag; choroid uvea; clinical trials; cooperative study; eye disorder diagnosis; eye neoplasms; eye surgery; health surveys; human mortality; human subject; human therapy evaluation; melanoma; mental health; neoplasm /cancer radiation therapy; psychology; quality of life; visual perception

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.

协作性眼黑色素瘤研究(COMS)是一组随机的 临床试验由国家眼科研究所赞助，旨在 评价放射治疗在脉络膜黑色素瘤治疗中的作用。 初级COMS试验将决定是摘除还是放射治疗 不摘除眼球为患者提供了最长的剩余寿命。 正在调查的两种治疗方法是摘除眼球与 放射治疗，可能会有不同的心理和 对接受治疗的患者的生理影响。除了……之外 考虑到治疗方法之间的任何生存差异， 治疗对患者生活质量的影响将是 在确定最佳治疗形式时的重要考虑因素。《通信》 目前没有纳入疾病对质量影响的衡量标准 对生活的评价，但对视力的评估除外。 拟议研究的目的是解决以下质量问题 生活与治疗对患者心理和生理的影响 使用COMS现有框架的脉络膜黑色素瘤。 具体而言，这项研究将： 1.评估基线生活质量及其随时间的变化 脉络膜黑色素瘤患者入选COMS并进行随访 为期5年； 2.比较患者的基线生活质量及其随时间的变化。 随机接受放射治疗与眼球摘除； 3.根据治疗情况对生活质量进行横断面比较 以前在COMS中登记的患者的分配。 为了实现这些目标，一个与健康有关的生活质量工具， SF-36健康调查和视觉功能评估工具， 日常活动视力量表，将纳入患者 在基线和COMS的后续行动中进行评估。这 研究将提供有价值的信息，关于患者如何 脉络膜黑色素瘤经历了疾病及其治疗。未来 患者将从这些结果中受益，这将帮助他们平衡 生活质量和数量之间的权衡与选择 治疗这种疾病的方法。

项目成果

Development and validation of disease-specific measures for choroidal melanoma: COMS-QOLS report No. 2.

• DOI: 10.1001/archopht.121.7.1010
• 发表时间: 2003-07
• 期刊: Archives of ophthalmology
• 作者: M. Melia;C. Moy;S. Reynolds;D. Cella;T. Murray;K. R. Hovland;J. Hayman;C. Mangione

Quality of life after iodine 125 brachytherapy vs enucleation for choroidal melanoma: 5-year results from the Collaborative Ocular Melanoma Study: COMS QOLS Report No. 3.

• DOI: 10.1001/archopht.124.2.226
• 发表时间: 2006-02
• 期刊: Archives of ophthalmology
• 作者: M. Melia;C. Moy;S. Reynolds;J. Hayman;T. Murray;K. R. Hovland;J. Earle;N. Kurinij;L. Dong;Päivi H. Miskala;C. Fountain;D. Cella;C. Mangione