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: 6129154
• 负责人: CLAUDIA S MOY
• 金额: $ 20.32万
• 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 2000-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6129154
• 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.

眼黑色素瘤协作研究（COMS）是一组随机 由国家眼科研究所赞助的临床试验，旨在 评价放射治疗在脉络膜黑色素瘤治疗中的作用。 主要的COMS试验将决定是眼球摘除还是放射治疗 不摘除的手术为患者提供了最长的剩余寿命。 研究中的两种治疗方法，眼球摘除术与 放射治疗，可能有不同的心理和 对患者的生理影响。除了 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 这是决定最佳治疗方式的重要考虑因素。COMS 目前没有纳入疾病对质量影响的措施 除了视力的评估之外。 拟议研究的目的是解决质量问题， 生活和治疗对患者的心理和身体的影响 与脉络膜黑色素瘤使用现有的框架的COMS。 具体而言，该研究将： 1.估计基线生活质量及其随时间的变化， 入组COMS的脉络膜黑色素瘤患者及其随访 5年; 2.比较患者的基线生活质量及其随时间的变化 随机接受放疗与眼球摘除术; 3.并根据治疗情况横向比较生活质量 在之前入组COMS的患者中进行分配。 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， 将纳入患者的日常视力活动量表 在基线和COMS随访期间进行的评价。这 这项研究将提供有关患者如何 脉络膜黑色素瘤经历的疾病和它的治疗。未来 患者将受益于这些结果，这将有助于他们平衡 生活数量和质量之间的权衡与选择 治疗这种疾病。