EXAMINING COMORBIDITY BURDEN AND PATIENT-REPORTED OUTCOMES OF CRC SURVIVORS

描述(申请人提供)：截至2008年1月，超过110万名结直肠癌(CRC)幸存者存活，这一数字随着美国人口老龄化、通过筛查早期诊断癌症以及结直肠癌治疗有效性的提高而继续增长。虽然有充分的证据表明，共病影响接受治疗和生存，但关于共病对患者报告的结果(PRO)的影响，如疾病症状、治疗的副作用和癌症诊断后的生活质量(QOL)，人们知之甚少。在癌症人群中使用了各种共病指标，如Charlson共病指数、功能性共病指数或慢性健康状况的列举，以衡量慢性健康状况的存在和临床严重程度，但没有考虑到现有健康状况对一个人从事日常活动的能力的影响或负担。贝利斯和他的同事开发了一项新的共病负担自我评估，评估了21种健康状况，以及每种健康状况对一个人从事日常活动的能力的自我评估影响。与目前使用的共病负担测量方法相比，共病负担的测量方法可能是预测癌症幸存者预后的更好、更有信息量的指标。这项拟议研究的目的是评估200例接受手术的新诊断的结直肠癌患者的术前共病负担的Bayliss测量方法与其他常用的共病负担测量方法在基线和术后PRO方面的比较。我们提出了以下具体目标：1.比较新近确诊的结直肠癌患者的基线Bayliss共病负担测量和常用的共病测量与术前症状和生活质量的优势；2.比较基线Bayliss测量对治疗副作用和生活质量评估的预测和区分能力：a)手术后4-6周和b)手术治疗后3个月；3.探索术前健康状况的具体组合是否与手术后4-6周和3个月的症状、治疗副作用或生活质量相关。我们的目的是证明，与现有的共病测量方法相比，共病负担的测量方法可以解释更多的PRO变化，并更好地预测随时间推移的PRO。这项研究的结果将为未来在癌症幸存者PRO研究中选择共病指标提供信息，解决关于共病负担和PRO的相关性和预测能力的概念性问题，并告知临床和行为干预的必要性，以改善患有共病的癌症幸存者的PRO。

DESCRIPTION (provided by applicant): Over 1.1 million colorectal cancer (CRC) survivors were alive as of January 2008 and this number continues to grow with the aging of the US population, the early diagnosis of cancer through screening, and the improved effectiveness of colorectal cancer treatments. While there is ample evidence showing that comorbidity affects treatment receipt and survival, little is known about the impact of comorbidity on patient- reported outcomes (PROs) such as disease symptoms, side effects of treatments, and quality of life (QOL) following a diagnosis of cancer. A variety of measures of comorbidity, such as the Charlson Comorbidity Index, the Functional Comorbidity Index, or an enumeration of chronic health conditions, have been used in cancer populations to measure the presence and clinical severity of chronic health conditions but none take into account the impact or burden of existing health conditions on a person's ability to engage in daily activities. A new self-assessment of comorbidity burden, developed by Bayliss and colleagues, assesses over 21 health conditions and the self-assessed impact of each on a person's ability to engage in daily activities. A measure of comorbidity burden may be a better, more informative, predictor of PROs among cancer survivors than currently used measures of comorbidity. The objectives of the proposed study are to evaluate the pre-operative Bayliss measure of comorbidity burden in comparison with other commonly used comorbidity measures on baseline and post-surgery PROs in 200 newly diagnosed CRC patients receiving surgery. We propose the following specific aims: 1. Compare the baseline Bayliss measure of comorbidity burden against commonly used measures of comorbidity with pre-operative PROs of symptoms and QOL among recently diagnosed CRC patients; 2. Compare the baseline Bayliss measure's predictive and discriminative ability for treatment side effects and QOL assessed at: a) 4-6 weeks post-surgery and b) 3 months after surgical treatment; 3. Explore whether specific combinations of pre-operative health conditions are associated with symptoms, treatment side effects, or QOL at 4-6 weeks and 3 months post surgery. We aim to demonstrate that a measure of comorbidity burden explains more of the variation in PROs and better predicts PROs over time than existing comorbidity measures. Findings from this study will inform future selection of comorbidity measures in PRO studies of cancer survivors, address conceptual questions about the associations and predictive ability of comorbidity burden and PROs, and inform the need for clinical and behavioral interventions to improve PROs among cancer survivors with comorbidities.