EXAMINING COMORBIDITY BURDEN AND PATIENT-REPORTED OUTCOMES OF CRC SURVIVORS

描述（由申请人提供）：截至2008年1月，超过110万结直肠癌（CRC）幸存者存活，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，这一数字继续增长。虽然有充分的证据表明合并症影响治疗接受和生存，但关于合并症对患者报告的结局（PRO）（如疾病症状、治疗副作用和癌症诊断后的生活质量（QOL））的影响知之甚少。多种合并症的测量，如查尔森合并症指数，功能性合并症指数，或慢性健康状况的枚举，已被用于癌症人群中，以测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。Bayliss及其同事开发的一项新的合并症负担自我评估了21种以上的健康状况以及每种状况对一个人从事日常活动能力的自我评估影响。与目前使用的合并症指标相比，合并症负担指标可能是癌症幸存者PRO的更好、更具信息性的预测指标。拟议研究的目的是在200例接受手术的新诊断CRC患者中，评价术前Bayliss合并症负担指标与其他常用的基线和术后PRO合并症指标的比较。我们提出以下具体目标：1。在近期诊断的CRC患者中，将基线Bayliss合并症负担指标与常用的合并症指标以及术前症状和QOL的PRO进行比较; 2.比较基线Bayliss测量对治疗副作用的预测和区分能力以及在以下时间评估的QOL：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特定组合是否与术后4-6周和3个月的症状、治疗副作用或QOL相关。 我们的目标是证明，合并症负担的措施解释更多的变化，在PRO和更好地预测PRO随着时间的推移比现有的合并症措施。这项研究的结果将为未来癌症幸存者PRO研究中合并症指标的选择提供信息，解决有关合并症负担和PRO的关联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，以改善合并症癌症幸存者的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.