Comprehensive Electronic Support System for Treatment of Cancer-Related Symptoms

描述(由申请者提供)：根据NIH国家科学共识声明，与癌症相关的三种最常见和未得到治疗的症状是疼痛、疲劳和抑郁。我们的团队和其他人已经证明，认知行为干预在使用传统的传递策略(面对面和电话)治疗癌症相关症状方面是有效的。在我们的第三癌症中心接受不能切除的肝细胞癌(HCC)治疗的人会在全国各地旅行接受治疗。肝细胞癌的治疗，化疗栓塞术或钇-90，是不常见的，(每8周)和短暂的(24小时住院)。因此，癌症相关症状的评估和循证干预措施的提供变得具有挑战性。我们已经证明，通过与患者进行有限的接触(3次面对面和2次电话会议)，我们可以通过循证干预减少抑郁和焦虑的症状，并提高与健康相关的生活质量的某些领域。然而，为了增加我们与被诊断为肝癌的患者的联系，并进一步减少与癌症相关的症状，我们正在提议使用新技术，即综合电子癌症支持系统(CECS)。CESS是一个网站，旨在促进患者报告症状，并增加我们通过多种媒介提供循证干预的机会。这项研究的具体目的是：(1)最终确定CECS的开发；(2)测试CECS在被诊断为肝癌的人中的可行性；(3)在一项针对被诊断为肝癌的人的前瞻性随机对照试验中，检验CECS的有效性。对于目标1，CECS的内容将放在网站上，激活，然后由研究小组进行测试。对于目标2，将招募20名被诊断为肝细胞癌的人作为样本，以测试CECS的可行性。目标3将通过招募256名被诊断为肝细胞癌的参与者并随机分配到研究的干预部门(CECS)或标准护理部门来实现。CECS的疗效将在基线(治疗前)和3个月、6个月和9个月的随访中使用患者报告的结果、代理评估的结果、卫生保健利用的衡量标准和生物标记物(例如甲胎蛋白、存活率)进行评估。这项研究的结果有望有助于我们了解CECS的疗效，并提高被诊断为肝癌的患者的生活质量。

DESCRIPTION (provided by applicant): According to the NIH State-of-the-Science consensus statement, the three most frequently reported and undertreated cancer-related symptoms are pain, fatigue, and depression. Cognitive behavioral interventions have been shown to be effective in the treatment of cancer-related symptoms using traditional delivery strategies (face to face and telephone) by our team as well as others. People who are treated at our tertiary cancer center for unresectable hepatocellular carcinoma (HCC) travel across country for treatment. The treatment for HCC, chemoembolization or Yttrium-90, is infrequent, (every 8 weeks) and brief (24 hour hospitalization). As a result, assessment of cancer-related symptoms, and delivery of evidence based interventions, becomes challenging. We have demonstrated that, with limited contact with patients (3 face to face and 2 telephone sessions) we can reduce symptoms of depression and anxiety and improve some domains of health-related quality of life with evidence based interventions. However, to increase our contact with patients diagnosed with HCC, and further reduce cancer-related symptoms, we are proposing the use of new technologies, a Comprehensive Electronic Cancer Support System (CECSS). The CECSS is a website designed to facilitate reporting of symptoms by patients and enhance our opportunities to deliver evidence- based interventions through multiple mediums. The specific aims of the study are: (1) To finalize the development of the CECSS; (2) To test the feasibility of the CECSS with people diagnosed with HCC; (3) To examine the efficacy of the CECSS in a prospective randomized controlled trial of people diagnosed with HCC. For Aim 1, the content for the CECSS will be placed on the website, activated, and then tested by the research team. For Aim 2, a sample of 20 people diagnosed with HCC will be recruited to test the feasibility of the CECSS. Aim 3 will be accomplished by recruiting 256 participants diagnosed with HCC and randomly assigning them to either the intervention arm of the study (CECSS) or the standard of care arm. The efficacy of the CECSS will be evaluated using patient-reported outcomes, proxy rated outcomes, measures of health care utilization, and biological markers (e.g., alfa fetoprotein, survival) at baseline (prior to treatment) and 3-, 6-, and 9-months follow-up. The results of this study are expected to contribute to our understanding of the efficacy of the CECSS and improve the quality of life for people diagnosed with HCC.