Comprehensive Electronic Support System for Treatment of Cancer-Related Symptoms

描述（由申请人提供）：根据美国国立卫生研究院最新科学共识声明，三种最常报告和未得到充分治疗的癌症相关症状是疼痛、疲劳和抑郁。认知行为干预已被证明是有效的治疗癌症相关症状使用传统的交付策略（面对面和电话），我们的团队和其他人。在我们三级癌症中心接受不可切除肝细胞癌（HCC）治疗的患者来自全国各地。肝细胞癌的治疗，化疗栓塞或钇-90，是罕见的，（每8周）和短暂的（24小时住院）。因此，评估癌症相关症状和提供基于证据的干预措施变得具有挑战性。我们已经证明，通过与患者的有限接触（3次面对面和2次电话会议），我们可以减少抑郁和焦虑的症状，并通过基于证据的干预措施改善与健康相关的生活质量的某些领域。然而，为了增加我们与诊断为HCC的患者的接触，并进一步减少癌症相关症状，我们建议使用新技术，即综合电子癌症支持系统（CECSS）。CECSS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。研究的具体目的是：(1)完成CECSS的开发；(2)验证CECSS在HCC诊断人群中的可行性；(3)在HCC诊断人群的前瞻性随机对照试验中检验CECSS的疗效。对于目标1，CECSS的内容将被放置在网站上，激活，然后由研究团队进行测试。在第二阶段，将招募20名确诊为HCC的患者来测试CECSS的可行性。目的3将招募256名诊断为HCC的参与者，并将他们随机分配到研究的干预组（CECSS）或标准护理组。CECSS的疗效将通过患者报告的结果、代理评分的结果、医疗保健利用的测量和基线（治疗前）的生物标志物（如甲胎蛋白、生存率）以及3、6和9个月的随访来评估。本研究的结果有望有助于我们了解CECSS的疗效，并改善HCC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.