TeleCare Management of Pain and Depression in Cancer

描述(由申请人提供)：疼痛和抑郁是最普遍和可治疗的癌症相关症状中的两种，至少20%-30%的肿瘤科患者存在这两种症状。然而，这两种症状往往要么没有被识别出来，要么得不到足够的治疗。四种常见的障碍包括检测不足、初始治疗不充分、未能监测依从性和症状反应，以及未能调整对初始治疗无反应或不耐受的患者的治疗。护士提供的护理管理模式被证明对初级保健中的抑郁症有效，在优化癌症患者的抑郁和疼痛护理方面具有相当大的潜力。因此，我们建议进行印第安纳州癌症疼痛和抑郁(INCPAD)研究，这是一项在位于农村和城市肿瘤学诊所的全州社区癌症诊所网络中进行的随机临床试验。INCPAD将招募480名患有癌症相关疼痛(n=240)或临床抑郁(n=240)的患者，将他们随机分为干预组或常规护理对照组。干预将基于经验性验证的三组分模型(Medics)，对于INCPAD，该模型将涉及肿瘤学实践、集中化护士护理经理和监督疼痛-精神病学家之间的合作。在这项试验中，中医将涉及一种创新的远程医疗方法，包括基于家庭的自动症状监测以及基于电话的护士护理管理。所有受试者在基线、1个月、3个月、6个月和12个月时由观察者对治疗组进行全面的结果评估。我们的主要目的是测试中医在改善抑郁症和疼痛的共同原发结局方面是否比常规护理更有效。其次，我们将测试干预对与健康相关的生活质量、护理成本效益和治疗满意度的影响。这种干预措施有可能通过广泛的肿瘤学实践来改善癌症患者的症状管理，这些实践可能在地理上分散，在地点(农村或城市)、医疗计划、付款人或其他特征上有所不同。此外，如果被证明对抑郁和疼痛有效，中医可以很容易地扩展到减少障碍和改善对其他癌症相关症状的护理。

DESCRIPTION (provided by applicant): Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20-30% of oncology patients. Both symptoms, however, frequently go either unrecognized and/or under-treated. Four common harriers include underdetection, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Nurse-delivered care management models proven effective for depression in primary care have considerable potential for optimizing both depression and pain care in cancer patients. Therefore, we propose to conduct the Indiana Cancer Pain and Depression (INCPAD) study, a randomized clinical trial conducted in a statewide network of community-based cancer clinics located in both rural and urban oncology practices. INCPAD will enroll 480 patients with cancer-related pain (n = 240) or clinical depression (n = 240), randomizing them to either the intervention or usual care control group. The intervention will be based upon the empirically-validated Three-Component Model (TCM) which for INCPAD will involve collaboration between the oncology practice, a centralized nurse care manager, and a supervising pain-psychiatrist. In this trial, TCM will involve an innovative telemedicine approach involving automated home-based symptom monitoring coupled with telephone-based nurse care management. All subjects will undergo comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. Our principal aim is to test whether TCM is more effective than usual care in improving the co-primary outcomes of depression and pain. Secondarily, we will test the intervention's impact on health-related quality of life, cost-effectiveness of care, and treatment satisfaction. This intervention has the potential for improving symptom management in cancer patients across a wide range of oncology practices that may be geographically dispersed and varying in location (rural or urban), health plan, payer, or other characteristics. Furthermore, if proven effective for depression and pain, TCM could readily be expanded to reducing barriers and improving care of other cancer-related symptoms.