TeleCare Management of Pain and Depression in Cancer

描述（由申请人提供）：疼痛和抑郁是两种最普遍和可治疗的癌症相关症状，每种症状至少存在于20-30%的肿瘤患者中。然而，这两种症状经常被忽视和/或治疗不足。四种常见的障碍包括未被发现、初始治疗不充分、未能监测依从性和症状反应，以及对初始治疗无反应或不耐受的患者未能调整治疗。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，我们建议开展印第安纳州癌症疼痛和抑郁（INCPAD）研究，这是一项随机临床试验，在位于农村和城市肿瘤实践的全州社区癌症诊所网络中进行。INCPAD将招募480名患有癌症相关疼痛（n = 240）或临床抑郁症（n = 240）的患者，将他们随机分为干预组或常规护理对照组。干预将基于经经验验证的三成分模型（TCM），对于INCPAD，该模型将涉及肿瘤实践、集中护理管理人员和监督疼痛精神科医生之间的合作。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。所有受试者将接受基线、1、3、6和12个月的综合结果评估，由盲法访谈者对治疗组进行评估。我们的主要目的是测试中医在改善抑郁和疼痛的共同主要结局方面是否比常规护理更有效。其次，我们将测试干预对健康相关生活质量、护理成本效益和治疗满意度的影响。这种干预措施有可能改善各种肿瘤患者的症状管理，这些肿瘤患者可能在地理上分散，在位置（农村或城市）、健康计划、付款人或其他特征上各不相同。此外，如果证实对抑郁和疼痛有效，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.