Mental Health Assessment and Dynamic Referral for Oncology (MHADRO)

描述(申请人提供)：根据美国癌症协会的数据，每年约有130万人被诊断为癌症，每年治疗癌症的费用超过609亿美元。与癌症相关的心理健康和心理社会因素没有得到很好的认识和治疗。肿瘤学心理健康评估和动态转诊(MHADRO)使肿瘤治疗提供者能够有效地筛选和监测五个重要的患者护理领域，包括：(1)心理健康功能；(2)与癌症相关的身体症状/副作用；(3)患者与提供者的伙伴关系；(4)治疗障碍；(5)遵守医疗方案和改变生活方式的建议。MHADRO的个性化摘要报告帮助肿瘤学治疗提供者决定是否以及如何在出现临床上升高的精神健康症状时进行干预，或者当患者报告希望治疗或支持时。选择动态转介的患者将获得他们的摘要报告、发布信息的授权，以及他们的个人联系信息以电子方式传输到有证书的精神健康提供者，后者然后负责联系患者讨论治疗方案。此过程使用安全的、符合HIPAA的传输技术。第二阶段的具体目标是：(1)在第一阶段结果的基础上进行设计改进；(2)从三个参与的肿瘤治疗中心挑选30名患者进行现场试验，测试改进的MHADRO；以及(3)在1,000名混合癌症患者的单盲随机对照试验中评估MHADRO的有效性。患者将被随机分配到干预组(n=500)或对照组(n=500)。所有受试者，无论分组，都将在基线以及基线后2、4、6和12个月接受相同的评估程序。那些被分配到干预组的人将在五项评估的每一项上打印他们的医疗保健提供者报告。他们的肿瘤学治疗小组将审查这些报告，并将为陷入困境的患者制定治疗计划。患者将收到一份患者反馈报告，该报告将由训练有素的研究协调员(医疗保健专业人员)与他或她一起审查。在评估期间，干预组受试者将有机会获得有关可用的心理社会支持小组的更多信息，并提供动态转介至精神病学家、心理健康顾问和/或戒烟计划。被分配到控制条件的受试者将接受同样的五次MHADRO评估。然而，他们的报告不会被打印出来，也不会向他们提供心理健康转介或心理社会支持小组的信息。相反，他们将使用现场提供的护理标准进行管理(即照常治疗)。我们将使用广义估计方程(GEE)和线性混合建模(LMM)来检查随时间变化的组内痛苦差异，同时调整潜在的混杂变量，如疾病严重程度和治疗阶段。公共卫生相关性：包括国家综合护理网络、国家癌症研究所和医学研究所在内的几个国家组织倡导对癌症患者的心理困扰进行常规筛查，并强调了建立患者-提供者合作伙伴关系以解决心理社会问题的核心作用。缺乏对心理社会因素和患者-提供者伙伴关系的一致评估是一个严重的问题，具有深远的后果，包括过度痛苦、生活质量受损、治疗不满意和治疗不坚持。MHADRO有可能通过识别痛苦的患者、帮助团队决定应该采取什么行动、加强患者与提供者的伙伴关系、制作个性化的患者反馈报告、促进精神健康治疗参与以及监测患者对治疗的反应来影响这些结果。

DESCRIPTION (provided by applicant): According to the American Cancer Society, approximately 1.3 million people are diagnosed with cancer each year, with the annual cost of treating cancer exceeding $60.9 billion. Mental health and psychosocial factors associated with cancer are poorly recognized and under-treated. The Mental Health Assessment and Dynamic Referral for Oncology (MHADRO) enables oncology treatment providers to efficiently screen for and monitor five important patient care domains, including: (1) mental health functioning; (2) cancer-related physical symptoms/side effects; (3) the patient-provider partnership; (4) barriers to treatment; and (5) adherence with medical regimen and lifestyle change recommendations. The MHADRO's individualized summary reports help oncology treatment providers to decide whether and how to intervene when clinically elevated mental health symptoms are present or when a patient reports a desire for treatment or support. Patients who choose the dynamic referral have their summary report, an authorization to release information, and their personal contact information electronically transmitted to a credentialed mental health provider, who is then responsible for contacting the patient to discuss treatment options. This process utilizes secure, HIPAA-compliant transmittal technologies. Phase 2 specific aims are: (1) Make design improvements based on Phase 1 results; (2) Test the improved MHADRO with a field trial of 30 patients selected from three participating oncology treatment centers; and (3) Evaluate the effectiveness of the MHADRO during a single blind, randomized controlled trial of 1,000 mixed cancer patients. Patients will be randomly assigned to the Intervention Group (n=500) or the Control Group (n=500). All subjects, regardless of group assignment, will undergo the same assessment procedures at baseline and at 2, 4, 6, and 12 months post-baseline. Those assigned to the Intervention Group will have their Healthcare Provider Reports printed at each of the five assessments. These reports will be reviewed by their oncology treatment team and a treatment plan will be developed for distressed patients. The patient will receive a Patient Feedback Report, which will be reviewed with him or her by a trained research coordinator (a healthcare professional). During the assessment, the Intervention Group subjects will be given the opportunity to obtain more information on available psychosocial support groups and offered a dynamic referral to a psychiatrist, mental health counselor, and/or smoking cessation program. Subjects assigned to the Control Condition will undergo the same five MHADRO assessments. However, their reports will not be printed, nor will they be offered the mental health referrals or psychosocial support group information. Rather, they will be managed using the standard of care provided at the site (i.e., treatment-as-usual). We will use Generalized Estimating Equations (GEE) and Linear Mixed Modeling (LMM) to examine group differences in distress over time, while adjusting for potential confounding variables such as illness severity and phase of treatment. PUBLIC HEALTH RELEVANCE: Several national organizations, including the National Comprehensive Care Network, the National Cancer Institute, and the Institute of Medicine, have advocated routine screening for psychological distress among cancer patients and have emphasized the central role of building a collaborative patient-provider partnership to address psychosocial issues. The lack of consistent assessment of psychosocial factors and the patient-provider partnership is a significant problem with far-reaching consequences, including excess suffering, impaired quality of life, treatment dissatisfaction, and treatment non-adherence. The MHADRO has the potential to impact these outcomes through identifying distressed patients, helping the team decide what action should be taken, strengthening the patient-provider partnership, producing a personalized patient feedback report, facilitating mental health treatment engagement, and monitoring patients' response to treatment.