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临床试验/NCT02594696
NCT02594696已完成不适用

Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Feasibility of implementing the intervention in patients with SMI and cancer

研究概览

简要总结

Individuals with severe mental illness (SMI) including schizophrenia and bipolar disorder are dying younger than the general population; cancer is a leading cause of death in this population. People with SMI have higher rates of dying from breast, lung, and colon cancer, and disparities in treatment appear to be one contributing factor. Individuals with SMI may be diagnosed with more advanced stage cancer and less likely to receive stage-appropriate cancer treatment. Although collaborative care models integrating medical and psychiatric care have shown promise in other populations, the challenge of treating SMI and cancer is distinct and relatively understudied. Patients may have uncontrolled psychiatric symptoms that can impact their understanding of their diagnosis and treatment decisions. Oncologists have less training and inadequate time to address multiple unmet needs. Mental health care is frequently fragmented from cancer care.

The investigators want to understand if it is helpful for patients with SMI to be connected to a psychiatrist and case manager when cancer is diagnosed. Optimizing psychiatric symptoms and facilitating communication between the patient, the oncology team, and mental health providers may improve care. The goal is to pilot a pragmatic intervention for patients with cancer and SMI that can be integrated into cancer care, is acceptable to patients and oncology clinicians, and may promote the delivery of stage-appropriate cancer treatment to an underserved population.

Patients will be connected to a psychiatrist and case manager at cancer diagnosis who will follow the patient and communicate with the oncology team during the 12 week intervention. All participants will complete brief surveys at baseline, 4 weeks, and 12 weeks. Oncology clinicians will provide feedback about the intervention at 12 weeks. Cancer treatment received and healthcare utilization will be assessed at 6 months post-intervention.

详细描述

Specific Aims:

Aim 1: To evaluate the feasibility and acceptability of proactive psychiatry consultation and case management among individuals with SMI treated at the MGH Cancer Center and their oncology clinicians.

Aim 2: To describe the rates of receipt of stage-appropriate cancer treatment and patterns of healthcare utilization in patients with SMI and cancer who are receiving the intervention

Aim 3: To explore patterns of change in psychiatric symptoms, quality of life, illness understanding, and alliance with the oncology clinician in patients with SMI and a recent cancer diagnosis who are receiving the intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with a diagnosis of a primary psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder), bipolar disorder, or major depressive disorder with prior psychiatric hospitalization, confirmed by diagnostic assessment of the PI, a psychiatrist with expertise in SMI and cancer
  • Within 8 weeks of initial oncology consultation at the MGH Cancer Center (patients who come for a second opinion and opt to have their cancer treatment at MGH will be considered eligible, patients who have been treated previously for other types of cancer will be considered eligible).
  • Age >18 years old, verbal fluency in English
  • Suspected or newly diagnosed lung, GI, head/neck, or breast cancer documented in initial oncology note or confirmed by pathology

排除标准

  • Cognitive impairment severe enough to interfere with completing the study assessments or providing informed consent
  • History of dementia or traumatic brain injury
  • Refuse participation

结局指标

主要结局

Feasibility of implementing the intervention in patients with SMI and cancer

时间窗: 12 weeks

Feasibility of participating in the intervention: * At least 75% of intervention participants complete the psychiatric diagnostic assessment and establish contact with the case manager * At least 75% of enrolled patients complete the patient-reported measures. Feasibility of enrollment process: • At least 50% of patients who are approached enroll in the intervention

次要结局

  • Change in alliance with the oncology clinician(Baseline to 12 weeks post intervention)
  • Rates of receipt of healthcare utilization in the acute care setting(6 Months)
  • Acceptability of the intervention for patients with SMI and cancer and oncology clinicians(12 weeks)
  • Rates of receipt of healthcare utilization in the outpatient setting(6 Months)
  • Change in quality of life(Baseline to 12 weeks post intervention)
  • Change in illness understanding(Baseline to 12 weeks post intervention)
  • Rates of receipt of stage-appropriate cancer treatment(6 Months)
  • Change in clinician-rated psychiatric symptoms(Baseline to 12 weeks post intervention)
  • Change in clinician-rated psychiatric illness severity(Baseline to 12 weeks post intervention)
  • Change in self-reported psychiatric symptoms(Baseline to 12 weeks post intervention)
  • Change in self-reported depression symptoms(Baseline to 12 weeks post intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelly Edwards Irwin

Instructor, Harvard Medical School

Massachusetts General Hospital

研究点 (2)

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