Improving Care Delivery for Patients With Mental Illness and Cancer Across a Cancer Center Network (BRIDGE-NET)
2026年7月15日 更新者：Kelly Edwards Irwin、Massachusetts General Hospital
Improving Care Delivery for Individuals With Mental Illness and Cancer Across a Cancer Center Network: A Randomized Trial
The proposed project is an implementation-effectiveness randomized trial of a person-centered collaborative care model for patients with serious mental illness and new cancer.
The BRIDGE NET intervention is theoretically informed, pragmatic, and delivered virtually by an interdisciplinary team and includes early psychiatry consultation, integrated oncology and mental health treatment planning and regular patient outreach to adddress barriers to care.
The BRIDGE NET intervention addresses the unique needs of patients with mental illness and cancer.
To increase the reach of specialty cancer and mental health care, there is a critical need for interventions that can be delivered virtually.
This work has can inform the standard of care for patients with serious mental illness and cancer and lay the groundwork for future multi--site trials.
研究概览
详细说明
This is a hybrid type I effectiveness-implementation randomized trial to evaluate the efficacy of the BRIDGE NET intervention.
The proposed project addresses multiple modifiable disparities in cancer treatment and outcomes for a marginalized population of adults with SMI, who experience inequities in cancer treatment.
The BRIDGE NET intervention is theoretically informed, pragmatic, and able to be delivered virtually by a diverse clinical team.
Informed by qualitative interviews with clinicians and collaboration with a community advisory board, the investigators rigorously developed, piloted and tested the BRIDGE NET intervention and tailored the approach to the unique needs of patients with SMI and cancer.
To increase the reach of specialty care and the limited mental health workforce, there is a critical need for interventions that can be delivered virtually.
This work has potential to be foundational for future multi-site trials across national community oncology research networks.
研究类型
介入性
注册 (估计的)
248
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kelly Irwin, MD, MPH
- 电话号码：617-726-2000
- 邮箱：kirwin1@mgb.org
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- be ≥18 years
- have a prior diagnosis of SMI, defined as schizophrenia spectrum disorder, bipolar disorder, or major depressive disorder with previous psychiatric hospitalization
- have a new primary diagnosis of invasive breast, head/neck, gastrointestinal (GI), genitourinary (GU), thoracic, or gynecological cancers that can be treated with curative intent
- be within 8 weeks of initial oncology consultation at or referral to a community cancer affiliate site of the Mass General Brigham Cancer Institute at MGH
- be able to read and write in English, Spanish, or Portuguese
Exclusion Criteria:
-
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：BRIDGE NET Intervention Arm
BRIDGE NET is a 24-week person-centered collaborative care intervention that engages a multidisciplinary team to improve cancer outcomes for patients with SMI and new cancers.
|
BRIDGE is a 24-week person-centered collaborative care intervention that engages a multidisciplinary team to improve cancer outcomes for patients with SMI and new cancers.
Modules include Evaluation, Treatment Planning, Weekly Outreach, Biweekly Outreach, and Transition Planning.
|
|
无干预：Enhanced Usual Care Arm
EUC includes proactive identification of patients with SMI and a new cancer diagnosis, sending a templated email to the oncologist describing the patient's primary psychiatric diagnosis (e.g.
schizophrenia, bipolar disorder, or major depression), and informing the patient of psychosocial services.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cancer Care Disruption
大体时间：24 weeks
|
Primary outcome is the proportion of patients who experience clinically relevant disruptions (at least one delay to cancer treatment initiation, deviation from stage-appropriate cancer treatment, or interruption in planned treatment) within 24 weeks of study enrollment.
|
24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to cancer treatment initiation
大体时间：Up to 24 weeks
|
Study staff will assess time to cancer treatment (interval from initial oncology consultation to cancer treatment initiation).
|
Up to 24 weeks
|
|
Depression (PHQ-9)
大体时间：Baseline, 6 weeks, 12 weeks, 24 weeks
|
The PHQ-9 (Patient Health Questionnaire-9) is a standardized, 9-item self-report tool used by healthcare providers to screen for, diagnose, and measure the severity of depression.
Higher score indicates more severe depression symptoms (minimum 0, maxiumum 27).
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
|
Anxiety (GAD-7)
大体时间：Baseline, 6 weeks, 12 weeks, 24 weeks
|
The GAD-7 (Generalized Anxiety Disorder-7) is a brief 7-item questionnaire used by healthcare providers to screen for Generalized Anxiety Disorder and measure the severity of anxiety symptoms.
Higher scores indicate higher anxiety symptoms.
(Minimum score 0, Maximum score 21).
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月1日
初级完成 (估计的)
2030年1月31日
研究完成 (估计的)
2030年7月31日
研究注册日期
首次提交
2026年7月6日
首先提交符合 QC 标准的
2026年7月15日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年7月16日
上次提交的符合 QC 标准的更新
2026年7月15日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
If the results of this research study are published in a medical journal, they will not identify individual patients in the interest of protecting patient privacy and confidentiality.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
BRIDGE NET的临床试验
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Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)尚未招聘
-
Andrew ParrentUniversity of Western Ontario, Canada; Synaptive Medical未知
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Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)招聘中
-
National Cancer Institute (NCI)招聘中鼻咽癌 | 嗅神经母细胞瘤 | 感觉神经母细胞瘤 | 生长抑素受体阳性 | 头颈部肿瘤 | 小细胞肺癌 | 胃肠道神经内分泌肿瘤 | 嗜铬细胞瘤/副神经节瘤 | 肾癌 | Sinonasal Neuroendocrine Carcinoma美国
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National Cancer Institute (NCI)招聘中嗜铬细胞瘤 | 生长抑素受体阳性 | 副神经节瘤 | 胃肠道神经内分泌肿瘤美国