Project SUPPORT (Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants
研究概览
简要总结
The investigators plan to compare standard patient navigation with an enhanced navigation partnered with the Medical Legal Partnership | Boston (MLP) to determine if assessing legal needs of newly diagnosed cancer patients in addition to other barriers to care leads to better clinical outcomes.
详细描述
Differences and delays in the delivery of cancer care lead to more advanced cancer at the time of diagnosis and ultimately to more deaths for low-income and minority communities. Our group helped develop a patient-navigation model using lay health workers to address patient barriers and coordinated cancer-care services, leading to more timely care. Despite the fact that patient navigation is now a standard required by the Commission on Cancer, the investigators' research shows that delays in care persist for our low-income patients with socio-legal barriers. Socio-legal barriers are defined as social problems related to meeting life's most basic needs that are supported by public policy or programming and thus potentially remedied through legal advocacy/action (e.g., unsafe/unstable housing, unlawful utility shutoffs, or job termination). Direct feedback from cancer patients suggests a critical need to address socio-legal barriers in order to achieve quality care for all. To expand the current impact of patient navigation on quality care for low-income patients, the investigators will partner with patients, key community stakeholders, and the Medical-Legal Partnership (MLP)|Boston, the founding site of a nationwide program assisting healthcare teams in addressing socio-legal barriers to health. Under direction from a Patient Advisory Group and a Community Advisory Board, the investigators will conduct a study to compare standard navigation with an MLP navigation intervention enhanced by legal support for low-income cancer patients.
The investigators will enroll 374 low-income, racially diverse, newly diagnosed cancer patients. Half will receive standard navigation, i.e., a lay navigator integrated into the healthcare team who provides one-on-one patient contact to address traditional system barriers to care. The other half will receive MLP navigation, i.e., standard navigation enhanced by legal support including:
- a full socio-legal needs assessment and care plan in consultation with MLP; and
- legal assistance for eligible urgent legal needs. We will compare each group on all outcomes.
Compared to standard navigation, we expect that addressing socio-legal barriers to care with MLP navigation will improve patient-reported outcomes and lead to more timely care delivery. Because of widespread national availability of patient navigation and MLP programs at hospitals serving vulnerable patients, this intervention can be quickly replicated to improve patient experience and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed breast and lung cancer patients
- •Within 30 days of patient being informed of diagnosis
- •Receiving cancer care at Boston Medical Center
- •No history of cancer treatment in past 5 years
- •No cognitive impairments
- •Over 18 years of age
- •Speak English, Spanish or Haitian Creole
排除标准
- •Patient informed of cancer diagnosis >30 days
- •Patient under 18 yrs. of age
- •Primary language something other than English, Spanish or Haitian Creole
- •Undergoing treatment for concurrent cancer
- •Patient has history of cancer or has received cancer treatment within the last 5 years
- •Institutionalized/cognitive impairment (such as: dementia or metabolic, medication or drug induced), given the unique challenges to their treatment decision making/adherence and the fact that the intervention would not include the patient directly, but rather the family.
研究组 & 干预措施
Patient navigation enhanced with legal support
In addition to receiving standard navigation, patients will be connected with a Patient Navigator who is partnered with a lawyer from Medical-Legal Partnership to provide personalized assistance with regard to social-legal barriers.
干预措施: Patient navigation enhanced with legal support (Other)
Standard patient navigation
These patients will receive standard patient navigation which will work to ensure that services are coordinated amongst medical personnel, while also addressing patients' needs.
结局指标
主要结局
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants
时间窗: Receipt of 1st treatment within 90 days from diagnosis
The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants
时间窗: Receipt of 1st treatment within 90 days from diagnosis
The receipt of timely care will be defined as initiation of care within 90 days, as this the shortest delay that has been shown to consistently affect mortality The time element was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.
次要结局
- Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients(6 months post-enrollment)
- Distress Thermometer at 3 Months for LUNG Cancer Patients(3 months after enrollment)
- Distress Thermometer at 6 Months for BREAST Cancer Patients(6 months after enrollment)
- Distress Thermometer at 6 Months for LUNG Cancer Patients(6 months after enrollment)
- Distress Thermometer at 3 Months for BREAST Cancer Patients(3 months after enrollment)
- Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients(6 months post-enrollment)
- Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients(6 months post-enrollment)
- Distress Thermometer at 12 Months for BREAST Cancer Patients(12 months after enrollment)
- Distress Thermometer at 12 Months for LUNG Cancer Patients(12 months after enrollment)
- Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients(12 months post-enrollment)
- Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients(12 months post-enrollment)
- Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients(6 months post-enrollment)
- Self-efficacy for BREAST Cancer Patients at 6 Months(6 months post-enrollment)
- Self-efficacy for BREAST Cancer Patients at 12 Months(12 months post-enrollment)
- Self-efficacy for LUNG Cancer Patients at 12 Months(12 months post-enrollment)
- Self-efficacy for LUNG Cancer Patients at 6 Months(6 months post-enrollment)
- Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis(Measured at 12 months)
- Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients(12 months post-enrollment)
- Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients(12 months post-enrollment)
研究者
Battaglia, Tracy
Associate Professor of Medicine and Epidemiology, Boston University School of Medicine, Chief of Women's Health Unit
Boston Medical Center