Breast Cancer Clinical Trial

Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment

Summary

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.

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Full Description

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.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

306

Study ID:

NCT02232074

Recruitment Status:

Completed

Sponsor:

Boston Medical Center

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There is 1 Location for this study

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Boston Medical Center
Boston Massachusetts, 02118, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

306

Study ID:

NCT02232074

Recruitment Status:

Completed

Sponsor:


Boston Medical Center

How clear is this clinincal trial information?

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