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

NCT ID: NCT02232074

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2018-10-01

Brief 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.

Detailed 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:

1. a full socio-legal needs assessment and care plan in consultation with MLP; and

2. 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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Patient navigation enhanced with legal support

Intervention Type: 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient navigation enhanced with legal support

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Battaglia, Tracy

Associate Professor of Medicine and Epidemiology, Boston University School of Medicine, Chief of Women's Health Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracy A Battaglia, M.D., M.P.H

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Sharon Bak, M.P.H

Role: STUDY_DIRECTOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

RSG-13-368-01-CPPB

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AD-1304-6272

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-32599

Identifier Type: -

Identifier Source: org_study_id