Clinical trial NCT02232074: Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment
Official title: Project SUPPORT (Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Patient Navigation
Medical Legal Partnership
Healthcare Disparities
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Patient-Centered Outcomes Research Institute
First posted: 2014-09-04
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants
timeFrame: Receipt of 1st treatment within 90 days from diagnosis
measure: Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants
timeFrame: Receipt of 1st treatment within 90 days from diagnosis
Secondary outcomes:
measure: Distress Thermometer at 3 Months for BREAST Cancer Patients
timeFrame: 3 months after enrollment
measure: Distress Thermometer at 3 Months for LUNG Cancer Patients
timeFrame: 3 months after enrollment
measure: Distress Thermometer at 6 Months for BREAST Cancer Patients
timeFrame: 6 months after enrollment
measure: Distress Thermometer at 6 Months for LUNG Cancer Patients
timeFrame: 6 months after enrollment
measure: Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients
timeFrame: 6 months post-enrollment
measure: Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients
timeFrame: 6 months post-enrollment
measure: Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients
timeFrame: 6 months post-enrollment
measure: Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients
timeFrame: 6 months post-enrollment
measure: Self-efficacy for BREAST Cancer Patients at 6 Months
timeFrame: 6 months post-enrollment
measure: Self-efficacy for LUNG Cancer Patients at 6 Months
timeFrame: 6 months post-enrollment
measure: Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis
timeFrame: Measured at 12 months
measure: Distress Thermometer at 12 Months for BREAST Cancer Patients
timeFrame: 12 months after enrollment
measure: Distress Thermometer at 12 Months for LUNG Cancer Patients
timeFrame: 12 months after enrollment
measure: Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients
timeFrame: 12 months post-enrollment
measure: Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients
timeFrame: 12 months post-enrollment
measure: Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients
timeFrame: 12 months post-enrollment
measure: Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients
timeFrame: 12 months post-enrollment
measure: Self-efficacy for BREAST Cancer Patients at 12 Months
timeFrame: 12 months post-enrollment
measure: Self-efficacy for LUNG Cancer Patients at 12 Months
timeFrame: 12 months post-enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Tracy A Battaglia, M.D., M.P.H
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Medical Center
name: Sharon Bak, M.P.H
role: STUDY_DIRECTOR
References: