Project SUPPORT (Socio-legal Services for Underserved Populations Thru Patient Navigation to Optimize Resources During Treatment)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02232074
Recruitment Status : Completed
First Posted : September 4, 2014
Last Update Posted : December 6, 2018
American Cancer Society, Inc.
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Battaglia, Tracy, Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Cancer Other: Patient navigation enhanced with legal support Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Project SUPPORT (Socio-legal Services for Underserved Populations Thru Patient Navigation to Optimize Resources During Treatment)
Actual Study Start Date : February 2014
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : October 1, 2018

Arm Intervention/treatment
Experimental: 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.
Other: Patient navigation enhanced with legal support
No Intervention: 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.

Primary Outcome Measures :
  1. Timely initiation of care [ Time Frame: Within 90 days from recruitment ]
    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 will be calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable will depend on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation, including but not limited to stage at diagnosis and co-morbid medical conditions.

Secondary Outcome Measures :
  1. Distress [ Time Frame: Baseline, 3, 6 and 12 months after enrollment ]
    Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument.

  2. Cancer Needs and Distress [ Time Frame: Baseline, 6, and 12 month ]
    Distress and patient centered needs will be assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 39-item self-report instrument that rates need and distress level in the past two weeks from a scale 5 -point Likert scale

  3. Self-efficacy [ Time Frame: Baseline, 6, and 12 month ]
    Self-Efficacy will be assessed through patient interviews utilizing the Communication and Attitudinal Self-Efficacy (CASE). The CASE is a 12-item instrument that rates self-efficacy in three domains: (1) seeking and obtaining information, (2) understanding and participating in care, and (3) maintaining a positive attitude.

  4. Patient Satisfaction [ Time Frame: 6 and 12 months ]
    Patient's satisfaction will be assessed through patient interviews utilizing the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. The 9-item instrument assesses the relationship with satisfaction with higher scores indicating higher satisfaction.

  5. Receipt of quality care [ Time Frame: Measured at 12 months ]
    The receipt of quality care will be defined as a dichotomous variable (Y/N) based on select measures of quality care, as developed jointly by the Commission on Cancer, NCCN and American Society of Clinical Oncology. Quality care will be measured using data abstracted from medical chart.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02232074

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
American Cancer Society, Inc.
Patient-Centered Outcomes Research Institute
Principal Investigator: Tracy A Battaglia, M.D., M.P.H Boston Medical Center
Study Director: Sharon Bak, M.P.H Boston Medical Center

Responsible Party: Battaglia, Tracy, Associate Professor of Medicine and Epidemiology, Boston University School of Medicine, Chief of Women's Health Unit, Boston Medical Center Identifier: NCT02232074     History of Changes
Other Study ID Numbers: H-32599
RSG-13-368-01-CPPB ( Other Grant/Funding Number: American Cancer Society )
AD-1304-6272 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Battaglia, Tracy, Boston Medical Center:
Patient Navigation
Medical Legal Partnership
Healthcare Disparities