Results Summary

What was the research about?

People with limited resources often have socio-legal problems that interfere with getting timely health care. Socio-legal problems are issues that may need legal action to get solved. These issues include unsafe housing, utility shutoffs, or job loss. Patients may delay getting the health care they need because of socio-legal problems.

In this study, the research team created a program to address socio-legal problems that may delay getting cancer care. The program included support to help patients

  • Identify socio-legal barriers to care
  • Provide information and solve problems as needed
  • Connect with free legal help for eligible urgent needs

The research team compared patients in the program with patients who received standard support.

What were the results?

After three months, patients in the program and those getting standard support didn’t differ in

  • Whether they received care within 90 days of being diagnosed
  • How soon they got their first treatment after diagnosis
  • How often they missed appointments
  • How many needs they had that were related to cancer or socio-legal problems
  • How they rated their quality of cancer care and the support they received
  • How much distress they felt

Who was in the study?

The study included 220 breast and lung cancer patients diagnosed in the previous 30 days. All patients received care at a medical center in Boston, Massachusetts. Of these, 50 percent were black, 24 percent were white, and 4 percent were another race; 22 percent were Hispanic. The average age was 55, and 96 percent were women. Also, 91 percent had breast cancer, and 9 percent had lung cancer. All patients had health insurance; 74 percent had public health insurance, and 26 percent had private health insurance. All had at least one socio-legal need.

What did the research team do?

The research team assigned patients by chance to be in the program or receive standard support. Patients in each group received support from a community health worker, or CHW, who helped patients review their treatment plans and find ways to reduce barriers to cancer care. CHWs are trained to link people in the community with health and social services. For patients in the program, CHWs also helped with socio-legal problems that might delay patients’ cancer care.

The research team looked at patients’ health records to see when they received their first treatment and how often they missed appointments. Patients completed a survey about distress, quality of care and support, and their needs related to cancer or socio-legal problems at the start of the study and again three months later.

Patients, providers, CHWs, and legal advocates gave input on the study.

What were the limits of the study?

Many patients in the study started treatment within 90 days, making it hard to see if the program worked better than standard support. Because only 9 percent of patients had lung cancer and 4 percent were men, the research team couldn’t say how the program worked for those patients.

Future research could explore ways to improve timely cancer care among patients for whom socio-legal problems delay treatment.

How can people use the results?

Clinics can consider the results when looking for ways to help patients address problems that delay cancer care.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers noted that the setting of the study may affect how broadly the study’s findings apply. Specifically, Massachusetts has strong programs for ensuring access to health insurance that are not available in other states. The researchers added to the limitations section by noting that the results may not be generalizable to other settings since they conducted this study in a single urban safety net hospital and all patients had health insurance coverage.
  • The reviewers said that the study intervention and the experiences of the comparator arm were not clear. Specifically, reviewers were unclear about what services the navigators were providing as part of the intervention rather than referring out. The researchers revised the descriptions of the intervention and comparator conditions in the methods section by adding more detail. They explained that the comparator group was provided with enhanced care navigation compared to patients not enrolled in the study.
  • The reviewers asked for clarification on what the researchers meant by socio-legal barriers and whether these are issues that social workers, professional case managers, or lawyers can address. The researchers acknowledged that the concept is complex and revised the report to clarify what they meant by socio-legal barriers and how such barriers shape the current public health landscape. The researchers said they designed the intervention to avert acute legal crises like homelessness but also had procedures to provide patients with free help from lawyers if necessary.

Reviewers asked whether researchers conducted study analyses on the larger group of patients or only on the patients who met the original entry criteria. The researchers confirmed that the study population included only the participants who met the necessary criteria, including demonstrating at least one legal need. The researchers did not include participants with no legal needs at baseline in the analyses, but these individuals still received the full intervention in their clinics.

Conflict of Interest Disclosures

Project Information

Tracy A. Battaglia, MD, MPH
Boston Medical Center
$1,745,683 *
Eliminating Patient-Identified Socio-Legal Barriers to Cancer Care

Key Dates

September 2013
September 2019

Study Registration Information

Final Research Report

View this project's final research report.

Journal Articles


Has Results
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Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
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Last updated: October 18, 2023