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.
Professional Abstract
Objective
To compare the effectiveness of a patient navigation program enhanced by legal support with standard patient navigation on improving timely treatment among patients newly diagnosed with breast or lung cancer
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 220 patients newly diagnosed with breast or lung cancer and at least 1 reported socio-legal need |
| Interventions/ Comparators |
|
| Outcomes | Primary: timely treatment Secondary: days to first treatment, quality of cancer care, rate of missed appointments, degree of patient distress, number of cancer-related needs, satisfaction with patient navigation, number of socio-legal needs |
| Timeframe | 3-month follow-up for primary outcome |
Patients with limited resources often face structural barriers to cancer care, including socio-legal barriers. Socio-legal barriers are problems that may interfere with health care and may be resolved through legal advocacy. Examples of socio-legal barriers include unsafe housing, utility shutoffs, or job loss. This randomized controlled trial compared the effectiveness of Project SUPPORT (Socio-legal Services for Underserved Populations through Patient Navigation to Optimize Resources during Treatment), a program designed to address socio-legal barriers to cancer treatment, with standard patient navigation on improving timely treatment, defined as patients’ initiation of cancer treatment within 90 days of their diagnosis.
Researchers randomized patients to receive either Project SUPPORT or standard patient navigation. Patients in both groups worked with a trained community health worker (CHW) who reviewed patients’ treatment plans, helped identify barriers to care, made a plan to address barriers, and remained in communication over the course of patients’ treatment. For patients in Project SUPPORT, CHWs also
- Completed an in-depth needs assessment to identify concerns about housing, employment, and disability benefits that are socio-legal barriers to care
- Provided information or collaborative socio-legal problem-solving support as needed
- Connected patients with free legal assistance for eligible urgent needs
The study included 220 patients with breast or lung cancer who were diagnosed in the previous 30 days and were receiving care at a medical center in Boston, Massachusetts. Of these, 50% were black, 24% were white, and 4% were another race; 22% were Hispanic. The average age was 55, and 96% were female; 91% had breast cancer, and 9% had lung cancer. All patients had health insurance; of these, 74% had public insurance, and 26% had private insurance. All had at least one socio-legal need.
Researchers used electronic health records to assess timely treatment and the rate of missed appointments. Patients completed a survey that addressed the remaining secondary outcomes at baseline and again three months later.
Patients, providers, CHWs, and legal advocates provided input on all aspects of the study.
Results
After three months, patients in Project SUPPORT and those receiving standard patient navigation did not differ in any primary or secondary outcomes.
Limitations
Patients in both groups initiated timely treatment at high rates, which may have made it difficult to demonstrate the impact of Project SUPPORT. Because only 9% of patients had lung cancer and 4% were male, researchers were unable to draw conclusions about those patients’ experiences.
Conclusions and Relevance
In this study, patients receiving legal problem solving and assistance through Project SUPPORT did not have higher rates of timely treatment than patients receiving standard patient navigation.
Future Research Needs
Future research could explore ways to promote timely treatment among patients newly diagnosed with cancer for whom socio-legal needs interfere with access to health care.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
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.