Lindsey R Enewold, Ph.D.

Background:

The SEER database collects data about people with cancer. SEER stands for Surveillance, Epidemiology, and End Results. Medicaid is a kind of health insurance. It is for people who have low income or serious medical needs. Many studies have shown that Medicaid recipients with cancer are more likely to be diagnosed later in the disease than people with other insurance. They are also less likely to get treatment. Researchers want to compare Medicaid data and SEER data. They want to make this available to other scientists.

Objectives:

To link people in the SEER database to Medicaid data for the years around their cancer diagnosis. To create a file that contains SEER case numbers linked to Medicaid numbers.

Eligibility:

No people are enrolled in this study.

Design:

The SEER finder file will be securely uploaded to the CMS Data Center.

The finder file will be matched against the Medicaid Personal Summary file at the CMS Data Center.

If participants appear in both the SEER file and Medicaid file, their data will be extracted.

The dates of Medicaid data will be compared with the SEER date of diagnosis. Researchers will see if the Medicaid dates fall in certain periods. These are 12 months before, the month of, and 11 months after diagnosis.

If participants are eligible for Medicaid for these periods, a flag will be created in the file. It will note the participants is eligible and why.

The SEER finder file will be destroyed.

The only data saved will be:

Each participant's unique random SEER case number linked to their Medicaid number

Monthly flags about Medicaid eligibility

Numerous studies have demonstrated that Medicaid recipients with cancer are more likely to be diagnosed at an advance stage and less likely to receive recommended treatment than are patients with other types of health insurance. The objective of this project is to link persons included in the Surveillance, Epidemiology and End Results (SEER) data to Medicaid enrollment information during the year before and after their cancer diagnosis. NCI is also seeking permission to create and maintain a file that crosswalks each patient's SEER case number to their Medicaid enrollment number. Information about Medicaid enrollment would be available by special request to all researchers who want to use SEER data to assess the impact of Medicaid enrollment on stage and treatment.

Linkage of Medicaid Enrollment Information to Surveillance, Epidemiology and End Results Data

Linkage of Medicaid Enrollment Lnformation to Surveillance, Epidemiology and End Results Data

National Cancer Institute (NCI)

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.

These patients will receive standard patient navigation which will work to ensure that services are coordinated amongst medical personnel, while also addressing patients' needs.

Patient navigation enhanced with legal support

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

Sharon Bak, M.P.H

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.

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.

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

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

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 was calculated from date of diagnosis (Time0) to date of treatment initiation (Time1) .The date chosen for the Time1 variable depends on the recommended care plan for each patient, as derived from the chart abstraction and based on patient presentation.

Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable.

Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress).Lower values are more favorable.

Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=4.10. Lower values are more favorable.

Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. For this analysis, the mean total score is reported with the minimum value=1 and the maximum value=2.3. Lower values are more favorable.

Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher values are more favorable.

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. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.

The receipt of quality care is defined as receiving radiation to the breast within one year of a breast cancer diagnosis if: under the age of 70, estrogen or progesterone tumor positive and had breast conserving surgery.

Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower values are more favorable

Distress will be assessed through patient interviews utilizing the Distress Thermometer (DT) instrument with a scale from 0 (no distress) to 10 (extreme distress). Lower scores are more favorable.

Patient needs were assessed through patient interviews utilizing the Cancer Needs Distress Inventory (CaNDI) instrument. The CaNDI is a 38-item self-report instrument that rates need and distress level in the past two weeks using a 5 -point Likert scale where 1=not a problem to 5=very severe problem. The mean total score is reported.

Patient's satisfaction assessed through the Patient Satisfaction with Interpersonal Relationship with Navigator Measure (PSN-1) questionnaire. Each question of the 9-item instrument has a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Responses are summed for a total score. The higher the score, the higher patient's satisfaction with navigation. The minimum value=9 and the maximum value=45. Higher scores are more favorable.

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. A higher score indicates a positive attitude and strong self-efficacy. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.

American Cancer Society, Inc.

Patient-Centered Outcomes Research Institute

Boston Medical Center

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

Involvement in this study has minimal risks. The main potential risk of this study is loss of confidentiality. As multiple safeguards were in place, including keeping files in a locked cabinets and only conducting data analysis on a data set that is coded and does not contain any direct identifiers.

For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.

Patient Navigation With Legal Support

For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation

Standard Patient Navigation

Total

Analysis includes those participants with at least 1 legal concern at baseline.

Age, Continuous

Sex: Female, Male

Race / Ethnicity

Race/Ethnicity, Customized

Language

Insurance

Tracy Battaglia

Compared to the control group, the Breast cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).

For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.

Breast Cancer Intervention

For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.

Breast Cancer Control

breast cancer participants with 1 or more legal concern as screened at baseline using the IHELP survey.

Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants

Compared to the control group, the Lung cancer INTERVENTION group will be more likely to have timely first treatment (i.e. receipt of first treatment within 90 days of diagnosis).

For lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.

Lung Cancer Intervention

For lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.

Lung Cancer Control

Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants

Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 3 months post-enrollment

The number of Intervention participants decreased by 5 to 99 and Control participants decreased by 3 to 90 due to missing Distress Thermometer data at 3 months.

Distress Thermometer at 3 Months for BREAST Cancer Patients

Compared to the control group, the LUNG cancer INTERVENTION group will have less distress at 3 months post-enrollment

The number of LUNG Control participants decreased by 3 for a total of 8 due to missing Distress Thermometer data at 3 months.

Distress Thermometer at 3 Months for LUNG Cancer Patients

Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 6 months post-enrollment

The number of BREAST Intervention participants decreased by 13 for a total of 91 and Control participants decreased by 8 for a total of 58 due to missing Distress Thermometer data at 6 months.

Distress Thermometer at 6 Months for BREAST Cancer Patients

Compared to the control group, the Lung cancer INTERVENTION group will have less distress at 6 months post-enrollment

The number of LUNG Intervention participants decreased by 2 for a total of 6 and Control patients decreased by 4 due to missing Distress Thermometer data at 6 months.

Distress Thermometer at 6 Months for LUNG Cancer Patients

The number of Breast Intervention participants decreased by 13 to 91 and the Control participants decreased by 8 to 85 due to missing CaNDi data at 6 month follow up

Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients

For Lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.

For Lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.

The number of Lung Intervention participants decreased by 2 to 6 and the Control participants decreased by 4 to 7 due to missing CaNDi data at 6 month follow up

Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients

Compared to the control group, the Breast cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment

Linear regression tested for an association between the intervention \& control groups in satisfaction with patient navigation at six months post-enrollment. The number of Breast Intervention participants decreased by 52 to 52 and the Control participants decreased by 41 to 52 due to missing Patient Satisfaction data at 6 month follow up

Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients

Compared to the control group, the Lung cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollment

Linear regression tested for an association between the intervention \& control groups in satisfaction with patient navigation at six months post-enrollment. The number of LUNG Intervention participants decreased by 4 to 4 and the Control participants decreased by 8 to 3 due to missing Patient Satisfaction data at 6 month follow up

Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients

Compared to the control group, the breast cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.

Within each cancer group (breast \& lung cancers analyzed separately), a linear regression was used to test whether there was an association between the intervention \& control groups in self-efficacy at six months post-enrollment, adjusting for baseline CASE Cancer score.

Self-efficacy for BREAST Cancer Patients at 6 Months

Compared to the control group, the lung cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.

Self-efficacy for LUNG Cancer Patients at 6 Months

We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will receive quality care (i.e. receipt of radiation within one year of diagnosis).

Excluded those women who did not meet requirements for receipt of radiation: over 70 years of age, with tumor negative for estrogen or progesterone

Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis

We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will have less distress at 12 months post-enrollment.

The number of BREAST Intervention participants decreased by 22 for a total of 82 and Control participants decreased by 18 for a total of 75 due to missing Distress Thermometer data at 12 months.

Distress Thermometer at 12 Months for BREAST Cancer Patients

We hypothesize that compared to the control group, the Lung cancer INTERVENTION group will have less distress at 12 months post-enrollment

The number of LUNG Intervention participants decreased by 3 for a total of 5. Control participants decreased by 6 for a total of 5 due to missing data at 12 months follow up.

Distress Thermometer at 12 Months for LUNG Cancer Patients

The number of BREAST Intervention participants decreased by 23 for a total of 81. The Control participants decreased by 18 for a total of 75 due to missing CaNDI data at 12 months.

Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients

Lung cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.

Lung cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.

Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients

The number of BREAST Intervention participants decreased by 52 for a total of 52 and Control participants decreased by 55 for a total of 38 due to missing data at 12 months post-enrollment.

Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients

The number of Lung Intervention participants decrease by 5 for a total of 3 and the number of Lung Control participants decreased by 7 for a total of 4 due to missing data at 12 months.

Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients

The number of BREAST Intervention participants decreased by 23 for a total of 81 and for control participants by 19 for a total of 74 due to missing values at 12 months post-enrollment.

Self-efficacy for BREAST Cancer Patients at 12 Months

The number of Lung Intervention participants decrease by 3 for a total of 5 and the number of Lung Control participants decreased by 6 for a total of 5 due to missing data at 12 months.

Self-efficacy for LUNG Cancer Patients at 12 Months

Overall Study

Standard patient group: advanced cancer patients receiving limited and acceptable care without access to advanced genetic testing tools or expertise; patients at facility prior to deployment of TSO500, ELIA, and molecular tumor boards.

Same patient population at the same facility after deployment of TSO500, ELIA, and molecular tumor board support.

TSO500; detect single nucleotide variants (SNV), INDELs, copy number alterations (CNAs), microsatellite instability (MSI), and tumor mutation burden (TMB) in eligible patients; ELIA software to interface clinic EMR to lab; Consultations and molecular tumor boards by molecular genetic pathologist (MGP)

Comprehensive Genomic Profile testing; ELIA software; Molecular Genetic Pathologist consultation

Minimal genetic testing for eligible patients or treatment without testing

limited genetic testing or no testing

Haydee Diaz, MBASCP

Lenee Bien-Willner, MS

Niyati Nathwani, MD

Gabriel A Bien-Willner, MD, PhD

The goal of this observational study is to measure and try to reduce leakage in precision medicine care in the community cancer clinic. The goal of precision medicine is to identify the best possible therapy the the patient based on the biology of the tumor. Leakage is defined as a failure or inefficiency of the system that leads to dropped or lost testing, reporting or action (including drug selection). It has been observed that there are healthcare disparities in the community setting compared to academic medical centers, particularly in the use of precision medicine. The main questions the study aims to answer are:

* How much leakage occurs in the use of precision medicine in the community setting?
* Can we reduce leakage by providing access to better tools and services typically found in the academic medical centers? Participants will not be directly impacted and will receive standard of care. Measurements will be made of how often physicians select the appropriate test for patients, and how often they select the most appropriate therapy for their patients before and after the implementation of tools created to reduce leakage.

We hope to reduce leakage in with the use of advanced tools and services, and use this study as a model to improve healthcare in the community cancer setting.

Precision Medicine in oncology requires the application of molecular diagnostic reporting to inform clinical decision making. However, its implementation has been slow and inefficient. Recent studies have demonstrated that contrary to new established standards of care and guidelines, eligible patients are often not getting the appropriate testing and test results are not being used appropriately to identify optimal therapies. This is especially true in the community oncology setting, resulting in healthcare disparities.

The investigators believe that the lack of efficiency and adoption of precision medicine is caused by "leakage" in the process of deploying genomic testing and reporting. Leakage is defined as a failure or inefficiency of the system that leads to dropped or lost testing, reporting or action (including drug selection). Evidence suggests that leakage occurs at many steps of the process, and it is much more common in the community setting. A great deal of leakage occurs in the handling of ordering, retrieving, and tracking of external testing for necessary molecular diagnostic tests, the lack of integration between ordering facility and the laboratory, and a lack of expertise with understanding the complex reports.

This study aims to supply a community oncology practice with expertise, best-in-class testing, and integrative solutions to try to reduce leakage and reduce care disparities between the community clinic and large academic cancer centers.

This study will include a retrospective component, where the investigators will measure leakage (a predefined series of metrics)at a community cancer center over a six month period.

The investigators will then deploy a series of tools and services, including:

* Molecular Genetic Pathology expertise for tumor boards and case support
* Access to a best-in-class molecular test (TSO500)
* A software solution to improve data access between the clinic and lab (EMR-Lab Integration Application, ELIA) that was especially designed to reduce leakage in the community cancer care setting.

These services will be implemented for at least one year. The investigators will then remeasure the metrics over a year and see if there is a decrease in leakage.

It is expected that the deployment of expertise, improved testing, and improved data access and communication will reduce leakage and lead to improved patient care and outcomes. It is hoped that this will serve as a model to decrease healthcare disparities in cancer patients in the community setting.

Formalin-fixed, paraffin-embedded tumor material for clinical testing, extracted DNA and RNA

Molecular Services and EMR-Lab Integration Application (ELIA) for Reducing Healthcare Disparities in Cancer Patients

Molecular Services and EMR-Laboratory Integration Application (ELIA) for Reducing Leakage and Improving Healthcare Disparities in Cancer Patients

Demonstration that deployment of SOC services and ELIA improves % of eligible patients placed on appropriate targeted therapies according to guidelines

Demonstration that standard-of-care services and ELIA improves turnaround times for getting actionable results, allowing physicians to make timely decisions.

defined as 1: FDA-approved targeted therapy on indication; 2- recommendation on non-FDA approved indication

percentage of patients getting the correct targeted treatment identified by testing

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Linkage of Medicaid Enrollment Information to Surveillance, Epidemiology and End Results Data	NCT02875327	Neoplasm Health Services... Outcome Assessm... Healthcare Disp...		1 Year - 120 Years	National Institutes of Health Clinical Center (CC)
Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment	NCT02232074	Cancer	Patient navigat...	18 Years -	Boston Medical Center
Molecular Services and EMR-Lab Integration Application (ELIA) for Reducing Healthcare Disparities in Cancer Patients	NCT06090513	Advanced Cancer Solid Tumor, Ad... Myeloid Maligna...	Comprehensive G... limited genetic...	18 Years -	Bien-Willner Physicians Group PA
Molecular Services and EMR-Lab Integration Application (ELIA) for Reducing Healthcare Disparities in Cancer Patients	NCT06090513	Advanced Cancer Solid Tumor, Ad... Myeloid Maligna...	Comprehensive G... limited genetic...	18 Years -	Bien-Willner Physicians Group PA

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