Trial Outcomes & Findings for Socio-legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment (NCT NCT02232074)

NCT ID: NCT02232074

Last Updated: 2019-10-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 306 participants
• Primary outcome timeframe: Receipt of 1st treatment within 90 days from diagnosis
• Results posted on: 2019-10-15

Participant Flow

Participant milestones

Measure	Patient Navigation With Legal Support For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.	Standard Patient Navigation For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation
Overall Study STARTED	154	152
Overall Study COMPLETED	113	107
Overall Study NOT COMPLETED	41	45

Reasons for withdrawal

Measure	Patient Navigation With Legal Support For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.	Standard Patient Navigation For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation
Overall Study Withdrawal by Subject	5	3
Overall Study No legal concerns at baseline	36	41
Overall Study deemed ineligible	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Patient Navigation With Legal Support n=113 Participants For those with legal concerns at baseline identified by the IHELP screening tool, intervention participants received Patient Navigation enhance with legal support.	Standard Patient Navigation n=107 Participants For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation	Total n=220 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 11.0 • n=5 Participants • Analysis includes those participants with at least 1 legal concern at baseline.	54.7 years STANDARD_DEVIATION 11.0 • n=7 Participants • Analysis includes those participants with at least 1 legal concern at baseline.	55.1 years STANDARD_DEVIATION 11.4 • n=5 Participants • Analysis includes those participants with at least 1 legal concern at baseline.
Sex: Female, Male Female	109 Participants n=5 Participants	102 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · White	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Hispanic	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Black \ African-American	60 Participants n=5 Participants	51 Participants n=7 Participants	111 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Other	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Language English	87 Participants n=5 Participants	71 Participants n=7 Participants	158 Participants n=5 Participants
Language Spanish	17 Participants n=5 Participants	27 Participants n=7 Participants	44 Participants n=5 Participants
Language Haitian Creole	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Insurance Public	83 Participants n=5 Participants	79 Participants n=7 Participants	162 Participants n=5 Participants
Insurance Private	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: Receipt of 1st treatment within 90 days from diagnosis

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

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.

Outcome measures

Measure	Breast Cancer Intervention n=98 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=96 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants	94 Participants	92 Participants

PRIMARY outcome

Timeframe: Receipt of 1st treatment within 90 days from diagnosis

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.

Outcome measures

Measure	Breast Cancer Intervention n=8 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=11 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 3 months after enrollment

Population: 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 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.

Outcome measures

Measure	Breast Cancer Intervention n=99 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=90 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Distress Thermometer at 3 Months for BREAST Cancer Patients	5.60 units on a scale Standard Deviation 3.20	5.90 units on a scale Standard Deviation 3.00

SECONDARY outcome

Timeframe: 3 months after enrollment

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

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.

Outcome measures

Measure	Breast Cancer Intervention n=8 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=8 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Distress Thermometer at 3 Months for LUNG Cancer Patients	4.50 units on a scale Standard Deviation 3.20	6.10 units on a scale Standard Deviation 2.70

SECONDARY outcome

Timeframe: 6 months after enrollment

Population: 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 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.

Outcome measures

Measure	Breast Cancer Intervention n=91 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=85 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Distress Thermometer at 6 Months for BREAST Cancer Patients	4.50 units on a scale Standard Deviation 3.30	5.20 units on a scale Standard Deviation 3.00

SECONDARY outcome

Timeframe: 6 months after enrollment

Population: 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 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.

Outcome measures

Measure	Breast Cancer Intervention n=6 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=7 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Distress Thermometer at 6 Months for LUNG Cancer Patients	1.50 units on a scale Standard Deviation 1.90	4.00 units on a scale Standard Deviation 2.60

SECONDARY outcome

Timeframe: 6 months post-enrollment

Population: 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

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.

Outcome measures

Measure	Breast Cancer Intervention n=91 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=85 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients	1.70 score on a scale Standard Deviation 0.70	1.70 score on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: 6 months post-enrollment

Population: 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

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.

Outcome measures

Measure	Breast Cancer Intervention n=6 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=7 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients	1.40 score on a scale Standard Deviation 0.40	1.50 score on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: 6 months post-enrollment

Population: 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'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.

Outcome measures

Measure	Breast Cancer Intervention n=52 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=52 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients	40.4 units on a scale Standard Deviation 7.44	39.7 units on a scale Standard Deviation 7.00

SECONDARY outcome

Timeframe: 6 months post-enrollment

Population: 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'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.

Outcome measures

Measure	Breast Cancer Intervention n=4 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=3 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients	40.3 units on a scale Standard Deviation 4.43	39.0 units on a scale Standard Deviation 2.65

SECONDARY outcome

Timeframe: 6 months post-enrollment

Population: 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 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.

Outcome measures

Measure	Breast Cancer Intervention n=90 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=83 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Self-efficacy for BREAST Cancer Patients at 6 Months	44.0 total score on a scale Standard Deviation 5.2	43.3 total score on a scale Standard Deviation 4.9

SECONDARY outcome

Timeframe: 6 months post-enrollment

Population: 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 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.

Outcome measures

Measure	Breast Cancer Intervention n=6 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=7 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Self-efficacy for LUNG Cancer Patients at 6 Months	47.0 total score on a scale Standard Deviation 0.90	43.0 total score on a scale Standard Deviation 5.00

SECONDARY outcome

Timeframe: Measured at 12 months

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

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.

Outcome measures

Measure	Breast Cancer Intervention n=57 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=66 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 12 months after enrollment

Population: 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 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

Outcome measures

Measure	Breast Cancer Intervention n=82 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=75 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Distress Thermometer at 12 Months for BREAST Cancer Patients	5.3 units on a scale Standard Deviation 3.5	5.3 units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 12 months after enrollment

Population: 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 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.

Outcome measures

Measure	Breast Cancer Intervention n=5 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=5 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Distress Thermometer at 12 Months for LUNG Cancer Patients	3.6 units on a scale Standard Deviation 3.0	6.0 units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: 12 months post-enrollment

Population: 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.

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.

Outcome measures

Measure	Breast Cancer Intervention n=81 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=75 Participants For breast 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 BREAST Cancer Patients	1.70 score on a scale Standard Deviation 0.70	1.70 score on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: 12 months post-enrollment

Population: 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.

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.

Outcome measures

Measure	Breast Cancer Intervention n=5 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=5 Participants For breast 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	1.50 score on a scale Standard Deviation 0.70	1.50 score on a scale Standard Deviation 0.40

SECONDARY outcome

Timeframe: 12 months post-enrollment

Population: 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'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.

Outcome measures

Measure	Breast Cancer Intervention n=52 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=38 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients	40.8 score on a scale Standard Deviation 6.9	38.4 score on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: 12 months post-enrollment

Population: 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'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.

Outcome measures

Measure	Breast Cancer Intervention n=3 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=4 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients	37.7 score on a scale Standard Deviation 2.9	42.5 score on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: 12 months post-enrollment

Population: 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 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.

Outcome measures

Measure	Breast Cancer Intervention n=81 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=74 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Self-efficacy for BREAST Cancer Patients at 12 Months	44.2 score on a scale Standard Deviation 4.5	43.0 score on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: 12 months post-enrollment

Population: 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 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.

Outcome measures

Measure	Breast Cancer Intervention n=5 Participants For breast cancer participants with at least 1 legal concern at baseline, intervention participants received patient navigation enhanced with legal support.	Breast Cancer Control n=5 Participants For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation.
Self-efficacy for LUNG Cancer Patients at 12 Months	44.2 score on a scale Standard Deviation 4.8	43.6 score on a scale Standard Deviation 5.5

Adverse Events

Patient Navigation With Legal Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Patient Navigation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tracy Battaglia

Boston Medical Center

Phone: 617.638.8036

Email: tracy.battaglia@bmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place