Cancer
Conditions
Keywords
Patient Navigation, Medical Legal Partnership, Healthcare Disparities
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.
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.
Interventions
OTHERPatient navigation enhanced with legal support
Sponsors
American Cancer Society, Inc.
Patient-Centered Outcomes Research Institute
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants | 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. |
| Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distress Thermometer at 6 Months for BREAST Cancer Patients | 6 months after enrollment | 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 Thermometer at 6 Months for LUNG Cancer Patients | 6 months after enrollment | 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. |
| Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients | 6 months post-enrollment | 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. |
| Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients | 6 months post-enrollment | 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 Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients | 6 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 values are more favorable. |
| Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients | 6 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 values are more favorable. |
| Self-efficacy for BREAST Cancer Patients at 6 Months | 6 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. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy. |
| Self-efficacy for LUNG Cancer Patients at 6 Months | 6 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. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy. |
| Distress Thermometer at 3 Months for BREAST Cancer Patients | 3 months after enrollment | 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 Thermometer at 12 Months for BREAST Cancer Patients | 12 months after enrollment | 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 Thermometer at 12 Months for LUNG Cancer Patients | 12 months after enrollment | 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. |
| Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients | 12 months post-enrollment | 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. |
| Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients | 12 months post-enrollment | 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 Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients | 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. |
| Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients | 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. |
| Self-efficacy for BREAST Cancer Patients at 12 Months | 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. |
| Self-efficacy for LUNG Cancer Patients at 12 Months | 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. |
| Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis | Measured at 12 months | 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 Thermometer at 3 Months for LUNG Cancer Patients | 3 months after enrollment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 113 |
| Standard Patient Navigation For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation | 107 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | deemed ineligible | 0 | 1 |
| Overall Study | No legal concerns at baseline | 36 | 41 |
| Overall Study | Withdrawal by Subject | 5 | 3 |
Baseline characteristics
| Characteristic | Patient Navigation With Legal Support | Standard Patient Navigation | Total |
|---|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 11 | 54.7 years STANDARD_DEVIATION 11 | 55.1 years STANDARD_DEVIATION 11.4 |
| Insurance Private | 30 Participants | 28 Participants | 58 Participants |
| Insurance Public | 83 Participants | 79 Participants | 162 Participants |
| Language English | 87 Participants | 71 Participants | 158 Participants |
| Language Haitian Creole | 9 Participants | 9 Participants | 18 Participants |
| Language Spanish | 17 Participants | 27 Participants | 44 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Black \ African-American | 60 Participants | 51 Participants | 111 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Hispanic | 22 Participants | 26 Participants | 48 Participants |
| Race/Ethnicity, Customized Race / Ethnicity Other | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Race / Ethnicity White | 26 Participants | 27 Participants | 53 Participants |
| Sex: Female, Male Female | 109 Participants | 102 Participants | 211 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 113 | 0 / 107 |
| other Total, other adverse events | 0 / 113 | 0 / 107 |
| serious Total, serious adverse events | 0 / 113 | 0 / 107 |
Outcome results
Primary
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Breast Cancer Intervention | Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants | 94 Participants |
| Breast Cancer Control | Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among BREAST Cancer Participants | 92 Participants |
Comparison: 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).p-value: 0.7795% CI: [0.21, 3.14]Regression, Logistic
Primary
Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants
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.
Time frame: Receipt of 1st treatment within 90 days from diagnosis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Breast Cancer Intervention | Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants | 7 Participants |
| Breast Cancer Control | Proportion of Participants Initiating Treatment Within 90 Days of Diagnosis Among LUNG Cancer Participants | 7 Participants |
Comparison: 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).p-value: 0.2695% CI: [0.35, 45.4]Regression, Logistic
Secondary
Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients | 1.70 score on a scale | Standard Deviation 0.7 |
| Breast Cancer Control | Cancer Needs and Distress Inventory at 12 Months for BREAST Cancer Patients | 1.70 score on a scale | Standard Deviation 0.6 |
p-value: 0.46Regression, Linear
Secondary
Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients | 1.50 score on a scale | Standard Deviation 0.7 |
| Breast Cancer Control | Cancer Needs and Distress Inventory at 12 Months for LUNG Cancer Patients | 1.50 score on a scale | Standard Deviation 0.4 |
p-value: 0.89Regression, Linear
Secondary
Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients | 1.70 score on a scale | Standard Deviation 0.7 |
| Breast Cancer Control | Cancer Needs and Distress Inventory at 6 Months for BREAST Cancer Patients | 1.70 score on a scale | Standard Deviation 0.6 |
p-value: 0.68Regression, Linear
Secondary
Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients | 1.40 score on a scale | Standard Deviation 0.4 |
| Breast Cancer Control | Cancer Needs and Distress Inventory at 6 Months for LUNG Cancer Patients | 1.50 score on a scale | Standard Deviation 0.5 |
p-value: 0.26Regression, Linear
Secondary
Distress Thermometer at 12 Months for BREAST Cancer Patients
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Distress Thermometer at 12 Months for BREAST Cancer Patients | 5.3 units on a scale | Standard Deviation 3.5 |
| Breast Cancer Control | Distress Thermometer at 12 Months for BREAST Cancer Patients | 5.3 units on a scale | Standard Deviation 3.3 |
Comparison: We hypothesize that compared to the control group, the Breast cancer INTERVENTION group will have less distress at 12 months post-enrollment.p-value: 0.71Regression, Linear
Secondary
Distress Thermometer at 12 Months for LUNG Cancer Patients
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Distress Thermometer at 12 Months for LUNG Cancer Patients | 3.6 units on a scale | Standard Deviation 3 |
| Breast Cancer Control | Distress Thermometer at 12 Months for LUNG Cancer Patients | 6.0 units on a scale | Standard Deviation 4.7 |
Comparison: We hypothesize that compared to the control group, the Lung cancer INTERVENTION group will have less distress at 12 months post-enrollmentp-value: 0.61Regression, Linear
Secondary
Distress Thermometer at 3 Months for BREAST Cancer Patients
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Distress Thermometer at 3 Months for BREAST Cancer Patients | 5.60 units on a scale | Standard Deviation 3.2 |
| Breast Cancer Control | Distress Thermometer at 3 Months for BREAST Cancer Patients | 5.90 units on a scale | Standard Deviation 3 |
Comparison: Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 3 months post-enrollmentp-value: 0.53Regression, Linear
Secondary
Distress Thermometer at 3 Months for LUNG Cancer Patients
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Distress Thermometer at 3 Months for LUNG Cancer Patients | 4.50 units on a scale | Standard Deviation 3.2 |
| Breast Cancer Control | Distress Thermometer at 3 Months for LUNG Cancer Patients | 6.10 units on a scale | Standard Deviation 2.7 |
Comparison: Compared to the control group, the LUNG cancer INTERVENTION group will have less distress at 3 months post-enrollmentp-value: 0.43Regression, Linear
Secondary
Distress Thermometer at 6 Months for BREAST Cancer Patients
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Distress Thermometer at 6 Months for BREAST Cancer Patients | 4.50 units on a scale | Standard Deviation 3.3 |
| Breast Cancer Control | Distress Thermometer at 6 Months for BREAST Cancer Patients | 5.20 units on a scale | Standard Deviation 3 |
Comparison: Compared to the control group, the Breast cancer INTERVENTION group will have less distress at 6 months post-enrollmentp-value: 0.18Regression, Linear
Secondary
Distress Thermometer at 6 Months for LUNG Cancer Patients
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Distress Thermometer at 6 Months for LUNG Cancer Patients | 1.50 units on a scale | Standard Deviation 1.9 |
| Breast Cancer Control | Distress Thermometer at 6 Months for LUNG Cancer Patients | 4.00 units on a scale | Standard Deviation 2.6 |
Comparison: Compared to the control group, the Lung cancer INTERVENTION group will have less distress at 6 months post-enrollmentp-value: 0.33Regression, Linear
Secondary
Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis
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.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Breast Cancer Intervention | Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis | 6 Participants |
| Breast Cancer Control | Number of Participants Receiving Radiation Within 365 Days of Cancer Diagnosis | 6 Participants |
Comparison: 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).p-value: 0.7995% CI: [0.28, 2.79]Regression, Logistic
Secondary
Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients | 40.8 score on a scale | Standard Deviation 6.9 |
| Breast Cancer Control | Patient Satisfaction With Navigation at 12 Months Among BREAST Cancer Patients | 38.4 score on a scale | Standard Deviation 8.9 |
p-value: 0.16Regression, Linear
Secondary
Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients | 37.7 score on a scale | Standard Deviation 2.9 |
| Breast Cancer Control | Patient Satisfaction With Navigation at 12 Months Among LUNG Cancer Patients | 42.5 score on a scale | Standard Deviation 4.4 |
p-value: 0.16Regression, Linear
Secondary
Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients | 40.4 units on a scale | Standard Deviation 7.44 |
| Breast Cancer Control | Patient Satisfaction With Navigation at 6 Months Among BREAST Cancer Patients | 39.7 units on a scale | Standard Deviation 7 |
Comparison: Compared to the control group, the Breast cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollmentp-value: 0.62Regression, Linear
Secondary
Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients | 40.3 units on a scale | Standard Deviation 4.43 |
| Breast Cancer Control | Patient Satisfaction With Navigation at 6 Months Among LUNG Cancer Patients | 39.0 units on a scale | Standard Deviation 2.65 |
Comparison: Compared to the control group, the Lung cancer INTERVENTION group will be more satisfied with patient navigation at 6 months post-enrollmentp-value: 0.69Regression, Linear
Secondary
Self-efficacy for BREAST Cancer Patients 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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Self-efficacy for BREAST Cancer Patients at 12 Months | 44.2 score on a scale | Standard Deviation 4.5 |
| Breast Cancer Control | Self-efficacy for BREAST Cancer Patients at 12 Months | 43.0 score on a scale | Standard Deviation 5.6 |
p-value: 0.13Regression, Linear
Secondary
Self-efficacy for BREAST Cancer Patients at 6 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. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Self-efficacy for BREAST Cancer Patients at 6 Months | 44.0 total score on a scale | Standard Deviation 5.2 |
| Breast Cancer Control | Self-efficacy for BREAST Cancer Patients at 6 Months | 43.3 total score on a scale | Standard Deviation 4.9 |
Comparison: Compared to the control group, the breast cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.p-value: 0.58Regression, Linear
Secondary
Self-efficacy for LUNG Cancer Patients 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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Self-efficacy for LUNG Cancer Patients at 12 Months | 44.2 score on a scale | Standard Deviation 4.8 |
| Breast Cancer Control | Self-efficacy for LUNG Cancer Patients at 12 Months | 43.6 score on a scale | Standard Deviation 5.5 |
p-value: 0.8Regression, Linear
Secondary
Self-efficacy for LUNG Cancer Patients at 6 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. Total scores range from 12 to 48. A higher score is more favorable, indicating a positive attitude and strong self-efficacy.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Breast Cancer Intervention | Self-efficacy for LUNG Cancer Patients at 6 Months | 47.0 total score on a scale | Standard Deviation 0.9 |
| Breast Cancer Control | Self-efficacy for LUNG Cancer Patients at 6 Months | 43.0 total score on a scale | Standard Deviation 5 |
Comparison: Compared to the control group, the lung cancer INTERVENTION group would have higher self-efficacy was adjusting for baseline self-efficacy scores.p-value: 0.09Regression, Linear