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| ID | Type | Description | Link |
|---|---|---|---|
| RSG-13-368-01-CPPB | Other Grant/Funding Number | American Cancer Society | |
| AD-1304-6272 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute |
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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient navigation enhanced with legal support | Experimental | 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. |
|
| Standard patient navigation | No Intervention | These patients will receive standard patient navigation which will work to ensure that services are coordinated amongst medical personnel, while also addressing patients' needs. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient navigation enhanced with legal support | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Receipt of 1st treatment within 90 days from diagnosis |
| 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. | Receipt of 1st treatment within 90 days from diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after enrollment |
| Distress Thermometer at 3 Months for LUNG Cancer Patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tracy A Battaglia, M.D., M.P.H | Boston Medical Center | Principal Investigator |
| Sharon Bak, M.P.H | Boston Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Patient Navigation | For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis includes those participants with at least 1 legal concern at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Standard Patient Navigation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Analysis includes those participants with at least 1 legal concern at baseline. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | breast cancer participants with 1 or more legal concern as screened at baseline using the IHELP survey. | Posted | Count of Participants | Participants | Receipt of 1st treatment within 90 days from diagnosis |
|
Study enrollment began 2/1/2014 and ended 9/30/2018. Participants were assessed throughout their study participation to 1 year after enrollment.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tracy Battaglia | Boston Medical Center | 617.638.8036 | tracy.battaglia@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 7, 2018 | Dec 26, 2018 | SAP_000.pdf |
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Sep 1, 2017 | Apr 17, 2019 | Prot_ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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. |
| 3 months after enrollment |
| 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. | 6 months after enrollment |
| 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. | 6 months after enrollment |
| 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. | 6 months post-enrollment |
| 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. | 6 months post-enrollment |
| 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. | 6 months post-enrollment |
| 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. | 6 months post-enrollment |
| 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. | 6 months post-enrollment |
| 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. | 6 months post-enrollment |
| 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. | Measured at 12 months |
| 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 | 12 months after enrollment |
| 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. | 12 months after enrollment |
| 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. | 12 months post-enrollment |
| 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. | 12 months post-enrollment |
| 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. | 12 months post-enrollment |
| 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. | 12 months post-enrollment |
| 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. | 12 months post-enrollment |
| 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. | 12 months post-enrollment |
| deemed ineligible |
|
For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Language | Count of Participants | Participants |
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| Insurance | Count of Participants | Participants |
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| OG001 | Breast Cancer Control | For breast cancer participants with at least 1 legal concern at baseline, control participants received standard of care patient navigation. |
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| 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. | Posted | Count of Participants | Participants | Receipt of 1st treatment within 90 days from diagnosis |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months after enrollment |
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| 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. | The number of LUNG Control participants decreased by 3 for a total of 8 due to missing Distress Thermometer data at 3 months. | Posted | Mean | Standard Deviation | units on a scale | 3 months after enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months after enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months after enrollment |
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| 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months post-enrollment |
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| 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | 6 months post-enrollment |
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| 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. | 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 | Posted | Mean | Standard Deviation | units on a scale | 6 months post-enrollment |
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| 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. | 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 | Posted | Mean | Standard Deviation | units on a scale | 6 months post-enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | total score on a scale | 6 months post-enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | total score on a scale | 6 months post-enrollment |
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| 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. | Excluded those women who did not meet requirements for receipt of radiation: over 70 years of age, with tumor negative for estrogen or progesterone | Posted | Count of Participants | Participants | Measured at 12 months |
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| 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months after enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months after enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-enrollment |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months post-enrollment |
|
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|
| 0 |
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | Standard Patient Navigation | For those with legal concerns at baseline identified by the IHELP screening tool, control participants received standard of care Patient Navigation | 0 | 107 | 0 | 107 | 0 | 107 |
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