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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00351 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1B-14-7 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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Principal Investigator left
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research trial studies how well patient navigation and tailored treatment planning work in Latina patients with breast cancer. Patient navigation and tailored treatment planning may provide extra support by guiding patients through the healthcare system, remove barriers to care and provide ease of access to essential resources, encourage patient participation in their care, provide in-language summaries and plans for follow-up care, improve patient access to needed supportive care services and may improve general healthcare experience in Latina patients with breast cancer.
PRIMARY OBJECTIVES:
I. Successful navigation of patients being screened or treated for breast cancer through the continuum of their care (from visit to visit; from surgical care to radiologic care to oncologic care; from oncologic care to supportive care; etc).
II. Supply individualized in-language treatment summaries and follow-up care plans to enrolled patients.
III. Supply tailored in-language survivorship plan summaries to enrolled patients.
OUTLINE:
Patients receive treatment summaries and plan report that captures patient data through the use of an "intake checklist" completed during the initial consultation with the breast oncology team and used to guide referrals to existing services and programmed with generic information related to disease and treatment management plan. Additional elements, such as psycho-social services, exercise, and/or nutrition, identified by the patient self-report, will be incorporated. Patients also complete 3 questionnaires at each clinic visit.
After completion of study, patients are followed up at 6 months or 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (treatment summaries and plan report) | Patients receive treatment summaries and plan report that captures patient data through the use of an "intake checklist" completed during the initial consultation with the breast oncology team and used to guide referrals to existing services and programmed with generic information related to disease and treatment management plan. Additional elements, such as psycho-social services, exercise, and/or nutrition, identified by the patient self-report, will be incorporated. Patients also complete 3 questionnaires at each clinic visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of missed appointments from the time of initial diagnosis to the completion of primary treatment (chemotherapy, surgery and radiation as applicable) as measured by CCCQ | Questionnaire scores will be expressed as median values with 95% confidence intervals. | Up to 12 months |
| Number of patients enrolled on clinical trials (interventional and non-interventional) | Number of patients enrolled on clinical trials (interventional and non-interventional) will be quantified and compared to historical controls. | Up to 12 months |
| Number of special referrals made | Number of special referrals made (eg. social worker, genetic counseling, fertility) through the navigation system will quantified and compared to historical controls. | Up to 12 months |
| Overall experience with breast cancer (broadly) and at LAC+USC as measured by experience-based questionnaire | Up to 12 months | |
| Usefulness, accessibility, and quality of the patient navigation model as measured by Continuity/Coordination of Care Questionnaire (CCCQ) | Means and standard deviations will be summarized per outcome measures at 3, 6, and 12 months after baseline, and 95% confidence intervals for the difference in means will be calculated for each assessment time for total scores and subscale scores. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Self-identified Latina (or Hispanic) who is receiving ongoing care at LAC+USC Medical Center will be recruited.
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| Name | Affiliation | Role |
|---|---|---|
| Heather Macdonald | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012816 | Signs and Symptoms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Questionnaire Administration | Other | Complete questionnaires |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |