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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-08092 | |||
| CDR0000629952 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life.
PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.
OBJECTIVES:
OUTLINE: For the first 3 months of the study, medical charts are reviewed.
Beginning in month 4, patients are introduced to the Patient Navigator who provides them with telephone and e-mail contact on an Appointment Reminder Card, and develops a plan for eliminating identified barriers and/or addressing immediate concerns. Patients' plans may include contacting others on behalf of the patient, coaching the patient on how to solve a problem, referring to resources within City of Hope (COH) or in the community, and investigating possible solutions. Patients are also oriented to COH's services, open clinical trials, and resources. Navigation of care includes assistance during initial and ongoing evaluations by all cancer specialists, during initiation and completion of all primary treatment, and through the first post-treatment follow up. Patients are contacted weekly for 8 weeks of the study and at least once a month for 9 months.
The Patient Navigator will track identified barriers, processes to resolution, and time required to resolve barriers.
Patients complete questionnaires at baseline, and periodically during study, on socio-demographic, quality of life, resource-use satisfaction, and satisfaction with care and Patient Navigator.
After completion of study intervention, patients continue to receive Patient Navigator support for up to 30 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study. | ||
| informational intervention | Other | Occurs weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study. | ||
| medical chart review | Other | Baseline, 3, 6 and 9 months after starting the study | ||
| questionnaire administration | Other | Baseline, 3, 6 and 9 months after starting the study | ||
| study of socioeconomic and demographic variables | Other | Baseline, 3, 6 and 9 months after starting the study | ||
| Measure | Description | Time Frame |
|---|---|---|
| Barrier resolution (information, transportation, appointments, and communication) and time to resolution | Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study. | |
| Quality of life (psychological, physical, social, and spiritual well-being) | Prior to starting treatment and 3, 6 and 9 months after starting the study. | |
| Navigation and care (patient's satisfaction and value, provider's perception of barriers) | 3, 6 and 9 months after starting the study. |
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DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed breast cancer
Insured with Medi-Cal OR ≥ 65 years old
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Crane-Okada, PhD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010-3000 | United States |
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| quality-of-life assessment |
| Procedure |
Baseline, 3, 6 and 9 months after starting the study |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000071960 | Breast Carcinoma In Situ |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
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