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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03229 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized clinical trial studies peer navigator education in improving survivorship care in African American breast cancer survivors. An educational intervention involving peer groups may help to improve the well-being and quality of life (QOL) in breast cancer survivors
PRIMARY OBJECTIVES:
I. To evaluate the ability of peer navigation (PN) to improve understanding of survivorship care planning (SCP) at 6 months.
II. To promote adherence to the SCP schedule of follow-up examinations at 12 months.
SECONDARY OBJECTIVES:
I. To evaluate the effect of PN on change from baseline in medical efficacy, preparedness for life as new survivor, and physical and health related QOL at 6 months.
OUTLINE: PNs are trained on medical issues and resources, and SCP. Participants are then randomized to 1 of 2 treatment arms.
ARM I: Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and American Cancer Society (ACS) materials.
ARM II: Participants receive ACS materials.
After completion of study treatment, patients are followed up at 6 and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (PN and ACS material) | Experimental | Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials. |
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| Arm II (ACS material) | Active Comparator | Participants receive ACS materials only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| educational intervention | Other | Receive ACS material |
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| Measure | Description | Time Frame |
|---|---|---|
| Ability of peer navigation to improve understanding of SCP | Chi-square and t-tests will be used to compare the baseline characteristics of subjects randomized to PN intervention vs control. For subjects in the intervention arm, the number of navigation sessions received will be reported, and correlated factors will be explored. The number of subjects navigated per PN will also be reported. Nonevaluable and evaluable subjects (defined at 6 and 12 months) will be compared. Site of care will be handled as a cluster level variable in generalized linear mixed (GLM) regression models. | At 6 months |
| Adherence to the SCP schedule of follow-up examinations | Measured using a newly created, 50-point scale that gives equal weight to completion of the recommended: physical exams, imaging, pelvic exam, annual oncology visit, and breast self-exams. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of PN on change in medical efficacy | Exploratory analyses will analyze the effect of PN intervention actually received, using the number of PN sessions completed and the quality of the subject's PN as measured by PN's post-training level of acuity and utility. | Baseline to 6 months |
| Preparedness for life as new survivor (PLANS) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimlin Ashing-Giwa | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| questionnaire administration | Other | Ancillary studies |
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| counseling intervention | Other | Undergo PN session |
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| survey administration | Other | Ancillary studies |
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| quality-of-life assessment | Procedure | Ancillary studies |
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PLANS consists of two subscales that measure patients' knowledge and self efficacy with regards to their Access and Quality of Survivorship Care Plan (SCP) and adherence with regard to following these tasks. The knowledge subscale (Cronbach's alpha 0.90) and adherence subscale (Cronbach's alpha 0.70) have good reliability. |
| At 6 months |
| Physical and health related QOL | At 6 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D008722 | Methods |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D008919 | Investigative Techniques |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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