Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors
NCT ID: NCT01450020
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
145 participants
INTERVENTIONAL
2012-06-01
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (PN and ACS material)
Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials.
educational intervention
Receive ACS material
questionnaire administration
Ancillary studies
counseling intervention
Undergo PN session
survey administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Arm II (ACS material)
Participants receive ACS materials only.
educational intervention
Receive ACS material
questionnaire administration
Ancillary studies
survey administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Interventions
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educational intervention
Receive ACS material
questionnaire administration
Ancillary studies
counseling intervention
Undergo PN session
survey administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient age 18 years or older who self-identifies as African-American
* In early survivorship phase, defined as being 1-12 months post completion of treatment for stage 0-3 breast cancer
* Receiving health care primarily through an health maintenance organization (HMO)
* Patients with metastatic cancer or a second primary cancer, because their medical characteristics (e.g. disease progression) are significantly different
* Breast cancer survivors (BCS) with other major disabling medical, psychiatric, or substance abuse conditions (e.g., anxiety, depression, alcohol/tobacco problems) will be excluded
* PEER NAVIGATORS:
* At least 25 years of age who self-identifies as African-American
* Previously participated in any type of research study
* Has at least high school education
* Has been diagnosed with breast cancer, currently in remission or eradicated
* Belongs to a breast cancer support group
* Has a valid driver's license
* Owns an operational vehicle
* Has access to a personal computer with internet access
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Kimlin Ashing-Giwa
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2011-03229
Identifier Type: REGISTRY
Identifier Source: secondary_id
11115
Identifier Type: -
Identifier Source: org_study_id
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