Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors

NCT01450020 | Active Not Recruiting DMC

• 2 other identifiers: 11115NCI-2011-03229
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

cancer survivor

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Effect of PN on change in medical efficacy

  Baseline to 6 months

• Preparedness for life as new survivor (PLANS)

  At 6 months

• Physical and health related QOL

  At 6 months

Study Arms (2)

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.

Other: educational intervention; Other: questionnaire administration; Other: counseling intervention; Other: survey administration; Procedure: quality-of-life assessment

Arm II (ACS material)

ACTIVE COMPARATOR

Participants receive ACS materials only.

Other: educational intervention; Other: questionnaire administration; Other: survey administration; Procedure: quality-of-life assessment

Interventions

educational intervention OTHER

Receive ACS material

Also known as: intervention, educational

Arm I (PN and ACS material); Arm II (ACS material)

questionnaire administration OTHER

Ancillary studies

Arm I (PN and ACS material); Arm II (ACS material)

counseling intervention OTHER

Undergo PN session

Also known as: counseling and communications studies

Arm I (PN and ACS material)

survey administration OTHER

Ancillary studies

Arm I (PN and ACS material); Arm II (ACS material)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (PN and ACS material); Arm II (ACS material)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TRIAL SUBJECTS:
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, Educational; Methods; Counseling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques; Mental Health Services; Behavioral Disciplines and Activities

Study Officials

• Kimlin Ashing-Giwa

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 12, 2011
• Study Start: June 1, 2012
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)