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

N/AActive Not RecruitingNCT01450020

City of Hope Medical Center145 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

145

Conditions

Breast Cancer

Interventions

educational interventionOTHER

Receive ACS material

questionnaire administrationOTHER

Ancillary studies

counseling interventionOTHER

Undergo PN session

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: At 12 months

Secondary Outcomes

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.

Time frame: Baseline to 6 months

Preparedness for life as new survivor (PLANS)

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.

Time frame: At 6 months

Physical and health related QOL

Time frame: At 6 months

Data from ClinicalTrials.gov

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