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

City of Hope

Status: Active, not recruiting

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01450020

NCI-2011-03229 (Registry Identifier)

11115 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 145 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

Arm I (PN and ACS material)

Experimental group

Description:

Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials.

Treatment:

Other: survey administration

Other: educational intervention

Other: questionnaire administration

Other: counseling intervention

Procedure: quality-of-life assessment

Arm II (ACS material)

Active Comparator group

Description:

Participants receive ACS materials only.

Treatment:

Other: survey administration

Other: educational intervention

Other: questionnaire administration

Procedure: quality-of-life assessment