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

Breast Cancer Clinical Trial

Official title:

Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01450020
• Other study ID #: 11115
• Secondary ID: NCI-2011-03229
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2012
• Est. completion date: June 1, 2024

Study information

• Verified date: December 2023
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• educational intervention
Receive ACS material
• questionnaire administration
Ancillary studies
• counseling intervention
Undergo PN session
• survey administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.	At 6 months
Secondary	Physical and health related QOL		At 6 months