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NCT Number: NCT01450020

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive ACS material

Other names: intervention, educational

Questionnaire Administration

Other

Ancillary studies

counseling intervention

Other

Undergo PN session

Other names: counseling and communications studies

Survey Administration

Other

Ancillary studies

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Primary outcomes

  1. Ability of peer navigation to improve understanding of SCP

    Time frame: At 6 months

    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.

  2. Adherence to the SCP schedule of follow-up examinations

    Time frame: At 12 months

    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.

Secondary outcomes

  1. Effect of PN on change in medical efficacy

    Time frame: Baseline to 6 months

    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.

  2. Preparedness for life as new survivor (PLANS)

    Time frame: At 6 months

    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.

  3. Physical and health related QOL

    Time frame: At 6 months

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Oct 12, 2011
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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