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

This study is currently recruiting participants.
Verified November 2012 by City of Hope Medical Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01450020
First received: October 6, 2011
Last updated: November 8, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention
Breast Cancer
 Other: educational intervention
Other: questionnaire administration
Other: counseling intervention
Other: survey administration
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Ability of peer navigation to improve understanding of SCP [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
    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 3 and 12 months) will be compared. Site of care will be handled as a cluster level variable in generalized linear mixed (GLM) regression models.

  • Adherence to the SCP schedule of follow-up examinations [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Effect of PN on change in medical efficacy [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    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.

  • Preparedness for life as new survivor (PLANS) [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
    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.

  • Physical and health related QOL [ Time Frame: At 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 145
Study Start Date: October 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (PN and ACS material)
Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials.
 Other: educational intervention
Receive ACS material
Other Name: intervention, educational
Other: questionnaire administration
Ancillary studies
Other: counseling intervention
Undergo PN session
Other Name: counseling and communications studies
Other: survey administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Active Comparator: Arm II (ACS material)
Participants receive ACS materials only.
 Other: educational intervention
Receive ACS material
Other Name: intervention, educational
Other: questionnaire administration
Ancillary studies
Other: survey administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the ability of peer navigation (PN) to improve understanding of survivorship care planning (SCP) at 3 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 3 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 3 and 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450020

Locations
United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Kimlin Ashing-Giwa, Ph.D.     626-256-4673 ext 61056     kashing@coh.org    
Principal Investigator: Kimlin Ashing-Giwa, Ph.D.            
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kimlin Ashing-Giwa City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01450020     History of Changes
Other Study ID Numbers: 11115, NCI-2011-03229
Study First Received: October 6, 2011
Last Updated: November 8, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
cancer survivor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013