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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01450020
First Posted: October 12, 2011
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
October 6, 2011
October 12, 2011
September 7, 2017
June 1, 2012
July 2018   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • Ability of peer navigation to improve understanding of SCP [ Time Frame: At 3 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 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 ]
    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.
Complete list of historical versions of study NCT01450020 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • Physical and health related QOL [ Time Frame: At 6 months ]
  • Effect of PN on change in medical efficacy [ Time Frame: Baseline to 3 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.
  • Preparedness for life as new survivor (PLANS) [ Time Frame: At 3 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.
  • Physical and health related QOL [ Time Frame: At 3 months ]
Not Provided
Not Provided
 
Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors
Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Breast Cancer
  • 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
  • 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.
    Interventions:
    • Other: educational intervention
    • Other: questionnaire administration
    • Other: counseling intervention
    • Other: survey administration
    • Procedure: quality-of-life assessment
  • Active Comparator: Arm II (ACS material)
    Participants receive ACS materials only.
    Interventions:
    • Other: educational intervention
    • Other: questionnaire administration
    • Other: survey administration
    • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
145
July 2018
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01450020
11115
NCI-2011-03229 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Yes
Not Provided
Not Provided
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Kimlin Ashing-Giwa City of Hope Medical Center
City of Hope Medical Center
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP