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

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
questionnaire administration
counseling intervention
survey administration
quality-of-life assessment
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring cancer survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (PN and ACS material)

Arm II (ACS material)

Arm Description

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

Participants receive ACS materials only.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Physical and health related QOL

Full Information

First Posted
October 6, 2011
Last Updated
April 4, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01450020
Brief Title
Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors
Official Title
Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2012 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
cancer survivor

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (PN and ACS material)
Arm Type
Experimental
Arm Description
Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials.
Arm Title
Arm II (ACS material)
Arm Type
Active Comparator
Arm Description
Participants receive ACS materials only.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive ACS material
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
counseling intervention
Other Intervention Name(s)
counseling and communications studies
Intervention Description
Undergo PN session
Intervention Type
Other
Intervention Name(s)
survey administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Ability of peer navigation to improve understanding of SCP
Description
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.
Time Frame
At 6 months
Title
Adherence to the SCP schedule of follow-up examinations
Description
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.
Time Frame
At 12 months
Secondary Outcome Measure Information:
Title
Effect of PN on change in medical efficacy
Description
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.
Time Frame
Baseline to 6 months
Title
Preparedness for life as new survivor (PLANS)
Description
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.
Time Frame
At 6 months
Title
Physical and health related QOL
Time Frame
At 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimlin Ashing-Giwa
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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