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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: educational intervention
* Other: questionnaire administration
* Other: counseling intervention
* Other: survey administration
* Procedure: quality-of-life assessment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (PN and ACS material)<br>Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials. | Other: educational intervention<br>* Receive ACS material<br>* Other names: intervention, educational;Other: questionnaire administration<br>* Ancillary studies<br>Other: counseling intervention<br>* Undergo PN session<br>* Other names: counseling and communications studies;Other: survey administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|
| Active Comparator: Arm II (ACS material)<br>Participants receive ACS materials only. | Other: educational intervention<br>* Receive ACS material<br>* Other names: intervention, educational;Other: questionnaire administration<br>* Ancillary studies<br>Other: survey administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Physical and health related QOL |  | At 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer survivor