Clinical trial NCT01450020: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: cancer survivor
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-10-12
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Ability of peer navigation to improve understanding of SCP
timeFrame: At 6 months
measure: Adherence to the SCP schedule of follow-up examinations
timeFrame: At 12 months
Secondary outcomes:
measure: Effect of PN on change in medical efficacy
timeFrame: Baseline to 6 months
measure: Preparedness for life as new survivor (PLANS)
timeFrame: At 6 months
measure: Physical and health related QOL
timeFrame: At 6 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Kimlin Ashing-Giwa
role: PRINCIPAL_INVESTIGATOR
References: