Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Ability of peer navigation to improve understanding of SCP
Outcome 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 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.
Outcome Time Frame:
At 3 months
Safety Issue:
No
Principal Investigator
Kimlin Ashing-Giwa
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Federal Government
Study ID:
11115
NCT ID:
NCT01450020
Start Date:
October 2011
Completion Date:
Related Keywords:
- Breast Cancer
- cancer survivor
- Breast Neoplasms
Name | Location |
|---|---|
| City of Hope Medical Center | Duarte, California 91010 |
