City of Hope Medical Center
Duarte, California, 91010, United States
NCT Number: NCT01450020
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
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Female
Interventional
Not applicable
Duarte, California, 91010, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Receive ACS material
Other names: intervention, educational
Ancillary studies
Undergo PN session
Other names: counseling and communications studies
Ancillary studies
Ancillary studies
Other names: quality of life assessment
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.
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.
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.
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.
Time frame: At 6 months
City of Hope Medical Center
Other
Sister Survivor: Improving the Survivorship Care of African-American Women With Breast Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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