改善非洲裔美国乳腺癌幸存者幸存者护理的同伴导航教育
幸存者姐妹：改善患有乳腺癌的非裔美国妇女的幸存者护理
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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
Duarte、California、美国、91010
- City of Hope Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm I (PN and ACS material)
Participants receive 4 PN sessions tailored to their needs followed by a 6 month booster session and ACS materials. |
Ancillary studies
其他名称：
Ancillary studies Receive ACS material
其他名称：
Undergo PN session
其他名称：
Ancillary studies |
|
有源比较器：Arm II (ACS material)
Participants receive ACS materials only. |
Ancillary studies
其他名称：
Ancillary studies Receive ACS material
其他名称：
Ancillary studies |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ability of peer navigation to improve understanding of SCP
大体时间：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. |
At 6 months
|
|
Adherence to the SCP schedule of follow-up examinations
大体时间：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. |
At 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
身体和健康相关的 QOL
大体时间：6个月时
|
6个月时
|
|
|
Effect of PN on change in medical efficacy
大体时间：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. |
Baseline to 6 months
|
|
Preparedness for life as new survivor (PLANS)
大体时间：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. |
At 6 months
|
合作者和调查者
调查人员
- 首席研究员：Kimlin Ashing-Giwa、City of Hope Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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