Effect of a Navigation Intervention on Care Equity for Women of Color Diagnosed With Breast Cancer: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Demand of BC-Navi: Recruitment Rate
研究概览
简要总结
The Chrysalis Initiative (TCI) has with its technology partner Eversana/Intouch developed the BC-Navigate website/application to help guide women through care delivery during breast cancer treatment.
TCI a nonprofit, breast cancer education and navigation organization is developing methods to address health inequities in cancer care delivery. TCI and its new academic/clinical partner, The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, propose to apply TCI's developed patient navigation support techniques to enhance knowledge and self-advocacy among a cohort of Black and African American women, and other women of color (WOC), receiving care in Northwestern's breast cancer program.
Therefore, the purpose of this study is to apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant treatment among WOC breast cancer patients and evaluate the feasibility and preliminary efficacy of this approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •Diagnosed with non-metastatic breast cancer (stages I-III)
- •An order placed for a post-operative chemotherapy cycle by a NM clinician
- •Not have initiated a recommended post-operative chemotherapy cycle at the time of study enrollment
- •Completed surgery for breast cancer
- •First-time diagnosis of breast cancer
- •Established care at Northwestern Medicine
- •English-speaking as the navigation website is not yet available in other languages
- •Access to internet on a smart phone or computer/tablet
- •Any ethnic background
- •We will only consider patients that sign an informed consent form
排除标准
- •Men will be excluded because the navigation website only contains content and resources for women. Men also make up less than 1% of all breast cancer diagnoses and the Breast Cancer-Navigate app/website content was developed for female breast cancer patients.
- •Diagnosis of additional, life-threatening condition (e.g., end-stage renal disease, heart failure) which can interfere with timely planned adjuvant chemotherapy treatment for cancer.
研究组 & 干预措施
BC-Navi
Apply TCI's patient navigation-and-coaching program and its website/mobile app (Breast Cancer-Navigate) platform to improve timely initiation to patient adjuvant chemotherapy treatment among diverse breast cancer patients.
干预措施: BC-Navigate (Behavioral)
结局指标
主要结局
Demand of BC-Navi: Recruitment Rate
时间窗: 12 weeks
We assess the demand for the BC-Navi application through study recruitment. Based on previous psychosocial and behavioral studies in oncology, a 75% recruitment rate is considered adequate.
Demand of BC-Navi: Retention Rate
时间窗: 12 weeks
Another way we assess demand of the BC-Navi application is through participant retention. Based on previous psychosocial and behavioral studies in oncology, a 75% retention rate is considered adequate .
Acceptability of BC-Navi
时间窗: 12 weeks
To assess acceptability, all participants are asked to complete an exit interview on BC-Navi. This interview assesses the usefulness, satisfaction, learnability, and usability of the application. This exit interview was synthesized from validated measures assessing eHealth intervention acceptability, and was adapted for our study to better fit our target population and our application design. Above-average scores on the questionnaire are considered acceptable.
Preliminary Efficacy: Chemotherapy Initiation
时间窗: 12 weeks
Preliminary efficacy will be measured by time to chemotherapy initiation, which will be operationalized as chemotherapy treatment initiation within 90 days of completion of surgery.
次要结局
未报告次要终点
研究者
Betina Yanez
Associate Professor
Northwestern University