Addressing Disparities in Breast Cancer Care: An Approach to Health Equity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Retention Rate
研究概览
简要总结
This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients.
详细描述
PRIMARY OBJECTIVE:
I. Implement a patient navigation program in the Roswell Park Breast Clinic focused on underserved women with a first cancer diagnosis of breast cancer or ductal carcinoma in situ (DCIS) (n=126).
SECONDARY OBJECTIVE:
I. Systematically address barriers to care by connecting women with multiple barriers of care with a first diagnosis of breast cancer or DCIS to supportive services and culturally appropriate resources.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Age ≥ 18 years of age
- •Have a confirmed diagnosis of breast cancer or Ductal Carcinoma In Situ (DCIS)
- •Currently identify their gender as woman or female
- •Was assigned female sex at birth (AFAB)
- •- Participant is experiencing ≥1 barrier to care as determined by the social needs screening tool
- •Participant must understand the investigational nature of this study and verbally consent to participate prior to receiving any study related intervention
排除标准
- •Participants who are not suspected of or diagnosed with breast cancer or Ductal Carcinoma in Situ (DCIS)
- •Participants who have had a previous diagnosis of any cancer
- •Participants who were assigned male sex or intersex at birth
- •Unwilling or unable to follow protocol requirements
研究组 & 干预措施
Health Services Research (Patient Navigation)
Patients receive patient navigation services from a patient navigator as needed to improve knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance skills related to management of cancer treatment
干预措施: Patient Navigation (Behavioral)
Health Services Research (Patient Navigation)
Patients receive patient navigation services from a patient navigator as needed to improve knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance skills related to management of cancer treatment
干预措施: Questionnaire (Other)
结局指标
主要结局
Retention Rate
时间窗: Up to 2 years
The number of patients that complete patient navigation divided by the number of patients enrolled
Enrollment rate
时间窗: Up to 2 years
Enrollment rate Will be defined as the number of patients enrolled divided by the number of patients approached. The enrollment rate will be estimated with a 90% credible region obtained by Jeffrey's prior method.
Reasons for refusal
时间窗: Up to 2 years
Reported reasons of refusal will be summarized using frequencies and relative frequencies
Reasons for discontinuation
时间窗: Up to 2 years
Will be summarized using frequencies and relative frequencies
次要结局
- Use of supportive services(Up to 2 years)
- Social Determinates of health(Up to 2 years)
- European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30)(Up to 2 years)
- Patient Satisfaction survey(up to 2 years)
- Barriers to care(Up to 2 years)