Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Barrier resolution (information, transportation, appointments, and communication) and time to resolution
研究概览
简要总结
RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life.
PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.
详细描述
OBJECTIVES:
- Identify barriers of receiving primary breast cancer treatment for older patients with either Medi-Cal insurance or who are 65 years of age and older.
- Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these patients.
- Identify barriers of receiving primary breast cancer treatment for patients who are Hispanic with either Medi-Cal insurance or aged 65 years and older.
- Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these Hispanic patients.
- Describe breast cancer participants' perceptions of Patient Navigation.
- Demonstrate the significant role of a Patient Navigator in identifying and resolving barriers to treatment.
- Increase opportunities for participation of breast cancer patients with either Medi-Cal insurance or who are 65 years of age and older, or who are Hispanic, to breast cancer clinical trials.
- Integrate a patient navigation program within City of Hope designed to support underserved patients during primary treatment for breast cancer.
OUTLINE: For the first 3 months of the study, medical charts are reviewed.
Beginning in month 4, patients are introduced to the Patient Navigator who provides them with telephone and e-mail contact on an Appointment Reminder Card, and develops a plan for eliminating identified barriers and/or addressing immediate concerns. Patients' plans may include contacting others on behalf of the patient, coaching the patient on how to solve a problem, referring to resources within City of Hope (COH) or in the community, and investigating possible solutions. Patients are also oriented to COH's services, open clinical trials, and resources. Navigation of care includes assistance during initial and ongoing evaluations by all cancer specialists, during initiation and completion of all primary treatment, and through the first post-treatment follow up. Patients are contacted weekly for 8 weeks of the study and at least once a month for 9 months.
The Patient Navigator will track identified barriers, processes to resolution, and time required to resolve barriers.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed breast cancer
- •Stage 0-III disease
- •No metastasis or recurrent disease
- •Insured with Medi-Cal OR ≥ 65 years old
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •English or Spanish-speaking
- •Intending to receive all primary breast cancer treatment at City of Hope
- •PRIOR CONCURRENT THERAPY:
- •No prior therapy for breast cancer
排除标准
- 未提供
结局指标
主要结局
Barrier resolution (information, transportation, appointments, and communication) and time to resolution
时间窗: Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
Quality of life (psychological, physical, social, and spiritual well-being)
时间窗: Prior to starting treatment and 3, 6 and 9 months after starting the study.
Navigation and care (patient's satisfaction and value, provider's perception of barriers)
时间窗: 3, 6 and 9 months after starting the study.
次要结局
未报告次要终点