A Feasibility and Acceptability Pilot Study Evaluating a Patient-Specific Targeted Intervention Using Patient Navigators or Routine Clinical Care
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- General Self-Efficacy (GSE) Scale Questionnaires
研究概览
简要总结
Project Lets start will provide individual support to breast cancer patients with the goal of reducing delay to chemotherapy initiation. In this study participants will identify areas of need and work with patient navigators who will provide weekly 1-1 support throughout patient's journey to beginning chemotherapy
详细描述
OBJECTIVES:
Among patients with early-stage breast cancer, delays with the administration of chemotherapy significantly reduce its benefit. Interventions aimed at reducing TTC have the potential of improving outcomes and reducing health disparities. In this study we propose to develop an effective targeted intervention that is culturally sensitive and that addresses the roots of chemotherapy delay.
Our objective is to conduct a pilot study randomizing patients with breast cancer, in whom adjuvant or neoadjuvant chemotherapy has been recommended, to a culturally sensitive and patient-specific targeted intervention using patient navigators or routine clinical care
Primary Aim: To establish feasibility and acceptability.
We hypothesize that the intervention will be feasible and accepted by participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •I. At least 18 years of age. II. Diagnosis of primary invasive breast cancer. III. Chemotherapy (adjuvant or neo-adjuvant) recommended by treating physician (including pregnant women in 2nd or 3rd trimester).
- •IV. Patient of the University of Texas MD Anderson Cancer Center or planning on receiving treatment at our Institution.
- •V. Can speak, read, and understand English and/or Spanish. VI. Participant can provide consent for themself
排除标准
- •I. Hospitalized for a critical condition or who are considered medically unstable by their medical team.
- •II. Patients that have been previously treated with chemotherapy.
结局指标
主要结局
General Self-Efficacy (GSE) Scale Questionnaires
时间窗: through study completion and average of 1 year.
Responses are made on a 4-point scale, ranging from 1 (not at all true) to 4 (exactly true). Scores could range from a composite score of 10 to 40, with higher score indicating more self-efficacy.25
次要结局
未报告次要终点