Engaging Patients in Decision Making: The Development and Pilot Testing of a Low Literacy Spanish Language Shared Medical Decision Tool for Ovarian Cancer Maintenance Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Decision Regret Scale questionnaire
研究概览
简要总结
To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make decisions about their maintenance therapy
详细描述
Objectives:
- Create a low literacy version of a shared decision-making (SDM) tool for ovarian cancer maintenance therapy for Spanish speaking individuals.
- To explore the feasibility and acceptability of incorporating the SDM tool into routine clinical care for Spanish speaking individuals.
- To estimate the effectiveness of the SDM tool on quality of the decision making in patients with ovarian cancer who are making decisions about maintenance therapy through a pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 否
入选标准
- •Study population: This study will enroll patients and clinical providers.
- •Inclusion criteria: Patients
- •Eligible patients must be: 1) individuals ≥ 18 years with advanced stage high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are receiving or have completed platinum-based chemotherapy for ovarian cancer and are potentially eligible to receive maintenance therapy; 2) able to understand, speak or read in Spanish.
排除标准
- •Inability or unwillingness to sign informed consent
- •Inclusion criteria: Clinicians
- •Eligible clinicians will include: 1) MD Anderson gynecologic oncologists and advanced practice providers who practice at the Houston Area Locations (HALs), MD Anderson Cancer Center, or our county safety net hospital, The Harris Health System (LBJ Hospital).
- •Exclusion criteria: Clinicians
- •Inability or unwillingness to sign informed consent
研究组 & 干预措施
Study Phase 2
Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group).
干预措施: Shared Medical Decision Tool (Other)
Study Phase 1
Pre-testing and cognitive interviews for the Decision Support Tool
干预措施: Shared Medical Decision Tool (Other)
Study Phase 1
Pre-testing and cognitive interviews for the Decision Support Tool
干预措施: Engaging Patients in Decision Making (Behavioral)
Study Phase 1
Pre-testing and cognitive interviews for the Decision Support Tool
干预措施: Literacy Spanish Language (Behavioral)
Study Phase 2
Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group).
干预措施: Engaging Patients in Decision Making (Behavioral)
Study Phase 2
Usual Care (Control Group) or Participants utilize the Decision Support Tool with Provider guidance (Intervention Group).
干预措施: Literacy Spanish Language (Behavioral)
结局指标
主要结局
Decision Regret Scale questionnaire
时间窗: through study completion; an average of 2 year.
This scale measures decisional regret related to health care decisions at a specific point in time. This tool consists of 5 questions answered on a Likert scale (1="Strongly agree" to 5="Strongly disagree").
次要结局
未报告次要终点