Improving Health Literacy in African-American Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 8
- 主要终点
- Change in Decisional Conflict Scale Score
研究概览
简要总结
Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.
详细描述
Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.
Investigators hypothesize that the delivery of a scripted, tailored, low literacy educational supplement will result in a statistically significant decrease in decisional conflict, and a statistically significant improvement in comprehension of cancer treatment and its side effects compared to standard practice.
The study team will measure patients' comprehension of treatment options and side effects, as well as decisional conflict; after standard practice, and again after exposure to the educational supplement. Investigators will compare the urologists' assessment of patients' 1) health literacy 2) preferences for side effects 3) stage of decision making, 4) treatment choice or predisposition toward treatment choice. 5) preference for role in decision making (active, passive, or shared with physician); to measures obtained from patients. These comparisons will allow investigators to quantify the potential benefit to the physician of information obtained through the interview and low literacy educational supplement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone pathology review of their prostate biopsy at Emory University, Grady Memorial Hospital, Saint Joseph's Hospital, and Atlanta VA Medical Center with AJCC clinical stage T1-T2 prostate cancer by physical exam
排除标准
- •RN or MD degree
- •History of head injury or dementia
- •History of cognitive impairment
- •Unable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist or urological provider
研究组 & 干预措施
Educational Supplement
Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.
干预措施: Educational Supplement (Other)
Educational Supplement
Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.
干预措施: Standard Practice Education (Other)
结局指标
主要结局
Change in Decisional Conflict Scale Score
时间窗: Baseline, Post-Intervention (Up to 6 Weeks)
The decisional conflict scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Change in Comprehension of Treatment Options Score assessed by Interview
时间窗: Baseline, Post-Intervention (Up to 6 Weeks)
Comprehension of treatment options will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand treatment after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
Change in Comprehension of Side Effects Score assessed by Interview
时间窗: Baseline, Post-Intervention (Up to 6 Weeks)
Comprehension of side effects will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand side effects after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
次要结局
- Rapid Estimate of Adult Literacy in Medicine (REALM) Score(Baseline)
- Change in the Stage of Decision Making Scale Score(Baseline, Post-Intervention (Up to 6 Weeks))