Education About Health and Cancer Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Percent change in attitudes and behavioral intentions toward enrolling in clinical trials
研究概览
简要总结
This study investigates different ways to educate rural residents living in New Hampshire and Vermont about cancer research studies and clinical trials to increase knowledge of, increase positive attitudes toward, and encourage enrollment in cancer research studies and clinical trials. The information learned from this study will contribute to a nation-wide initiative to educate the public about clinical trials, including a nation-wide evaluation of that initiative. The results of this study may also help researchers understand how education about clinical trials/research affects knowledge of and attitudes toward cancer research and clinical trials, as well as behavioral intentions and actual behaviors related to enrolling in cancer research studies and clinical trials.
详细描述
The study team will implement and evaluate the research study and clinical trials education via online video about clinical trials and cancer research
The education will be based on a set of key messages that cover information about research studies and clinical trials, including what research studies are, the benefits, the risks, and connection to available research studies and clinical trials. We will evaluate the effect on knowledge of, attitudes and behavioral intentions toward, and actual enrollment into clinical trials and cancer research studies.
Participants will watch a video and view website materials ('online module') developed by DCC using messaging provided by the National Cancer Institute (NCI) and tailored to our local context. The online module's learning objectives will focus on improving participants' knowledge about what clinical trials and cancer research studies are and how to access trials and studies, increase positive attitudes toward participating in trials and studies, and increase their intent to enroll in trials and studies. Eligible participants will complete pre- and post- surveys to assess achievement of the learning objectives, and they will also be asked a series of questions to assess their eligibility for existing DCC clinical trials and research studies.
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
- All
- 接受健康志愿者
- 是
入选标准
- •- Participants must be a resident of one of the RUCC 7-9 counties in NH or VT: Coos, Sullivan Counties in New Hampshire, or Caledonia, Windsor, Windham, Orange, Orleans, Lamoille or Essex Counties in Vermont. They will be invited to participate in the study through social media, listservs, or from flyers in community settings.
排除标准
- •- Cognitive impairment preventing participation in informed consent process
结局指标
主要结局
Percent change in attitudes and behavioral intentions toward enrolling in clinical trials
时间窗: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention
A pre-test and post-test questionnaire conducted with participants to assess any changes in attitudes and behavioral intentions related to clinical trial enrollment (assessed via 4 Likert-scale questions)
Percent change in participant knowledge related to what cancer research studies and clinical trials are as assessed before and after educational intervention
时间窗: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention
A pre-test and post-test knowledge questionnaire conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via percent of correct and incorrect responses to 19 true/false questions and 6 multiple choice questions).
Percent change in enrollment status in cancer research studies and clinical trials as measured by tracking individual enrollment statuses at the time of intervention and after education
时间窗: Tracking from time of study participation in educational intervention and following study participants for six months monitoring change in enrollment status in cancer research and clinical trials
Actual enrollment into a clinical trial or cancer research study will be assessed via Dartmouth Cancer Center (DCC) Office of Clinical Research enrollment records over 6 months post-intervention. Enrollment records for specified DCC trials/research studies will also be assessed, and change in enrollment status in cancer research or clinical trials will be measured by direct participant's active status in cancer research or clinical trials project participation.
Change in % of Participants With Correct Knowledge Related to What Cancer Research Studies and Clinical Trials Are as Assessed Before and After Educational Intervention, Measured on the Same Day
时间窗: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention on same day. Number represents change in knowledge (increase in % of respondents getting the answer correct).
A pre-test and post-test knowledge questionnaire conducted with participants to assess changes in knowledge related to key learning outcomes expected from the educational intervention, assessed via percent of correct and incorrect responses to 11 true/false "knowledge" questions. A large positive number indicates the percent increase in people getting the answer right after the intervention. % change is a unique number that was calculated as the difference between the % answering correctly after the intervention minus the % correct before the intervention; it is representative of the entire data set and not calculated on an individual participant level. Each row represents a unique survey question evaluating the topic listed in the row title.
Mean Change in Intent to Enroll in Clinical Trials
时间窗: Pre-test questionnaire administered before educational intervention; post-test questionnaire administered after educational intervention on same day
A pre-test and post-test questionnaire conducted with participants to assess any changes in attitudes and behavioral intentions related to clinical trial enrollment (assessed via 5 Likert-scale questions: 1 Strongly disagree, 2 Disagree, 3 Unsure, 4 Agree, 5 Strongly agree). The values reported are the mean scores of pre-intervention and post-intervention scores both measured on the same day. Each row represents a unique survey question evaluating the topic listed in the row title.
Change in Enrollment Status in Cancer Research Studies and Clinical Trials as Measured by Comparing Individual % Enrolled at the Time of Intervention and % Who Have Enrolled Within 6 Months After the Intervention
时间窗: From time of study participation in educational intervention up to six months.
Actual enrollment into a clinical trial or cancer research study will be assessed via Dartmouth Cancer Center (DCC) Office of Clinical Research enrollment records over 6 months post-intervention, measured as a change from the baseline value of 0 participants. Enrollment records for specified DCC trials/research studies will also be assessed and change in enrollment status in cancer research or clinical trials will be measured by direct participant's active status in cancer research or clinical trials project participation.
次要结局
未报告次要终点
研究者
Judith R. Rees
Associate Professor of Epidemiology; Associate Professor of Community and Family Medicine; Associate Director for Community Outreach and Engagement
Dartmouth-Hitchcock Medical Center