Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,277
- 试验地点
- 2
- 主要终点
- Feelings of Being Fully Informed and Clear About the Importance of the Components for Making Informed Decisions as Measured by the Decisional Conflict Scale (DCS), Values Clarity Subscale
研究概览
简要总结
The purpose of this investigation is to conduct a feasibility study to evaluate the potential for implementing the developed decision support tool with Latina, Black, and non-Latina White women. The investigators will collect feasibility data and assess the use of the decision support tool with end-users. The aim is to determine if women using the decision support tool make more informed choices measured by knowledge, attitudes, and intentions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Latina, Black, or non-Latina White women
- •Between the ages of 40-49 years
- •Can write, read, and understand English
排除标准
- •Women with greater than an average self-reported risk of breast cancer will be ineligible for participation, as evidenced by any of the following:
- •Self-reported personal history of breast cancer (invasive, ductal carcinoma in situ [DCIS], or lobular carcinoma in situ[LCIS])
- •Self-reported personal history of atypical hyperplasia
- •Self-reported first degree family member with history of breast cancer (e.g., mother, sister)
- •Self-reported known underlying genetic mutation such as a BRCA1/BRCA2 gene
- •Self-reported prior thoracic or chest wall radiation therapy
结局指标
主要结局
Feelings of Being Fully Informed and Clear About the Importance of the Components for Making Informed Decisions as Measured by the Decisional Conflict Scale (DCS), Values Clarity Subscale
时间窗: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-The 3-item Values Clarity Subscale (questions 4-6) uses a 5-point response format, ranging from 0 (yes) to 4 (no) to assess feelings of clarity about personal values for benefits and risks/side effects. Items are summed and scores are calculated on a range of 0 (feels extremely clear about personal values for benefits/risks) to 100 (feels extremely unclear about personal values). A higher score indicates less clarity on personal values.
Change in Total Knowledge Score of Screening Mammography Guidelines
时间窗: In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)
* The total knowledge score will be collected by the Breast Cancer and Breast Cancer Screening Mammography knowledge questions. * This questionnaire was modified from an existing breast cancer screening knowledge from Hersch et al. This questionnaire covers mammography, screening benefits and downsides, and guidelines. * Six of the knowledge questions were scored as correct (1) or incorrect/unsure (0). The percentage of correct scores was calculated per participant pre-intervention and post-intervention (range, 0-100). A higher score indicates higher knowledge.
Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale
时间窗: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-The 5-Point Decision Self-Efficacy Scale will be modified for breast cancer screening and will measure self-confidence or belief in one's decision-making abilities, including shared decision-making. Questions ask participants how confident they are in a variety of health related skills. This 11-item scale has five response options from "not at all confident" (0) to "extremely confident" (4). Items are summed and scores are calculated on a range of 0-100. A higher score indicates higher decisional self-efficacy.
Preparation for Decision Making Scale as Measured by PrepDM
时间窗: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-The Preparation for Decision Making Scale (PrepDM) assesses a patient's perception of how useful a decision aid or educational materials are in making a screening or treatment decision. The 10-item scale uses a 5-point Likert response format, ranging from 0 (not at all) to 4 (a great deal). Items are summed and scores are calculated on a range of 0-100. Higher scores indicate higher perceived levels of preparation for decision making.
次要结局
- Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information(In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes))
- Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making(In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes))
- Intention to Screen(In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes))
- Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance(In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes))
- Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool(In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes))
- Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information(In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes))
- Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool(In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes))
- Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making(In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes))