Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT04741503
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.
Looking for future studies?
Notify Me40 year–49 year
Female
Interventional
Not applicable
St Louis, Missouri, 63110, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-Women with greater than an average self-reported risk of breast cancer will be ineligible for participation, as evidenced by any of the following:
-Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.
-Provides current information about breast cancer screening and is meant to inform and help patients
Time frame: In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-Adapted acceptability measures from the Ottawa Acceptability Measures including questions eliciting ratings of the information presented in the tool. Each question will ask the participant to rate the information in the tool they viewed as poor, fair, good, or excellent to show what they thought about the way the information was presented.
Time frame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the length of tool. The questionnaire asks the participant to rate the length of the tool they viewed as too long, too short, just right, or prefer not to answer.
Time frame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the amount of information in the tool. The questionnaire asks the participant to rate the amount of information as too much information, too little information, just right, or prefer not to answer.
Time frame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the balance of the tool's balance. The questionnaire asks the participant to rate the tool as slanted towards screening, slanted towards NOT screening, balanced, or prefer not to answer
Time frame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the usefulness of the tool for decision-making. The questionnaire asks the participant if they would find this decision tool useful when making decision for when to start screening mammography (yes, no, prefer not to answer).
Time frame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the helpfulness for decision making of the breast cancer screening decision support tool's questions. The questionnaire asks the participant if the questions in the tool made decision making easier or more difficult or if they prefer not to answer.
Time frame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-Adapted acceptability measures from the Ottawa Acceptability Measures eliciting acceptability ratings of the amount of information in the tool for decision making. The questionnaire asks the participant if the tool provided enough information to help a woman decide when to start breast cancer screening mammography (yes, no, prefer not to answer).
Time frame: In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)
-This is the participants' intention to undergo breast cancer screening within the upcoming year. The questionnaire asks the participant how likely they are to have a screening mammography this upcoming year. Response options include: leaning toward screening (definitely will be tested or probably will be tested), leaning away from screening (probably won't be tested or definitely won't be tested), unsure, and prefer not to answer.
Washington University School of Medicine
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07472036
Behavior, Breast Cancer Screening
Antwerp, Belgium
View Trial DetailsNCT06939699
Breast Cancer Screening, Cervical Cancer Screening
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT06640426
Annual Wellness Visit, Breast Cancer Screening
St Louis, Missouri, United States
View Trial DetailsNCT07355569
Attendance, Breast Cancer Screening
Oslo, Norway
View Trial Details