An interventional study of Breast Cancer Screening Decision Support Tool and National Cancer Institute Breast Cancer Screening PDQ in Breast Cancer Screening, Oncology and Preventative Medicine, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 40 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Health services research
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.
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's enrollment of 1,277 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 270 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
Other: Breast Cancer Screening Decision Support Tool
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
Other: National Cancer Institute Breast Cancer Screening PDQ
-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
Change in Total Knowledge Score of Screening Mammography Guidelines
* 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.
Time frame: In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)
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
-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)
Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale
-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)
Preparation for Decision Making Scale as Measured by PrepDM
-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)
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
-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)
Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool
-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)
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information
-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)
Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance
-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)
Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool
-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)
Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making
-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)
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making
-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 the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
Intention to Screen
-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.
Time frame: In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)
| Milestone | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education | Participants Who Were Not Randomized |
|---|---|---|---|
| Started | 160 | 164 | 953 |
| Completed | 160 | 164 | 0 |
| Not completed | 0 | 0 | 953 |
| Withdrew: Failed to meet screening criteria | 0 | 0 | 767 |
| Withdrew: Overquotas removed | 0 | 0 | 186 |
| Milestone | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education | Participants Who Were Not Randomized |
|---|---|---|---|
| Started | 160 | 164 | 0 |
| Completed | 137 | 147 | 0 |
| Not completed | 23 | 17 | 0 |
| Withdrew: Removed from study for not meeting protocol criteria for free responses to knowledge questions | 23 | 17 | 0 |
* 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.
| score on a scale | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Pre-questionnaire | 51.0 ± 26.1 | 47.0 ± 26.4 |
| Post-questionnaire | 56.2 ± 28.6 | 54.6 ± 29.3 |
-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.
| score on a scale | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| 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 | 19.6 ± 19.7 | 16.4 ± 19.5 |
-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.
| score on a scale | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale | 69.2 ± 20.2 | 73.2 ± 21.1 |
-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.
| score on a scale | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Preparation for Decision Making Scale as Measured by PrepDM | 69.2 ± 21.9 | 68.5 ± 27.0 |
-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.
| Participants | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Breast cancer — Poor | 2 | 7 |
| Breast cancer — Fair | 29 | 19 |
| Breast cancer — Good | 66 | 73 |
| Breast cancer — Excellent | 40 | 47 |
| Breast cancer — Missing responses | 0 | 1 |
| Breast cancer screening mammography — Poor | 2 | 7 |
| Breast cancer screening mammography — Fair | 22 | 15 |
| Breast cancer screening mammography — Good | 66 | 72 |
| Breast cancer screening mammography — Excellent | 47 | 53 |
| Breast cancer screening mammography — Missing responses | 0 | 0 |
| Guidelines for screening — Poor | 1 | 5 |
| Guidelines for screening — Fair | 23 | 17 |
| Guidelines for screening — Good | 63 | 78 |
| Guidelines for screening — Excellent | 50 | 47 |
| Guidelines for screening — Missing responses | 0 | 0 |
| Benefits of screening — Poor | 1 | 4 |
| Benefits of screening — Fair | 20 | 15 |
| Benefits of screening — Good | 63 | 66 |
| Benefits of screening — Excellent | 53 | 62 |
| Benefits of screening — Missing responses | 0 | 0 |
| Downsides of screening — Poor | 4 | 8 |
| Downsides of screening — Fair | 30 | 34 |
| Downsides of screening — Good | 61 | 64 |
| Downsides of screening — Excellent | 42 | 41 |
| Downsides of screening — Missing responses | 0 | 0 |
| Questions to help make the decision — Poor | 2 | 4 |
| Questions to help make the decision — Fair | 26 | 20 |
| Questions to help make the decision — Good | 63 | 77 |
| Questions to help make the decision — Excellent | 46 | 46 |
| Questions to help make the decision — Missing responses | 0 | 0 |
| Stories about other women — Poor | 2 | — |
| Stories about other women — Fair | 29 | — |
| Stories about other women — Good | 67 | — |
| Stories about other women — Excellent | 39 | — |
| Stories about other women — Missing responses | 0 | — |
-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.
| Participants | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Too long | 16 | 33 |
| Too short | 4 | 6 |
| Just right | 113 | 105 |
| Prefer not to answer | 4 | 3 |
-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.
| Participants | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Too much information | 11 | 19 |
| Too little information | 18 | 15 |
| Just right | 105 | 109 |
| Prefer not to answer | 3 | 4 |
-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
| Participants | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Slanted towards screening | 30 | 31 |
| Slanted towards NOT screening | 4 | 5 |
| Balanced | 98 | 103 |
| Prefer not to answer | 3 | 8 |
-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).
| Participants | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Yes | 114 | 119 |
| No | 17 | 20 |
| Prefer not to answer | 6 | 8 |
-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.
| Participants | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Easy | 119 | — |
| Difficult | 7 | — |
| Prefer not to answer | 10 | — |
-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).
| Participants | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Yes | 125 | 129 |
| No | 10 | 13 |
| Prefer not to answer | 2 | 5 |
-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.
| Participants | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education |
|---|---|---|
| Pre-questionnaire — Leaning toward screening | 95 | 104 |
| Pre-questionnaire — Leaning away from screening | 17 | 24 |
| Pre-questionnaire — Unsure or unknown (no response) | 25 | 19 |
| Post-questionnaire — Leaning toward screening | 96 | 103 |
| Post-questionnaire — Leaning away from screening | 16 | 27 |
| Post-questionnaire — Unsure or unknown (no response) | 25 | 17 |
Collected over Adverse events were followed through completion of questionnaires (day 1 - approximately 30 minutes). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Breast Cancer Screening Decision Support Tool | 0/137 (0%) | 0/137 (0%) | 0/137 (0%) |
| Standard Breast Cancer Screening Education | 0/147 (0%) | 0/147 (0%) | 0/147 (0%) |
| Age, Categorical(Participants) | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 160 | 164 | 324 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education | Total |
|---|---|---|---|
| Female | 160 | 164 | 324 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education | Total |
|---|---|---|---|
| Hispanic or Latino | 46 | 52 | 98 |
| Not Hispanic or Latino | 114 | 111 | 225 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education | Total |
|---|---|---|---|
| American Indian or Alaska Native | 4 | 1 | 5 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 51 | 61 | 112 |
| White | 81 | 72 | 153 |
| More than one race | 13 | 12 | 25 |
| Unknown or Not Reported | 10 | 17 | 27 |
| Region of Enrollment(participants) | Breast Cancer Screening Decision Support Tool | Standard Breast Cancer Screening Education | Total |
|---|---|---|---|
| United States | 160 | 164 | 324 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after De-identified data may be shared upon reasonable request.
Time frame: Up to 36 months following publication
Access criteria: Please contact the principal investigator with requests.
Ran from Apr 2021 to primary completion in Aug 2021, 4 months.
Results were first posted in Sep 2022, 1 year after primary completion.
Of 1,358 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 71. This study's 4 months is below that.
Counting every sponsor, half of 1,404 studies reached it within 38 months; a quarter within 17 and three quarters within 71.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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