Trial Outcomes & Findings for Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool (NCT NCT04741503)
NCT ID: NCT04741503
Last Updated: 2022-09-28
Results Overview
* 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.
COMPLETED
NA
1277 participants
In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)
2022-09-28
Participant Flow
1277 participants consented to participate in the study. 767 participants were removed prior to randomization as they failed to meet screening criteria. 186 participants were removed prior to randomization as overquotas (i.e., having already met the targeted goals for race/ethnicity) were removed.
Participant milestones
| Measure |
Breast Cancer Screening Decision Support Tool
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
Participants Who Were Not Randomized
Participants who consented to participate in the study but were removed prior to randomization.
|
|---|---|---|---|
|
Initial Enrollment
STARTED
|
160
|
164
|
953
|
|
Initial Enrollment
COMPLETED
|
160
|
164
|
0
|
|
Initial Enrollment
NOT COMPLETED
|
0
|
0
|
953
|
|
Met Protocol Criteria for Data Inclusion
STARTED
|
160
|
164
|
0
|
|
Met Protocol Criteria for Data Inclusion
COMPLETED
|
137
|
147
|
0
|
|
Met Protocol Criteria for Data Inclusion
NOT COMPLETED
|
23
|
17
|
0
|
Reasons for withdrawal
| Measure |
Breast Cancer Screening Decision Support Tool
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
Participants Who Were Not Randomized
Participants who consented to participate in the study but were removed prior to randomization.
|
|---|---|---|---|
|
Initial Enrollment
Failed to meet screening criteria
|
0
|
0
|
767
|
|
Initial Enrollment
Overquotas removed
|
0
|
0
|
186
|
|
Met Protocol Criteria for Data Inclusion
Removed from study for not meeting protocol criteria for free responses to knowledge questions
|
23
|
17
|
0
|
Baseline Characteristics
Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
Baseline characteristics by cohort
| Measure |
Breast Cancer Screening Decision Support Tool
n=160 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=164 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
160 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
160 participants
n=5 Participants
|
164 participants
n=7 Participants
|
324 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Change in Total Knowledge Score of Screening Mammography Guidelines
Pre-questionnaire
|
51.0 score on a scale
Standard Deviation 26.1
|
47.0 score on a scale
Standard Deviation 26.4
|
|
Change in Total Knowledge Score of Screening Mammography Guidelines
Post-questionnaire
|
56.2 score on a scale
Standard Deviation 28.6
|
54.6 score on a scale
Standard Deviation 29.3
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
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 score on a scale
Standard Deviation 19.7
|
16.4 score on a scale
Standard Deviation 19.5
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale
|
69.2 score on a scale
Standard Deviation 20.2
|
73.2 score on a scale
Standard Deviation 21.1
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Preparation for Decision Making Scale as Measured by PrepDM
|
69.2 score on a scale
Standard Deviation 21.9
|
68.5 score on a scale
Standard Deviation 27.0
|
SECONDARY outcome
Timeframe: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)Population: Stories about other women question was only asked of the Breast Cancer Screening Decision Support Tool arm.
-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.
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Guidelines for screening · Missing responses
|
0 Participants
|
0 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Guidelines for screening · Good
|
63 Participants
|
78 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Guidelines for screening · Excellent
|
50 Participants
|
47 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer · Poor
|
2 Participants
|
7 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer · Fair
|
29 Participants
|
19 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer · Good
|
66 Participants
|
73 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer · Excellent
|
40 Participants
|
47 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer · Missing responses
|
0 Participants
|
1 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer screening mammography · Poor
|
2 Participants
|
7 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer screening mammography · Fair
|
22 Participants
|
15 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer screening mammography · Good
|
66 Participants
|
72 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer screening mammography · Excellent
|
47 Participants
|
53 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Breast cancer screening mammography · Missing responses
|
0 Participants
|
0 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Guidelines for screening · Poor
|
1 Participants
|
5 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Guidelines for screening · Fair
|
23 Participants
|
17 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Benefits of screening · Poor
|
1 Participants
|
4 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Benefits of screening · Fair
|
20 Participants
|
15 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Benefits of screening · Good
|
63 Participants
|
66 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Benefits of screening · Excellent
|
53 Participants
|
62 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Benefits of screening · Missing responses
|
0 Participants
|
0 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Downsides of screening · Poor
|
4 Participants
|
8 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Downsides of screening · Fair
|
30 Participants
|
34 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Downsides of screening · Good
|
61 Participants
|
64 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Downsides of screening · Excellent
|
42 Participants
|
41 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Downsides of screening · Missing responses
|
0 Participants
|
0 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Questions to help make the decision · Poor
|
2 Participants
|
4 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Questions to help make the decision · Fair
|
26 Participants
|
20 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Questions to help make the decision · Good
|
63 Participants
|
77 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Questions to help make the decision · Excellent
|
46 Participants
|
46 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Questions to help make the decision · Missing responses
|
0 Participants
|
0 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Stories about other women · Poor
|
2 Participants
|
—
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Stories about other women · Fair
|
29 Participants
|
—
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Stories about other women · Good
|
67 Participants
|
—
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Stories about other women · Excellent
|
39 Participants
|
—
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Stories about other women · Missing responses
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool
Too long
|
16 Participants
|
33 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool
Too short
|
4 Participants
|
6 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool
Just right
|
113 Participants
|
105 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool
Prefer not to answer
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information
Too much information
|
11 Participants
|
19 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information
Too little information
|
18 Participants
|
15 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information
Just right
|
105 Participants
|
109 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information
Prefer not to answer
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance
Slanted towards screening
|
30 Participants
|
31 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance
Slanted towards NOT screening
|
4 Participants
|
5 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance
Balanced
|
98 Participants
|
103 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance
Prefer not to answer
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool
Yes
|
114 Participants
|
119 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool
No
|
17 Participants
|
20 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool
Prefer not to answer
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)Population: This question was for participants enrolled in the Breast Cancer Screening Decision Support Tool arm only.
-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.
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making
Easy
|
119 Participants
|
—
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making
Difficult
|
7 Participants
|
—
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making
Prefer not to answer
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making
Yes
|
125 Participants
|
129 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making
No
|
10 Participants
|
13 Participants
|
|
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making
Prefer not to answer
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Breast Cancer Screening Decision Support Tool
n=137 Participants
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
|
Standard Breast Cancer Screening Education
n=147 Participants
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
|
|---|---|---|
|
Intention to Screen
Post-questionnaire · Unsure or unknown (no response)
|
25 Participants
|
17 Participants
|
|
Intention to Screen
Pre-questionnaire · Leaning toward screening
|
95 Participants
|
104 Participants
|
|
Intention to Screen
Pre-questionnaire · Leaning away from screening
|
17 Participants
|
24 Participants
|
|
Intention to Screen
Pre-questionnaire · Unsure or unknown (no response)
|
25 Participants
|
19 Participants
|
|
Intention to Screen
Post-questionnaire · Leaning toward screening
|
96 Participants
|
103 Participants
|
|
Intention to Screen
Post-questionnaire · Leaning away from screening
|
16 Participants
|
27 Participants
|
Adverse Events
Breast Cancer Screening Decision Support Tool
Standard Breast Cancer Screening Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ashley J. Housten, OTD, MSCI
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place