Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool

Not Applicable

Completed

Conditions: Oncology
Breast Cancer Screening
Mammography
Preventative Medicine

Interventions: Other: National Cancer Institute Breast Cancer Screening PDQ
Other: Breast Cancer Screening Decision Support Tool

Registration Number: NCT04741503

Lead Sponsor: Washington University School of Medicine

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1277

Inclusion Criteria

Latina, Black, or non-Latina White women
Between the ages of 40-49 years
Can write, read, and understand English

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:

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Breast Cancer Screening Education	National Cancer Institute Breast Cancer Screening PDQ	-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
Breast Cancer Screening Decision Support Tool	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.

Primary Outcome Measures

Name	Time	Method
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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
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)	-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.
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)	-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).
Intention to Screen	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.
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)	-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
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)	-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).
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)	-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.
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)	-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.
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)	-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.