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

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.

Study Overview

• Status: Completed
• Conditions: Oncology; Breast Cancer Screening; Mammography; Preventative Medicine
• Intervention / Treatment: Other: Breast Cancer Screening Decision Support Tool; Other: National Cancer Institute Breast Cancer Screening PDQ

• Study Type: Interventional
• Enrollment (Actual): 1277
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Other: Breast Cancer Screening Decision Support Tool; -Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.
ACTIVE_COMPARATOR: 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.	Other: National Cancer Institute Breast Cancer Screening PDQ; -Provides current information about breast cancer screening and is meant to inform and help patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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).	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.	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).	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.	In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Ashley J Housten, OTD, MSCI, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 19, 2021
• Primary Completion (ACTUAL): August 30, 2021
• Study Completion (ACTUAL): August 30, 2021

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (ACTUAL): February 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Health Literacy; Health Disparities; Shared Decision Making
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 202101073; 5R00MD011485-04 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after De-identified data may be shared upon reasonable request.
• IPD Sharing Time Frame: Up to 36 months following publication
• IPD Sharing Access Criteria: Please contact the principal investigator with requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No