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

Primary Purpose

Breast Cancer Screening, Oncology, Preventative Medicine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast Cancer Screening Decision Support Tool
National Cancer Institute Breast Cancer Screening PDQ
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer Screening focused on measuring Health Literacy, Health Disparities, Shared Decision Making

Eligibility Criteria

40 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breast Cancer Screening Decision Support Tool

Standard Breast Cancer Screening Education

Arm Description

-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.

-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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
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).
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.
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).
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.

Full Information

First Posted
January 25, 2021
Last Updated
August 30, 2022
Sponsor
Washington University School of Medicine
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04741503
Brief Title
Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
Official Title
Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Screening, Oncology, Preventative Medicine, Mammography
Keywords
Health Literacy, Health Disparities, Shared Decision Making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breast Cancer Screening Decision Support Tool
Arm Type
Experimental
Arm Description
-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.
Arm Title
Standard Breast Cancer Screening Education
Arm Type
Active Comparator
Arm Description
-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.
Intervention Type
Other
Intervention Name(s)
Breast Cancer Screening Decision Support Tool
Intervention Description
-Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.
Intervention Type
Other
Intervention Name(s)
National Cancer Institute Breast Cancer Screening PDQ
Intervention Description
-Provides current information about breast cancer screening and is meant to inform and help patients
Primary Outcome Measure Information:
Title
Change in Total Knowledge Score of Screening Mammography Guidelines
Description
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)
Title
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
Description
-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)
Title
Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale
Description
-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)
Title
Preparation for Decision Making Scale as Measured by PrepDM
Description
-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)
Secondary Outcome Measure Information:
Title
Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
Description
-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)
Title
Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool
Description
-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)
Title
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information
Description
-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)
Title
Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance
Description
-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)
Title
Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool
Description
-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)
Title
Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making
Description
-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)
Title
Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making
Description
-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)
Title
Intention to Screen
Description
-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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley J Housten, OTD, MSCI
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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

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