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Completed

NCT Number: NCT04741503

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.

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Key information

Age range

40 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast Cancer Screening Decision Support Tool

Other

-Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.

National Cancer Institute Breast Cancer Screening PDQ

Other

-Provides current information about breast cancer screening and is meant to inform and help patients

Primary outcomes

  1. Change in Total Knowledge Score of Screening Mammography Guidelines

    Time frame: 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.
  2. 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

    Time frame: 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.

  3. Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale

    Time frame: 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.

  4. Preparation for Decision Making Scale as Measured by PrepDM

    Time frame: 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 outcomes

  1. Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information

    Time frame: 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.

  2. Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool

    Time frame: 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.

  3. Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information

    Time frame: 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.

  4. Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance

    Time frame: 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

  5. Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool

    Time frame: 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).

  6. Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making

    Time frame: 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.

  7. Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making

    Time frame: 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).

  8. Intention to Screen

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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