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

NCT04741503 | Completed Results

• 2 other identifiers: 2021010735R00MD011485-04
• Study Type: interventional
• Target: 1,277
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Screening; Oncology; Preventative Medicine; Mammography

Keywords

Health Literacy; Health Disparities; Shared Decision Making

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Breast Cancer Screening Decision Support Tool

EXPERIMENTAL

-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

Standard Breast Cancer Screening Education

ACTIVE COMPARATOR

-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

Interventions

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.

Breast Cancer Screening Decision Support Tool

National Cancer Institute Breast Cancer Screening PDQ OTHER

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

Standard Breast Cancer Screening Education

Eligibility Criteria

• Age: 40 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.

  PMID: 38726892 DERIVED

Related Links

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

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Ashley J. Housten, OTD, MSCI
• Organization: Washington University School of Medicine

ahousten@wustl.edu

314-454-7958

Study Officials

• Ashley J Housten, OTD, MSCI

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 5, 2021
• Study Start: April 19, 2021
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Up to 36 months following publication
• Access Criteria: Please contact the principal investigator with requests.

Locations

US (1)