Clinical trial NCT04741503: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Screening
Oncology
Preventative Medicine
Mammography
Keywords: Health Literacy
Health Disparities
Shared Decision Making
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-02-05
Enrollment: 1277
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Change in Total Knowledge Score of Screening Mammography Guidelines
timeFrame: In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: 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
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: Preparation for Decision Making Scale as Measured by PrepDM
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
Secondary outcomes:
measure: Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making
timeFrame: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
measure: Intention to Screen
timeFrame: In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ashley J Housten, OTD, MSCI
role: PRINCIPAL_INVESTIGATOR
References: