N/A
N=1,277
Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
Breast Cancer Screening · Oncology · Preventative Medicine · Mammography
Bottom Line
View on ClinicalTrials.gov: NCT04741503 ↗Enrolled (actual)
1,277
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Change in Total Knowledge Score of Screening Mammography Guidelines — 51.0; 47.0; 56.2; 54.6 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Breast Cancer Screening Decision Support Tool (Other); National Cancer Institute Breast Cancer Screening PDQ (Other)
- Age
- Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Knowledge Score of Screening Mammography Guidelines |
51.0; 47.0; 56.2; 54.6 | — |
| PRIMARY 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 |
19.6; 16.4 | — |
| PRIMARY Decision Self-efficacy as Measured by the 5-Point Decision Self-Efficacy Scale |
69.2; 73.2 | — |
| PRIMARY Preparation for Decision Making Scale as Measured by PrepDM |
69.2; 68.5 | — |
| SECONDARY Acceptability as Measured by the Ottawa Acceptability Measures - Presented Information |
2; 7; 29; 19; 66; 73 | — |
| SECONDARY Acceptability as Measured by the Ottawa Acceptability Measures - Length of Tool |
16; 33; 4; 6; 113; 105 | — |
| SECONDARY Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information |
11; 19; 18; 15; 105; 109 | — |
| SECONDARY Acceptability as Measured by the Ottawa Acceptability Measures - Tool's Balance |
30; 31; 4; 5; 98; 103 | — |
| SECONDARY Acceptability as Measured by the Ottawa Acceptability Measures - Usefulness of Tool |
114; 119; 17; 20; 6; 8 | — |
| SECONDARY Acceptability as Measured by the Ottawa Acceptability Measures - Helpfulness of Tool for Decision Making |
119; 7; 10 | — |
| SECONDARY Acceptability as Measured by the Ottawa Acceptability Measures - Amount of Information for Decision Making |
125; 129; 10; 13; 2; 5 | — |
| SECONDARY Intention to Screen |
95; 104; 17; 24; 25; 19 | — |
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
Data sourced from ClinicalTrials.gov (NCT04741503). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.