Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Breast Cancer Screening Decision Support Tool -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
-Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.
|
| Active Comparator: Standard Breast Cancer Screening Education -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
-Provides current information about breast cancer screening and is meant to inform and help patients
|
Outcome Measures
Primary Outcome Measures
- Change in total knowledge score of screening mammography guidelines as measured by percentage of correct responses [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
- 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 [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) to assess feelings of clarity about personal values for benefits and risks/side effects. This scale has high internal consistency and reliability.
- Decision self-efficacy as measured by the 5-Point Decision Self-Efficacy Scale [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 response options from "not at all confident" to "extremely confident". Items are summed and scores are calculated on a range of 0-100. There is high reliability with an alpha of 0.92.
- Preparation for decision making scale as measured by PrepDM [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 1 (not at all) to 5 (a great deal). Items are summed and scores are calculated on a range of 0-100. Internal reliability of the scale is excellent, with alpha coefficients ranging from 0.92 to 0.96.
Secondary Outcome Measures
- Acceptability as measured by the Ottawa Acceptability Measures [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 tool regarding length, clarity, balance of information.
- Intention to screen [In the post-questionnaire 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. Response options include: definitely will be tested, probably will be tested, probably won't be tested, definitely won't be tested, and unsure.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Latina, Black, or non-Latina White women
-
Between the ages of 40-49 years
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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:
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Self-reported personal history of breast cancer (invasive, ductal carcinoma in situ [DCIS], or lobular carcinoma in situ[LCIS])
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Self-reported personal history of atypical hyperplasia
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Self-reported first degree family member with history of breast cancer (e.g., mother, sister)
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Self-reported known underlying genetic mutation such as a BRCA1/BRCA2 gene
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Self-reported prior thoracic or chest wall radiation therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
- Principal Investigator: Ashley J Housten, OTD, MSCI, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 202101073
- 5R00MD011485-04