Breast Cancer ScreeningNCT04741503
Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
A study testing Breast Cancer Screening Decision Support Tool and National Cancer Institute Breast Cancer Screening PDQ in people with Breast Cancer Screening and Oncology, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening, Oncology, Preventative Medicine
- What is being tested?
- Breast Cancer Screening Decision Support Tool and National Cancer Institute Breast Cancer Screening PDQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,277 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Latina, Black, or non-Latina White women
- Between the ages of 40-49 years
- Can write, read, and understand English
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
- Being tested
- Breast Cancer Screening Decision Support Tool, National Cancer Institute Breast Cancer Screening PDQ
- Keywords
- Health Literacy, Health Disparities, Shared Decision Making
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer Screening Decision Support ToolOther
-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 PDQOther
-Provides current information about breast cancer screening and is meant to inform and help patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: National Cancer Institute Breast Cancer Screening PDQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
-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.
Measured: 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
-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.
Measured: 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
-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.
Measured: 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
-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
Measured: 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
-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).
Measured: 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 - Helpfulness of Tool for Decision Making
-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.
Measured: 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 for Decision Making
-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).
Measured: In the post-questionnaire occurring in a single encounter in one day (Day 1 approximately 30 minutes)
Intention to Screen
-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.
Measured: In both the pre-questionnaire and post-questionnaires occurring in a single encounter in one day (Day 1 approximately 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start19 Apr 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Ashley J Housten, OTD, MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741503
- Sponsor's protocol ID
- 202101073
- Other IDs
- 5R00MD011485-04
- Status last verified
- Aug 2022
- First submitted
- 25 Jan 2021
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after De-identified data may be shared upon reasonable request.
Publications
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.
PubMed 38726892
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
- ClinicalTrials.gov ID
- NCT04741503
- Acronym / sponsor ID
- 202101073
- Conditions
- Breast Cancer Screening, Oncology, Preventative Medicine, Mammography
- Keywords
- Health Literacy, Health Disparities, Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,277 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Screening Decision Support Tool | Experimental | Other: 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. |
| Standard Breast Cancer Screening Education | Active comparator | Other: National Cancer Institute Breast Cancer Screening PDQ-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire. |
Who may qualify
- Ages
- 40 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Latina, Black, or non-Latina White women
- Between the ages of 40-49 years
- Can write, read, and understand English
Key exclusion criteria (6 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Breast Cancer Screening Decision Support Tool |
| National Cancer Institute Breast Cancer Screening PDQ-Provides current information about breast cancer screening and is meant to inform and help patients | Other | Standard Breast Cancer Screening Education |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38726892Riganti 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.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after De-identified data may be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley J Housten, OTD, MSCI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast Cancer Screening Decision Support Tool and National Cancer Institute Breast Cancer Screening PDQ in people with Breast Cancer Screening and Oncology, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04741503, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.