Acceptability of Active Monitoring (AM) as a Treatment Option for Ductal Carcinoma in Situ (DCIS)
NCT ID: NCT03775213
Last Updated: 2023-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
322 participants
INTERVENTIONAL
2021-10-12
2022-01-31
Brief Summary
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Detailed Description
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Here the study team seeks to answer the question: if AM is found to be a safe alternative to immediate surgery, how likely are women to choose it as their first course of treatment?
In this study, women are asked to imagine having recently been diagnosed with DCIS. For some in the intervention arm, in-depth information about surgical options and AM are presented with a web-based decision support tool. After exploring the decision support tool, participants are asked to make a hypothetical treatment choice and to answer a series of additional questions about their decision-making process and personal preferences. Women in the control arm receive a reduced version of the decision support tool that only provides in-depth information about the surgical options (AM is mentioned as an experimental approach).
The overarching hypothesis of this study is that patients who are offered AM as a guideline-concordant care option (a potential future scenario if ongoing trials confirm the safety of AM) are more likely to choose it compared to women in current clinical practice (who receive information about surgical options only).
Primary research question: Compared to presenting active monitoring (AM) as an experimental option, does presenting AM as a guideline-concordant care option increase its uptake as treatment choice?
Secondary research questions: Compared to presenting active monitoring (AM) as an experimental option, does presenting active monitoring as a guideline-concordant care option increase AM acceptability, decrease perceived AM riskiness, and decrease uptake of mastectomy as treatment choice?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Standard Treatment Options + Active Monitoring
Participants explore decision support tool that includes current standard treatment options for DCIS, as well as active monitoring.
Decision Support Tool with Active Monitoring
The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Standard Treatment Options
Participants explore decision support tool that includes current standard treatment options for DCIS.
Decision Support Tool without Active Monitoring
The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Interventions
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Decision Support Tool with Active Monitoring
The decision support tool communicates trade-offs for different management strategies for DCIS, including active monitoring and surgery options.
Decision Support Tool without Active Monitoring
The decision support tool communicates trade-offs for different management strategies for DCIS, including surgery options only.
Eligibility Criteria
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Inclusion Criteria
* Age: 50-79 years
* Has had a negative mammographic screen in the past 12 months
Exclusion Criteria
50 Years
79 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Marc D Ryser, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Mammography Clinic
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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Pro00101109
Identifier Type: -
Identifier Source: org_study_id
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