A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer
NCT ID: NCT06813053
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-21
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Interventional Group
Newly detected, early stage breast cancer patients in the treatment group will be provided an electronic copy of the DA for their reference via email.
Decision Aid (DA)
Tools designed to foster shared decision-making by contextualizing the risks and benefits of treatment options around the patient's personal values, thereby allowing them to weigh personal preferences when making treatment decisions. The study team has developed a prototype DA incorporating longitudinal institutional QoL data among patients who have undergone breast cancer surgery .
Control Group
Newly diagnosed, early stage breast cancer patients in the control group will be provided an electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.
Standard of Care (SOC)
Electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.
Interventions
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Decision Aid (DA)
Tools designed to foster shared decision-making by contextualizing the risks and benefits of treatment options around the patient's personal values, thereby allowing them to weigh personal preferences when making treatment decisions. The study team has developed a prototype DA incorporating longitudinal institutional QoL data among patients who have undergone breast cancer surgery .
Standard of Care (SOC)
Electronic copy of an alternative educational pamphlet discussing surgical options for breast cancer.
Eligibility Criteria
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Inclusion Criteria
* English speaking
* Clinical stage 0-III breast cancer
* Eligible for both lumpectomy and mastectomy
Exclusion Criteria
* Previous history of breast cancer
* Requires neoadjuvant chemotherapy prior to surgical intervention
18 Years
100 Years
FEMALE
No
Sponsors
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Association of Academic Surgery
UNKNOWN
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Sarah Tevis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Universtiy of Colorado Hospital
Aurora, Colorado, United States
UCHealth Cherry Creek Medical Center
Denver, Colorado, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCT-2025-02972
Identifier Type: OTHER
Identifier Source: secondary_id
25-0577.cc
Identifier Type: -
Identifier Source: org_study_id
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