Decision Aid for Early-Stage Breast Cancer Surgical Options
This study is testing a new tool called a Decision Aid (DA) to help women with early-stage breast cancer choose their surgical treatment. The DA helps you understand the risks and benefits of different options, like lumpectomy or mastectomy, and considers your personal values. Researchers want to see if this DA is easy to use and helpful compared to a standard educational pamphlet. They will gather feedback from about 60 women aged 18-100 who speak English and are eligible for both lumpectomy and mastectomy. The goal is to improve the DA and plan for a larger study in the future. The current recruitment status is unclear.
- Study design
- This is an interventional study involving about 60 participants. It compares a new Decision Aid (DA) to a Standard of Care (SOC) educational pamphlet.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will assess the feasibility and how well patients receive the decision aid for up to 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer
At a glance
Conditions
Where it's being run
3 sites across 1 statesStudy leadership
- Sarah Tevis, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Assess the feasibility of prospectively providing a novel DA to early stage breast cancer patients1 year
Monitor the recruitment process of eligible patients. Including tracking how many patients are approached, how many participate and how effective the decision aid engages patient in the decision making process. High participation and engagement indicates a successful implementation. Compare clinician reported length of encounter between interventions as a balancing measure.
- Evaluate how well patients receive the decision aid1 year
Use the validated and accepted Ottawa Decision Aid metrics to assess decision quality, decisional conflict, acceptability, and regret. Conduct semi-structured interviews to gather additional qualitative data regarding the patient experience, and use feedback to modify and improve the content and design of the Decision Aid.