A new decision aid for women with early-stage breast cancer
A Novel Decision Aid for Early Stage Breast Cancer Patients Choosing Between Lumpectomy and Mastectomy: a Pilot Study
NA · University of Colorado, Denver · NCT06813053
This study is testing a new tool to help women recently diagnosed with early-stage breast cancer make decisions about their treatment and see how well it works for them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver (other) |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Aurora, Colorado and 2 other locations) |
| Trial ID | NCT06813053 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility and acceptability of a novel decision aid designed for women newly diagnosed with early-stage breast cancer. The study will gather patient feedback and assess the implementation process using various tools, including patient-reported outcomes and health literacy assessments. Insights from this study will inform improvements to the decision aid and help plan a larger trial comparing it to standard care.
Who should consider this trial
Good fit: Ideal candidates are adult women aged 18-100 who are English-speaking and have clinical stage 0-III breast cancer eligible for both lumpectomy and mastectomy.
Not a fit: Patients who have had prior surgical consultations for breast cancer treatment or those requiring neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this decision aid could empower patients to make more informed choices regarding their surgical treatment options.
How similar studies have performed: Other studies have shown success with decision aids in cancer treatment, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult women age 18-100 * English speaking * Clinical stage 0-III breast cancer * Eligible for both lumpectomy and mastectomy Exclusion Criteria: * Prior surgical consultation regarding treatment options for breast cancer * Previous history of breast cancer * Requires neoadjuvant chemotherapy prior to surgical intervention
Where this trial is running
Aurora, Colorado and 2 other locations
- Universtiy of Colorado Hospital — Aurora, Colorado, United States (RECRUITING)
- UCHealth Cherry Creek Medical Center — Denver, Colorado, United States (RECRUITING)
- UCHealth Highlands Ranch Hospital — Highlands Ranch, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Sarah Tevis, MD — University of Colorado, Denver
- Study coordinator: Jakob Durden, MD
- Email: jakob.durden@cuanschutz.edu
- Phone: 1-719-751-8466
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Early-Stage, Newly Diagnosed