RECRUITING

A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a study to assess the feasibility and acceptability of a novel decision aid (DA) in a newly diagnosed, early-stage breast cancer population. Insights gained from patient feedback and the implementation process will be used to improve the information delivered in the decision aid itself and to plan for a larger scale trial to compare the decision aid to standard of care.

Official Title

A Novel Decision Aid for Early Stage Breast Cancer Patients Choosing Between Lumpectomy and Mastectomy: a Pilot Study

Quick Facts

Study Start:2025-12
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06813053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult women age 18-100
  2. * English speaking
  3. * Clinical stage 0-III breast cancer
  4. * Eligible for both lumpectomy and mastectomy
  1. * Prior surgical consultation regarding treatment options for breast cancer
  2. * Previous history of breast cancer
  3. * Requires neoadjuvant chemotherapy prior to surgical intervention

Contacts and Locations

Study Contact

Jakob Durden, MD
CONTACT
1-719-751-8466
jakob.durden@cuanschutz.edu

Principal Investigator

Sarah Tevis, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Universtiy of Colorado Hospital
Aurora, Colorado, 80045
United States
UCHealth Cherry Creek Medical Center
Denver, Colorado, 80206
United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Sarah Tevis, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-12
Study Completion Date2027-03

Study Record Updates

Study Start Date2025-12
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • Early-Stage
  • Newly Diagnosed

Additional Relevant MeSH Terms

  • Breast Cancer