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Can a personalized tool help breast cancer patients choose the right surgery?

NCT ID NCT06813053

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This pilot study tests a decision aid designed to help women with early-stage breast cancer choose between lumpectomy and mastectomy. The tool uses quality-of-life data from past patients to help women weigh the risks and benefits based on their own values. Researchers will see if the tool is practical and acceptable to patients, and whether it improves decision quality and reduces regret. The goal is to refine the tool for a larger trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A decision aid tool that presents personalized quality-of-life data to help patients weigh surgical options, compared to standard educational material.
What this could lead to
If successful, this decision aid could help future breast cancer patients make more informed, values-aligned surgical choices, potentially reducing regret and improving satisfaction.
What could go wrong
This is a small pilot study focused on feasibility, not outcomes. The decision aid may not improve decision quality or may be difficult to implement in routine care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • UCHealth Cherry Creek Medical Center

    Denver, Colorado, 80206, United States

  • UCHealth Highlands Ranch Hospital

    Highlands Ranch, Colorado, 80129, United States

  • Universtiy of Colorado Hospital

    Aurora, Colorado, 80045, United States

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