NCT05064098

Brief Summary

This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2021Jun 2027

Study Start

First participant enrolled

June 29, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

4.9 years

First QC Date

September 29, 2021

Last Update Submit

July 28, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

  • Predicted patient reported outcomes up to 1 year after

    Predicted patient reported outcomes for each domain six-months and 1 year after breast surgery.

    12 months

  • Actual patient reported outcomes for each domain after surgery

    Actual PRO scores for each domain six-months after surgery

    6 month

  • Compare predicted and actual outcomes

    Comparison of predicted versus actual PRO scores in patients undergoing surgery

    12 months

  • Patients preferred method of communicating results

    Patients' preferred means of receiving and communicating PRO results.

    12 months

Study Arms (2)

Pre-Surgical Breast Cancer Patients

Adult female patients newly diagnosed with stage 0-III breast cancer seen as a surgical consultation from 06/01/2019 to present.

Breast Cancer Survivors

Breast Cancer Survivors

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pre-surgical breast cancer patients and breast cancer survivors

You may qualify if:

  • Pre-surgical female breast cancer patients
  • Female breast cancer survivors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hopspital

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sarah Tevis

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Huynh

CONTACT

8327202162victoria.d.huynh@cuanschutz.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 1, 2021

Study Start

June 29, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)