Interpretations and Predictions of Patient Reported Outcomes by Breast Cancer Patients

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

Detailed Description

This study will assess how patients' long-term quality of life after different surgical approaches compares to their predicted quality of life. It will also provide the research team with improved understanding of how patients interact with and prefer to receive QOL information. Improved understanding of patient predictions and perceptions of information display will allow us to incorporate predicted future PROs into the shared decision making process as well as allow us to provide this important information to patients in a meaningful way.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Victoria Huynh; Phone Number: 8327202162; Email: victoria.d.huynh@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hopspital
      • Contact: Victoria Huynh; Phone Number: 832-720-2162; Email: victoria.d.huynh@cuanschutz.edu
      • Principal Investigator: Sarah Tevis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Pre-surgical breast cancer patients and breast cancer survivors

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Sarah Tevis, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 21-3576.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No