Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey

A Randomized Study of Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey Results

The purpose of this research protocol is to measure Patient Reported Outcome Measures (PROMs) in breast cancer patients. PROM results will be provided to patients and providers and the investigators will evaluate the relationship between patient engagement with PROM results and patient and clinicopathologic variables, utilization of supportive and hospital services, and patient satisfaction with patient-provider communication.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Patient Reported Outcome Measure Survey result feedback

Detailed Description

PROM Survey The BREAST-Q survey will be utilized to evaluate PROMs at the designated survey time points. The investigators will utilize the mastectomy and breast conserving therapy pre-operative and post-operative modules dependent on the type of surgery each patient chooses. The BREAST-Q survey has questions that pertain to the following domains: 1. Satisfaction with breasts, 2. Psychosocial well-being, 3. Physical well-being, 4. Sexual well-being, 5. Adverse effects of radiation, and 6. Patient experience with the health care team. Scores for each domain are scored with an equivalent Rasch transformed score (range 0-100). These scores can then be tracked over time. In addition to the BREAST-Q modules, the investigators will ask 3 open ended questions. These questions will allow patients to share concerns or outcomes at each time point in an effort to identify currently unmeasured outcomes that are important to patients.

Timing of Surveys For patients having surgery first: At the pre-operative visit, patients will be provided the pre-operative module. The post-operative modules will then be administered via email or in the clinic at the post-operative visit (~2 weeks after surgery), and then at 3 months, 6 months, 9 months, and 12 months after surgery. After one year, patients will be surveyed annually.

For patients receiving neoadjuvant chemotherapy, surveys will be administered every 3 months during the pre-operative period. The post-operative modules will then be administered via email or in the clinic at the post-operative visit (~2 weeks after surgery), and then at 3 months, 6 months, 9 months, and 12 months after surgery. After one year, patients will be surveyed annually.

Patients will be randomized to receive the results of PROM surveys graphed over time (experimental group) or to not receive the results of the PROM surveys (normative control group). Results of the BREAST-Q surveys will be available to providers for all patients.

Statistical Analyses Study data will be collected in a prospective database using the CCTSI RedCap database, with which the breast cancer program has extensive experience. The database will include demographic information, clinicopathologic data, surgical details, neoadjuvant and adjuvant treatments, and the equivalent Rasch transformed scores for each PROM metric at all recorded time points.

Descriptive statistics will be utilized to characterize the patient population and patient engagement with PROMs. Univariate and multivariate analyses will be used to evaluate demographic and clinicopathologic variables and variations in PROMs across the course of treatment. The study endpoints will be evaluated with the following statistical methods:

• Study Type: Interventional
• Enrollment (Estimated): 925
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Tevis; Phone Number: 3037242731; Email: sarah.tevis@ucdenver.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
      • Contact: Sarah Tevis; Email: sarah.tevis@ucdenver.edu
      • Principal Investigator: Sarah Tevis
    • Denver, Colorado, United States, 80206
      • Not yet recruiting
      • Cherry Creek Medical Center
      • Principal Investigator: Sarah Tevis
      • Contact: Sarah Tevis, MD; Phone Number: 608-692-0836; Email: sarah.tevis@cuanschutz.edu
    • Lone Tree, Colorado, United States, 80124
      • Not yet recruiting
      • Lone Tree Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

We will target all patients with a new diagnosis of breast cancer who present to the breast multi-disciplinary clinic.

Inclusion:

• Adult (18 years of age or more)
• Female
• Patients with breast cancer
• Patients who can independently complete surveys

Exclusion

• Age <18 years
• Male
• Patients who cannot independently complete surveys

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Patients will receive the results from the PROM survey in graphical form each time they complete a survey.	Other: Patient Reported Outcome Measure Survey result feedback; Patients will receive a graph of their results from the PROM survey each time they complete a survey
No Intervention: Normative Control; These patients will complete the PROM surveys, but will not be presented with the results of the survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BREAST Q patient satisfaction with breast surgeon domain	Patient satisfaction with patient-provider communication using the BREAST Q satisfaction with breast surgeon domain. The domain is scored from 0 to 100 points with more points representing higher patient satisfaction.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BREAST Q Patient reported outcome measure survey domains including: Satisfaction with breasts, psychosocial well being, physical well being, sexual well being, and effects of radiation domains.	Validated BREAST Q survey domains. All domains are scored 0 to 100 points. Higher points represent a better outcome. The subscales will not be used to create a total score.	24 months
Healthcare utilization including the use of social work services, psycho-oncology services, oncology fitness service, nutrition service, and urgent/emergent services including visits to urgent care or the emergency room.	The number of participants using supportive services will be scored as yes or no if the patient used the specific service or did not use the service.	24 months
Currently unmeasured patient reported outcomes using open ended questions	The investigators will use open ended questions to identify currently unmeasured patient reported outcomes. Responses will be evaluated as qualitative data using descriptive coding to identify themes. Expected common themes include financial concerns, concerns about caring for family or imposing on family, fertility concerns, etc. The questions will include: "what are your top 3 concerns", "what are you most worried about going forward", "how could the healthcare team better help you", "if you could start your treatment over what would you have done differently."	24 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sarah Tevis, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 22, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 18-2562.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