Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey

NCT ID: NCT03995082

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 925 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2026-06-30

Brief Summary

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.

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:

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

Patients will receive the results from the PROM survey in graphical form each time they complete a survey.

Group Type: EXPERIMENTAL

Patient Reported Outcome Measure Survey result feedback

Intervention Type: OTHER

Patients will receive a graph of their results from the PROM survey each time they complete a survey

Normative Control

These patients will complete the PROM surveys, but will not be presented with the results of the survey.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Tevis

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Denver, Colorado, United States

Site Status: RECRUITING

Cherry Creek Medical Center

Denver, Colorado, United States

Site Status: NOT_YET_RECRUITING

Lone Tree Medical Center

Lone Tree, Colorado, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Sarah Tevis

Role: CONTACT

sarah.tevis@ucdenver.edu

3037242731

Facility Contacts

Sarah Tevis

Role: primary

sarah.tevis@ucdenver.edu

Sarah Tevis, MD

Role: primary

sarah.tevis@cuanschutz.edu

608-692-0836

Other Identifiers

18-2562.cc

Identifier Type: -

Identifier Source: org_study_id