Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey

NCT03995082 | Recruiting DMC

• 1 other identifier: 18-2562.cc
• Study Type: interventional
• Target: 925
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  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.

  24 months

• Currently unmeasured patient reported outcomes using open ended questions

  24 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Normative Control

NO INTERVENTION

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

Interventions

Patient Reported Outcome Measure Survey result feedback OTHER

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

Experimental Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Colorado Hospital

Denver, Colorado, 80045, United States

RECRUITING

Cherry Creek Medical Center

Denver, Colorado, 80206, United States

NOT YET RECRUITING

Lone Tree Medical Center

Lone Tree, Colorado, 80124, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sarah Tevis

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Tevis

CONTACT

3037242731; sarah.tevis@ucdenver.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: June 21, 2019
• Study Start: October 30, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)