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Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03995082
Recruitment Status : Recruiting
First Posted : June 21, 2019
Last Update Posted : July 22, 2020
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Patient Reported Outcome Measure Survey result feedback Not Applicable

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:

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: A Randomized Study of Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey Results
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.

Primary Outcome Measures :
  1. BREAST Q patient satisfaction with breast surgeon domain [ Time Frame: 24 months ]
    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.

Secondary Outcome Measures :
  1. 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. [ Time Frame: 24 months ]
    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.

  2. 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. [ Time Frame: 24 months ]
    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.

  3. Currently unmeasured patient reported outcomes using open ended questions [ Time Frame: 24 months ]
    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."

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03995082

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Contact: Sarah Tevis 3037242731

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United States, Colorado
University of Colorado Hospital Recruiting
Denver, Colorado, United States, 80045
Contact: Sarah Tevis   
Principal Investigator: Sarah Tevis         
Cherry Creek Medical Center Not yet recruiting
Denver, Colorado, United States, 80206
Contact: Sarah Tevis, MD    608-692-0836   
Principal Investigator: Sarah Tevis         
Lone Tree Medical Center Not yet recruiting
Lone Tree, Colorado, United States, 80124
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
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Principal Investigator: Sarah Tevis University of Colorado, Denver
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Responsible Party: University of Colorado, Denver Identifier: NCT03995082    
Other Study ID Numbers:
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases