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Recruiting NCT03995082

Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Reported Outcome Measure Survey result feedback.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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:

Interventions

  • 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

Primary outcome measures

  • BREAST Q patient satisfaction with breast surgeon domain [Time frame: 24 months]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 24 months]
  • Currently unmeasured patient reported outcomes using open ended questions [Time frame: 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 3 centers
  • University of Colorado Hospital — Denver
  • Cherry Creek Medical Center — Denver
  • Lone Tree Medical Center — Lone Tree

Identifiers

NCT: NCT03995082 · 18-2562.cc

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗