Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03995082 |
| Other study ID # |
18-2562.cc |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 30, 2019 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
July 2023 |
| Source |
University of Colorado, Denver |
| Contact |
Sarah Tevis |
| Phone |
3037242731 |
| Email |
sarah.tevis[@]ucdenver.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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:
