Clinical trial NCT03995082: Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey
Official title: A Randomized Study of Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey Results
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-06-21
Enrollment: 370
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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

Primary outcomes:
measure: BREAST Q patient satisfaction with breast surgeon domain
timeFrame: 24 months
Secondary outcomes:
measure: 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.
timeFrame: 24 months
measure: 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.
timeFrame: 24 months
measure: Currently unmeasured patient reported outcomes using open ended questions
timeFrame: 24 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Cherry Creek Medical Center
state: Colorado
city: Lone Tree
country: United States
facility: Lone Tree Medical Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarah Tevis
role: PRINCIPAL_INVESTIGATOR
References: