Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey
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|ClinicalTrials.gov Identifier: NCT03995082|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : September 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Patient Reported Outcome Measure Survey result feedback||Not Applicable|
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:
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Study of Breast Cancer Patient Engagement With Patient Reported Outcome Measure Survey Results|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||July 2021|
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.
- 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.
- 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.
- 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.
- 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."
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995082
|Contact: Sarah Tevisfirstname.lastname@example.org|
|Principal Investigator:||Sarah Tevis||University of Colorado, Denver|