Breast Cancer Clinical Trial
Evaluating Patient Reported Outcomes in Radiation Therapy, The PRO-RT Study
Summary
This study explores the use of the Hugo platform to involve study participants in their healthcare and treatments. The Hugo platform may allow researchers to collect better and more accurate real-time health data, from other clinics/hospitals, pharmacies and other electronic devices. The purpose of this research is to see if the use of the Hugo platform is consistent, accurate, cost effective, and time efficient, as it collects and transmits important real-time health information from other clinics/hospitals, pharmacies, and other electronic devices.
Full Description
PRIMARY OBJECTIVES:
I. Evaluate the data aggregation from a patient centered platform over a follow up period for completeness and quality, including externally linked electronic health record (EHR) information, toxicity completion, and the patient reported outcomes (PRO) response rates for study patients, compared with historical pre-coronavirus disease (COVID) cohort of registry patients.
II. To explore biometric information obtained from wearables as it pertains to the toxicity of treatment for patients using a wearable device.
III. To estimate app-based survey completion rates using Hugo-based survey incentive completion (gift cards).
IV. To explore the cost data available on the platform.
OUTLINE:
Patients complete surveys via the Hugo Platform at baseline (before treatment), after treatment, and at 3 and 6 months after treatment. Patients' medical records and Fitbit information are also collected into the Hugo Platform.
Eligibility Criteria
Inclusion Criteria:
Age 18+
English speaking
Consented for Outcomes Registry Study (15-000136)
Undergoing radiotherapy for cancer treatment with curative intent
Willing to and able to give consent and participate in study
Willing to complete all surveys
Able to access a device (computer, smartphone, or tablet) with web access every day to complete study surveys
Willing to connect to a device (i.e., a smartphone, Fitbit, or tablet) that can regularly link to Hugo for data transfer
Willing to share personal information to Tremendous to be able to obtain the Visa e-cards for time and effort put into this study
Willing to use the Hugo health data sharing platform
Willing to create a Mayo Clinic Patient Portal (if not already created)
Exclusion Criteria:
Unable to give consent and enroll prior to administration of baseline survey
Partial breast radiation therapy (RT) (3 fraction), due to overlap in cadence used for all disease sites
Stereotactic body radiation therapy (SBRT) to the lung, due to overlap in cadence used for all disease sites
Co-enrollment on another PRO related study (soft rule)
Coordinator would need to get source data from Adam via Hugo
Response data will only be accessible by select people
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There is 1 Location for this study
Rochester Minnesota, 55905, United States More Info
Principal Investigator
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