Evaluating Patient Reported Outcomes in Radiation Therapy, The PRO-RT Study

Active, not recruiting

Conditions: Malignant Solid Neoplasm
Breast Carcinoma
Head and Neck Carcinoma
Lung Carcinoma

Interventions: Other: Electronic Health Record Review
Other: Medical Device Usage and Evaluation
Other: Survey Administration

Brief 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.

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Observational (surveys, medical records & Fitbit collection)	Medical Device Usage and Evaluation	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.
Observational (surveys, medical records & Fitbit collection)	Survey Administration	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.
Observational (surveys, medical records & Fitbit collection)	Electronic Health Record Review	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.

Primary Outcome Measures

Name	Time	Method
Survey completion rate	Baseline up to 6 months after completion of radiation therapy	The difference in rates will be estimated. A chi square, or Fisher's exact test as appropriate, will be used to compare the rates between cohorts. A logistic regression model will be used to understand the association of patient and disease variables with the odds of completion (at least one of the surveys at the treated site).
Percentage of patients with access to wearable device	Up to 6 months after completion of radiation therapy	A logistic regression model will be used to understand the association of patient and disease variables with the odds of access to a wearable device.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Up to 6 months after completion of radiation therapy	Logistic regression will be used to predict presence of a patient toxicity. Baseline patient and disease characteristics, along with biometric information will be used to assess associations with toxicity. Multiple variable models will be considered depending on the number of patients identified with a toxicity.

Locations (1): Mayo Clinic in Rochester
🇺🇸
Rochester, Minnesota, United States