Clinical trial NCT05224271: Evaluating Patient Reported Outcomes in Radiation Therapy, the PRO-RT Study
Official title: Patient Reported Outcomes in Radiation Therapy (PRO-RT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma
Head and Neck Carcinoma
Lung Carcinoma
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast, head and neck, and lung tumor types, who are undergoing simulation for treatment in the Radiation Oncology Department at Mayo Clinic

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.

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

Primary outcomes:
measure: Survey completion rate
timeFrame: Baseline up to 6 months after completion of radiation therapy
measure: Percentage of patients with access to wearable device
timeFrame: Up to 6 months after completion of radiation therapy
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 6 months after completion of radiation therapy
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Kimberly S. Corbin, MD
role: PRINCIPAL_INVESTIGATOR
References: