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

Patient Reported Outcomes in Radiation Therapy (PRO-RT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Solid Neoplasm; Breast Carcinoma; Head and Neck Carcinoma; Lung Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (surveys, medical records & Fitbit collection); 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.	Other: Survey Administration; Complete surveys; Other: Electronic Health Record Review; Medical records are collected; Other: Medical Device Usage and Evaluation; Fitbit information is collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey completion rate	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).	Baseline up to 6 months after completion of radiation therapy
Percentage of patients with access to wearable device	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.	Up to 6 months after completion of radiation therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	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.	Up to 6 months after completion of radiation therapy

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kimberly S. Corbin, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Breast Neoplasms; Carcinoma
• Other Study ID Numbers: ROR2103 (Mayo Clinic in Rochester); NCI-2021-12580 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No