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OpenTrials
Completed

NCT Number: NCT05224271

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

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Head and Neck Carcinoma Lung Carcinoma Lung Diseases Lung Neoplasms Malignant Solid Neoplasm Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Health Record Review

Other

Medical records are collected

Medical Device Usage and Evaluation

Other

Fitbit information is collected

Survey Administration

Other

Complete surveys

Primary outcomes

  1. Survey completion rate

    Time frame: 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).

  2. Percentage of patients with access to wearable device

    Time frame: 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 outcomes

  1. Incidence of adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Patient Reported Outcomes in Radiation Therapy (PRO-RT)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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