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

NCT05224271 | Completed

• 3 other identifiers: ROR2103NCI-2021-1258021-003294
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Head and Neck Carcinoma; Lung Carcinoma; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Incidence of adverse events

  Up to 6 months after completion of radiation therapy

Study Arms (1)

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

Interventions

Electronic Health Record Review OTHER

Medical records are collected

Observational (surveys, medical records & Fitbit collection)

Medical Device Usage and Evaluation OTHER

Fitbit information is collected

Observational (surveys, medical records & Fitbit collection)

Survey Administration OTHER

Complete surveys

Observational (surveys, medical records & Fitbit collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kimberly S. Corbin, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: March 2, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)