Clinical trial · Observational
Evaluating Patient Reported Outcomes in Radiation Therapy, the PRO-RT Study
Patient Reported Outcomes in Radiation Therapy (PRO-RT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Carcinoma | Head and Neck Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Carcinoma | Lung Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (surveys, medical records & Fitbit collection)
- description
- 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.
- interventionNames
- Other: Electronic Health Record Review
- Other: Medical Device Usage and Evaluation
- Other: Survey Administration
Primary outcomes (2)
- measure
- Survey completion rate
- timeFrame
- Baseline up to 6 months after completion of radiation therapy
- description
- 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).
- measure
- Percentage of patients with access to wearable device
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available