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

Overview

About this study

The purpose of this study is to address the gaps in data completeness regarding treatment toxicities, patient reported outcomes, and biometric information. Hugo device enabled patient specific data aggregation, will increase the completeness and accuracy of the Outcomes Registry and improve patient engagement with the care teams, post radiation, by acquiring linked outside EHR information facilitating improved collection of patient reported outcome surveys, and biometric data via a wearable device.

With a rise in health care costs, there is an urgent need to evaluate patient outcomes and the value of care levering real patient, big data from the Electronic Health Record (EHR). The department of Radiation Oncology has invested years of time and resources developing a Radiation Oncology outcomes database. This dataset is a compilation of clinical details, radiation dose/plan characteristics, patient and clinician reported toxicities, and cancer specifics which is integrated into the Mayo Clinic Unified Data Platform. However, critical gaps exist in the completeness of toxicity and patient reported outcomes information.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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 questionnaires and 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 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 RT (3 fraction), due to overlap in cadence used for all disease sites.
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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Kimberly Corbin, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office 855-776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kimberly Corbin, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Clinical Trials