Evaluating Patient Reported Outcomes in Radiation Therapy, The PRO-RT Study
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-003294
NCT ID: NCT05224271
Sponsor Protocol Number: ROR2103
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
|
More information
Publications
Publications are currently not available