Breast CarcinomaNCT05224271
Evaluating Patient Reported Outcomes in Radiation Therapy, the PRO-RT Study
An observational study of Breast Carcinoma and Head and Neck Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Head and Neck Carcinoma, Lung Carcinoma
- What is being tested?
- Electronic Health Record Review, Medical Device Usage and Evaluation and Survey Administration
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2022to 10 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Patient Reported Outcomes in Radiation Therapy (PRO-RT)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Electronic Health Record Review, Medical Device Usage and Evaluation, Survey Administration
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Medical records are collected
Medical Device Usage and EvaluationOther
Fitbit information is collected
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 6 months after completion of radiation therapy
Secondary outcomes (1)
Incidence of adverse events
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.
Measured: Up to 6 months after completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start2 Mar 2022
- Primary completion10 Apr 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly S. Corbin, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224271
- Sponsor's protocol ID
- ROR2103
- Other IDs
- NCI-2021-12580, 21-003294
- Status last verified
- Sep 2024
- First submitted
- 25 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes in Radiation Therapy (PRO-RT)
- ClinicalTrials.gov ID
- NCT05224271
- Acronym / sponsor ID
- ROR2103
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (surveys, medical records & Fitbit collection) | – | Other: Electronic Health Record Review, Other: Medical Device Usage and Evaluation, Other: Survey AdministrationPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewMedical records are collected | Other | Observational (surveys, medical records & Fitbit collection) |
| Medical Device Usage and EvaluationFitbit information is collected | Other | Observational (surveys, medical records & Fitbit collection) |
| Survey AdministrationComplete surveys | Other | Observational (surveys, medical records & Fitbit collection) |
Primary outcome
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).
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.
1 secondary outcome
Incidence of adverse events
Time frame: Up to 6 months after completion of radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly S. Corbin, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Head and Neck Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey completion rate (time frame: Baseline up to 6 months after completion of radiation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.