CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,197 enrolled
Drug / intervention
Patient Self-Reporting of Symptoms +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03249090
NCT03249090N/ACompleted
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"PRO-TECT" Patient Reported Outcomes to Enhance Cancer Treatment

Alliance Foundation Trials, LLC.·interventional·Posted Aug 15, 2017·Updated Jan 14, 2025

In Brief

A clinical study evaluating Patient Self-Reporting of Symptoms and Usual Care Delivery for Metastatic Cancer. Completed, enrolled 1,197 participants across 45 sites.

Detailed Summary

The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Cancer
CountriesUnited States
CollaboratorsPatient-Centered Outcomes Research Institute, University of North Carolina, Mayo Clinic, American Society of Clinical Oncology, American Cancer Society, Inc., Dana-Farber Cancer Institute

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 15, 2017
Enrollment StartOct 30, 2017
Primary CompletionMar 30, 2022
Study CompletionAug 30, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.9 years ago

Interventions

Patient Self-Reporting of Symptomsother

At baseline, CRAs will train patients to self-report symptoms and physical functioning weekly for up to a year, with a choice to do so online or via an automated telephone system. Whenever a concerning symptom is reported, an automated "email alert" notification will be sent to the site CRA. The CRA will forward the alert to the responsible clinical nurse (or other covering clinician) and CC the site's Nurse Champion. Within 72 hours, the CRA will document what action(s), if any, were taken by the nurse in response to the alert (entered by the CRA into a form in the PRO-Core system). A symptom report will be printed/generated by the site CRA whenever the patient has a clinic visit and will be given to the oncologist and nurse caring for the patient.

Usual Care Deliveryother

Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms