Electronic Patient Reporting of Symptoms During Cancer Treatment

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.

Conditions

• Metastatic Cancer

Interventions

OTHER

Patient Self-Reporting of Symptoms

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.

OTHER

Usual Care Delivery

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

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• American Society of Clinical Oncology

  collaborator OTHER

• American Cancer Society, Inc.

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Alliance Foundation Trials, LLC.

  lead OTHER

Principal Investigators

• Ethan Basch, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-30

Primary Completion

2022-03-30

Completion

2023-08-30

Countries

• United States

Study Locations