Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. In the meantime, results have been published in peer-reviewed journals, as listed below.

What is the research about?

Patients with advanced cancer often have symptoms like pain, nausea, or difficulty breathing. Sometimes patients don’t get the chance to discuss their symptoms with their healthcare provider during a clinic visit. Other times, symptoms occur between clinic visits. In these cases, symptoms can cause patients distress and may lead them to seek urgent care. One solution to this problem is for clinics to ask patients to regularly report their symptoms. Reports of severe symptoms can then trigger providers to give advice or prescribe medicine to help with symptoms.

In this study, the research team is comparing two ways to improve quality and length of life and avoid urgent care visits in patients with advanced cancer. The first way is to give patients information on symptom management and help them report their symptoms, either online or by phone, between clinic visits. The second way is to give patients information on symptom management only.

Who can this research help?

Findings from this study may help patients with advanced cancer and their doctors address patients’ symptoms between visits. Results may also help cancer clinic directors decide whether to have patients with advanced cancer report symptoms between clinic visits.

What is the research team doing?

Fifty cancer clinics from a large US research network are taking part in this study. Adult patients with advanced cancer and nurses at all 50 sites receive a booklet on how to manage symptoms, based on research. They also get a link to a webpage with the same information.

The research team is assigning clinics to one of two groups by chance. In the first group of 25 clinics, the team is training patients to report 12 common symptoms online or over the telephone for up to one year. When a patient reports severe or worsening symptoms, clinic nurses receive an email alert; a provider may then reach out to the patient to discuss symptoms. The site research staff is recording any actions taken within 72 hours in response to the alert. When patients visit the clinics, their providers receive a chart of the symptoms they reported over the past 10 weeks.

The second group of 25 clinics is offering usual cancer care and symptom management information only.

Patients are completing surveys at the start of the study and every 3 months up to 12 months later. The surveys ask patients about their ability to do regular activities and how happy they are with their cancer care. They also ask about patients’ quality of life and urgent care use.  

Patients with cancer and clinicians are helping to plan and carry out the study and design patient materials.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population Adults ≥ 21 with metastatic cancer of any type except leukemia or indolent lymphoma receiving outpatient, systemic, noncurative cancer treatment 
Interventions/
Comparators
  • Usual cancer care delivery and a standardized symptom management guideline plus patient symptom reporting
  • Usual cancer care delivery and a standardized symptom management guideline only
Outcomes

Primary: physical function, survival

Secondary: emergency room/hospital use, duration of cancer treatment, health-related quality of life, patient satisfaction

Timeframe Timeframe Length of follow-up for collecting data on primary outcomes. View Glossary Up to 2-year follow-up for primary outcomes

Journal Citations

Article Highlight: Patients with advanced cancer who used telehealth to regularly report symptoms improved their overall well-being, compared with those who were seen less frequently via in-person clinical visits, according to results from this study. The findings were published online in the Journal of the American Medical Association (JAMA)* and presented at the 2022 American Society of Clinical Oncology annual meeting on June 5, 2022. In the trial involving 1,191 participants across 52 clinical sites in 25 states, patients who used telehealth to communicate about their symptoms on a weekly basis said they experienced improved physical function, better control of their symptoms, and improved quality of life, compared with those who were evaluated less frequently, during in-person clinical visits.

Project Information

Ethan Basch, MD, MSc
The Alliance for Clinical Trials In Oncology Foundation
$5,813,333
Electronic Patient Reporting of Symptoms during Outpatient Cancer Treatment: A US National Randomized Controlled Trial

Key Dates

July 2016
April 2023
2016

Study Registration Information

*JAMA has made the full text of this journal publication available free of charge.

Tags

Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Funding Opportunity Type
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: June 29, 2022