NLM logo

National Information Center on Health Services Research and Health Care Technology (NICHSR)

HSRProj (Health Services Research Projects in Progress)

Information about ongoing health services research and public health projects


Electronic patient reporting of symptoms during outpatient cancer treatment: a US national randomized controlled trial
Investigator (PI): Basch, Ethan
Performing Organization (PO): (Current): Alliance for Clinical Trials in Oncology Foundation
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2022
Record Source/Award ID: PCORI/IHS-1511-33392
OTHER ID:
  • HSRR / 1552
Funding: Total Award Amount: $5,455,651
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Patients with metastatic cancer frequently experience symptoms that cause distress and disability, and lead to urgent care visits. These symptoms often go unrecognized and unaddressed by clinicians even though there are many interventions that can provide relief. Sometimes this happens because patients do not have the opportunity to discuss symptoms at an office visit; sometimes the symptoms occur between visits. One solution to this problem is to enable patients to report their own symptoms electronically at regular intervals. Patient reports of severe symptoms can then trigger clinicians to respond with interventions ranging from advice to prescriptions or triage for evaluation. Prior studies have found most patients willing and able to self-report symptoms during cancer care, and clinicians find this information valuable. Preliminary data suggest this approach leads to better patient quality of life, avoids emergency room (ER) and hospital visits, and may lengthen survival. Many health care systems are currently considering if and how to integrate patient-reported outcomes (PROs), like symptoms, into care delivery; however, before it can be concluded that it is indeed worthwhile to ask patients to self-report PROs systematically, a multicenter study that includes a diverse group of patients and establishes the size of benefits and burdens is necessary. A national randomized trial is proposed to address these questions. In the trial's intervention arm, patients will regularly self-report 12 common symptoms from the National Cancer Institute's validated PRO-CTCAE and PROMIS questionnaire systems. Patients will have the option to choose reporting via the web or an automated telephone system for up to 12 months. Email alerts will be triggered to nurses when patients report severe or worsening symptoms. Nurses and patients will be provided with evidence-based symptom management recommendations. In the trial's control arm, nurses and patients will be provided with symptom management recommendations, but there will be no self-reporting of symptoms. Outcomes include physical function; quality of life; survival; ER/hospital visits; and perspectives about relative benefits and burdens from patients, clinicians, and national organizations. This trial is proposed in partnership with three national patient organizations and two major US oncology professional organizations. The trial will be conducted through the Alliance for Clinical Trials in Oncology, a national research network of oncology practices. The trial will be led by a multistakeholder team, including established PRO researchers, patients, and clinicians. Purposeful enrollment will include patients from diverse racial, ethnic, geographic, and educational backgrounds. We hypothesize that the PRO intervention will yield clinical benefits that stakeholders perceive to outweigh the burdens of implementation. The study's results could prompt fundamental changes to symptom management practices in oncology.
MeSH Terms:
  • Automation
  • Clinical Trials as Topic
  • Humans
  • Medical Oncology /*methods
  • Neoplasm Metastasis
  • Neoplasms /psychology
  • /*therapy
  • Oncology Nursing
  • Outcome Assessment, Health Care
  • Outpatients
  • Patient-Centered Care
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • * Self Report
  • Surveys and Questionnaires
  • Symptom Assessment
  • Telemedicine
  • United States
Country: United States
State: Illinois
Zip Code: 60606
UI: 20164092
Project Status: Ongoing
Record History: ('2017: Project extended to 2022',)