E-Newsletter - October 2016

alliance researcher approved for $5.45M Funding Award for patient-Centered research

An Alliance researcher has been approved for a multi-year funding award from the Patient-Centered Outcomes Research Institute (PCORI) to fund comparative effectiveness research that will study electronic patient reporting of symptoms during outpatient cancer treatment. Ethan M. Basch, MD, MSc, is Director of Cancer Outcomes Research Program at the University of North Carolina-Chapel Hill Lineberger Comprehensive Cancer Center, and Professor in Department of Medicine in the Division of Hematology and Oncology at the UNC-Chapel Hill. He is a Co-Chair of the Alliance Health Outcomes Committee and a member of the Alliance American College of Surgeons Clinical Research Program’s Cancer Care Delivery Research Committee.

The PCORI award will fund “Electronic Patient Reporting of Symptoms during Outpatient Cancer Treatment: A US National Randomized Controlled Trial” ($5,455,651 over five years). The proposal was sponsored by the Alliance for Clinical Trials in Oncology Foundation.

Many healthcare 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.

Dr. Basch and his team propose to address these questions in a national randomized trial.  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. E-mail 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 will partner with three national patient organizations and two major US oncology professional organization, and will be conducted through the Alliance for Clinical Trials in Oncology. It will be led by a multi-stakeholder team, including established PRO researchers, patients, and clinicians. Purposeful enrolment will include patients from diverse racial, ethnic, geographic, and educational backgrounds.

It is hypothesized 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.

The study was selected for PCORI funding through a highly competitive review process in which patients, clinicians, and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders, and their methodological rigor among other criteria. The award to Dr. Basch has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org or http://www.pcori.org/funding/opportunities.

For other articles in the October issue of the Alliance E-News newsletter, see below.