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People with advanced cancers who reported their symptoms weekly using a digital tool received more timely, and potentially life-saving treatment, compared to those who were evaluated less frequently via regular in-person clinical visits, according to findings from a study. The PRO-TECT (Patient Reported Outcomes To Enhance Cancer Treatment) trial was led by researchers at the University of North Carolina Lineberger Comprehensive Cancer Center and conducted at community cancer centers nationwide.

The findings were presented Nov. 16, 2021, as part of the first American Society of Clinical Oncology Virtual Plenary Series.

Symptoms can arise between regular visits for cancer care and often go undetected and unreported. To help improve clinician awareness and responsiveness to patients’ symptoms, the study investigators used a digital system, available via the internet or through an automated phone system, to easily and quickly facilitate collection of patient-reported outcomes (PRO) and convey them in real time to cancer care team members.

Ethan Basch
UNC Lineberger’s Ethan Basch, MD, MSc.

“Many patients are living longer with cancer and are undergoing treatment for extended periods,” said Ethan Basch, MD, MSc, Distinguished Professor and director of the Cancer Outcomes Research Program at UNC Lineberger, and the study’s lead author. “We designed a strategy to help care teams better connect with patients when they’re at home between visits, with an aim to catch symptoms early before they worsen and cause complications, unnecessary suffering, or avoidable hospitalizations.”

In the PRO-TECT trial, 52 community sites were randomized to either have their patients input weekly electronic accounts of symptoms for up to a year or to the usual delivery of care, which meant, for most, waiting until their next regularly scheduled clinic visit. Of the 1,191 patients enrolled in the trial, half electronically reported on common symptoms seen in advanced cancers, including fatigue, nausea, insomnia, appetite loss, diarrhea, pain, difficulty breathing and constipation. Alerts were sent to nurses if a patient’s reported symptoms were severe or worsening.

“In contemporary oncology care, we need to focus on the overall patient experience, including between visits, and not just our experience of the patient when they come to see us in the clinic,” noted Basch, director of medical oncology at the UNC School of Medicine and physician-in-chief of the N.C. Cancer Hospital.

Compliance was high as patients completed over 90 percent of weekly surveys during the trial period. The researchers combined self-reported scores for improvement and lack of worsening related to several factors to determine overall benefit for PRO vs standard care. After three months on the trial, of the patients that used PRO, there was a 13.8% increase in the number of patients with benefits in physical function compared to those who only had regular clinical visits; a 16.1% increase in the number of patients with benefits in symptom control if they used PRO vs. regular clinical visits; and a 13.4% increase in the number with benefits in quality of life using PRO compared to regular clinical visits. These were all statistically significant and clinically meaningful improvements over the current standard of care.

“This study provides compelling evidence that a digital intervention without toxicity can improve the experience of patients, raise the patient-centeredness of treatment, and enhance quality of care,” Basch said. “That said, it’s one thing to demonstrate these benefits but it’s another to determine the optimal approach to implement them in a given practice. This is a complex intervention that relies on technology, patient engagement, as well as clinical and administrative staff engagement. A quality improvement approach and mindset are necessary when rolling out such a PRO program.”

The researcher’s next goal is to figure out what are the best models for implementation and approaches to make the intervention more efficient for practices. The impact of PRO on overall survival is also an outcome built into the trial, with results expected in the next one to two years.

Authors and disclosures

In addition to Basch, the abstract’s other authors at UNC include Sydney Henson, Jennifer Jansen, MPH, Angela M. Stover, PhD, Philip Carr, MPH, Patricia A. Spears, Mattias Jonsson, BA, Allison M. Deal MS, Antonia V. Bennett, PhD and Cleo A. Samuel-Ryals, PhD. Other authors include Deborah Schrag, MD, MPH, Lauren J. Rogak, MA and Victoria S. Blinder, Memorial Sloan Kettering Cancer Center, New York; Brenda Ginos, MS, Gina L. Mazza, PhD and Amylou C. Dueck, PhD, Mayo Clinic, Scottsdale, AZ; Angela M. Gita Thanarajasingam, MD, and Lisa A. Kottschade, MSN, Mayo Clinic, Rochester, MN; Bryce B. Reeve, PhD, Duke Cancer Institute, Durham, NC; Claire Snyder, PhD, Johns Hopkins Schools of Medicine and Public Health, Baltimore; Deborah Bruner, PhD, Emory University, Atlanta; David Cella, PhD, Northwestern University, Chicago; Jane Perlmutter, PhD, Gemini Group, Ann Arbor, MI; Cindy Geoghegan, MA, Patient and Partners, Madison, CT; Barbara Given, PhD, Michigan State University, East Lansing, MI; Robert Miller, MD, American Society of Clinical Oncology, Alexandria, VA; Jon F. Strasser, MD, Christiana Care Health Services, Wilmington, DE; Dylan M. Zylla, MD, The Cancer Research Center, HealthPartners/Park Nicollet, Minneapolis; and Anna Weiss, MD, Brigham and Women’s Hospital, Boston.

Basch serves on the Board of Directors for ASCO, receives research funding from NCI and PCORI (Patient-Centered Outcomes Research Institute) and is a scientific advisor to Sivan, CareVive, AstraZeneca and Navigating Cancer, Inc.

Funded by PCORI award No. IHS-1511-33392. The trial made use of technology systems provided by the Patient-Reported Outcomes Core at UNC Lineberger, funded by NCI Center Core Support grant no. 5-P30-CA016086 and the University Cancer Research Fund.  The trial was sponsored by the Foundation of the Alliance for Clinical Trials in Oncology.