Patient-Reported Outcomes Study Finds Severe Symptoms in Meaningful Minority of Patients With Cancer

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Routine monitoring in the real world may help to identify patients with cancer who are experiencing challenging symptoms, without significantly disrupting clinical workload, according to data presented during the 2022 ASCO Quality Care Symposium.1,2

The analysis of nearly 40,000 patient-reported outcomes completed by patients with thoracic, gastrointestinal, and gynecologic cancers found that approximately one of every six questionnaire responses included a severe symptom. Results of the study, conducted by the SIMPRO (Symptom Management Implementation of Patient-Reported Outcomes in Oncology) study group, also identified fatigue, general pain, and constipation as the most reported symptoms.

“Multidisciplinary supportive care is absolutely needed to address these symptoms, which are challenging to treat with medications alone,” said lead study author Jessica J. Bian, MD, a thoracic medical oncologist at Maine Medical Center, Portland. “We hope to develop embedded interventions to aid patients and care teams to better manage their symptoms in a way that will not overburden clinical teams.”

Jessica J. Bian, MD

Jessica J. Bian, MD

As Dr. Bian explained, symptom management in patients with cancer has historically been reactive and not proactive. Previous clinical trials have shown that monitoring electronic patient-reported symptoms has improved clinical outcomes by decreasing symptom burden, improving quality of life, reducing the use of acute care, and even prolonging overall survival. However, trials supporting the efficacy of electronic patient-reported outcomes have been primarily conducted at large academic centers. It’s unknown whether these benefits are generalizable to cancer care in the real-world setting, said Dr. Bian, specifically in community-based and rural oncology settings.

Study Details

Beginning in 2019, the SIMPRO Research Consortium designed and implemented an electronic symptom management program to address some of these challenges. The program is fully integrated into EPIC, and patients are automatically prompted to report symptoms after starting a new treatment plan.

“The program consists of automated survey reminders to patients to report their symptoms, symptom tip sheets for self-management, and automated alerts to clinical teams in case of any severe symptom reports,” said Dr. Bian. She noted the patient questionnaires were based on validated PRO-CTCAE (Patient-Reported Outcomes–Common Terminology Criteria for Adverse Events) items, including 12 common treatment-related symptoms and 2 study-generated questions assessing overall well-being and functional status. Six cancer centers serving a catchment area of 12 states participated in the study.

From September 2019 through June 2022, 3,133 patients submitted a total of 39,607 questionnaires, representing 45% of all medical oncology patients invited to report their symptoms. The median age of responders was 67 years, with 54% female, 78% White, 54% married, and 50% retired.


  • A large study of patient-reported outcomes has found that approximately 16% of responses included a severe symptom.
  • Fatigue, pain, and constipation were the top reported symptoms, although all three decreased in severity over time.
  • Routine monitoring in the real-world may help to identify patients experiencing bothersome symptoms with minimal disruption to clinical workload.

At the patient level, 55% of patients reported one or more severe symptoms at any point in their reporting. At the questionnaire level, 16.2% of questionnaires included one or more severe symptoms.

White patients were more likely to report severe symptoms, employed patients were less likely to report severe symptoms, and patients with gynecologic and thoracic cancers were more likely to report severe symptoms compared with those who had gastrointestinal cancer. Fatigue, pain, and constipation were the top reported symptoms, although all three decreased in severity over time. Numbness and tingling, which reflect cumulative chemotherapy-induced neuropathy, were the only symptoms that increased over time, Dr. Bian added.

“Of note, nausea and vomiting were two of the least frequently reported severe symptoms,” said Dr. Bian. “I think this likely reflects advances in antiemesis prophylaxis and treatment over the years, but it was still somewhat surprising to see.” 

DISCLOSURE: Dr. Bian reported no conflicts of interest. This research was supported by the National Cancer Institute of the National Institutes of Health.


1. Bian JJ, Cronin C, Tramontano A, et al: Severe symptom reporting in medical oncology patients at community cancer centers assessed through eSyM. 2022 ASCO Quality Care Symposium. Abstract 242. Presented September 30, 2022.

2. Wong SL, Hazard-Jenkins HW, Schrag D, et al: Severe symptom reporting in surgical patients assessed through an EHR-integrated ePRO questionnaire at 6 cancer centers. 2022 ASCO Quality Care Symposium. Abstract 243. Presented September 30, 2022.

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