A better understanding of the burden of treatment side effects in patients with gynecological malignancies could help guide symptom interventions and oncologic therapy decision-making, according to Ashley D. Hickman, MD, the lead author of a paper presented at the recent virtual Annual Meeting of ASCO.  “Chemotherapy regimens for ovarian cancer are frequently examined for their effectiveness in controlling disease,” Dr. Hickman says. “However, the symptoms associated with specific chemotherapy regimens are less frequently studied. Understanding the burden of these side effects can help determine individualized treatment decisions.”

Dr. Hickman and colleagues aimed to enhance understanding of symptom burden in epithelial ovarian cancer (EOC) by analyzing patient -reported symptom data from patients treated for this condition during a 16-month period, through the Enhanced Electronic Health Record Facilitated Cancer Symptom Control Study (E2C2). Patients receiving medical oncology care at Mayo Clinic Rochester and at Midwest Mayo Clinic Health System community sites have received symptom-focused surveys prior to each medical oncology visit since March 28, 2019, through the E2C2.

Beneficial for Both Patients & Healthcare Providers

Surveys administered either through the electronic medical record portal or on a clinic tablet prior to each oncology office visit, and no more frequently than every 2 weeks, include six linear analogue scales measuring sleep disturbance, pain, anxiety, emotional distress, and fatigue (SPADE), as well as physical dysfunction on a scale of 0 (none) to 10 (as bad as can be imagined). Scores of 0-3 were considered mild symptoms, 4-6 moderate symptoms, and 7-10 severe symptoms. The researchers collected survey results and reviewed the number of surveys per patient in addition to the average symptom scores.

“With this project, we hope to demonstrate the impact of the E2C2 research databank and the effectiveness of survey-based symptom assessment,” Dr. Hickman says. “These surveys provide an outlet for patients to inform their healthcare team about their symptom burden and a way for their medical team to learn how patients’ symptoms are progressing throughout treatment.”

 For patients with EOC, there were 2,974 encounter-based surveys from 762 patients from March 2019 to July 2020. The number of surveys completed by each patient ranged from 1-20. The following number of patients returned the correlating number of surveys: one survey: 240 patients; two surveys: 145; three surveys: 79; four surveys: 56; five surveys: 58; six surveys: 45; seven surveys :38; eight surveys: 27; nine surveys: 22; and greater to or equal to 10 surveys: 52. The average score from all surveys for each symptom was: 2.41 for sleep disturbance, 2.03 for pain, 2.32 for anxiety, 1.97 for emotional distress, 3.26 for fatigue, and 2.50 for physical dysfunction.

Fatigue & Physical Dysfunction Reported Most Frequently

Dr. Hickman and colleagues found that fatigue and physical dysfunction were reported most frequently in patients with EOC, while emotional distress and pain were reported least frequently. Patients between the ages of 30 and 49 years experienced a higher-than-average symptom burden in each category.  “This information allows us to better understand which patients are a high risk for significant symptom burden, so that we may be proactive in monitoring them and offering support,” says Dr. Hickman. “Our next step in this analysis includes an assessment of potential predictors of greater symptom burden, such as specific treatments, age, and other clinical and sociodemographic characteristics.”

The E2C2 Pragmatic Clinical Trial databank has provided a unique insight into the real-world experiences of patients undergoing diagnosis and treatment of malignancy, Dr. Hickman concludes. “With this information, oncologists have begun providing patients with symptom self-management education, based on their individual needs,” she says. “We plan to analyze the results to determine if these interventions help to lessen symptoms over time and reduce the need for unplanned healthcare resources.”





Symptom Identification and Management in Epithelial Ovarian Cancer