Abstract
Background: Women undergoing treatment for breast cancer experience both disease- and treatment-related symptoms. Remote symptom management programs allow real time symptom documentation, earlier intervention, and opportunities to improve quality of life and decrease symptom burden. This study describes patient-reported outcomes (PROs) in women undergoing treatment for early stage and metastatic breast cancer.
Methods: Women with breast cancer using Carevive’s remote symptom management (RSM) program completed weekly surveys to assess the presence of 14 common symptoms over 16 weeks. Symptoms assessed were anxiety, decreased appetite, fatigue, general pain, mouth sores, muscle pain, nausea, vomiting, numbness, sadness, shortness of breath, diarrhea, constipation, and insomnia. When a symptom was reported, additional questions were asked regarding symptom severity, frequency, and interference using the National Cancer Society’s Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE produced composite scores, which classified each symptom reporting event as mild, moderate-severe, or severe. A mild symptom classification generates an electronic care plan with recommendations for symptom management; moderate-severe and severe classifications trigger an alert to the care team. Descriptive analyses summarize PROs for early stage and metastatic patients. Symptom burden was assessed by calculating the frequency distribution of each patient’s highest reported composite score for each symptom by month (Table 1).
Results: Between September 2020 and April 2022, 280 women enrolled in the RSM program; 201 of these women had complete staging information for analysis. 80% (n=160) had early stage (0-III) and 20% (n=41) had metastatic (IV) disease. 32% (n=64) were less than 50 years old and 68% (n=137) were age 50 or older. 58% (n=116) were hormone receptor (HR) positive/HER2 negative, 22% (n=45) HR+ or -/HER2+ and 19% (n=39) HR-/HER2-. In Month 1, patients with metastatic disease most frequently reported moderate to severe symptoms for general pain (51%), nausea (32%), decreased appetite (22%), and diarrhea (29%). In Month 1, patients with early stage disease most frequently reported moderate to severe symptoms for general pain (32%) and diarrhea (28%). In Month 1, general pain was the most frequently reported symptom for both early stage (34%) and metastatic (51%) groups. In both groups over 16 weeks, nausea, diarrhea, and constipation were among the five most reported symptoms along with muscle pain for early stage patients and shortness of breath for metastatic patients. The frequency of all symptoms decreased over 16 weeks, but there remained cases of moderate-severe and severe symptom intensity through Week 16 for several symptoms.
Conclusion: Women with metastatic and early stage breast cancer both report severe symptoms during treatment. Early stage patients may have different symptom profiles and unmet needs not captured by common PROs. Future work should further evaluate symptom profiles of early stage patients to understand how to best use PRO monitoring in the curative intent setting.
Percentage of Moderate-Severe and Severe Symptom Reports By Month and Symptom for Women with Early Stage and Metastatic Breast Cancer MO=Month
Citation Format: Tara Kaufmann, Aaron Galaznik, Nicholas Coombs, Gabrielle B. Rocque. Patient-Reported Symptom Burden in Women Undergoing Treatment for Early Stage and Metastatic Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-07-12.