Patient‐Reported Toxicity Outcomes Collected from a Diverse Sample of Ambulatory Oncology Practices: Feasibility, Patterns, and Correlates

Abstract

Research ObjectiveIn the United States, adult patients with cancer receive most chemotherapy treatments in ambulatory settings. Yet outside of clinical trials, these setting rarely collect and report patient‐reported outcomes (PROs), such as treatment‐associated toxicities. As novel cancer treatments expand, we examined the feasibility of collecting PROs from adults with cancer receiving chemotherapy treatment and described the patterns and correlates of patient‐reported toxicities.Study DesignWe conducted secondary data analysis from a multisite study of ambulatory oncology care quality and safety. On‐site practice champions identified eligible patients who completed an anonymous questionnaire at their appointment check‐in. Patients receiving chemotherapy completed 11 items from the Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO‐CTCAE), with a recall period of the past seven days. Patients rated each item on a 5‐point scale across three domains: frequency, severity, and interference with daily activities. Patients rated the frequency of nausea, vomiting, diarrhea, and pain (1 = never, 5=almost constantly); the severity of nausea, vomiting, constipation, numbness/tingling, and pain (1 = none, 5 = very severe); and how much numbness/tingling and pain interfered with usual or daily activities (1=not at all, 5=very much). Patients could report two additional side effects in an open‐text section. Descriptive statistics were calculated at both the patient and practice levels to generate practice‐level data summaries.Population StudiedAdults with invasive, nonmetastatic cancer and received systemic intravenous chemotherapy treatment at one of 29 medical oncology practices that participated in a statewide quality improvement collaborative. Patients either read English or had a nonclinician proxy available.Principal FindingsOf 3,565 eligible patients, 2,245 participated (63%). A total of 1,302 (58%) were female, 389 (17%) were nonwhite, and 257 (11%) were treated in rural settings. A total of 457 patients (20%) rated at least one toxicity as severe/very severe. At the practice level, the proportion of patients per practice who reported at least severe/very severe toxicity ranged from eight to 50 percent. The toxicities rated with the highest severity were pain frequency (mean 2.3, SD 1.3), pain severity (2.1, 1.1), and diarrhea frequency (1.9, 1.0). From completed assessments, 1,653 (74%) self‐reported at least one additional toxicity in the open‐text section. After thematic analysis, the most frequently reported toxicities in the open‐text section were fatigue (n=182), generalized stomach discomfort (n=53), and skin/nail changes (n=41). Regarding consequences of toxicities experienced since the last chemotherapy treatment, 156 patients (7%) reported unplanned health care service use for toxicity management: 41 (26%) visited an emergency department, and 32 (21%) were admitted to a hospital.ConclusionsQuerying patients directly on their toxicity and related treatment experience was highly feasible. Notable variation in reported toxicities occurred across practices and enabled them to act on their own data. Toxicity severity and related service use exceeded the incidence reported in clinical trials.Implications for Policy or PracticeSoliciting patient‐reported outcomes from patients outside of clinical trials can inform the clinical community on the patient experience and motivate clinical practice changes. Adults treated for invasive cancer continue to report persistent challenges in managing pain, fatigue, and gastrointestinal issues. Providing patients with open‐text sections enabled the study team to explore toxicities emerging from newer treatment regimens.Primary Funding SourceAgency for Healthcare Research and Quality.