Dana-Farber Cancer Institute, Boston, MA
Nadine Jackson McCleary , Ellana Haakenstad , Jessica Cleveland , Sunyi Zhang , Michael J. Hassett , Deborah Schrag
Background: In clinical trials, the systematic collection of patient (pt) reported outcomes has been shown to improve quality of life & overall survival. To develop predictive care models for symptom management, we explored the frequency & distribution of SAEs reported by pts who reported electronic patient reported outcomes (ePRO) prior to outpatient visits to the Gastrointestinal Cancer Center (GCC) at Dana Farber Cancer Institute (DFCI). Methods: ePRO is a modified NCI Patient Reported Outcomes – Common Terminology Criteria for Adverse Events instrument distributed weekly to GCC pts with a medical/surgical/radiation oncology encounter. Responses are available to the care team in the electronic health record. ePRO consists of presence/frequency/severity/interference of 15 core SAEs (fatigue, insomnia, general pain, decreased appetite, nausea, vomiting, constipation, diarrhea, shortness of breath, numbness and tingling, rash, concentration, fever, anxiety, sadness). Responses are scored 0 to 3 (with 2 and 3 indicating moderate and severe SAEs, respectively). We examined the frequency & distribution of grade 2 and 3 SAEs in ePRO responders by age, gender, race/ethnicity. All pts had gastrointestinal cancer and an outpatient visit for treatment, symptom management, follow-up care. Results: From 9/1/2018 to 8/31/2020, 1912 unique pts responded (response rate 23%). Most respondents were age 50-69 years (58% compared to 15% age <50, 27% age ≥70; range 18-95), male (53%), white (75%). Grade 3 SAE frequencies were pain (12%), fatigue (11%), anxiety/constipation/insomnia/decreased appetite (5%), sadness/numbness and tingling/diarrhea (3%), concentration/shortness of breath (2%), nausea/rash (1%), fever/vomiting (0%). Across pts, fatigue, general pain, insomnia, anxiety were the most common grade 2 and 3 SAEs. Shortness of breath, vomiting, rash, fever were least common (Table). Conclusions: In GCC pts responding to ePRO, the most frequent SAEs were pain, fatigue, insomnia, anxiety. Shortness of breath, nausea, vomiting, diarrhea were less often severe. Pts <50 were more likely to report severe anxiety but there were no other major differences based on age, sex, race/ethnicity. Ongoing efforts will increase pt/provider engagement and develop predictive models & symptom management interventions from ePRO responses.
General pain | Fatigue | Insomnia | Anxiety | Shortness of breath | Vomiting | Rash | Fever | ||
---|---|---|---|---|---|---|---|---|---|
Age | < 50 | 35.8 | 33.6 | 22.2 | 30.9 | 5.3 | 5.4 | 1.9 | 1.3 |
50-70 | 32.4 | 34.7 | 21.1 | 18.4 | 7.5 | 5.0 | 1.3 | 0.9 | |
70+ | 29.7 | 38.5 | 21.7 | 18.4 | 11.8 | 3.2 | 3.4 | 0.9 | |
Sex | Female | 32.3 | 35.5 | 21.6 | 24.4 | 6.9 | 4.1 | 1.7 | 1.0 |
Male | 32.2 | 35.7 | 21.3 | 16.7 | 9.6 | 5.0 | 2.1 | 0.9 | |
Race/ Ethnicity | Black | 40.2 | 30.7 | 16.5 | 15.3 | 8.1 | 7.3 | 0.0 | 1.6 |
Latinx | 36.4 | 36.4 | 27.3 | 9.1 | 0.0 | 0.0 | 0.0 | 0.0 | |
Other | 37.0 | 36.0 | 24.4 | 17.3 | 9.9 | 5.0 | 1.7 | 2.0 | |
White | 32.2 | 38.6 | 22.5 | 22.5 | 7.6 | 3.8 | 1.9 | 0.9 |
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