Initial findings from a prospective, large scale patient reported outcomes program in patients with gynecologic malignancy.

INTRODUCTION: Patient reported outcome measures (PROMs) are associated with improved overall survival in patients with metastatic malignancy; however, routine collection of PROMs is nascent. Little is known about PROs in women with gynecologic malignancy outside of a trial setting, limiting our understanding of how routine populations experience treatment, disease and morbidity. The goal of this study was to prospectively collect and describe disease-specific PROs in a non-trial population of women with gynecologic malignancy. METHODS: PROMs were assigned electronically to all patients presenting for care in our gynecologic oncology clinic. Patients received a general oncology questionnaire (EORTC QLQ C30) a disease specific questionnaire (FACT V, EORTC EN24, EORTC OV28, EORTC Cx 24), and questionnaires assessing support at home. Responses were mapped to relevant clinical variables. Descriptive statistics were performed, and comparisons made with parametric and nonparametric analyses. The association between support at home and perioperative complications was assessed via logistic regression. RESULTS: In the study period, 3239 unique patients were evaluated at new patient visits, post-operative visits, chemotherapy visits and surveillance visits with a PROMs completion rate of 78.1% (n = 2530 women with 4402 completions). There was no difference in completion rates based on age or self-identified race. The EORTC QLQ C-30 questionnaire was able to adequately discern differences between disease sites. Overall, scores were lower than those obtained in trial populations. PROMs responses were not associated with perioperative complications. CONCLUSION: Systematic collection of PROMs is feasible and tech-enabled workflows result in high collection rates. Quality of life scores in our clinic population were lower than published data, indicating caution should be used when extrapolating quality of life data from clinical trials to counseling and decision making around routine patient populations.

Patient reported outcome measures among patients with vulvar cancer at various stages of treatment, recurrence, and survivorship.

OBJECTIVE: Our goal was to pragmatically describe patient reported outcomes (PROs) in a typical clinic population of vulvar cancer patients, as prior studies of vulvar cancer PROs have examined clinical trial participants. METHODS: A prospective PRO program was implemented in the Gynecologic Oncology clinic of a tertiary academic institution in January 2018. Vulvar cancer patients through September 2019 were administered the European Organization for the Research and Treatment of Cancer Quality of life Questionnaire, the Patient Reported Outcome Measurement Information System Instrumental and Emotional Support Scales, and the Functional Assessment of Cancer Therapy-Vulvar questionnaire. Binary logistic regressions were performed to determine adjusted odds ratios for adverse responses to individual questions by insurance, stage, age, time since diagnosis, recurrence, radiation, and surgical radicality. RESULTS: Seventy vulvar cancer patients responded to PROs (85.4% response rate). Seventy-one percent were > 1 year since diagnosis, 61.4% had stage I disease, and 28.6% recurred. Publicly insured women had less support and worse quality of life (QOL, aOR 4.15, 95% CI 1.00-17.32, p = 0.05). Women who recurred noted more interference with social activities (aOR 4.45, 95% CI 1.28-15.41, p = 0.019) and poorer QOL (aOR 5.22 95% CI 1.51-18.10, p = 0.009). There were no major differences by surgical radicality. Those >1 year since diagnosis experienced less worry (aOR 0.17, 95% CI 0.04-0.63, p = 0.008). CONCLUSIONS: Surgical radicality does not affect symptoms or QOL in vulvar cancer patients, whereas insurance, recurrence, and time since diagnosis do. This data can improve counseling and awareness of patient characteristics that would benefit from social services referral.