University of North Carolina at Chapel Hill Chapel Hill, NC
V. Xu1, O. Roberts1, N. Patel1, X. Tan2, E. L. Jones3, S. Sud3, J. M. Wilson4, and A. A. Weiner3; 1University of North Carolina, Chapel Hill, NC, 2Lineberger Comprehensive Cancer Center, University of North Carolina Hospitals, Chapel Hill, NC, 3Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC, 4Department of Radiation Oncology, Mayo Clinic, Rochester, MN
Purpose/Objective(s): Women with gynecologic malignancies can face high symptom burden related to cancer and cancer-directed therapy. The impact on fertility, menopause, sexual health, and GI/GU systems can be associated with worsened quality of life. Patient reported outcomes (PRO) are instrumental to providing patient centered care by helping convey the impact of symptoms to the medical team. This is especially true with the sensitive nature of symptoms related to gynecologic cancer. There are limited reports of PRO for patients with gynecologic cancer and even fewer related to radiation therapy (RT). As such, we have implemented electronic PRO (ePRO) via this feasibility study for patients treated with RT for gynecologic cancer (cervical, vulvar, and endometrial cancers). The primary objective is to evaluate the feasibility of ePRO monitoring before, during, and 6 weeks after RT for gynecologic cancer at a high-volume center. Secondary objectives include examining the feasibility of collecting ePRO at late time points, monitoring late and acute symptoms, and comparing disease sub-sites. Materials/
Methods: In this prospective, observational study, 100 patients will be accrued with the plan to collect ePRO for up to two years post RT. Eligibility criteria include >18 years of age, English speaking, gynecologic cancer with plans for RT , and being able and willing to complete a web-based survey. Current accrual is 38. After informed consent, baseline surveys are administered including general demographics, validated general, sub-site specific, and sexual function surveys. During RT, weekly ePRO surveys are completed in clinic or via email. Following treatment, surveys are administered 1,2, and 6-weeks post RT and then every 3 months for 2 years. Surveys are distributed via email; however, patients are given the option to complete the surveys during a standard of care clinic visit. The primary endpoint is to evaluate the feasibility of survey completion with a goal of >60% of patients completing 75% of surveys during and within 6 weeks of completing RT. The null hypothesis is that the compliance rate is no larger than 47%. The sample size of 100 can reach a power of 81% to reject the null hypothesis when compliance rate is >60% using a one-sided binomial test at alpha level 5%. Specifically, null hypothesis will be rejected if more than (>) 56 patients (out of 100) complete > 75% of surveys. If feasibility of acquiring ePRO is demonstrated, ePRO can eventually improve symptom monitoring for women with gynecologic cancers and help providers to gauge how treatment impacts patient symptoms. ePRO (rather than in-person surveys) allow inclusion of patients who receive a portion of RT at outside facilities and capture information from a wider patient population. However, ePRO may be a barrier for patients who are impacted by social determinants of health and minimal access to technology. Results: TBD Conclusion: TBD
