Do reminder emails and past due notifications improve patient completion and institutional data submission for patient-reported outcome measures?

PURPOSE: NRG Oncology, part of the National Cancer Institute's National Clinical Trials Network, took efforts to increase patient-reported outcome measures (PROMs) completion and institutional data submission rates within clinical trials. Lack of completion diminishes power to draw conclusions and can be a waste of resources. It is hypothesized that trials with automatic email reminders and past due notifications will have PROM forms submitted more timely with higher patient completion. METHODS: Automatic emails sent to the research associate were added to selected NRG Oncology trials. Comparisons between trials with and without automatic emails were analyzed using Chi-square tests with respect to patient completion and timeliness of form submission rates. Multivariable analyses were conducted using repeated measures generalized estimating equations. If PROMs were not completed, a form providing the reason why was submitted and counted towards form submission. RESULTS: For both disease sites, form submission was significantly higher within 1 month of the form's due date for the studies with automatic emails vs. those without (prostate: 79.7% vs. 75.7%, p < 0.001; breast: 59.2% vs. 31.3%, p < 0.001). No significant differences in patient completion were observed between the breast trials. The prostate trial with automatic emails had significantly higher patient completion but this result was not confirmed in the multivariable analysis. CONCLUSIONS: Although patient completion rates were higher on trials with automatic emails, there may be confounding factors requiring future study. The automatic emails appeared to have increased the timeliness of form submission, thus supporting their continued use on NRG Oncology trials.

Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials.

PURPOSE: To assess the reasons why patients do not consent to patient-reported outcome (PRO) and electronic PRO data capture components of clinical trials and potential selection bias by having a separate consent. METHODS AND MATERIALS: Selected NRG Oncology trials were included based on disease site and inclusion of PROs and electronic PRO data capture via VisionTree Optimal Care as separate consent questions. Reasons for not participating were assessed. Pretreatment characteristics between patients who did and did not consent were tested using χ2 and t tests for univariate comparisons and logistic regression for multivariable analyses. RESULTS: Ten trials were selected in head and neck, prostate, gynecologic, breast, lung, and gastrointestinal cancers, with 4 of these trials having electronic PRO data capture. Most patients consented to the PRO component (75.3%) but not electronic PRO data capture (37.8%). More white patients consented to PROs than nonwhite patients across all trials (odds ratio [OR], 0.53; 95% confidence interval [CI], 0.45-0.63; P < .001), and more patients with education after high school consented compared with those with less education (OR, 1.71; 95% CI, 1.46-2.02; P < .001). Patients who are younger (OR, 0.63; 95% CI, 0.47-0.85; P = .002), white (OR, 0.60; 95% CI, 0.44-0.82; P = .001), and a never or former smoker (OR, 0.57; 95% CI, 0.41-0.78; P = .001) are more likely to participate in electronic PRO data capture. CONCLUSIONS: These results suggest that a patient's race, age, and education can affect whether a patient chooses to consent or is offered to participate in PRO or electronic PRO data capture components. More investigation is needed, but this analysis provides support for making PROs integrated in the trial.

Phase I trial using patupilone (epothilone B) and concurrent radiotherapy for central nervous system malignancies.

PURPOSE: Based on preclinical data indicating the radiosensitizing potential of epothilone B, the present study was designed to evaluate the toxicity and response rate of patupilone, an epothilone B, with concurrent radiotherapy (RT) for the treatment of central nervous system malignancies. METHODS AND MATERIALS: The present Phase I study evaluated the toxicities associated with patupilone combined with RT to establish the maximal tolerated dose. Eligible patients had recurrent gliomas (n = 10) primary (n = 5) or metastatic (n = 17) brain tumors. Dose escalation occurred if no dose-limiting toxicities, defined as any Grade 4-5 toxicity or Grade 3 toxicity requiring hospitalization, occurred during treatment. RESULTS: Of 14 patients, 5 were treated with weekly patupilone at 1.5 mg/m(2), 4 at 2.0 mg/m(2), 4 at 2.5 mg/m(2), and 1 at 4 mg/m(2). Of 18 patients, 7 were treated in the 6-mg/m(2) group, 6 in the 8-mg/m(2) group, and 5 in the 10-mg/m(2) group. Primary central nervous system malignancies received RT to a median dose of 60 Gy. Central nervous system metastases received whole brain RT to a median dose of 37.4 Gy, and patients with recurrent gliomas underwent stereotactic RT to a median dose of 37.5 Gy. One dose-limiting toxicity (pneumonia) was observed in group receiving 8-mg/m(2) every 3 weeks. At the subsequent dose level (10 mg/m(2)), two Grade 4 dose-limiting toxicities occurred (renal failure and pulmonary hemorrhage); thus, 8 mg/m(2) every 3 weeks was the maximal tolerated dose and the recommended Phase II dose. CONCLUSION: Combined with a variety of radiation doses and fractionation schedules, concurrent patupilone was well tolerated and safe, with a maximal tolerated dose of 8 mg/m(2) every 3 weeks.