Patient-Reported Outcomes as a Recruitment Strategy for Clinical Trial Enrollment.

Importance: Clinical trials are critical for progress in oncology; however, only 5% of the adult cancer population participates. Harnessing data that are routinely collected (ie, electronic patient-reported outcomes [ePROs]) may serve as a method to promote trial enrollment. Objective: To evaluate if an ePRO-prompted recruitment strategy is associated with increased clinical trial enrollment. Design, Setting, and Participants: A randomized substudy was conducted from September 2022 to March 2023 at a multisite tertiary cancer center as part of an ongoing clinical trial that was testing a symptom-intervention for cancer-related fatigue. Patients with breast cancer who were undergoing radiotherapy who completed at least 1 ePRO questionnaire during the study period were included. Physician-level cluster randomization assigned fatigue-eligible patients to either receive a portal message invitation to a symptom-intervention trial or standard of care (SOC; physician-based referral). Exposure: ePRO questionnaires distributed in routine practice were queried weekly and screened for moderate or greater fatigue, the principle inclusion criterion for the primary trial. To assess the association of the portal message source with response and enrollment, every other patient received a message from the primary radiation oncology team or the referral service. Main Outcomes and Measures: Clinical trial response/referral and enrollment. Results: A total of 1041 patients completed ePRO questionnaires, of whom 394 (38%; 53 Asian [13.6%], 43 Black [11.0%], 29 Hispanic [7.4%], and 262 White individuals [66.5%]; median [IQR] age, 55 [47-65] years) endorsed moderate or greater fatigue while receiving treatment. A total of 210 patients (53.3%) were assigned to receive a portal message and 184 (46.7%) patients, SOC. In the portal message group, 73 patients (35%) responded and 41 (20%) enrolled compared with 1 patient (0.5%) referred and 0 enrolled in the SOC group (P < .001). The response rate to portal messages favored the referral service vs the primary radiation oncology service (44% vs 26%; P = .01), but there was no significant difference in enrollments. Conclusions and Relevance: The study results suggest that use of routine care ePROs was associated with greater enrollment in a symptom-intervention trial compared with physician-based referral. Messaging directly from the referral service may support enrollment and help reduce oncology physician-level barriers to trial enrollment for studies testing symptom interventions.

When Is Telemedicine Appropriate in the Management of Head and Neck Cancer? A Mixed-Methods Assessment Among Patients and Physicians.

PURPOSE: Evidence suggests that oncology patients are satisfied with and sometimes prefer telemedicine compared with in-person visits; however, data are scarce on when telemedicine is appropriate for specific cancer populations. In this study, we aim to identify factors that influence patient experience and appropriateness of telemedicine use among a head and neck cancer (HNC) population. METHODS: We performed a mixed-methods study at a multisite cancer center. First, we surveyed patients with HNC and analyzed factors that may influence their telemedicine experience using multivariate regression. We then conducted focus groups among HNC oncologists (n = 15) to evaluate their perception on appropriate use of telemedicine. RESULTS: From January to December 2020, we collected 1,071 completed surveys (response rate 24%), of which 551 first unique surveys were analyzed. About half of all patients (56%) reported telemedicine as "same or better" compared with in-person visits, whereas the other half (44%) reported "not as good or unsure." In multivariate analyses, patients with thyroid cancer were more likely to find telemedicine "same or better" (adjusted odds ratio, 2.08 [95% CI, 1.35 to 3.25]) compared with other HNC populations (mucosal/salivary HNC). Consistently, physician focus group noted that patients with thyroid cancer were particularly suited for telemedicine because of less emphasis on in-person examinations. Physicians also underscored factors that influence telemedicine use, including clinical suitability (treatment status, visit purpose, examination necessity), patient benefits (travel time, access), and barriers (technology, rapport-building). CONCLUSION: Patient experience with telemedicine is diverse among the HNC population. Notably, patients with thyroid cancer had overall better experience and were identified to be more appropriate for telemedicine compared with other patients with HNC. Future research that optimizes patient experience and selection is needed to ensure successful integration of telemedicine into routine oncology practice.

Disparities in Access to Radiotherapy Among Hispanic/Latinx Populations in the United States: How Far Have We Left to Go?

OBJECTIVES: The Hispanic/Latinx population has consistently faced disparities in oncology access and outcomes with cancer being the leading cause of death in this population. We evaluate recent research in radiation therapy disparities among the Hispanic/Latinx population in the United States since our seminal analysis from 2017. METHODS: A PubMed literature search was conducted for articles published from January 2017 through March 2023. Four term combinations were utilized, including: (1) "Hispanic" and "Radiotherapy" and "Disparities", (2) "Latino" and "Radiotherapy" and "Hispanic", (3) "Hispanic" and "Radiation" and "Disparities", and (4) "Latino" and "Radiation" and "Disparities." Included studies were those taking place in the United States, examined radiation oncology care, and examined health disparities. RESULTS: Fifty-eight of 245 articles returned met inclusion criteria and spanned 6 disparity-types: (1) Stage at Presentation, (2) Time to Treatment Initiation & Completion, (3) Receipt of Treatment and Guideline-Concordant Care, (4) Geography, (5) Clinical Trial Access and (6) Insurance Barriers and Treatment Center Type. The most common disparity was receipt of treatment and guideline-concordant care (n=39 studies), demonstrating that the Hispanic/Latinx population was less likely to receive guideline-concordant treatment or treatment at all. In additon, studies identified disparities in time to treatment and completion (n=12), geography (n=5), clinical trial access (n=3), and insurance and treatment center access (n=5). CONCLUSIONS: Disparities in radiotherapy access remain prominent for the Hispanic/Latinx population through a multitude of barriers, despite increasing interest in disparities research. Continued health care disparities research with tangible interventions are needed in radiation oncology to properly understand and address this problem.

Evaluating a Physician Audit and Feedback Intervention to Increase Clinical Trial Enrollment in Radiation Oncology in a Multisite Tertiary Cancer Center: A Randomized Study.

PURPOSE: Clinical trial participation continues to be low, slowing new cancer therapy development. Few strategies have been prospectively tested to address barriers to enrollment. We investigated the effectiveness of a physician audit and feedback report to improve clinical trial enrollment. METHODS AND MATERIALS: We conducted a randomized quality improvement study among radiation oncologists at a multisite tertiary cancer network. Physicians in the intervention group received quarterly audit and feedback reports comparing the physician's trial enrollments with those of their peers. The primary outcome was trial enrollments. RESULTS: Among physicians randomized to receive the feedback report (n = 30), the median proportion of patients enrolled during the study period increased to 6.1% (IQR, 2.6%-9.3%) from 3.2% (IQR, 1.1%-10%) at baseline. Among those not receiving the feedback report (n = 29), the median proportion of patients enrolled increased to 4.1% (IQR, 1.3%-7.6%) from 1.6% (IQR, 0%-4.1%) at baseline. There was a nonsignificant change in the proportion of enrollments associated with receiving the feedback report (-0.6%; 95% CI, -3.0% to 1.8%; P = .6). Notably, there was an interaction between baseline trial accrual and receipt of feedback reports (P = .005), with enrollment declining among high accruers. There was an increase in enrollment throughout the study, regardless of study group (P = .001). CONCLUSIONS: In this study, a positive effect of physician audit and feedback on clinical trial enrollment was not observed. Future efforts should avoid disincentivizing high accruers and might consider pairing feedback with other patient- or physician-level strategies. The increase in trial enrollment in both groups over time highlights the importance of including a comparison group in quality improvement studies to reduce confounding from secular trends.

Patient-Reported Outcomes in Clinical Trials: From an Endpoint to an Intervention in Cancer Care.

Underreporting of patient symptoms by clinicians is a common and well-documented phenomenon that has led to integrating patient-reported outcomes (PROs) as endpoints into clinical trials. While PROs are often used to measure disease symptoms, cancer therapy toxicities, and quality of life, they can also assess patients' general experiences and preferences. With the increasing use of electronic medical records and the digital health revolution in oncology, conversion from paper to electronic PROs (ePROs) has also facilitated the integration of PROs into routine care. Evidence from clinical trials is rapidly emerging to support ePROs as a care delivery innovation, given the potential for ePROs to improve patient outcomes through timely evaluation and response to patient needs. Meanwhile, work is ongoing to understand and address ePRO use and challenges to equitable integration, including technical and language barriers for patients, clinicians, and health systems. Nonetheless, the health system and regulatory bodies continue to develop stipulations to promote the use of ePROs. Herein, we review the evolution of PROs from an endpoint to an intervention in prospective clinical trials in oncology.

Improved Overall Survival of Patients with Pancreatic Cancer through Multiagent Chemotherapy and Increased Rates of Surgical Resection.

BACKGROUND: Seminal trials have demonstrated improved survival in pancreatic adenocarcinoma with novel multiagent chemotherapy regimens. To understand the clinical ramifications of this paradigm shift, we reviewed our institutional experience. METHODS: This retrospective cohort study utilized a prospective database at a single institution to study all patients diagnosed with and treated for pancreatic adenocarcinoma between 2000 and 2020. RESULTS: 1,572 patients were included of which 36% were diagnosed before (Era 1) and 64% after (Era 2) 2011. Survival improved in Era 2 (Median survival 10 vs 8 months, HR .79; P < .001). The survival advantage for Era 2 was primarily seen in patients with high-risk disease (12 vs10 months, HR .71; P < .001). A similar trend was noted for patients undergoing surgical resection (26 vs 21 months, HR .80; P = .081) and with imminently resectable tumors (19 vs 15 months, HR .88; P = .4); however, this was not statistically significant. There was no survival advantage for patients with stage IV disease (4 vs 4 months). Patients in Era 2 were more likely to undergo surgery (OR 2.78; CI 2.00-3.92, P < .001). This increase was driven primarily by increased surgical resection for those with high-risk disease (42 vs 20%, OR 3.74; P < .001). DISCUSSION/CONCLUSIONS: This single institutional study showed improved survival after the shift to novel chemotherapy regimens. This was driven by improved survival for patients with high-risk disease and may be due to more effective eradication of microscopic metastatic disease with adjuvant chemotherapy and increased resection rates.

Pathologic Tumor Regression is Associated With Improved Survival in Pancreatic Cancer.

OBJECTIVES: The advent of effective chemotherapy regimens has increased the use of neoadjuvant multiagent chemotherapy in pancreatic cancer. However, the effect of tumor downstaging with neoadjuvant treatment on survival is unclear. METHODS: Retrospective study included all resected patients with pancreatic adenocarcinoma who underwent neoadjuvant chemotherapy with FOLFIRINOX or gemcitabine/Abraxane. Downstaging was quantified using (1) difference between presenting AJCC clinical and final pathologic stage and (2) College of American Pathologists (CAP) Tumor Regression Grading Schema. RESULTS: Eighty-seven patients met inclusion criteria. FOLFIRINOX was the most common regimen, 63.2% vs 21.8%. Change in regimen occurred in 15% of patients. Downstaging based on a difference in AJCC stage group occurred in only 4.6%. In contrast, 45.2% were classified as downstaged by the CAP Tumor Regression of 0-2. Downstaging was similar for FOLFIRINOX gemcitabine/Abraxane (64.7 vs 53.6, P = .12) using the CAP criteria. On univariate analysis, treatment regimen (gemcitabine/Abraxane vs FOLFIRINOX, median survival 27 vs 29 mo; HR 1.57, P = .2) had similar survival. Downstaging by the AJCC stage was not associated with improved survival (HR 1.51, P = .4). However, there was a survival benefit for those downstaged by the CAP Tumor Regression Grading Schema, the median survival of 41 mo vs 25 mo; HR 3.05, P = .009. Improved survival 3.32 (1.35-8.16), P = .009) was maintained on multivariate analysis. CONCLUSION: Survival is significantly improved in those downstaged, as assessed by the CAP Tumor Regression Schema. Downstaging is an important prognostic variable that can help with joint decision making for clinicians and patients.

Social Determinants of Health Amplify the Association Between Ethnicity and COVID19: A Retrospective-Cohort study.

BACKGROUND: People in racial and ethnic minority groups have been shown to be at increased risk for a variety of diseases, including COVID-19. However, the role that social needs play in this increased risk has not yet been quantified. Investigating these roles can elicit a greater understanding of how social needs influence the manner in which this disease is contracted and spread. METHODS: A retrospective analysis was conducted of 1,969 Lynn Community Health Center patients. Patients that visited the center between February 1st and July 1st, 2020, tested for COVID-19, and screened for social determinants of health (SDOH) risk factors. Demographics were compared between COVID-19 positive and negative patients. Confounding by age on the association between ethnicity and COVID-19 status was evaluated. A stratified analysis was performed to evaluate the effect modification of SDOH on the relationship between race, ethnicity, and COVID-19 status. RESULTS: Hispanic patients had 2.93 times the odds of a positive COVID-19 test compared to non-Hispanics (95% CI: 2.37 - 3.64, p<0.0001). With at least one SDOH risk factor, Hispanics had 4.71 times the odds of a positive COVID-19 test relative to non-Hispanics (95% CI: 3.10 - 7.14). With no SDOH risk factors, Hispanics had 2.45 times the odds of a positive COVID-19 test relative to non-Hispanics (95% CI: 1.91 - 3.16). No significant associations were found for race. CONCLUSION: Ethnicity had a significant impact on COVID-19 status in our population, where the effect of ethnicity on COVID-19 status was amplified for those with SDOH risk factors.

18F-Sodium fluoride PET/CT predicts overall survival in patients with advanced genitourinary malignancies treated with cabozantinib and nivolumab with or without ipilimumab.

PURPOSE: We evaluated the prognostic value of 18F-sodium fluoride (NaF) PET/CT in patients with urological malignancies treated with cabozantinib and nivolumab with or without ipilimumab. METHODS: We prospectively recruited patients with advanced urological malignancies into a phase I trial of cabozantinib plus nivolumab with or without ipilimumab. NaF PET/CT scans were performed pre- and 8 weeks post-treatment. We measured the total volume of fluoride avid bone (FTV) using a standardized uptake value (SUV) threshold of 10. We used Kaplan-Meier analysis to predict the overall survival (OS) of patients in terms of SUVmax, FTV, total lesion fluoride (TLF) uptake at baseline and 8 weeks post-treatment, and percent change in FTV and TLF. RESULT: Of 111 patients who underwent NaF PET/CT, 30 had bone metastases at baseline. Four of the 30 patients survived for the duration of the study period. OS ranged from 0.23 to 34 months (m) (median 6.0 m). The baseline FTV of all 30 patients ranged from 9.6 to 1570 ml (median 439 ml). The FTV 8 weeks post-treatment was 56-6296 ml (median 448 ml) from 19 available patients. Patients with higher TLF at baseline had shorter OS than patients with lower TLF (3.4 vs 14 m; p = 0.022). Patients with higher SUVmax at follow-up had shorter OS than patients with lower SUVmax (5.6 vs 24 m; p = 0.010). However, FTV and TLF 8 weeks post-treatment did not show a significant difference between groups (5.6 vs 17 m; p = 0.49), and the percent changes in FTV (12 vs 14 m; p = 0.49) and TLF (5.6 vs 17 m; p = 0.54) also were not significant. CONCLUSION: Higher TLF at baseline and higher SUVmax at follow-up NaF PET/CT corresponded with shorter survival in patients with bone metastases from urological malignancies who underwent treatment. NaF PET/CT may be a useful predictor of OS in this population.