Bakitas, Marie

Abstract Oncology Advanced Practice Providers (APPs), including Advanced Practice Registered Nurses, Physician Assistants, and Clinical Pharmacists (CPs), play a vital role in delivering high-quality, patient-centered cancer care across the United States. Despite their widespread presence in oncology practices, APPs remain underutilized in cancer clinical research, representing a missed opportunity to expand trial access and improve patient outcomes. Clinical trials are essential to advancing oncology care, yet participation remains critically low among adult patients. Given Oncology APPs’ and CPs’ central role in cancer care delivery, their meaningful engagement in oncology clinical trial research is imperative as the standard of oncology care. This position article, with contributions from 5 professional societies, presents solutions and resources to barriers limiting APPs’ and CPs’ involvement in cancer clinical research, including gaps in education, role expectations, limited protected time, restrictive policies, insufficient financial support, and underrecognition of contributions. Integrating APPs and CPs more fully into the clinical research enterprise is essential to improving trial access, patient outcomes, closing equity gaps, and accelerating innovation in oncology care.

1649 Background: Findings from our prior large-scale comparative effectiveness trial showed the equivalent effect of delivering early palliative care via video versus in-person on quality of life among patients with advanced non-small cell lung cancer (NSCLC). We now report on whether the two care delivery modalities were equivalent with respect to patient-reported communication with clinicians about their end-of-life (EOL) care preferences and hospice utilization. Methods: Between 6/14/2018 and 5/4/2023, we enrolled 1250 patients with newly diagnosed advanced NSCLC in a randomized trial of early palliative care across 22 US cancer centers. Patients were randomly assigned to meet with a palliative care clinician every 4 weeks from enrollment through the course of the disease, either via video or in the outpatient clinic. Participants completed self-report surveys at baseline and weeks 12, 24, 36, and 48, including an item asking if they had discussed with their clinicians the care they would want to receive if dying (yes/no); patients’ final assessments prior to death or last follow up were analyzed. We reviewed patients’ health records to collect data on hospice referral and length of stay. To test the equivalence in these outcomes, we used a binomial generalized linear model with the identity link function (pre-specified equivalence margin of ±8% for patient-reported communication about EOL care) and linear regression (pre-specified equivalence margin of ±6 days for mean length of stay in hospice). P-values were adjusted for multiplicity using a Bonferroni correction. Results: Of the 1250 enrolled participants, 888 (71.0%) completed at least one survey post baseline regarding whether they communicated with clinicians about EOL care preferences. Among those, 29.1% of the video group and 26.0% of the in-person group reported “yes,” indicating that they recalled such EOL care discussions (difference = 3.1%, 95% CI: -1.8%, 8.1%; p = 0.26 for equivalence). During the course of the trial, 733/1250 (58.6%) patients died, of whom 537/733 (73.3%) were referred to hospice. Mean lengths of hospice stay were 25.3 days for the video group versus 25.1 days for the in-person group (difference = 0.2, 95% CI: -7.0, 7.4; p = 0.46 for equivalence). When excluding outlying patients receiving hospice services > 180 days (n = 13), the mean lengths of hospice stay were 19.1 (video group) versus 19.7 (in-person group) days (difference = -0.6, 95% CI: -4.6, 3.3; p = 0.06 for equivalence). Conclusions: Although thresholds were not met to confirm equivalence statistically, the two modalities for delivering early palliative care demonstrate very similar outcomes with respect to patient-clinician communication about EOL care and hospice utilization. These findings provide further evidence of the utility of video visits for providing high quality palliative and EOL care. Clinical trial information: ClinicalTrials.gov Identifier ( NCT03375489 ) .

Importance Numerous studies show that early palliative care improves quality of life and other key outcomes in patients with advanced cancer and their caregivers, although most lack access to this evidence-based model of care. Objective To evaluate whether delivering early palliative care via secure video vs in-person visits has an equivalent effect on quality of life in patients with advanced non–small cell lung cancer (NSCLC). Design, Setting, and Participants Randomized, multisite, comparative effectiveness trial from June 14, 2018, to May 4, 2023, at 22 US cancer centers among 1250 patients within 12 weeks of diagnosis of advanced NSCLC and 548 caregivers. Intervention Participants were randomized to meet with a specialty-trained palliative care clinician every 4 weeks either via video visit or in person in the outpatient clinic from the time of enrollment and throughout the course of disease. The video visit group had an initial in-person visit to establish rapport, followed by subsequent virtual visits. Main Outcomes and Measures Equivalence of the effect of video visit vs in-person early palliative care on quality of life at week 24 per the Functional Assessment of Cancer Therapy-Lung questionnaire (equivalence margin of ±4 points; score range: 0-136, with higher scores indicating better quality of life). Participants completed study questionnaires at enrollment and at weeks 12, 24, 36, and 48. Results By 24 weeks, participants (mean age, 65.5 years; 54.0% women; 82.7% White) had a mean of 4.7 (video) and 4.9 (in-person) early palliative care encounters. Patient-reported quality-of-life scores were equivalent between groups (video mean, 99.7 vs in-person mean, 97.7; difference, 2.0 [90% CI, 0.1-3.9]; P = .04 for equivalence). Rate of caregiver participation in visits was lower for video vs in-person early palliative care (36.6% vs 49.7%; P < .001). Study groups did not differ in caregiver quality of life, patient coping, or patient and caregiver satisfaction with care, mood symptoms, or prognostic perceptions. Conclusions and Relevance The delivery of early palliative care virtually vs in person demonstrated equivalent effects on quality of life in patients with advanced NSCLC, underscoring the considerable potential for improving access to this evidence-based care model through telehealth delivery. Trial Registration ClinicalTrials.gov Identifier: NCT03375489

PURPOSE: Patient-reported outcomes may be associated with cancer outcomes. We evaluated clinically significant fatigue (CSF), overall survival, adverse events (AEs), and quality of life (QOL) during cancer treatment. METHODS: We compared outcomes in four phase II or III chemotherapy trials, two advanced non–small-cell lung cancer and two advanced hormone-refractory prostate cancer, with or without baseline CSF. CSF was defined as a rating of two or greater on the Functional Assessment of Cancer Therapy fatigue question or a European Organization for Research and Treatment of Cancer Quality of Life Questionnaire—Core 30 fatigue symptom score of 50% or greater. Survival was compared according to CSF using Kaplan-Meier estimates and Cox regression models. Differences in AE rates by CSF were assessed via chi-squared tests, and QOL changes from baseline to 3 months via linear regression. RESULTS: Of 1,994 participants, 1,907 (median age 69 years, range: 32-91) had complete baseline QOL survey data, with 52% reporting CSF at baseline. For the two hormone-refractory prostate cancer studies, baseline CSF was associated with higher mortality rates, with adjusted hazard ratios of (95% CI, P value) 1.32 (1.13 to 1.55, P < .001) and 1.31 (1.02 to 1.67, P = .03) and with increased incidence of grade 3-5 constitutional (16.5% v 9.4%, P = .002; 13.9% v 6.3%, P = .002) and neurologic (11.7% v 6.1%, P = .006; 9.0% v 3.9%, P = .01) AEs, respectively. Baseline CSF was associated with a higher mortality rate in one non–small-cell lung cancer study: hazard ratio 1.44 and 1.04 to 2.00, P = .03. CONCLUSION: Oncology trial participants with baseline CSF had poorer survival and experienced more AEs than participants without CSF. This indicates fatigue as an important baseline prognostic factor in oncology treatment trials.

Background: Guidelines recommend involvement of palliative care (PC) for patients with cardiovascular (CV) disease and their families. Little is known about the current integration of PC and CV services. Research Objectives: Our national survey aimed to describe current practices and to identify benefits, challenges, and barriers with collaboration. Methods: Qualitative content analysis of open-response questions in an investigator-developed electronic survey study of CV and PC providers (MDs, NPs, PAs, and other allied health) using email listservs, social media, and crowdsourcing. Frequencies were tabulated using SAS statistical software. Results: Of 134 respondents, most were physicians (n=56, 57%) or advanced practice RNs or PAs (n=37, 28%), from 52 U.S. institutions, representing 33 states. The most common care for which PC was integrated were mechanical circulatory support, advanced heart failure, and heart transplantation; the least common care for which PC was integrated were TAVR, ECMO, and pulmonary hypertension. Integrated practice (n=80, 61%), PC identification of goals of care (n=20, 15%) and PC aid in patient/family communication (n=15, 11%) were the most commonly identified as positives in current practice. PC provider workforce (n=22, 16%), underutilization of PC referrals (n=20, 15%), late disease PC referral (n=19, 14%), and fundamental knowledge deficit of specialty scope (n=18, 14%) were most frequently identified as challenges. Other barriers specifically noted were underdeveloped health infrastructure and limited allocated resources (n=23,17%) and mis-/negative perception of services (n=15, 11%). Conclusion: PC and CV collaboration occurs for a high proportion of CV patients and is viewed as overwhelming positive, despite the challenges of limited PC specialists availability, underdeveloped healthcare infrastructure, limited understanding of specialty practice, and late referrals. Priorities includes increasing PC provider availability, expanding knowledge of PC services, educating providers on models of collaboration, and improving institutional support.

Effective delivery of cancer care via telehealth requires a planned care system that accounts for myriad patient, provider, and practice/cancer center resources before, during, and after the care episode. Telehealth is broadly defined as a method to have virtual, bidirectional communication between patients and providers. Telehealth can include methods such as audio-only, video-consultation, and tele-monitoring, which can occur in a synchronous, asynchronous, or blended format. The purpose of this review is to present common foundational principles for providing clinical cancer care via telehealth, followed by an overview of three distinct examples of comprehensive telehealth programs that have been developed to meet the needs of patients and families across the cancer trajectory, including survivorship, rehabilitation, and palliative care phases. The programs described are exemplars that were developed and implemented prior to the coronavirus pandemic, so they reflect many years of planning and evidence. Lessons learned include the need for ongoing patient support, clinician training, and cancer health system/practice programmatic considerations such as billing, scheduling, reimbursement, software, and hardware/platform security. Although the COVID-19 pandemic produced an explosive shift in regulations and implementation, sustainability of these changes may not be long-term. Nevertheless, a permanent shift in cancer care to include telehealth is likely here to stay.

140 Background: Prior studies have suggested that patient-reported outcomes may be associated with cancer outcomes. We evaluated the association between clinically significant fatigue (CSF) and adverse events (AEs), quality of life (QOL), and overall survival (OS) during cancer treatment. Methods: Four phase II or III chemotherapy trials, two each in advanced non-small cell lung cancer (NSCLC) and advanced hormone-refractory prostate cancer (HRPC), were used to compare patients with or without baseline CSF. Baseline CSF was defined as a rating of 2 or greater on the FACT fatigue survey question or an EORTC QLQ-C30 fatigue symptom score of 50% or greater. Change in QOL from baseline, AE rates, and survival were compared according to baseline CSF with linear regression models, equality of proportions chi-squared tests, and Kaplan-Meier survival estimates and Cox regression models, respectively, separately for each trial. Results: Of 1,994 participants, 1,907 had complete baseline QOL survey data, with 52% reporting CSF at baseline. Baseline CSF was associated with an increased incidence of grade 3-5 constitutional (16.5% vs 9.4%, p = 0.002 and 13.9% vs 6.3%, p = 0.002) and neurological (11.7% vs 6.1%, p = 0.006 and 9.0% vs 3.9%, p = 0.01) AEs, respectively, in two studies of advanced HRPC. Overall, patients with baseline CSF had significantly lower baseline QOL across all four domains (p < 0.01). Across all four studies, baseline CSF was associated with higher mortality rates, with adjusted hazard ratios (95% confidence interval, p-value): 1.34 (1.14, 1.57, p < .001) and 1.30 (1.02, 1.66, p = 0.03) in NSCLC studies, 1.49 (0.95, 2.35, p = 0.09) and 1.53 (1.12, 2.11, p = 0.008) in HRPC studies. Conclusions: Oncology trial participants with baseline CSF had significantly lower baseline QOL, experienced more adverse events and had poorer survival compared to participants without CSF. We have confirmed previous work indicating that fatigue is an important baseline stratification factor that should be considered in all oncology treatment trials. Consistent with other research, our results indicate that fatigue should be measured and ameliorated wherever possible among advanced cancer patients.