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PURPOSE: To identify early-phase clinical trial (EP-CT) participants at risk for experiencing worse clinical outcomes and describe receipt of supportive care services. METHODS: A retrospective review of the electronic health records of consecutive patients enrolled in EP-CTs from 2017 to 2019 examined baseline characteristics, clinical outcomes, and receipt of supportive care services. The validated Royal Marsden Hospital (RMH) prognosis score was calculated using data at the time of EP-CT enrollment (scores range from 0 to 3; scores ≥ 2 indicate poor prognosis). Differences in patient characteristics, clinical outcomes, and receipt of supportive care services were compared on the basis of RMH scores. RESULTS: Among 350 patients (median age = 63.2 years [range, 23.0-84.3 years], 57.1% female, 98.0% metastatic cancer), 31.7% had an RMH score indicating a poor prognosis. Those with poor prognosis RMH scores had worse overall survival (hazard ratio [HR], 2.00; P < .001), shorter time on trial (HR, 1.53; P < .001), and lower likelihood of completing the dose-limiting toxicity period (odds ratio, 0.42; P = .006) versus those with good prognosis scores. Patients with poor prognosis scores had greater risk of emergency room visits (HR, 1.66; P = .037) and hospitalizations (HR, 1.69; P = .016) while on trial, and earlier hospice enrollment (HR, 2.22; P = .006). Patients with poor prognosis scores were significantly more likely to receive palliative care consultation (46.8% v 27.6%; P < .001), but not other supportive care services. CONCLUSION: This study found that RMH prognosis score could identify patients at risk for decreased survival, shorter time on trial, and greater use of health care services. The findings underscore the need to develop supportive care interventions targeting EP-CT participants' distinct needs.

236 Background: EP-CTs are an increasingly important treatment option for patients with cancer, yet often require intensive monitoring. Little is known about the time that EP-CT participants spend in-hospital, and how that time compares to study requirements. Methods: We retrospectively reviewed the electronic health record (EHR) of consecutive patients enrolled in EP-CTs at Massachusetts General Hospital from 2017-2019 to obtain patient characteristics (demographics and clinical factors) and EP-CT investigational agent (immunomodulatory therapy [IM], targeted inhibitor [TI], antibody drug conjugate [ADC]/chemotherapy prodrug). We identified protocol requirements by reviewing the study calendar for in-hospital days for any reason, including clinician visits and diagnostic tests. We identified the real-world number of days spent at the hospital by reviewing the EHR for in-hospital days. We used descriptive statistics to compare patient characteristics and outcomes for those with higher time toxicity, defined as 5+ real-world visits during the first 28 days on trial, versus lower time toxicity. Results: Among 421 patients (median age = 63.0 years, 56.9% female, 97.6% metastatic disease), 43.2% participated in IM trials, 43.0% TI, and 13.8% ADC. Most common tumor types were gastrointestinal (GI) (22.3%) and lung (20.0%). Over the first 28 days on trial, protocol requirements listed an average of 5.2 in-hospital days, yet real-world data demonstrated that patients had an average of 6.6 in-hospital days (p < 0.001). TI trial participants had the highest average number of anticipated protocol visits compared with those on other trials (5.5 [TI] vs 5.3 [ADC] vs 5.0 [IM], p = 0.027). In real-world data, those on ADC trials had the highest average number of visits (7.5 [ADC] vs 7.1 [TI] vs 5.7 [IM], p < 0.001). Those with 5+ real-world visits during the first 28 days were more likely to have GI cancer (25.8% vs 13.9%, p = 0.011) and less likely to have lung cancer (16.7% vs 27.9%, p = 0.011). Patients with more visits were also less likely to have traveled 50+ miles to the hospital (48.8% vs 59.8%, p = 0.04). Notably, 19.5% of patients (N = 82) were hospitalized during the first 28 days on trial, with an average length of stay of 4.9 days. Those with 5+ visits had fewer days, on average, from trial start to admission (371.9 vs 650.8, p < 0.001) and fewer days on trial (mean 156.0 vs 235.0, p = 0.001). There was no significant difference in days from trial start to death for those with higher versus lower time toxicity (mean 464.6 vs 526.4, p = 0.177). Conclusions: EP-CTs represent a potentially time-intensive treatment option, as we found that patients spend over one-fifth of their first 28 days on trial at the hospital for various visits. Our findings indicate that patients may often experience more in-hospital days than what the protocol states. These data could help inform patient-clinician discussions regarding EP-CT participation and the potential time toxicity involved.

275 Background: Early phase clinical trials (EP-CTs) investigate novel treatment options in oncology, with recent advances in personalized therapy leading to improved outcomes and offering hope to patients with cancer. However, little research has sought to understand associations of patient-reported hope with quality of life (QOL), symptom burden, coping, and financial toxicity in EP-CT participants. Methods: We prospectively enrolled consecutive adults with cancer participating in EP-CTs at Massachusetts General Hospital from 04/2021-05/2022. Participants completed baseline surveys prior to treatment initiation that assessed hope (Herth Hope Index [HHI], higher scores indicate greater hope), QOL (Functional Assessment of Cancer Therapy-General), symptom burden (physical: Edmonton Symptom Assessment System [ESAS]; psychological: Patient Health Questionaire-4 [PHQ4]), coping (Brief COPE: self-blame, acceptance, denial, emotional support, active, behavioral disengagement), and financial toxicity (COST tool, higher scores indicate greater financial wellbeing). We used regression models to determine associations of hope scores with patient-reported QOL, symptom burden, coping, and financial toxicity. Results: Of 157 eligible patients, we enrolled 129 (enrollment rate 82.2%, median age = 62.5 years [range 33.0-83.0], 53.9% female, and 96.0% metastatic cancer). Most common cancer types were gastrointestinal (37.5%), breast (20.3%), lung (8.6%), and head and neck (7.8%). Patients had an average HHI score of 27.5 (range 15.3 – 36.0), with 30.5% reporting high levels of hope. We found associations of higher hope scores with better QOL (B = 0.24, p < 0.001) and lower symptom burden (ESAS-physical: B = -0.14, p < 0.001; PHQ4-depression: B = -2.07, p < 0.001; PHQ4-anxiety: B = -0.93, p = 0.001). We also found that hope scores were associated with patients’ coping (self-blame [B = -1.44, p < 0.001]; acceptance [B = 1.40, p < 0.001], denial [B = -1.12, p = 0.004], emotional support [B = 0.99, p < 0.001], active [B = 1.02. p = 0.001], behavioral disengagement [B = -2.52, p < 0.001]). Lastly, we found that higher hope scores were associated with greater financial wellbeing (B = 0.11, p = 0.026). Conclusions: In this prospective cohort study, we demonstrated a substantial proportion of EP-CT participants had high baseline hope and identified associations of hope scores with other important patient-reported outcomes. Specifically, we found novel associations of higher hope scores with better QOL, lower symptom burden, more adaptive coping mechanisms, and greater financial wellbeing, underscoring the importance of targeting these patient-reported outcomes when seeking to enhance the care experience of EP-CT participants.

301 Background: EP-CTs investigate novel treatment options, with recent advances in personalized therapy leading to increased response rates, decreased toxicity, and improved survival. Identifying EP-CT participants at risk for poor outcomes could help identify those who may benefit most from targeted supportive care efforts. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), clinical outcomes (survival, time on trial, completion of dose-limiting toxicity [DLT] period, emergency room [ER] visits, hospitalizations, and hospice use), and receipt of supportive care services before/during trial (palliative care, social work, physical therapy [PT], and nutrition). We calculated the validated Royal Marsden Hospital (RMH) prognosis score using data at the time of EP-CT enrollment based on patients’ lactate dehydrogenase, serum albumin, and number of sites of metastasis. RMH scores range from 0-3, with scores of 2+ indicating a poor prognosis. We examined differences in patient characteristics, clinical outcomes, and receipt of supportive care services based on the RMH prognosis score. Results: Among 350 patients (median age = 63.2 years [range 23.0-84.3]; 57.1% female, 98.0% metastatic cancer), the most common cancer types were lung (23.4%), gastrointestinal (20.3%), and breast (12.0%). Nearly one-third (31.7%) had an RMH score indicating a poor prognosis. Patients with a poor prognosis RMH score had a worse performance status (ECOG ≥1: 80.2% vs 58.1%, p

84 Background: EP-CTs are increasingly important options for patients with cancer and often involve intensive monitoring. Thus, characterizing the time burden and logistical intensity of EP-CTs could help patients and clinicians make informed decisions regarding trial participation. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs at Massachusetts General Hospital from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), EP-CT investigational agent (immunomodulatory therapy [IM], targeted inhibitor(s) [TI], antibody drug conjugate [ADC]/chemotherapy prodrug), and logistical intensity (trial visit frequency, presence of extended visits, distance traveled in one direction from home zip code to trial site). We defined visit frequency as the number of visits per protocol within the first 28 days on trial. We defined an extended visit as six or more hours in clinic on at least one day during the first 28 days on study. We investigated associations among patient characteristics, investigational agent, and logistical intensity. Results: Among 421 patients (median age=60.6 years, 55.8% female, 97.4% metastatic disease), most (73.6%) had two or more sites of metastatic disease. EP-CTs included 43.2% IM, 43.0% TI, and 13.8% ADC/chemotherapy prodrug. Patients enrolled in ADC/prodrug trials had the highest burden of metastatic disease (mean sites: 2.8 [ADC] vs 2.4 [TI] vs 2.3 [IM], p = 0.007) and oldest age (mean years: 64.0 [ADC] vs 61.7 [IM] vs 58.5 [TI], p = 0.003). Patients enrolled on TI trials had the highest visit frequency compared with those enrolled on other trials (mean visits: 5.5 [TI] vs 5.3 [ADC] vs 5.0 [IM], p = 0.027) and the fewest days spent on trial (mean days: 78.3 [TI] vs 102.2 [IM] vs 131.8 [ADC], p = 0.003). Patients enrolled on TI trials were also most likely to have an extended visit (82.3% [TI] vs 58.2% [IM] vs 29.3% [ADC], p < 0.001) and least likely to receive first in human therapy (38.1% [TI] vs 74.1% [ADC] vs 74.2% [IM], p < 0.001). Distance traveled from home to clinic did not significantly differ across trial type (median miles traveled: 35.1 [TI] vs 34.1 [IM] vs 33.2 [ADC], p = 0.884). Conclusions: In this cohort of patients participating in EP-CTs, we found that a plurality enrolled in IM studies. Those receiving ADC/prodrug regimens were older and had a higher burden of disease. On average, patients participating in EP-CTs had over five visits in the first month, with those enrolled on TI trials having the highest visit frequency and greatest likelihood of extended visits. Patients on TI trials also spent the fewest total days on trial. Despite the lack of significant differences in distance traveled, most patients were still traveling over 30 miles to get to the trial site. These data highlight the time burden and logistical intensity of various EP-CTs, which may help inform patient-clinician discussions about trial participation.

26 Background: EP-CTs investigate novel therapeutic approaches for patients with cancer, but little is known about the use of supportive care services and timing of goals of care (GOC) discussions in EP-CTs. Methods: We conducted a retrospective review of consecutive patients with cancer enrolled on EP-CTs at Massachusetts General Hospital from 2017-2019. We collected information about patients’ demographic/clinical characteristics, use of supportive care services (palliative care [PC], social work [SW], physical therapy [PT], and nutrition), as well as documentation of GOC discussions and code status (before/during EP-CT vs after/never) via chart review. We examined patient characteristics associated with earlier receipt of supportive care services (before/during EP-CT vs after/never) and compared differences in the timing of GOC discussions and code status documented based on the receipt of supportive care services. Results: Among 425 patients enrolled on EP-CTs (median age 63.0; 56.0% female; 97.4% metastatic cancer; 22.1% gastrointestinal cancer), under half received supportive care services before/during trial (PC: 33.2% before/during, 66.8% post/never; SW: 41.9% before/during, 58.1% post/never; PT: 38.4% before/during, 61.6% post/never; and Nutrition: 33.2% before/during, 62.1% post/never). We identified the most common reasons for consulting each of the supportive care services (PC: 82.4% symptom management and 12.4% GOC; SW: 65.3% adjustment to illness and 23.8% referral for resources; PT: 44.8% safety/discharge planning and 24.6% mobility concerns; Nutrition: 73.2% for symptoms of anorexia/poor appetite and 21.5% nutrition assessment). Patients with GI cancer were more likely than those with other cancers to receive PC and SW before/during EP-CT (PC: 29.8% v 18.3%, p =.009; SW: 27.5% v 18.2%, p =.025). Earlier PC was associated with earlier hospice referral (HR = 1.95, p =.014) and shorter survival (HR = 1.54, p

29 Background: EP-CTs investigate novel therapeutic approaches for patients with cancer, but little is known about the utilization of supportive care services, specifically palliative care (PC), in this population. Methods: We conducted a retrospective review of consecutive patients enrolled on EP-CTs at the MGH Cancer Center from 2017-2019. Sociodemographic and clinical variables, including utilization of PC services, were obtained via chart review. Details of the PC evaluation were compared between patients who received first referral to PC while enrolled on an EP-CT versus those who received a PC referral at any point after diagnosis. Results: Among 426 patients enrolled on EP-CTs (median age 63 years; 44% male), 249 (59%) received a PC referral at any time following a diagnosis of cancer (median age 57 years, 58% male). Eighty-six (35%) were referred prior to enrollment on EP-CT, 44 (18%) were referred while on EP-CT, and 119 (48%) were referred post-EP-CT. Patients referred on EP-CT were younger (median 56 vs 63 years, p < 0.0001) than those enrolled on EP-CTs. For patients referred while on EP-CT, 48% had a PC consult within 30 days of enrollment (range: 0-530 days); median number of PC visits was 3 (range: 0-37); median time from first PC consult to death or termination of EP-CT was 32 days (range: 1-213). Of 44 patients referred on EP-CT, 2 (5%) died while on EP-CT. Of the remaining patients, median time from first PC consult to date of death was 79 days (IQR: 45-178 days). Most common reasons for referral included pain (22, 50%), non-pain symptoms (21, 48%), and goals of care/advanced care planning (20, 45%). Of these referrals, 13 (30%) were initiated as inpatients versus 31 (70%) as outpatients. Pain was most commonly cited for outpatient referral (35%), followed by non-pain symptoms (25%) and goals of care (23%). Non-pain symptoms (40%) and goals of care (36%) were most commonly cited reasons for inpatient referral, followed by pain (24%). Of referrals while on EP-CT, 23 (52%) were made by EP-CT staff, including MD and APP, 7 (16%) from the primary oncologist, and 1 (2%) was self-referral. 26 (57%) of patients referred to PC during trial were also referred to hospice, with a median time from last PC consult to hospice referral of 24 days (range: -2-322). Conclusions: A majority of patients with advanced cancer enrolled on EP-CTs received a PC referral. The timeline and method of referral varied, but most patients did not receive a referral until or following enrollment on an EP-CT. Future work will focus on developing a standard referral protocol for patients enrolled on EP-CTs.

28 Background: Early integration of supportive care in patients with advanced cancer has improved quality of life, symptom burden, and survival. Participants in EP-CTs often are highly pre-treated and the demands of participation can exacerbate financial and psychosocial concerns. Integration of social work services can address a broad scope of concerns including behavioral health, psychosocial needs, physical health, and financial concerns. Little data exists regarding the use of social work services in this patient population. Methods: We conducted a retrospective chart review of consecutive patients enrolled in EP-CTs at the MGH Cancer Center during 2017-2019. Information including sociodemographic data, clinical variables, and the use of social work services were captured from the electronic health record. We reviewed documentation in social work notes to determine reason for referral while participating on trial. Results: Of 426 EP-CT participants, 64% ( n = 272) received social work consultations at any time during their cancer course (consultations occurred a median of 23 months [range 0 – 444] following diagnosis). Compared to those who did not receive consultation, patients receiving consultation were younger (median age 60.5 years vs 65 years, p < .001) and more likely to have children (63% vs 46%, p < .001). More than half (59%, n = 159) of consultations occurred prior to EP-CT enrollment, while 14% (n = 39) were during patients’ time on EP-CT. The most common reasons for referral on trial included adjustment to illness (41%), limited patient resources (23%), and home/family support (15%). A quarter of referrals (27%, n = 74) were initiated after patients left the trial (27%, n = 74). There were no significant differences in demographic or clinical variables between those referred on EP-CT versus before or after EP-CT. For those who received social work consultation while on EP-CT, median time from date on treatment to consultation was 18 days (0 – 182 days) while median time on EP-CT was 55 days (2 – 576 days). Patients received a median of 2 visits (1 – 20) while on EP-CT. Physicians and research nurses were most likely to refer patients (31% vs 26%, respectively) while 10% of patients self-referred to social work. Conclusions: Over half of EP-CT participants received social work consultations during their cancer course. Most patients who received consultation on an EP-CT did so for psychosocial support. Future research should focus on determining how best to integrate social work into the care of EP-CT participants.