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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.