A nurse-led intervention to enhance quality of life (QOL) among early phase cancer clinical trial participants.

336 Background: Efforts to address supportive care (SC) concerns among EPCT participants are key for improving QOL and decreasing symptom burden. Clinical Research Nurses (CRNs) are uniquely positioned to address SC concerns among EPCT participants, and thus we sought to determine feasibility and acceptability of a nurse-led intervention in this population. Methods: We conducted an open pilot study, prospectively enrolling EPCT participants, CRNs, and collaborative team clinicians (clinicians) from palliative care, social work, and psychology at Massachusetts General Hospital from 7/2023-09/2024. The intervention included three structured CRN visits with EPCT participants and implementation of bi-monthly collaborative team meetings. Participants completed patient-reported outcomes (PROs) at enrollment and three monthly timepoints: QOL (Functional Assessment of Cancer Therapy-General [FACT-G]), hope (Herth Hope Index), symptoms (Edmonton Symptom Assessment System), and coping (Brief-Cope). We assessed CRN and clinician acceptability (Acceptability of Intervention Measure [AIM]). Exit interviews with CRNs and clinicians assessed perceptions of usefulness, effectiveness, relevance. The primary endpoint was feasibility, defined as ≥ 60% enrollment of patients approached and > 70% of participants completing ≥ 60% of PROs. Results: We enrolled 50/61 patients approached (enrollment rate: 85%; median age: 58.7 years [IQR: 52.8-65.7 years], 60% female, 94% metastatic cancer, ECOG 0=38% and ECOG 1=62%). Most common cancers were gastrointestinal (22%) and breast (7%). At enrollment, 24% (n=12) reported bill paying concerns, 54% had seen a social worker (n=27), and 24% (n=12) had seen palliative care. Median time on trial (TOT) was 3.4 months. Taking TOT in account, 90% (n=45) completed ≥ 60% of PROs. Changes in mean PRO scores from baseline to month 3 showed improvement over time: FACT-G total (+5.8, p<0.01), FACT-G subscales: physical (+1.7, p=0.04), social (+1.3, p=0.04), emotional (+1.8, p=0.02). Among 10 CRNs and 10 clinicians approached, all participated, and acceptability of the intervention was demonstrated by high AIM scores (mean=17.6; scale range: 4-20) and exit interviews (themes identified: appreciated patient-centric collaboration, logistically possible and meaningful, unexpected positive outcomes). Conclusions: In this pilot study, we demonstrated feasibility and acceptability of an innovative nurse-led intervention to address SC concerns among EPCT participants. Notably, we found promising results for improved PROs over time and favorable exit interview feedback, which underscore the intervention’s potential usefulness, effectiveness, and relevance. Findings support the need for randomized trials to assess efficacy of this intervention.