Technology-enhanced palliative care for patients with cancer on phase 1 clinical trials.
Authors: Subbiah Ishwaria Mohan , Amaram-Davila Jaya Sheela , Wong Angelique , Shih Kaoswi Karina , Anderson Aimee Elizabeth , Mendoza Tito R. , Williams Loretta A. , Reddy Akhila Sunkepally , Joy Manju P , Harnden Katie M , Gaffney Melissa L , Shelal Zeena , Maddi Rama , Nelson Christina LD , De la Cruz Vera J , Elder Saline Liselle , Ray Desiree Q , Subbiah Vivek , Hong David S. , Bruera Eduardo 
Published: June 2021

TPS12136 Background: Patients w advanced cancer participating in Phase I trials carry a high symptom burden from cancer and prior therapies. Our prior work shows patients on phase I trials w multiple active symptoms impacting their immediate quality of life with implications on toxicities and clinical outcomes on subsequent therapy. To identify an effective scalable approach to comprehensive symptom management for patients w adv cancer on phase I trials, we leveraged the increased technology use to design a technology-enhanced symptom management and palliative care intervention (TEC). Methods: Patients w adv cancer seen in the phase I clinic will be given the Edmonton Symptom Assessment System (ESAS), a validated patient-reported outcomes (PRO) tool of common cancer symptoms to identify those with a high symptom burden defined as ≥4 out of 10 on >1 ESAS symptom and a Global Distress Score (GDS) of ≥20. The GDS, a validated score of overall symptom intensity derived from the ESAS, is comprised of 6 physical (pain, fatigue, nausea, drowsiness, appetite, shortness of breath) & 2 psychosocial symptoms (depression, anxiety), and overall wellbeing. TEC is an innovative patient-centered care program of strategic vigorous symptom management where standard-of-care clinic visits are complemented by proactive symptom monitoring between clinic visits remotely and through provider-initiated calls. In this pilot randomized study, we will determine the effect sizes of High-Intensity TEC (HI-TEC; q3day remote PRO assessments w preset provider-initiated call bw visits), Low-Intensity TEC (LO-TEC; q5day remote PRO assessments w preset provider-initiated call bw visits), and Standard Palliative Care (no preset provider contact bw visits). Our guiding hypothesis is that a comprehensive, proactive, technology-enhanced symptom management program led by a Palliative Care team can mitigate the high symptom burden of patients with advanced cancers enrolling in phase I trials. The primary objective assesses the effect size of each TEC intervention on the GDS measure of symptom burden prior to C1D1 on phase I trial. Our working hypothesis is that HI-TEC and LO-TEC will be associated with a lower overall symptom burden signifying symptom optimization prior to starting on a phase I trial. Secondary objectives aim to estimate the effect size of TEC on the following: Symptom burden over 12 weeks on a phase I trial using ESAS, quality of life using FACIT-Sp, PRO-CTCAE and patient satisfaction using FAMCARE-P13. clinical outcomes at 6 months including OS, treatment outcomes (interruptions, dose reductions, discontinuation, time on trial) and quality metrics for end-of-life (EOL) (chemotherapy in the last 14 days of life, ICU admit in last 30 days of life, death without hospice or < 3d of hospice). Qualitatively assessment of patients’ + caregivers’ perceptions of receiving TEC-based cancer care. Clinical trial information: NCI-2020-07465.