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Neural Correlates of Palliative Care: A Feasibility Trial in Patients with Metastatic Gastrointestinal and Lung
Eleni Fanouraki1, J D Knotts2, Cheryl A Page3
1The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth.
Background:
The fundamental affective and decisional processes by which specialty palliative care (SPC) reduces suffering and decreases aggressive treatment at the end of life are not completely understood. We sought to test the feasibility, acceptability, and tolerability of conducting a clinical trial of SPC for advanced cancer patients and their care partners involving functional magnetic resonance imaging (fMRI) to further understand the mechanisms of action of SPC.
Methods:
This pilot open-label, single-arm observational case series was conducted at the Dartmouth Cancer Center (DCC) in collaboration with the Dartmouth Brain Imaging Center (DBIC). Participants included patients with metastatic gastrointestinal or lung cancer, their care partners, and their palliative care physician. The intervention consisted of 8-16 weeks of specialty palliative care integrated with usual oncologic care. Assessments included two fMRI study visits involving the collection of physiological measurements during audiovisual stimulation pre- and post-SPC receipt.
Results:
The primary outcomes were feasibility (rates of enrollment, intervention receipt), acceptability (closed-ended start and end-of- study feedback for participants and open-ended feedback for non-enrollees), and tolerability (study burden). Of 1216 screened electronic medical records, 21 patients fulfilled the eligibility criteria, of which four patients (19%) and three care partners consented to participate in the study. One participant and their care partner completed all study procedures, one participant withdrew before the first session due to disease progression, and the other two withdrew after 6 and 3 visits, respectively, due to health-related decline, logistical challenges, or emotional concerns.
Conclusion:
The study did not achieve its pre-determined criteria for success. Primary reasons for infeasibility were low recruitment and high attrition rates. The study's results suggest that a more definitive mechanistic study cannot be conducted at this site without addressing critical barriers to enrollment and retention in this vulnerable clinical population.
Trial Registration:
ClinicalTrials.gov NCT05137782, first release date 11/17/2021.