Recruitment lessons learned from a cross-sectional study of quality of life experienced by people receiving treatments for hepatocellular carcinoma.

Abstract

e24162 Background: People with advanced-stage hepatocellular carcinoma (HCC) are living longer given improved treatment effectiveness, yet we know little of their unmet palliative and supportive care needs. Previous studies of palliative care in populations of people facing liver diseases and liver cancer have cited difficulty with recruitment. Methods: This is a cross-sectional study at a single academic medical center. Participants are recruited from a multi-specialty liver cancer practice that includes surgery, interventional radiology, and medical and radiation oncology. Treating physicians identify appropriate participants from a list of pre-screened eligible individuals generated by the study team. Once enrolled validated survey instruments are used to collect data at two time points separated by one month and a qualitative interview is conducted that focuses on the experience of living with HCC. PDSA framework was used to improve recruitment procedures to a rate of 3-4 per month. Results: During the first four months we identified 19 potential participants. Of these, ten were ineligible: four did not meet timing criteria (enrollment before treatment initiation); three lacked English proficiency; and three were identified by their physician as not appropriate for the study. Of the remaining nine potential participants, four were unable to be contacted by phone, two were uninterested (including one who specifically ended the call after hearing the term palliative care), one was lost to follow-up, and two were consented and enrolled. In response, the following modifications were made to the protocol: (1) Medical eligibility criteria were liberalized so that enrollment could occur at any time during treatment; (2) a protocol to involve trained interpreters (in-person when possible) was implemented and a study team member who can conduct qualitative interviews in Spanish was added; (3) the title of the study was changed to more accurately focus on understanding quality of life (from “Palliative Care for People Facing HCC”) to address patient and physician concern; and (4) recruitment efforts are now focused on in-person introduction of the study to develop rapport. Since implementation of these changes, enrollment doubled in just one month. Conclusions: We identified actionable protocol modifications to increase study enrollment. Liberalized inclusion criteria, language inclusivity, and careful attention to stigma around palliative care may be generalizable to similar studies about supportive care, palliative care, and hospice in the population of people facing liver cancer. Additionally, avoiding language-based exclusions for lack of resources (rather than scientific ones) increases inclusivity in research and will allow for a more meaningful and accurate description of all our participants’ needs.