Design, Setting, and Participants
The “CAR T Patient Reported Outcome (PRO)” study was a prospective, mixed methods study with a primary objective to describe patient-centered outcomes in children and young adults during CAR T cell therapy. Seattle Children’s Hospital (SCH), St. Jude Children’s Research Hospital (SJ), and the Pediatric Oncology Branch of the National Cancer Institute (NCI) served as study sites. All sites are large referral centers for CAR T cell therapy, primarily delivered as part of clinical trials. Local IRB approval was granted at all centers in accordance with the US Federal Policy for the Protection of Human Subjects.
Recruitment took place from February 2020 through December 2022. Patient and parent caregiver (“parent”) participants were recruited as dyads (patient and parent together). Enrollment of both patient and parent was not required for study participation. Patient eligibility criteria included age 8-25 years, ability to speak/read English or Spanish, and scheduled to receive CAR T cell therapy for any malignancy. Parent eligibility included being a primary caregiver of a patient aged 2-25 years undergoing treatment with CAR T cell therapy as described above and ability to speak/read English or Spanish. Exclusion criteria included lack of fluency in English or Spanish, impairment preventing interview participation, or parent refusal to allow minor participation. Study staff reviewed clinic schedules to identify eligible participants. Participants were sequentially recruited in-person before lymphodepleting chemotherapy. Per institutional standards, written informed consent (> 18 years)/written assent with parental permission (<18 years) was obtained by a trained study member. As participants approached three-months post-infusion, they were sequentially invited to participate in an optional interview. Recruitment continued until thematic saturation was achieved, determined by study team consensus.