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.