Weathering the storm when the end of the road is near: A qualitative analysis of supportive care needs during CAR T-cell therapy in pediatrics.

BACKGROUND: Chimeric antigen receptor (CAR) T-cell therapy provides promising outcomes in relapsed/refractory B acute lymphoblastic leukemia (ALL), yet still carries high toxicity rates and relatively poor long-term survival. Efficacy has yet to be demonstrated in other diagnoses while toxicity and risk profiles remain formidable. To date, treatment-related symptom burden is gleaned from clinical trial toxicity reports; the patient perspective remains understudied. METHODS: English- or Spanish-speaking patients (ages 8-25 years) undergoing CAR T-cell therapy for any malignancy and their primary caregivers were recruited from Seattle Children's Hospital (SCH), St. Jude Children's Research Hospital (SJCRH), and the Pediatric Oncology Branch of the National Cancer Institute (NCI). Both patient and caregiver completed semi-structured dyadic interviews 3 months post treatment. We used directed content analysis for codebook development and thematic network analysis for inductive qualitative analysis. RESULTS: Twenty families completed interviews (13 patients, 15 parents). Patients were a median age 16.5 years, predominantly female (65%), White (75%), and diagnosed with ALL (75%). Global themes included "A clear decision," "Coping with symptoms," and "Unforeseen psychosocial challenges." When families were asked to describe the "most challenging part of treatment," most described "the unknown." Most reported "the symptoms really weren't that bad," even among patients hospitalized for severe toxicity events. Fatigue, pain, and nausea were the most prevalent symptoms. Importantly, only one family would have chosen a different therapy, if given another opportunity. CONCLUSIONS: Although physical symptoms were largely tolerable, recognizing supportive care opportunities remains imperative, particularly psychosocial concerns.

Ensuring Intervention Fidelity of an Attention Control Arm in a Multisite Randomized Controlled Trial.

BACKGROUND: Intervention fidelity is a critical element of randomized controlled trials, yet reporting of intervention fidelity among attention control arms is limited. Lack of fidelity to attention control procedures can affect study outcomes by either overestimating or underestimating the efficacy of the intervention under examination. OBJECTIVES: This brief report describes the approach researchers took to promote fidelity to the attention control arm of a pediatric palliative care randomized controlled trial funded by the National Institutes of Health. METHODS: The Informational Meetings for Planning and Coordinating Treatment trial aims to determine the efficacy of a communication intervention that uses care team dyads (i.e., physicians partnered with nurses or advanced practice providers) to engage parents of children with cancer who have a poor prognosis in structured conversations about prognostic information, goals of care, and care planning. The intervention is compared with an attention control arm, which provides parents with structured conversations on common pediatric cancer education topics, such as talking to their child about their cancer, clinical trials, cancer treatment, side effects, and so forth. National Institutes of Health guidelines for assessing and implementing strategies to promote intervention fidelity were used to design (a) the attention control arm of a randomized controlled trial, (b) related attention control arm training, and (c) quality assurance monitoring. RESULTS: Attention control study procedures were designed to mirror that of the intervention arm (i.e., same number, frequency, and time spent in study visits). Cluster randomization was used to allocate care team dyads to one arm of the randomized controlled trial. Care team dyads assigned to the attention control arm participated in online training sessions to learn attention control procedures, the different roles of research team members, and quality assurance methods. Fidelity to attention control procedures is assessed by both the interveners themselves and a quality assurance team. DISCUSSION: Study design, training, and delivery are all critical to attention control fidelity. Baseline training often needs to be supplemented with booster training when time gaps occur between study start-up and implementation. Quality assurance procedures are essential to determine whether interveners consistently deliver attention control procedures correctly.

Social support resources in adolescents and young adults with advanced cancer: a qualitative analysis.

PURPOSE: Adolescents and Young Adults (AYAs) with cancer are an at-risk group with unique palliative and supportive care needs. Social support in AYAs with cancer is associated with better coping, quality of life, and psychosocial well-being. Here, we extend existing research to examine the sources and types of support received by AYAs with advanced cancer. METHODS: AYAs participated in a semi-structured, 1:1 interview on communication and psychosocial support needs. The present analysis focused on social support experiences for AYAs with advanced cancer. Directed content analysis was used to develop the codebook. Established social support constructs provided a coding framework. We presented our qualitative findings as a code frequency report with quantified frequency counts of all "source of support" and "type of support" codes. We assigned a global "sufficiency of support code" to each AYA. RESULTS: We interviewed 32 AYAs with advanced cancer (Mage = 18, SDage = 3.2, 41% female). Most AYAs identified family (namely, caregivers) as their primary source of support and stated that family universally provided all types of support: emotional, informational, instrumental, and social companionship. They received informational and emotional support from clinicians, and received emotional support and social companionship from healthy peers, cancer peers, and their existing community. One-third of participants were coded as having "mixed support" and described a lack of support in some domains. CONCLUSION: AYAs with advanced cancer described caregivers as their universal source of support, and that other support sources provided support for specific needs. Future research should continue to evaluate social support needs and family-based palliative and supportive care interventions to bolster social support resources in this high-risk group.