Disparities Associated with Decision to Undergo Oncologic Surgery: A Prospective Mixed-Methods Analysis.

BACKGROUND: Underrepresented minority patients with surgical malignancies experience disparities in outcomes. The impact of provider-based factors, including communication, trust, and cultural competency, on outcomes is not well understood. This study examines modifiable provider-based barriers to care experienced by patients with surgical malignancies. METHODS: A parallel, prospective, mixed-methods study enrolled patients with lung or gastrointestinal malignancies undergoing surgical consultation. Surveys assessed patients' social needs and patient-physician relationship. Semi-structured interviews ascertained patient experiences and were iteratively analyzed, identifying key themes. RESULTS: The cohort included 24 patients (age 62 years; 63% White and 38% Black/African American). The most common cancers were lung (n = 18, 75%) and gastroesophageal (n = 3, 13%). Survey results indicated that food insecurity (n = 5, 21%), lack of reliable transportation (n = 4, 17%), and housing instability (n = 2, 8%) were common. Lack of trust in their physician (n = 3, 13%) and their physician's treatment recommendation (n = 3, 13%) were identified. Patients reported a lack of empathy (n = 3, 13%), lack of cultural competence (n = 3, 13%), and inadequate communication (n = 2, 8%) from physicians. Qualitative analysis identified five major themes regarding the decision to undergo surgery: communication, trust, health literacy, patient fears, and decision-making strategies. Five patients (21%) declined the recommended surgery and were more likely Black (100% vs. 21%), lower income (100% vs. 16%), and reported poor patient-physician relationship (40% vs. 5%; all p < 0.05). CONCLUSIONS: Factors associated with declining recommended cancer surgery were underrepresented minority race and poor patient-physician relationships. Interventions are needed to improve these barriers to care and racial disparities.

Adherence to caregiver-administered intravenous immunosuppressant medications in pediatric hematopoietic stem cell transplant.

BACKGROUND: The purpose of this study was to describe taking, timing, and dosing adherence to home caregiver-administered intravenous (IV) immunosuppressants in a sample of pediatric hematopoietic stem cell transplant (HCT) recipients. PROCEDURES: Sixteen children who had undergone HCT, ages 3 months to 15 years, and their caregivers participated. All caregivers were biological mothers. Caregivers completed a demographic questionnaire as part of a larger study and brought in portable infusion pumps to download the pump data at the time of their child's post-HCT clinic visit. Pump data were then examined for dose taking, timing, and amount for 30 days following discharge. RESULTS: Despite the importance of the precise timing of IV immunosuppressants, adherence taking, dosing, and timing varied widely in this sample. The mean percentage of doses administered was 98.72%, and 81.3% of children received all doses of immunosuppressant. However, only 62% of doses were given on time and the mean difference between the prescribed and actual administration time was 67.03 minutes. CONCLUSIONS: Although taking adherence was high, the timing and dosing adherence to IV immunosuppressants in the home was poor. Additional support to promote adherence should be provided including assisting caregivers to identify and use adherence strategies specific to their child's IV immunosuppressant regimen in the home.

Factors influencing caregiver decisions to use complementary and integrative therapies in pediatric oncology settings: Findings from a qualitative analysis.

PURPOSE: Complementary and integrative medicine (CIM) therapies (i.e., non-conventional Western medicine interventions) may reduce side-effects associated with pediatric oncology treatment. CIM therapies may also improve caregiver psychological and physical health that is exacerbated during pediatric cancer treatment. Despite known benefits, these therapies are not widely used within pediatric oncology populations in the United States. To guide and promote CIM use among this population, the aim of this project was to qualitatively explore factors that contribute to caregivers' decision to include CIM use in their own and child's care. METHODS: Twenty caregivers of children (ages 0.5-14 years) being treated for cancer participated in this study. Each completed a demographic form and the CIM use questionnaire. Qualitative interviews followed by a card sort task were used to assess barriers and facilitators of uptake for caregivers and their child with cancer. RESULTS: A number of predisposing (e.g., child age, beliefs) and needs factors (e.g., potential to treatment-related side-effects) provide insight into caregivers' decisions to use CIM for their child. Analyses also revealed the importance of enabling factors (e.g., resources) for caregiver use. Caregivers also reported benefiting from additional information about risk/benefit analysis of these therapies, and current research for CIM use in caregivers and children being treated for cancer. CONCLUSION: Children may benefit from individually tailored complementary and integrative medicine consultations that explore patient history and specific needs factors to improve preference concordant care and uptake. Caregivers may benefit from support that improves enabling factors associated with care (e.g., improved accessibility).

Feasibility pilot trial of a tailored medication adherence-promotion intervention for adolescents and young adults with cancer: Study design and protocol.

BACKGROUND: Medication non-adherence is common among adolescents and young adults (AYAs) with cancer and associated with poor health outcomes. AYAs with cancer endorse multiple barriers to adherence that differ across individuals, suggesting that tailoring intervention content to an AYA's specific barriers may have the potential to improve adherence. The purpose of this manuscript is to report on ORBIT-guided Phase I design efforts to create the first tailored adherence-promotion intervention for AYAs with cancer and the study protocol for the ongoing Phase II pilot feasibility trial. METHODS: Phase I design included qualitative interviews (n = 15 AYAs) to understand patient preferences for adherence-promotion care, development and refinement of a best-worst scaling exercise barriers tool (n = 5 AYAs), and development of intervention modules and a tailoring algorithm. In the ongoing Phase II pilot feasibility trial, AYAs (ages 15-24 years) with cancer currently taking oral chemotherapy or prophylactic medication will be recruited from three children's hospitals. Feasibility, acceptability, and usability will be assessed and these outcomes along with data on medication adherence will be used to inform the next phases of intervention development and testing. CONCLUSIONS: If promising, this program of research ultimately has the potential to equip clinicians with additional strategies for supporting adherence among AYAs with cancer. NCT05706610.

Social determinants of health predict health outcomes following pediatric allogeneic hematopoietic stem cell transplant.

BACKGROUND: Pediatric hematopoietic stem cell transplantation (HCT) is an intensive medical procedure that places substantial financial and logistical burdens on families and is associated with significant health risks, such as graft-versus-host disease (GVHD), and infections. The influence of the social determinants of health (SDoH) on outcomes following pediatric HCT is understudied. This study aimed to examine whether SDoH predicts outcomes following pediatric HCT. PROCEDURE: Data were collected from 84 children who received HCT (Mage  = 5.8 years, SD = 3.7) and their primary caregiver. Detailed demographic information was collected from caregivers at baseline, and child health information was extracted from the electronic medical records. Multivariate logistic regression was used to examine the association between SDoH and health outcomes within a 24-month period following pediatric HCT. RESULTS: After controlling for malignancy as reason for transplant and donor type, lower family income predicted the incidence of chronic GVHD. Neighborhood deprivation, total family income, public health insurance, caregiver relationship status, caregiver educational attainment, and perceived family financial difficulties did not predict acute GVHD or the number of infections. CONCLUSIONS: Total family income is a simple family indicator of SDoH that predicts chronic GVHD after pediatric allogeneic HCT. These findings provide further support for the importance of screening of child and family SDoH risks to ensure that fundamental needs can be met to mitigate potential health disparities for up to 2 years following pediatric HCT.

Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant.

Medication non-adherence rates in children range between 50% and 80% in the United States. Due to multifaceted outpatient routines, children receiving hematopoietic stem cell transplant (HCT) are at especially high risk of non-adherence, which can be life-threatening. Although digital health interventions have been effective in improving non-adherence in many pediatric conditions, limited research has examined their benefits among families of children receiving HCT. To address this gap, we created the BMT4me© mobile health app, an innovative intervention serving as a "virtual assistant" to send medication-taking reminders for caregivers and to track, in real-time, the child's medication taking, barriers to missed doses, symptoms or side effects, and other notes regarding their child's treatment. In this randomized controlled trial, caregivers will be randomized to either the control (standard of care) group or the intervention (BMT4me© app) group at initial discharge post-HCT. Both groups will receive an electronic adherence monitoring device (i.e., medication event monitoring system "MEMS" cap, Medy Remote Patient Management "MedyRPM" medication adherence box) to store their child's immunosuppressant medication. Caregivers who agree to participate will be asked to complete enrollment, weekly, and monthly parent-proxy measures of their child's medication adherence until the child reaches Day 100 or complete taper from immunosuppression. Caregivers will also participate in a 15 to 30-minute exit interview at the conclusion of the study. Descriptive statistics and correlations will be used to assess phone activity and use behavior over time. Independent samples t-tests will examine the efficacy of the intervention to improve adherence monitoring and reduce readmission rates. The primary expected outcome of this study is that the BMT4me© app will improve the real-time monitoring and medication adherence in children receiving hematopoietic stem cell transplant following discharge, thus improving clinical outcomes.

Quality of Life Outcomes for Patients Who Underwent Conventional Resection and Liver Transplantation for Locally Advanced Hepatoblastoma.

Hepatoblastoma is the most common malignant liver tumor of childhood, with liver transplant and extended resection used as surgical treatments for locally advanced tumors. Although each approach has well-described post-operative complications, quality-of-life outcomes have not been described following the two interventions. Long-term pediatric survivors of hepatoblastoma who underwent conventional liver resection or liver transplantation at a single institution from January 2000-December 2013 were recruited to complete quality-of-life surveys. Survey responses for the Pediatric Quality of Life Generic Core 4.0 (PedsQL, n = 30 patient and n = 31 parent surveys) and Pediatric Quality of Life Cancer Module 3.0 (PedsQL-Cancer, n = 29 patient and n = 31 parent surveys) were collected from patients and parents. The mean total patient-reported PedsQL score was 73.7, and the parent-reported score was 73.9. There were no significant differences in scores on the PedsQL between patients who underwent resection compared to those who underwent transplantation (p > 0.05 for all comparisons). On the PedsQL-Cancer module, procedural anxiety scores were significantly lower for patients who underwent resection as compared to transplant (M = 33.47 points less, CI [-60.41, -6.53], p-value 0.017). This cross-sectional study demonstrates that quality of life outcomes are overall similar among patients receiving transplants and resections. Patients who received a resection reported worse procedural anxiety.

Health Competence Beliefs and Health-Related Quality of Life Among Adolescent and Young Adult Survivors of Childhood Cancer and Healthy Peers.

Purpose: Adolescent and young adult (AYA) survivors of childhood cancer are at risk for late-effects that can impact how one perceives their health and well-being. Understanding beliefs about health competence and well-being among survivors can help identify support needs and increase adherence to long-term follow-up guidelines. This study examined differences in health competence beliefs and health-related quality of life (HRQOL) between AYA survivors of childhood cancer and matched healthy peers. In addition, the relationship between health competence beliefs and HRQOL, as well as the moderating effect of cancer survivorship, was investigated. Methods: Survivors (n = 49) and healthy peers (n = 54) completed measures about health competence beliefs (i.e., Health Perception, Cognitive Competence, Autonomy, and School/Work Functioning) and HRQOL. Multiple group analysis was used to investigate differences in health competence beliefs and HRQOL between survivors and peers. Multivariate multiple regression analyses were used to investigate the relationships between health competence beliefs and HRQOL. Finally, a history of cancer was examined as a possible moderator using additional multivariate multiple regression analyses. Results: Survivors reported significantly lower Health Perception, Cognitive Competence, Autonomy, and School/Work Functioning scores compared to healthy peers. Among both groups, Health Perception and Cognitive Competence scores were associated with multiple domains of HRQOL. These relationships were not moderated by having a history of cancer. Conclusions: Perceptions about one's health and cognitive abilities may impact HRQOL among AYA survivors of childhood cancer and health peers. Identifying those at risk for poor well-being may help to guide interventions aimed at increasing adherence to medical recommendations.

Psychosocial impact of COVID-19 on caregivers and adolescents and young adult survivors of childhood cancer.

BACKGROUND: Caregivers and adolescents and young adult (AYA) cancer survivors may be at greater psychosocial risk from the COVID-19 pandemic than healthy peers due to complex and traumatic medical histories. This study describes COVID-19-related event exposures, impact, and distress among a large sample of caregivers and AYA cancer survivors and the relationship of these variables to demographic and cancer characteristics. PROCEDURE: From May 2020 to December 2021, 422 caregivers and 531 AYA survivors completed the COVID-19 Exposures and Family Impact Survey (CEFIS) and CEFIS-AYA, respectively. Total COVID-19-related exposures, average COVID-19-related impact, and COVID-19-related distress were calculated. Conventional content analysis was used to analyze free-text responses about the negative and positive effects of COVID-19. RESULTS: Caregivers and AYA reported an average of 7.4-7.8 COVID-19 exposures to pandemic-related events and a slightly negative impact of COVID-19 across psychosocial domains, with some positive impacts reported. COVID-19-related distress was moderate and clinically meaningful (4.9-5.2/10) for AYA and caregivers. Racial and ethnically minoritized AYA and caregivers reported higher COVID-19-related distress than non-Hispanic white caregivers. For AYA, distress was also higher among female, college-age (18-22 years), and long-term survivors compared with males, younger AYA, White and those recently off treatment. CEFIS outcomes remained relatively stable over time. CONCLUSIONS: COVID-19 had a significant and consistent negative impact on caregivers and AYA survivors. Racial and ethnically minoritized families and female, college-age, and long-term AYA survivors may require additional psychosocial support. Assessing for COVID-19 impact and distress is important in pediatric oncology to evaluate adjustment and plan targeted interventions.

Barriers to medication adherence among adolescents and young adults with cancer.

BACKGROUND: Adherence promotion is a critical component of adolescent and young adult (AYA) cancer care, but predictors of nonadherence that could be targeted in intervention efforts remain largely unknown. The purpose of this multi-site longitudinal observational study was to examine the relationship between barriers and medication adherence among AYAs with cancer. PROCEDURE: Sixty-five AYAs (ages 15-24 years; mean age = 18.97 years, SD = 2.51; Mmean time since diagnosis = 1.42 years, SD = 1.95) with newly diagnosed or relapsed cancer completed self-report measures of barriers and adherence at quarterly study visits and used an electronic adherence monitoring device for 12 months. Longitudinal mixed effects models were used to examine our primary hypothesis that greater barriers are related to lower adherence over time. Descriptive statistics were used to explore our secondary aim of describing the frequency and patterns of barriers endorsed by AYAs with cancer. RESULTS: After controlling for covariates (time, medication type, race, ethnicity, diagnosis, time since diagnosis), a greater number of barriers was associated with lower electronically monitored (ß = -5.99, p = .005) and self-reported (ß = -1.92, p < .001) adherence. The specific barriers endorsed by AYAs differed across participants, and the majority of AYAs endorsed an entirely different pattern of barriers than any other AYA in the study. CONCLUSION: Barriers are associated with nonadherence and may be a promising target for intervention. Individual variability across barriers, however, suggests that tailoring may be necessary, and a promising next step is to explore personalized approaches to adherence promotion.

Recommendations for Providing Medication Adherence Support After Pediatric Hematopoietic Stem Cell Transplant: Caregivers' Lived Experience.

Background. Medication adherence is challenging after pediatric hematopoietic stem cell transplant (HCT), particularly after hospital discharge. Post-HCT medication adherence is important to manage morbidity and mortality risk. Designing interventions that are effective and acceptable to caregivers is key to improving post-HCT medication adherence. This study aimed to characterize caregiver preferences about medication adherence support from their child's medical team. Methods. Twenty-nine caregivers of children who received an HCT completed semi-structured qualitative interviews about their experience with, and recommendations for improving, medication adherence support provided by the medical team. Twenty-two caregivers also completed a card sort task to clarify the content of received support and caregiver recommendations for future HCT families. Results. Thematic analysis revealed eight themes grouped into two categories: Communication Is Key and Practical Medication Adherence Support. Caregivers emphasized the importance of communication in helping them manage their child's outpatient medications and provided suggestions to further strengthen communication. The types of practical medication adherence support used varied across caregivers highlighting the importance of tailoring adherence support to each family's needs. Caregivers also identified all the domains as potentially helpful for other families. Discussion. Findings suggest that caregivers prefer that efforts to improve outpatient medication adherence post-HCT prioritize the medical team initiating frequent, clear, and open communication about medications, and provide educational materials on adherence (e.g., handouts). Results also indicate that practical medication adherence supports should be offered based on family preferences but that families may particularly appreciate tips about addressing medication challenges based on other caregivers' lived experience.

Pediatric Hematopoietic Stem Cell Transplant Medication Adherence Facilitators and Strategies: A Qualitative Study.

OBJECTIVE: Taking medications as prescribed after hematopoietic stem cell transplant (HCT) is key for ensuring children's survival; however, suboptimal medication adherence is common. Development of evidence-based interventions to improve medication adherence post-HCT is contingent upon understanding what adherence facilitators (i.e., unique traits, characteristics, or resources inherent to the individual, medical treatment, or healthcare team) and strategies (i.e., tools caregivers or medical providers intentionally use) promote medication adherence in this population. Therefore, this study examined caregiver-perceived medication facilitators post-HCT. METHODS: Semi-structured qualitative interviews and demographic questionnaires were completed by 29 caregivers of children (≤12 years) who had received an HCT within the past 2 years. RESULTS: Thematic analysis guided by grounded theory revealed 14 saturated themes that were grouped into 4 categories: family facilitators, medication facilitators, caregiver strategies, and multidisciplinary treatment team strategies. CONCLUSIONS: Overall, findings suggest that caregivers of children who received an HCT are highly resourceful and independently develop many strategies to assist them with medication management after their child's HCT. These facilitators and strategies varied between caregivers and over time. Despite prevalent facilitators and strategies, caregiver burden associated with medication adherence remains high. Caregivers may benefit from the multidisciplinary treatment team providing individualized and multicomponent (educational and behavioral) medication adherence supports to ease this burden particularly shortly after hospital discharge.

Symptoms of Survivors of Pediatric Hematopoietic Stem Cell Transplant by Age, Sex, and Transplant Type.

Purpose: The purpose of this study was to describe symptoms experienced by survivors of pediatric hematopoietic stem cell transplant (HSCT), and demographic and treatment-factors associated with ongoing symptomology. Methods: Fifty pediatric survivors completed a cross-sectional pilot study. Questionnaires were administered online via REDCap to assess symptoms experienced in the last week. Survivors also consented to a medical record chart review. Results: Survivors were on average 5.4 years post-HSCT (range 1.1 to 9 years), male (58%), and Caucasian (80%) who received an allogeneic HSCT (92%). The most commonly reported symptoms were difficulty concentrating (42.5%), pain (38%), worry (38%), nervousness (37.5%), and lack of energy/fatigue (34%). Survivors reported up to 14 symptoms, with 90% of the sample experiencing at least one symptom in the previous week. Average number of symptoms varied by age group between 2.1 (8-9 years) and 6.8 (18 and older). Age and female gender were associated with higher levels of fatigue. Conclusions: The majority of survivors experienced at least one symptom in the previous week. Neuropsychological symptoms and pain endure well into survivorship that can influence outcomes such as function and health-related quality of life (HRQOL). Research is needed on biological mechanisms of ongoing symptomology, effective interventions to prevent or mitigate symptoms, and the impact of symptoms on patient outcomes including daily functioning and HRQOL. Implications Survivors of pediatric HSCT continued to experience symptoms for up to nine years. Survivors should be frequently screened for symptoms, as symptoms may affect function, learning/employment outcomes, and HRQOL.

An mHealth App to Promote Adherence to Immunosuppressant Medication and Track Symptoms in Children After Hematopoietic Stem Cell Transplant: Protocol for a Mixed Methods Usability Study.

BACKGROUND: In the United States, poor adherence accounts for up to 70% of all medication-related hospital admissions, resulting in $100 billion in health care costs annually. In pediatrics, adherence is largely dependent on caregivers. In a high-risk hematopoietic stem cell transplant (HSCT) population, caregivers are isolated with their child due to infection risk and must manage challenging treatment regimens at home, often with limited time and support. Complex behavioral interventions, typically employed to address adherence, are difficult to deliver and manage in the context of these daily tasks. The most successful adherence interventions, and thus improved clinical outcomes, have included mobile health (mHealth) reminder approaches and a direct measure of adherence. OBJECTIVE: This is a 3-phase project, with this protocol describing phase 2, to determine the usability and feasibility of an mHealth app (BMT4me) designed to promote adherence to immunosuppressant medication and to track symptoms among children who received HSCT. METHODS: This study uses an iterative convergent mixed methods design to develop and assess the usability and feasibility of an adherence digital health intervention. We will recruit 15 caregivers of pediatric patients receiving HSCT to complete user testing. Qualitative and quantitative data will be integrated to enhance and expand upon study findings. RESULTS: Enrollment began in September 2021 and is ongoing. A total of 7 caregivers have enrolled. We anticipate completion by fall 2022. We anticipate high usability scores and a better understanding of unique features within the app that are needed for HSCT families post transplant. To date, usability scores among enrolled participants are greater than 70%. Feedback from qualitative interviews is being used to further adapt the app by adding specific weekly logs, call provider options, and voice to text. CONCLUSIONS: This protocol describes a mixed methods usability and feasibility study to develop and implement a smartphone app for caregivers of children receiving HSCT. The app was designed to improve immunosuppressant adherence and to track symptoms in the acute phase post discharge. Study findings will inform further refinement of the app and the feasibility of a pilot randomized controlled trial examining efficacy on clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04976933; https://clinicaltrials.gov/ct2/show/NCT04976933. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/39098.

Secondary Impact of the Coronavirus Disease 19 Pandemic on Patients and the Cellular Therapy Healthcare Ecosystem.

The Coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has significantly impacted global health and healthcare delivery systems. To characterize the secondary effects of the COVID-19 pandemic and mitigation strategies used in the delivery of hematopoietic stem cell transplantation (HSCT) care, we performed a comprehensive literature search encompassing changes in specific donor collection, processing practices, patient outcomes, and patient-related concerns specific to HSCT and HSCT-related healthcare delivery. In this review, we summarize the available literature on the secondary impacts the COVID-19 pandemic on the fields of HSCT and cellular therapy. The COVID-19 pandemic has had numerous secondary impacts on patients undergoing HSCT and the healthcare delivery systems involved in providing complex care to HSCT recipients. Institutions must identify these influences on outcomes and adjust accordingly to maintain and improve outcomes for the transplantation and cellular therapy community.

Pain, depressive symptoms, and health-related quality of life among survivors of pediatric hematopoietic stem cell transplant.

OBJECTIVE: Pediatric hematopoietic stem cell transplant (HCT) is an intensive medical procedure associated with significant late effects, of which pain is a prominent example. While pain is associated with increased depressive symptoms and health-related quality-of-life (HRQoL) impairments in other pediatric chronic illness populations, associations between these variables are not well understood in pediatric HCT. Clarifying these associations may inform clinical interventions to improve health outcomes following pediatric HCT. This study aimed to investigate the relations between pain intensity, depressive symptoms, and HRQoL in survivors of pediatric HCT. METHOD: Fifty-one survivors of pediatric HCT (Mage  = 14.3 years, standard deviation [SD] = 4.3; 58.8% male; 80.4% White) completed self-report measures of pain intensity, depressive symptoms, and HRQoL. Demographic and disease information was collected via demographic forms and medical record review. Path analysis was used to examine hypothesized associations between pain intensity, depressive symptoms, and HRQoL. RESULTS: Analyses revealed direct effects of pain intensity on depressive symptoms (estimate [Est.] = .23, p < .001) and HRQoL (Est. = -.2, p = .04), and direct effects of depressive symptoms on HRQoL (Est. = -.68, p < .001). Depressive symptoms also mediated the relationship between pain intensity and HRQoL (Est. = -.16, p = .006). CONCLUSIONS: Greater pain intensity was associated directly with increased depressive symptoms and indirectly with HRQoL through depressive symptoms. Results of this study suggest that multitargeted cognitive behavioral interventions that address pain and depressive symptoms may improve HRQoL ratings in survivors of pediatric HCT.

COVID-19 Exposure and Family Impact Scales for Adolescents and Young Adults.

OBJECTIVE: To understand the impact of the coronavirus disease 2019 (COVID-19) pandemic on adolescents and young adults (AYAs), we adapted the COVID-19 Exposure and Family Impact Scales (CEFIS; Kazak et al., 2021) for AYAs. Here, we report on the development, structure, and psychometric properties of the CEFIS-AYA. METHODS: The CEFIS-AYA was developed by a multidisciplinary, multi-institutional team using a rapid iterative process. Data from 3,912 AYAs from 21 programs at 16 institutions across the United States were collected from May 2020 to April 2021. We examined the underlying structure of the CEFIS-AYA using principal component analysis (PCA), calculated internal consistencies, and explored differences in scores by gender and age. RESULTS: Participants reported exposure to a range of COVID-19-related events (M = 9.08 events, of 28). On the bidirectional 4-point Impact scale, mean item scores were mostly above the midpoint, indicating a slightly negative impact. Kuder-Richardson 20/Cronbach's Alpha was good for Exposure (α = .76) and excellent for Impact (α = .93). PCA identified seven factors for Exposure (Severe COVID-19, Loss of Income, Limited Access to Essentials, COVID-19 Exposure, Disruptions to Activities, Disruptions to Living Conditions, and Designation as an Essential Worker) and five for Impact (Self and Family Relationships, Physical Well-Being, Emotional Well-Being, Social Well-Being, and Distress). Gender and age differences in CEFIS-AYA scores were identified. DISCUSSION: Initial reliability data are strong and support use of the CEFIS-AYA for measuring the effect of the COVID-19 pandemic on AYAs in research and clinical care.

Development and Preliminary Validation of a Multidimensional Psychosocial Assessment Strategy for Young Adults With Cancer.

OBJECTIVE: Regular psychosocial assessment is a best-practice guideline for young adult oncology care, but multipurpose, multidimensional, developmentally appropriate patient-reported outcome measurement strategies for young adults with cancer are lacking. This study reported on the development and preliminary validation of the Young Adult Psychosocial Assessment Strategy (YA-PAS), a tool designed to meet this clinical need. METHODS: The YA-PAS was developed based on the literature and clinician feedback. 20 young adults with cancer participated in cognitive interviews to provide feedback on complexity, readability, and applicability to inform measure refinement. Following refinements, 100 young adults with a history of cancer participated in an observational study including a preliminary evaluation of YA-PAS factor structure, internal consistency, test-retest reliability, construct and criterion validity, feasibility, and acceptability. RESULTS: Cognitive interviews and psychometric evaluation informed modifications and resulted in a measure with 9 domains (anxiety, depression, cognitive functioning, post-traumatic stress, family stressors, support, social isolation, self-efficacy for symptom management, and self-efficacy for medication management) and nonscoring items assessing substance use, life stressors, resources, educational/vocational status, and relationship status. 8 of 9 domains demonstrated acceptable internal consistency (Cronbach's α ≥ 0.70), substantial (r = 0.61-0.80) or almost perfect (r > 0.80) test-retest reliability, and evidence of domain and cut-point validity. 89% of participants were able to complete the YA-PAS within 20 min and 87% were satisfied with the measure. CONCLUSIONS: The YA-PAS demonstrated promising psychometric properties, feasibility, and acceptability. Clinical implications and research recommendations are discussed.

Quality Improvement in Hematopoietic Stem Cell Transplant and Cellular Therapy: Using the Model for Improvement to impact Outcomes.

Quality improvement and quality assurance form a complementary and independent relationship. Quality assurance measures compliance against industry standards using audits, whereas quality improvement is a continuous process focused on processes and systems that can improve care. The Model for Improvement is a robust quality improvement tool that transplant and cellular therapy teams can use to redesign healthcare processes. The Model for Improvement uses several components addressed in sequence to organize and critically evaluate improvement activities. Unlike other health sciences clinical research, quality improvement projects, and research are based on dynamic hypotheses that develop into observable, serial tests of change with continuous collection and feedback of performance data to stakeholders.

Caregivers' Experience of Medication Adherence Barriers during Pediatric Hematopoietic Stem Cell Transplant: A Qualitative Study.

OBJECTIVE: Medications are critical for reducing morbidity and mortality risk in pediatric hematopoietic stem cell transplant (HCT). Nonetheless, medication adherence is suboptimal in this population. Identifying and managing barriers to medication management (i.e., medication barriers) is a key component of supporting medication adherence. However, understanding how medication barriers uniquely impact the pediatric HCT population and which barriers characterize each treatment stage remain unclear. Therefore, this study examined caregiver-perceived medication barriers over the course of pediatric HCT. METHODS: Semi-structured qualitative interviews and demographic questionnaires were completed by 29 caregivers of children (≤12 years) who had received an HCT in the past 24 months and were either still admitted to, or had been discharged from, the hospital. RESULTS: Grounded methodology revealed 21 qualitative themes grouped into 6 hierarchical categories. Findings reflected barriers to be present across HCT treatment but to differ based on treatment stage with only child medication refusal being a consistent barrier across all stages. Barriers were particularly prevalent after hospital discharge post-HCT when caregivers assumed full responsibility for medication management. In addition, families approaching hospital discharge often lacked insight about these post-discharge barriers such that they did not report anticipating the range of barriers described by caregivers who had already been discharged from the hospital and taken on full responsibility for medication management. CONCLUSIONS: Findings support the benefit of medication barrier assessment across HCT treatment. These results suggest that families may benefit from intervention to address the specific barriers they experience around medication adherence especially during the post-HCT outpatient period.