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.

INSPIRED Symposium Part 4A: Access to CAR T Cell Therapy in Unique Populations with B Cell Acute Lymphoblastic Leukemia.

The approval of tisagenlecleucel (tisa-cel) for use in children with B cell acute lymphoblastic leukemia (B-ALL) was based on the phase 2 ELIANA trial, a global registration study. However, the ELIANA trial excluded specific subsets of patients facing unique challenges and did not include a sufficient number of patients to adequately evaluate outcomes in rare subpopulations. Since the commercialization of tisa-cel, data have become available that support therapeutic indications beyond the specific cohorts previously eligible for chimeric antigen receptor (CAR) T cells targeted to CD19 (CD19 CAR-T) therapy on the registration clinical trial. Substantial real-world data and aggregate clinical trial data have addressed gaps in our understanding of response rates, longer-term efficacy, and toxicities associated with CD19 CAR-T in special populations and rare clinical scenarios. These include patients with central nervous system relapsed disease, who were excluded from ELIANA and other early CAR-T trials owing to concerns about risk of neurotoxicity that have not been born out. There is also interest in the use of CD19 CAR-T for very-high-risk patients earlier in the course of therapy, such as patients with persistent minimal residual disease after 2 cycles of upfront chemotherapy and patients with first relapse of B-ALL. However, these indications are not specified on the label for tisa-cel and historically were not included in eligibility criteria for most clinical trials; data addressing these populations are needed. Populations at high risk of relapse, including patients with high-risk cytogenetic lesions, infants with B-ALL, patients with trisomy 21, and young adults with B-ALL, also may benefit from earlier treatment with CD19 CAR-T. It is important to prospectively study patient-reported outcomes given the differential toxicity expected between CD19 CAR-T and the historic standard of care, hematopoietic cell transplantation. Now that CD19 CAR-T therapy is commercially available, studies evaluating potential access disparities created by this very expensive novel therapy are increasingly pressing.

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.

"I won't get to live my life the way I planned it": A qualitative analysis of the experiences of adolescents and young adults with advanced cancer.

BACKGROUND: Individuals with advanced cancer face complex challenges, including prognostic uncertainty and evolving goals of care. Despite the unique psychosocial support needs of adolescents and young adults (AYAs), few studies have specifically examined AYA perspectives of and experiences with advanced cancer. The objective of this study was to describe the experience, needs, and perspectives of pediatric AYAs with advanced cancer. PROCEDURE: We invited English-speaking AYAs (age 14-25 years) who were receiving treatment for advanced cancer at our single tertiary pediatric cancer center to participate in semi-structured interviews. We used directed content analysis for codebook development and then applied in-depth thematic network analysis to describe their perspectives and experiences with advanced cancer. RESULTS: A total of 32 AYAs (86% of approached) completed interviews. A slight majority were male (59%) and non-Hispanic White (56%). Most were diagnosed with leukemia/lymphoma, had recurrent disease (84%), and were a mean 53 months from initial diagnosis. Organizing themes of "not being able to beat this," "not wanting to miss out," and "living each day" generated the global theme "do I have a future?" "Making tough medical decisions," "adjusting life/plans/perspectives," and "decisions about dying" were organized into the global theme "those decisions … were really hard." "Feeling like there is no one to talk to," "being away from family and friends," and "feeling like a burden" generated the global theme "I felt very alone." CONCLUSIONS: Pediatric AYAs with advanced cancer describe unique challenges. Psychological support interventions are needed to empower AYAs to navigate difficult decisions and to cope with isolation.

Biobehavioral Implications of Chimeric Antigen Receptor T-cell Therapy: Current State and Future Directions.

Chimeric antigen receptor (CAR) T-cell therapy has demonstrated remarkable clinical responses in hematologic malignancies. Recent advances in CAR T-cell therapy have expanded its application into other populations including older patients and those with central nervous system and solid tumors. Although its clinical efficacy has been excellent for some malignancies, CAR T-cell therapy is associated with severe and even life-threatening immune-mediated toxicities, including cytokine release syndrome and neurotoxicity. There is a strong body of scientific evidence highlighting the connection between immune activation and neurocognitive and psychological phenomena. To date, there has been limited investigation into this relationship in the context of immunotherapy. In this review, we present a biobehavioral framework to inform current and future cellular therapy research and contribute to improving the multidimensional outcomes of patients receiving CAR T-cell therapy.

Seeking virtual support: Digital technology use in adolescent and young adults with advanced cancer.

BACKGROUND: A cancer diagnosis, especially advanced cancer, interferes with adolescent/young adult (AYA) peer relationships. AYAs increasingly use digital technologies (i.e., social media, video games) as a social instrument; little is known about the role of digital technologies in the AYA cancer experience. The objective of this analysis was to describe the use and impact of digital technologies among AYAs with advanced cancer. PROCEDURE: As part of the "Exploring the Concept of a 'Good Death'" study, semi-structured interviews were conducted with 32 English-speaking AYAs (14-25 years) with advanced cancer (relapsed/refractory disease, estimated survival <50%). Interviews were audio recorded, deidentified, and transcribed verbatim. Questions focused on communication and sources of psychosocial support. Directed content analysis was used for codebook creation. Three reviewers completed transcript coding and reconciled discrepancies. Thematic analysis identified hierarchical themes. The present analysis focused on the specific theme of "digital technologies as a support mechanism." RESULTS: When asked about sources of support, social media and multiplayer online games were most often recognized by AYAs. Three themes emerged regarding the role of digital technologies: distraction, maintaining existing peer support, and connecting with peers with cancer. Two AYAs acknowledged negative consequences of social media. CONCLUSIONS: AYAs with advanced cancer cite digital technologies as a mechanism for maintaining and seeking peer support. Digital technologies may be leveraged to provide psychosocial support for AYAs with advanced cancer.

Quality of Life in Adolescents and Young Adults: The Role of Symptom Burden.

CONTEXT: Adolescents and young adults (AYAs) with cancer report worse health-related quality of life (HRQOL) than other age groups. Symptom burden is a modifiable predictor of HRQOL. OBJECTIVES: The objective of this study was to identify which symptoms are most burdensome to AYAs with advanced cancer. METHODS: In this observational study, English-speaking individuals aged 12-25 years undergoing treatment for advanced cancer completed assessments of symptom burden (Memorial Symptom Assessment Scale) and HRQOL (Pediatric Quality of Life Inventory Generic Form and Cancer Module; minimal clinically important difference 4.4). We dichotomized participants as having low (<7) or high (≥7) symptom prevalence. Mixed regression models estimated HRQOL differences between groups. For individual symptoms, unadjusted mixed models estimated HRQOL reductions. RESULTS: N = 58 AYAs completed baseline surveys. The median age was 17 years (IQR 15-19), 58% were male, 59% identified as white, and 44% were diagnosed with leukemia/lymphoma. High symptom prevalence was associated with a mean generic HRQOL 7 points lower (95% CI: -11, -3; P < 0.01) and cancer-specific HRQOL score 12 points lower (95% CI: -17, -7; P < 0.01) than low symptom prevalence. The most prevalent symptoms were fatigue (71%), pain (58%), and difficulty sleeping (58%). Fatigue (-8), difficulty concentrating (-7), and mouth sores (-6) were associated with the greatest generic HRQOL score reductions. Dysphagia (-12), difficulty concentrating (-12), and sadness (-11) were associated with the greatest cancer-specific HRQOL score reductions. CONCLUSION: The symptom experience among AYAs with advanced cancer is unique. Separate evaluation of AYA's symptoms may optimize management and improve HRQOL.

A novel combined resilience and advance care planning intervention for adolescents and young adults with advanced cancer: A feasibility and acceptability cohort study.

BACKGROUND: Few evidence-based psychosocial programs have been tested among adolescents and young adults (AYAs) with advanced cancer (AC), and early advance care planning (ACP) in this population is rare. The authors aimed to determine the feasibility and acceptability of 1) delivering an established resilience-coaching program, and 2) integrating ACP into that program, among AYAs with AC. METHODS: Eligible AYAs were 12 to 24 years old, diagnosed with advanced cancer (recurrent/refractory disease or a diagnosis associated with <50% survival) and fluent in English. The Promoting Resilience in Stress Management-Advanced Cancer (PRISM-AC) program included PRISM's standard sessions targeting stress-management, goal-setting, cognitive-restructuring, and meaning-making, delivered 1:1, 1 to 2 weeks apart, plus a new session involving elements of the AYA-specific Voicing My Choices ACP guide. Participants completed surveys at baseline and 12 weeks, and exit interviews following study completion. Feasibility was defined as ≥70% completion of 1) standard 4-session PRISM and 2) the new ACP session among those completing standard PRISM. Acceptability was defined qualitatively. Trajectories of patient-reported anxiety, depression, and hope were examined descriptively. RESULTS: Of 50 eligible, approached AYAs, 26 (52%) enrolled and completed baseline surveys. The AYAs had a mean age of 16 years (SD = 2.7 years), and the majority were male (73%) and White/Caucasian (62%). Twenty-two AYAs (85%) completed standard PRISM, and of those, 18 (82%) completed the ACP session. Feedback was highly positive; 100% and 91% described the overall and ACP programs as valuable, respectively. Anxiety, depression, and hope were unchanged after the program. CONCLUSIONS: Resilience coaching followed by integrated ACP is feasible and acceptable for AYAs with AC. Participating did not cause distress or decrease hope. LAY SUMMARY: Advance care planning (ACP) among adolescents and young adults (AYAs) with advanced cancer can be difficult to introduce. We investigated whether it is feasible and acceptable to integrate ACP into an existing resilience-coaching program for AYAs. In this cohort study of 26 AYAs with advanced cancer, we found the Promoting Resilience in Stress Management-Advanced Cancer program to be feasible (≥70% intervention-completion) and highly acceptable (positive post-participation feedback, no evidence of participant-distress). We conclude that an intervention integrating resilience coaching and ACP is feasible and acceptable among AYAs with advanced cancer.

Tincture of Time: The Evolution of Goals in Adolescents and Young Adults with Cancer.

Purpose: A diagnosis of cancer often derails an individual's goals. The purpose of this mixed-methods analysis was to describe the evolution of adolescent and young adult (AYA)-reported goals in the year after a diagnosis of new or advanced cancer. Methods: As part of the Promoting Resilience in Stress Management (PRISM) phase 2 randomized controlled trial, AYAs with cancer (ages 12-25 years) were asked at baseline, 6 months, and 12 months: "Please give an example of a goal you hope to accomplish over the next month/year." We used content analysis to categorize goals as follows: life milestones, physical health, mental/emotional health, cancer specific, and hobbies/interests. We summarized goal categories at each time point: for the entire cohort, by baseline diagnosis status (new vs. advanced cancer), treatment status (on-therapy vs. off-therapy), and baseline health-related quality of life (high vs. low). Results: Eighty-six participants completed the study and were included in the analysis (control: n = 41, PRISM: n = 45); 69 reported their goals at 6 months, and 54 at 12 months. Participants submitted a total of 169 goals at baseline, 148 at 6 months, and 126 at 12 months. At baseline, cancer-specific goals were most common for the short-term (35%), whereas milestone goals were most common for the long-term (46%). At 6 months, milestone goals were most common in both short- (38%) and long-term (51%) categories. A similar pattern was seen at 12 months. Conclusion: AYAs' goals change over the first year of their cancer experience, with a shift in short-term goals from cancer-specific goals at baseline to milestone goals at later time points. ClinicalTrials.gov (NCT02340884).

Objectifying the Subjective: The Use of Heart Rate Variability as a Psychosocial Symptom Biomarker in Hospice and Palliative Care Research.

Measuring psychosocial symptoms in hospice and palliative care research is critical to understanding the patient and caregiver experience. Subjective patient-reported outcome tools have been the primary method for collecting these data in palliative care, and the growing field of biobehavioral research offers new tools that could deepen our understanding of psychosocial symptomatology. Here we describe one psychosocial biomarker, heart rate variability (HRV), and simple techniques for measurement in an adolescent and young adult cancer population that are applicable to palliative care studies. Complementing self-reported measures with objective biomarkers like HRV could facilitate a more nuanced understanding of physiologic and perceived well-being in patients with serious or life-limiting illness and inform future "precision supportive care" in hospice and palliative medicine.

Hospitalization and mortality outcomes in the first 5 years after a childhood cancer diagnosis: a population-based study.

PURPOSE: Children with cancer are frequently hospitalized. However, hospitalization and death by disease category are not well defined < 5 years from diagnosis. METHODS: We conducted a retrospective cohort study using linked cancer registry-hospital discharge-vital records to identify cancer cases < 20 years at diagnosis during 1987-2012 (n = 4,567) and comparison children without cancer, matched on birth year and sex (n = 45,582). Data linkage identified serious morbidities resulting in cancer- and non-cancer-related hospitalizations or deaths < 5 years from diagnosis. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated to compare relative hospitalization and mortality by disease category and after excluding cancer-related outcomes. Among cancer cases, relative risks of these outcomes for children with solid tumors compared with children with leukemia/lymphoma were also estimated. RESULTS: Greater rates of all-cause hospitalization (281.5/1,000 vs. 6.2/1,000 person years) and death (40.7/1,000 vs. 0.15/1,000 person years) were observed in childhood cancer cases than comparators and across all diagnosis categories. Increased hospitalization (31.0/1,000 vs. 6.2/1,000 person years; HR 5.0, 95% CI 4.5-5.5) and death (1.0/1,000 vs. 0.15/1,000 person years; HR 10.4, 95% CI 5.6-19.1) rates remained when cancer-related outcomes were excluded. Although HRs for hospitalization and death did not differ greatly by treatment era, absolute rates of hospitalization were greater (1987-1999: 233.3/1,000; 2000-2012: 320.0/1,000 person years) and death were lesser (1987-1999: 46.3/1,000; 2000-2012: 36.8/1,000 person years) in the later treatment era among cases. Children with solid tumors were less likely to have a cancer-related hospitalization than were those with leukemia/lymphoma (RR 0.91, 95% CI 0.84-0.98). CONCLUSION: Even after excluding cancer-related diagnoses, children with cancer experience greater rates of hospitalization and death in all disease categories. Results may guide future toxicity mitigation initiatives and inform anticipatory guidance for families of children with cancer.

Adverse childhood experiences (ACEs) and medically traumatic events (TEs) in adolescents and young adults (AYAs) with cancer: a report from the Promoting Resilience in Stress Management (PRISM) randomized controlled trial.

OBJECTIVE: In adolescents and young adults (AYAs) with cancer, we examined (1) the distribution and type of traumatic events (TEs) experienced prior to baseline assessment and (2) how a resilience intervention, Promoting Resilience in Stress Management (PRISM), impacted changes in patient-reported outcomes (PROs) for AYAs with and without TEs. METHODS: AYAs (12-25 years) within 1-10 weeks of diagnosis of new malignancy or ever diagnosed with advanced cancer were enrolled and randomly assigned to usual care (UC) with or without PRISM. To assess TEs, we screened medical records for traditionally defined adverse childhood experiences (ACEs) and medical traumatic events. Age-validated PROs assessed resilience, benefit-finding, hope, generic health-related quality of life (QoL), cancer-specific QoL, depression, and anxiety at enrollment and 6 months later. We calculated effect sizes (Cohen's d) for PRISM vs. UC effect on PRO score change at 6 months for 1+ TEs and 0 TE groups. RESULTS: Ninety-two AYAs enrolled and completed baseline surveys (44-UC, 48-PRISM; N = 74 at 6 months, 38-UC, 36-PRISM); 60% experienced 1+ TEs. PROs at baseline were similar across groups. PRISM's effect on score change was greater (Cohen's d ≥ 0.5) for the 1+ TE group on domains of benefit-finding and hope; and similar (d < 0.5) on domains of resilience, depression, anxiety, and both generic and cancer-specific QoL. CONCLUSIONS: In AYAs with cancer, TEs occurred at similar rates as the general population. PRISM may be particularly helpful for improving benefit-finding and hope for those who have experienced TEs.

Creating a Resilient Research Program-Lessons Learned From a Palliative Care Research Laboratory.

Conducting palliative care research can be personally and professionally challenging. Although limitations in funding and training opportunities are well described, a less recognized barrier to successful palliative care research is creating a sustainable and resilient team. In this special report, we describe the experience and lessons learned in a single palliative care research laboratory. In the first few years of the program, 75% of staff quit, citing burnout and the emotional tolls of their work. To address our sustainability, we translated resilience theory to practice. First, we identified and operationalized shared mission and values. Next, we conducted a resilience resource needs assessment for both individual team members and the larger team as a whole and created a workshop-based curriculum to address unmet personal and professional support needs. Finally, we changed our leadership approach to foster psychological safety and shared mission. Since then, no team member has left, and the program has thrived. As the demand for rigorous palliative care research grows, we hope this report will provide perspective and ideas to other established and emerging palliative care research programs.

Psychosocial care for children receiving chimeric antigen receptor (CAR) T-cell therapy.

Chimeric antigen receptor (CAR) T-cell therapy has transformed the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). However, this new paradigm has introduced unique considerations specific to the patients receiving CAR T-cell therapy, including prognostic uncertainty, symptom management, and psychosocial support. With increasing availability, there is a growing need for evidence-based recommendations that address the specific psychosocial needs of the children who receive CAR T-cell therapy and their families. To guide and standardize the psychosocial care offered for patients receiving CAR T-cell therapy, we propose the following recommendations for addressing psychosocial support.

Examining key sociodemographic characteristics of adolescents and young adults with cancer: A post hoc analysis of the Promoting Resilience in Stress Management randomized clinical trial.

BACKGROUND: The "Promoting Resilience in Stress Management" intervention is a skills-based, early palliative care intervention with demonstrated efficacy in adolescents and young adults with cancer. AIM: Utilizing data from a randomized clinical trial of Promoting Resilience in Stress Management versus Usual Care, we examined whether response to Promoting Resilience in Stress Management differed across key sociodemographic characteristics. DESIGN: Adolescents and young adults with cancer completed patient-reported outcome measures of resilience, hope, benefit-finding, quality of life, and distress at enrollment and 6 months. Participants were stratified by sex, age, race, and neighborhood socioeconomic disadvantage based on home address (Area Deprivation Index scores with 8-10 = most disadvantaged). Differences in the magnitude of effect sizes between stratification subgroups were noted using a conservative cutoff of d > 0.5. SETTING/PARTICIPANTS: Participants were 12 to 25 years old, English-speaking, and receiving cancer care at Seattle Children's Hospital. RESULTS: In total, 92 adolescents and young adults (48 Promoting Resilience in Stress Management, 44 Usual Care) completed baseline measures. They were 43% female, 73% 12 to 17 years old, 64% White, and 24% most disadvantaged. Effect sizes stratified by sex, age, and race were in an expected positive direction and of similar magnitude for the majority of outcomes with some exceptions in magnitude of treatment effect. Those who lived in less disadvantaged neighborhoods benefited more from Promoting Resilience in Stress Management, and those living in most disadvantaged neighborhoods benefited less. CONCLUSION: The "Promoting Resilience in Stress Management" intervention demonstrated a positive effect for the majority of outcomes regardless of sex, age, and race. It may not be as helpful for adolescents and young adults living in disadvantaged neighborhoods. Future studies must confirm its generalizability and integrate opportunities for improvement by targeting individual needs.

A Psychosocial Intervention's Impact on Quality of Life in AYAs with Cancer: A Post Hoc Analysis from the Promoting Resilience in Stress Management (PRISM) Randomized Controlled Trial.

Promoting Resilience in Stress Management (PRISM), a psychosocial intervention for adolescents and young adults (AYAs) with serious illness, enhances resilience resources via four skills-based training sessions. A recent randomized controlled trial showed PRISM improved health-related quality of life (HRQOL) compared to usual care (UC). This post hoc exploratory analysis aimed to better understand the effect of PRISM on HRQOL by describing changes in HRQOL subdomain scores. English-speaking AYAs (12-25 years) with cancer were randomized to PRISM or UC. At enrollment and six months later, HRQOL was assessed using the Pediatric Quality of Life Inventory (PedsQL) Generic Short Form (SF-15) and Cancer Module. Scores at each time point were summarized descriptively and individual HRQOL trajectories were categorized (<70 vs. ≥70). "Positive" trajectories indicate participants maintained scores ≥70 or improved from <70 to ≥70 during the study period. Baseline assessments were completed by 92 participants (48 PRISM, 44 UC); six-month assessments were completed by 74 participants (36 PRISM, 38 UC). For the SF-15, positive trajectories in psychosocial domains were more common with PRISM; trajectories in the physical subdomain were similar across groups. For the Cancer Module, positive trajectories were more common with PRISM in the following subdomains: nausea, treatment anxiety, worry, cognitive, physical appearance, and communication. From this, we conclude PRISM may improve HRQOL, especially in psychosocial domains of wellbeing.

Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care.

OBJECTIVE: Adolescents and young adults (AYAs) with cancer are at high risk of negative psychosocial outcomes. Promoting Resilience in Stress Management (PRISM), a novel, brief, skill-based intervention, has demonstrated efficacy in improving psychosocial well-being for AYAs. We utilized data from a recent randomized trial of PRISM versus usual care (UC) to categorize and explore group differences in change trajectories of patient reported outcomes (PROs) over time. METHODS: One hundred English-speaking AYAs (aged 12-25 years old) with cancer were randomized to PRISM versus UC. At enrollment and 6 months later, AYAs completed validated PROs measuring resilience (Connor-Davidson Resilience Scale [CDRISC-10]), hope (Hope Scale), benefit finding (Benefit and Burden Scale for Children), cancer-specific quality of life (Pediatric Quality of Life [PedsQL] Cancer Module), and distress (Kessler-6). Patient response trajectories were categorized as "improved," "consistently well," "consistently at risk," or "deteriorated" using minimal clinically important differences (MCIDs) or established measure cutoffs for all PROs. Positive response trajectories consisted of the first two categories ("improved" and "consistently well"), and negative response trajectories consisted of the latter two categories ("consistently at risk" and "deteriorated"). RESULTS: Across all PROs, more patients in the PRISM arm "improved" in psychosocial well-being over time, and fewer PRISM recipients "deteriorated" over time. Across all PROs, a greater proportion of PRISM participants (vs UC) experienced positive response trajectories. Across all PROs, a greater proportion of UC participants experienced negative response trajectories. CONCLUSIONS: PRISM shows evidence of both a prevention effect and an intervention effect. Thus, PRISM may serve as a viable prevention and early intervention model for psychosocial care.