OBJECTIVES:To characterize patient and caregiver end-of-life (EOL) information needs through analysis of inquiries received by the National Cancer Institute's Cancer Information Service (CIS). SAMPLE & SETTING:The sample consisted of CIS inquiries received between September 2018 and June 2024 that were (a) initiated by patients or caregivers and (b) coded as focusing on the EOL phase of the cancer continuum. METHODS & VARIABLES:Descriptive and network analyses were conducted to characterize CIS inquiries and explore patterns of co-occurrence related to subjects of inquiry. RESULTS:Of the 81,836 inquiries received by the CIS during the study period, 3% (n = 2,333) focused on EOL; of these, 90% were initiated by caregivers. Patterns of subject-of-inquiry co-occurrence related to palliative care/hospice, finding healthcare services, cancer-directed therapies, coping, and clinical trials were observed. Patient and caregiver network structures were highly correlated (r = 0.799, p < 0.001), suggesting similar patterns of information needs. IMPLICATIONS FOR NURSING:Tailoring informational support and bundling common information needs are crucial strategies to optimally support patients with cancer and caregivers at the EOL. These findings highlight the need for nurse-led, novel care delivery models that can address unmet needs and improve the provision of support, such as caregiver-focused, community-based navigation; delivery of palliative care concurrent with cancer-directed therapies; and embedded caregiver clinics within cancer centers.
12009 Background: AYA BC survivors often have unmet concerns that are understudied and sub-optimally addressed. Primary results from the YES trial (NCT04906200) demonstrated that YES, an AYA-focused mHealth intervention, improved quality of life and reduced specific symptoms in AYA BC survivors at 6 months (mo) post-enrollment. Here we report a pre-specified secondary analysis of YES on reducing AYA survivorship concerns. Methods: We conducted a multicenter (Dana-Farber Cancer Institute, The Ohio State University, Columbia University Medical Center) RCT of YES, an mHealth intervention which provides tailored information, resources and support in response to monthly electronic patient-reported outcome monitoring, a journal platform, and a chat room. Participants age ≤39 at diagnosis (dx) of stage 0-3 BC, < 3 years post-dx were randomized 1:1 to YES or Usual Care (UC). Survivorship concerns were measured at baseline, 3, and 6 mo with AYA HOPE survey items; participants rated their level of concern across a range of domains. Generalized linear mixed effects models analyzed the binary endpoint of somewhat/very vs no/low concern for each issue. Odds of being somewhat/very concerned about a domain at 6 mo were compared between arms, adjusting for baseline concern. Results: From 6/2021-12/2024, 360 participants were randomized (YES:179; UC: 181) following baseline survey completion. Participant characteristics were balanced between arms. Median time from dx was 19 (IQR: 12-27) mo. Median age at dx was 34 (IQR: 31-37) yrs; 61% had stage 2 or 3 BC. Overall, a majority of participants endorsed high levels of concern at baseline related to: long-term side effects of treatment (67%), long-term health effects of cancer (70%), recurrence (79%), checking for signs of recurrence (57%), possibility of a new cancer (67%), exercise (60%), nutrition (58%), familial cancer risk (51%), and body image (56%). Other endorsed concerns included: fertility (43%), financial support for medical care (37%), financial concerns (38%), talking about cancer experience with family/friends (27%), having enough information about treatment (25%), meeting other AYAs (22%), alcohol and cancer (15%), and smoking cessation (3%). At 6 mo, adjusting for baseline concern, the YES group (vs UC) had lower odds of being somewhat/very concerned about finances (OR: 0.36, 95% CI: 0.13 – 0.98, p = 0.05), financial support for medical care (OR 0.35, 95% CI 0.13-0.96, p = 0.04), family cancer risk (OR 0.36, 95% CI 0.17-0.77, p = 0.009), and alcohol and cancer (OR 0.15, 95% CI 0.03-0.75, p = 0.02). Conclusions: Concerns across a range of survivorship domains are prevalent in AYA BC survivors. The YES mHealth intervention reduced concerns about several survivorship issues, supporting the potential for this highly scalable intervention to help manage these concerns as an adjunct to routine clinical care for AYA BC survivors. Clinical trial information: NCT04906200 .
CONTEXT:Outpatient palliative care (PC) improves symptom management and quality of life for patients with advanced cancer, yet most do not receive PC services. Remote symptom surveillance and collaborative care (CC) interventions may increase appropriate and timely PC. OBJECTIVES:To assess whether an electronic health record (EHR)-facilitated CC intervention to monitor and manage SPPADE symptoms (Sleep interference, Pain, impaired Physical function, Anxiety, Depression, and Energy deficit/fatigue) increases outpatient PC use in advanced cancer patients. METHODS:This is a secondary analysis of data from the Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) cluster-randomized pragmatic trial. Oncology patients in a multistate health system completed visit-linked questionnaires that included numeric rating scales for SPPADE symptoms during usual care and intervention periods. Intervention periods added monthly surveys, automated delivery of symptom self-management, and access to symptom care managers for severe symptoms. Our analysis was restricted to patients with metastatic disease. Outpatient PC encounters were identified from the EHR. Mixed effects Poisson regression with offset for exposure time was used to compare the rates of initial PC consults between study groups. RESULTS:From March 2019 to January 2023, 16,406 patients with metastatic cancers were assigned a symptom questionnaire. At first assessment, mean age was 65; 49% were female, and 26.7% lived in rural areas. After adjustment, there was a 50% higher rate of PC consultation during the intervention period compared with the usual care period (incidence rate ratio = 1.50, P < 0.001). CONCLUSION:EHR-facilitated symptom surveillance and CC management significantly increased outpatient PC utilization in a large metastatic cancer population.
635 Background: Prospective data on efficacy, quality of life, and treatment-related toxicities in older adults with breast cancer are limited. The ATOP trial (NCT03587740) evaluated T-DM1 in older adults and demonstrated favorable 5-year invasive disease-free survival. Here, we report patient-reported adverse events (AEs) and health-related quality of life (HRQOL) findings from ATOP. Methods: ATOP was a single-arm, phase II, multicenter study of adjuvant T-DM1 for those aged 60 with stage I-III HER2+ breast cancer. Protocol therapy included postoperative administration of T-DM1 (3.6 mg/kg) every 21 days for one year (17 cycles). PRO-CTCAE (assessing specific symptoms) and EQ-5D (a measure of HRQOL) surveys were administered electronically or on paper at baseline (pre-treatment), on Day 1 of each treatment cycle, and at a single 6–12-month post-treatment time point. Participants who responded to the baseline and at least one follow-up survey were included in the PRO analysis. EQ-5D changes from baseline were assessed using general linear mixed models. Summary statistics were used to assess PRO-CTCAE scores to evaluate which symptoms developed between baseline and 1 subsequent survey(s) and their severity. Results: Among the 111 patients enrolled on ATOP (median age=71, range 60-88 years), 98 responded to the baseline survey and 1 subsequent survey(s). 1435 surveys were returned that included at least one PRO-CTCAE response, and 1661 surveys were returned that included EQ-5D. The Table displays the % of participants who reported PRO-CTCAE symptoms that worsened from baseline to any severity level (scores >0) or to a severe level (scores ≥3). More than 60% of survey respondents reported new or increased dry mouth, fatigue, muscle aches, decreased appetite, nausea, pain, and/or numbness/tingling at some point during or after treatment, but these were usually not severe. EQ-5D scores did not change significantly from baseline at any time point. Conclusions: In this adjuvant trial for patients aged >60, participation rates for PRO data collection were high. Reassuringly, global HRQOL was not impacted by T-DM1, and though frequently reported, the vast majority of patient-reported symptoms were mild. Future analyses of this trial will focus on duration and predictors (clinical and biomarker-based) of severe AEs, agreement between patient-reported and clinician-reported AEs, and whether sharing PRO reports with clinicians impacted clinician-reported AE grades. Clinical trial information: NCT03587740 . Most common new or worsening symptoms reported via PRO-CTCAE in ATOP (n=95). Symptom % with score >0 n (%) with score 3+ Dry mouth 79% 26% Fatigue 71% 29% Muscle aches 69% 20% Decreased appetite 69% 12% Nausea 67% 6% Pain 66% 21% Numbness/tingling 65% 9% Blurry vision 60% 4% Mouth or throat sores 60% 5%
64 Background: The incidence of eoCRC (diagnosed at age <50) is increasing. We have previously shown higher rates of severe anxiety and depression in this group compared to adults diagnosed at age ≥50 (average-onset CRC, aoCRC). We assessed the impact of ePROM collection coupled with a CC-based supportive care intervention on symptom burden in patients with eoCRC. Methods: The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) trial was a cluster-randomized, pragmatic trial conducted at Mayo Clinic Rochester and within the Mayo Clinic Health System (in Minnesota and Wisconsin) between 2019 and 2023. Enrolled patients serially reported the severity of six SPPADE symptoms (Sleep deficit, Pain, Physical function impairment, Anxiety, Depression, and Energy deficit/fatigue) on 11-point numerical rating scales. Symptom scores were interpreted as none to mild (0-3), moderate (4-6), or severe (7-10). Those with moderate symptoms were offered symptom management education and self-management materials, while those with severe symptoms were offered the option to work with a symptom care manager. In this post hoc analysis we examined the effects of the intervention on change in symptom scores among those with eoCRC, and using the Kaplan-Meier method, the median time to improvement to a mild/moderate level in those with a severe symptom, comparing eoCRC with aoCRC. Results: Among 4,422 patients with CRC, 887 had eoCRC. Forty-six percent of patients were female ( p =0.61), and a greater proportion of eoCRC patients were of a non-white race (11.6% vs 4.7%), lived in an urban setting (65.6% vs 50.5%), had a Bachelor’s degree or higher (36.8% vs 24.4%), were employed (78.5% vs 36.7%), on a non-government insurance plan (83.4% vs 35.3%), single (19.7% vs 11.2%) or married (74.2% vs 67.9%), and had metastatic disease (54.8% vs 46.1%, p <0.0001 for all). Compared to a pre-intervention baseline, the mean change in symptom scores for eoCRC patients following the intervention demonstrated improvements in anxiety (-0.238), depression (-0.134), and fatigue (-0.146, p <0.05 for all). Time to symptom improvement from severe to mild/moderate was longer for anxiety and depression in eoCRC patients compared to aoCRC patients (Table 1). Conclusions: Collection of ePROMs coupled with a CC-based intervention led to improvements in anxiety, depression, and fatigue among eoCRC patients, although time to symptom improvement was longer among eoCRC patients compared to aoCRC patients. Time to improvement of severe symptom (months), median (95% CI). eoCRC aoCRC p -value Sleep 4.2 (3.1-5.8) 3.8 (2.7-5.4) 0.4 Pain 4.1 (3.0-7.5) 3.2 (2.3-5.0) 0.5 Physical function impairment 3.1 (1.9-6.3) 2.8 (2.2-4.2) 0.5 Anxiety 4.3 (3.4-9.1) 2.6 (2.0-3.5) 0.009 Depression 4.3 (2.6-7.5) 2.6 (2.1-3.5) 0.04 Fatigue 4.3 (3.7-9.5) 3.4 (2.7-4.2) 0.06
The Clinical Sustainability Assessment Tool (CSAT) is designed to capture determinants of sustainable clinical practices over time. Although the full 49-item CSAT instrument has demonstrated strong psychometric properties, the 21-item short form has had limited evaluation. This study aimed to assess the CSAT short form (CSAT Short) across different respondent characteristics and care delivery settings. We evaluated the CSAT Short in a sample of healthcare personnel (N = 256 respondents) drawn from across three hybrid effectiveness-implementation studies in a research consortium, all of which tested routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings in the US. Confirmatory factor analyses (CFA) and mIRT were conducted to assess the CSAT Short's fit to the hypothesized factor structure. Multiple-group CFA was used to test for measurement invariance across groups of respondents with different professional roles, years in current role, and different work settings. The hypothesized seven factor structure of the CSAT Short exhibited good fit to the data and strong internal consistency in our sample of healthcare personnel drawn from across three large pragmatic trials (CFI = .99,TLI = .98,X2(182) = 658.99,p < .001;SRMR = .031,RMSEA = .10). Tests of measurement invariance indicated the respondent’s role in the clinical setting (i.e., clinician vs. non-clinician) and years in current role (< 10 years vs. ≥10 years) were invariant. However, significant variance was found between respondents from three different Research Centers within the IMPACT consortium. The second-order mIRT model demonstrated acceptable fit based on most indices (M2(56) = 148.69, p < .001; RMSEA = 0.059, 90
Background/Objectives: The PRO-CTCAE Average Composite Score (ACS), calculated as the mean of PRO-CTCAE composite scores, summarizes overall symptom and side effect burden. This study evaluated the test-retest reliability, responsiveness to change, known-groups validity, and sensitivity to group differences in the ACS. Methods: Analyses used the original PRO-CTCAE validation dataset, including lung (n = 174), breast (n = 222), and head and neck (n = 139) cancer cohorts, and data from the COMET-2 randomized phase III trial comparing cabozantinib (n = 53) and mitoxantrone-prednisone (n = 54) in men with previously treated prostate cancer. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs) from two-way mixed-effects models for agreement. Responsiveness was evaluated by relating ACS change scores (Visit 1 minus follow-up Visit 2) to patient-reported global ratings of change (GRC; worsened, unchanged, or improved) using standardized response means (SRMs) and Jonckheere-Terpstra trend tests. Known-groups validity was examined by comparing mean ACS values between ECOG performance status groups (0-1 vs. 2-4). Sensitivity to treatment group differences was assessed using model-based area-under-the-curve (AUC) comparisons of longitudinal ACS trajectories. Results: Test-retest reliability was acceptable, with ICCs among GRC-defined stable patients of 0.80 (95% CI: 0.70-0.87) in lung cancer, 0.84 (95% CI: 0.77-0.89) in breast cancer, and 0.77 (95% CI: 0.63-0.86) in head and neck cancer; ICCs based on assessments completed one day apart ranged from 0.88 to 0.90. The ACS demonstrated responsiveness, with SRMs of 0.30/0.15/-0.37 (lung), 0.29/0.14/-0.40 (breast), and -0.01/-0.20/-0.56 (head/neck) for improved/no-change/worsened groups, respectively, and significant monotonic trends across GRC categories (all p < 0.01). Known-groups validity was supported by conceptually expected differences in ACS values across distinct levels of self-reported patient-reported physical functioning and ECOG performance status categories. Mean ACS values were lower among patients with good versus limited physical functioning (0.71 vs. 1.23 in lung cancer, 0.52 vs. 1.19 in breast cancer, and 0.69 vs. 1.29 in head and neck cancer) and among patients with ECOG PS 0-1 versus 2-4 (0.93 vs. 1.31, 0.74 vs. 1.22, and 0.90 vs. 1.06, respectively). In COMET-2, higher symptom burden was detected in the cabozantinib arm compared with the mitoxantrone-prednisone arm (AUC difference = 1.5, 95% CI: 0.2-2.8, p = 0.02). Conclusions: The ACS demonstrated acceptable test-retest reliability, responsiveness, and known-groups validity across multiple cancer populations. These findings support its use as a complementary summary measure of overall symptomatic adverse event burden alongside individual symptom-level analyses.
The ASCENT Consortium was funded by the National Institutes of Health (NIH) in August 2025 with the goal of advancing palliative care (PC) research, evidence, implementation and practice to improve care of persons with serious illness and those who care for them across the lifespan. ASCENT aims to: (1) Develop and coordinate the national scientific infrastructure and community needed to advance PC research, marshalling research expertise currently distributed across research centers and leveraging the impact of that expertise via partnership and collaboration. Partners include persons who have lived experiences with serious illness personally or as caregivers, practicing clinicians, patient advocacy organizations, professional organizations, community organizations, health care systems/settings/payers across the continuum of care and other NIH-funded consortia and networks. (2) Generate new PC research knowledge and methodologies, directly by conducting projects to establish new knowledge or methods that support the work of PC scientists. (3) Foster career development and impact of the PC scientist workforce by funding career development and pilot and exploratory awards, providing access to methodologic consultations and resources such as PC research methodology and career development curricula and facilitating mentoring. (4) Disseminate PC research findings and facilitate subsequent implementation via a multi-pronged approach, including providing resource libraries, guidance documents, best practices, training, and toolkits to facilitate collaboration and co-design with health system partners and relevant organizations. This article describes the goals, organization, resources, programs and activities of the ASCENT Consortium, intending to raise awareness about ASCENT and encourage engagement with, utilization of and collaboration with ASCENT.
12007 Background: YAs with cancer, defined as those diagnosed prior to the age of 40, may experience greater symptom burden compared to those diagnosed at older ages. We evaluated the impact of an ePROM-triggered, CC-based, supportive care intervention on symptom burden in YAs with cancer. Methods: The Enhanced, Electronic Health Record-facilitated Cancer Symptom Control (E2C2) trial was a cluster-randomized, pragmatic trial (NCT03892967) that enrolled oncology patients seen at Mayo Clinic Rochester and within the Mayo Clinic Health System (sites in Minnesota and Wisconsin) between March 2019 and January 2023. Patients routinely reported the severity of six SPPADE symptoms (Sleep deficit, Pain, Physical function impairment, Anxiety, Depression, and Energy deficit/fatigue) on 11-point numerical rating scales. Symptom severity was classified as none to mild (0-3), moderate (4-6), or severe (7-10). Those with moderate or severe symptoms were offered symptom management education, while those with severe symptoms were also offered the option to work virtually with a symptom care manager. In this post hoc analysis, we examined the effects of the intervention on change in symptom scores among YAs and time to improvement to a mild/moderate level in those with at least one severe symptom. Results: Among 40,659 patients who responded to at least one survey, 2,598 were YAs and 38,061 were adults ≥ 40 years. Among YAs, 10.7%, 24.3%, and 65.1% were 18-24 years, 25-31 years, and 32-39 years, respectively. A greater proportion of YA patients were female (61.5% vs 57.0%), of a non-white race (12.4% vs 5.3%), living in an urban setting (65.7% vs 55.1%), single (36.4% vs 9.6%), on non-government insurance (78.1% vs 36.6%), employed (72.6% vs 37.4%), and had a Bachelor’s degree or greater (37.8% vs 28.3%, p < 0.001 for all). Fewer YA patients had metastatic disease compared to older patients (24.2% vs 35.2%, p < 0.001). Compared to a pre-intervention baseline, the mean change in symptom score for YA patients following the intervention demonstrated improvements in anxiety (-0.195) and depression (-0.168, p < 0.0001 for both), while physical function impairment worsened over the intervention period (0.101, p = 0.014). Compared to adults ≥ 40 years, YAs experienced greater intervention effects for management of depression ( p < 0.001), fatigue ( p = 0.01), pain ( p < 0.0001), and physical function impairment ( p < 0.0001). Among YAs with a severe symptom during the intervention period, median time to improvement to a mild/moderate level was longer for anxiety compared to those ≥ 40 years (3.5 vs 2.7 months, p = 0.009). Conclusions: Routine ePROM surveillance, coupled with CC-based symptom management, led to improvements in anxiety and depression among YAs with cancer, although, time to improvement was longer for anxiety compared to adults ≥ 40 years.
The Normalization MeAsure Development (NoMAD) questionnaire is used to assess implementation processes based on Normalization Process Theory (NPT). However, its psychometric properties have not been extensively evaluated. This study aimed to examine the factorial validity, internal consistency, and measurement invariance at both scale and item levels of the NoMAD across three hybrid effectiveness-implementation studies determining the impact of routine symptom surveillance and guideline-based symptom management interventions in ambulatory oncology care settings. A cross-sectional survey was conducted with 328 healthcare personnel (74.
Background: The PRO-CTCAE provides patient-reported data on symptomatic AEs. A summary metric—the ACS—reflecting total AE burden can be calculated by averaging AE-level composite scores at a given timepoint for each participant. This study investigated the psychometric properties and interpretability of this PRO-CTCAE ACS in patients with breast, lung, or head/neck cancers. Methods: We conducted a secondary analysis of a PRO-CTCAE validation dataset comprising 940 adults undergoing chemotherapy or radiation therapy (clinicaltrials.gov: NCT02158637). We focused on empirically recommended symptom terms for three cancer sites. Analyses included Spearman’s correlations, coefficient alpha, and eigenvalues from the correlation matrices, confirmatory factor analysis (CFA), and principal component analysis (PCA). Latent profile analysis (LPA) was used to assess ACS interpretability in the lung cohort. Results: Mean composite score inter-correlations were moderate (0.30–0.35), and coefficient alphas were high (0.81–0.91). Eigenvalue ratios and CFA supported retention of a single factor/component, with suitable model fit indices. ACS correlated highly with factor scores and the first principal component from the PCA. Reduced sets of terms produced reliable scores that closely approximated the full set scores and aligned with external criteria. LPA in the lung subgroup identified four latent classes; ACS differentiated high vs. low symptom burden groups but did not distinguish the two groups expressing distinct symptom profiles. Conclusion: The ACS demonstrated structural validity through adequately fitting linear factor models and effectively summarized symptomatic AE burden. However, similar ACS values may mask clinically distinct symptomatic AE profiles, underscoring the value of both summary metrics and profile-based approaches.
The Enhanced EHR-facilitated Cancer Symptom Control (E2C2) Trial is a pragmatic trial testing a collaborative care approach for managing common cancer symptoms. There were challenges in identifying cancer site and metastatic status. This study compares three different approaches to determine cancer site and six strategies for identifying the presence of metastasis using EHR and cancer registry data. The E2C2 cohort included 50,559 patients seen in the medical oncology clinics of a large health system. SPPADE symptoms were assessed with 0 to 10 numeric rating scales (NRS). A multistep process was used to develop three approaches for representing cancer site: the single most prevalent International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) code, the two most prevalent codes, and any diagnostic code. Six approaches for identifying metastatic disease were compared: ICD-10 codes, natural language processing (NLP), cancer registry, medications typically prescribed for incurable disease, treatment plan, and evaluation for phase 1 trials. The approach counting the two most prevalent ICD-10 cancer site diagnoses per patient detected a median of 92% of the cases identified by counting all cancer site diagnoses, whereas the approach counting only the single most prevalent cancer site diagnosis identified a median of 65%. However, agreement among the three approaches was very good (kappa > 0.80) for most cancer sites. ICD and NLP methods could be applied to the entire cohort and had the highest agreement (kappa = 0.53) for identifying metastasis. Cancer registry data was available for less than half of the patients. Identification of cancer site and metastatic disease using EHR data was feasible in this large and diverse cohort of patients with common cancer symptoms. The methods were pragmatic and may be acceptable for covariates, but likely require refinement for key dependent and independent variables.
Electronic Patient-Reported Outcome Measures (ePROMs) are digital tools that allow patients to report symptoms using computers, tablets, or smartphones. In cancer care, ePROMs are increasingly used to monitor SPPADE symptoms: sleep disturbance, pain, physical function decline, anxiety, depression, and energy deficit or fatigue. While ePROMs can support timely symptom recognition and clinical response, their influence on how patients and clinicians connect and understand one another during care remains notably underexplored. This study investigates how the integration of digital symptom reporting into clinical routines may shape both the content of symptom reporting and the relational dynamics between patients and providers.We conducted 46 in-depth interviews with cancer patients enrolled in a multi-year symptom management trial (E2C2) at Mayo Clinic. Using a combination of deductive frame analysis and inductive analysis informed by Boundary Object Theory, we first examined how patients with advanced cancer understood and approached the sharing of SPPADE symptoms. We then explored how ePROM technology shaped their experiences and perceptions of symptom reporting.We found that three interrelated factors shaped patient engagement with ePROMs: (1) personal orientations toward perceiving and expressing symptoms, (2) coping styles, including tensions between appropriate self-monitoring and positive self-presentation, and (3) expectations shaped by prior interactions with the care team. While ePROMs helped patients articulate symptoms, they also raised questions about whether responses were reviewed and how they were interpreted by clinicians. Patients described ePROMs as signaling what kinds of symptoms “counted” to providers, subtly reshaping their understanding of illness and their role in managing it.Our findings engage and extend Boundary Object Theory by showing that ePROMs function not only as tools for coordinating information, but also as relational artifacts. Attending to their interpretive and emotional effects highlights new opportunities to design systems that support connection and shared understanding, alongside efficient data flow.
Pediatric oncology providers can help childhood cancer survivors protect their health by ensuring they receive routine preventive services. Management of these services by survivorship providers is necessary due to patients’ suboptimal rates of re‐engaging with pediatric primary care after treatment completion. This is especially the case with cancer prevention interventions, like human papillomavirus (HPV) vaccination, as survivors have greater confidence in the recommendations offered by their oncology versus primary care providers when counseling of this nature occurs. As these preventive pediatric interventions have traditionally been tested and delivered in primary care, they may lack appropriate tailoring or adaptation to the pediatric oncology setting. This article serves as a guide for using a best practice (ADAPT) framework for adapting and implementing a provider‐focused intervention to increase the uptake of HPV vaccination in the pediatric oncology setting. Once the rationale and guiding principles for engaging in this process are presented, the intervention adaptation processes are illustrated via descriptions of assessment, planning, piloting, evaluation, implementation, and maintenance. Additional considerations specific to the pediatric oncology setting are also provided. By applying ADAPT or other appropriate frameworks when adapting and implementing pediatric interventions in the cancer survivorship setting, progress will be made toward establishing a gold standard in approaching these tasks. Ultimately, these collective efforts will maximize the likelihood of effective intervention delivery and reduce health risk in this vulnerable population.
1543 Background: Treatment toxicity may limit the ability of cancer patients to receive all recommended cycles of therapy. Four to six cycles of docetaxel plus cyclophosphamide (TC) is a common adjuvant chemotherapy regimen for early-stage breast cancer. We assessed the impact of routine collection of patient-reported outcomes (PROs), coupled with a collaborative care model-based symptom management intervention, on the number of cycles of TC received by patients with breast cancer. Methods: The Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) trial was a cluster-randomized, pragmatic clinical trial, conducted between March 2019 and January 2023 at Mayo Clinic Rochester and within the Mayo Clinic Health System in Minnesota and Wisconsin. Patients regularly reported the severity of 6 SPPADE symptoms (Sleep deficit, Pain, Physical function impairment, Anxiety, Depression, and Energy deficit/fatigue) on 11-point numerical rating scales. Each symptom score was interpreted as none to mild (0-3), moderate (4-6), or severe (7-10). The E2C2 intervention included symptom management education modules, clinician decision support aids, and the option to discuss severe symptoms with a nurse, physical therapist, or social worker. Patients with breast cancer who received at least one cycle of TC were included in this analysis. We compared the number of cycles of docetaxel and cyclophosphamide completed by patients in the control condition versus those in the intervention condition. Results: We identified 198 patients with breast cancer who received TC during the control condition and 128 who received TC during the intervention condition. Median age was 61.3 years in the control group and 60.3 years in the intervention group, and 94% and 95% were white, respectively. Those receiving treatment during the control condition, on average, completed 3.53 cycles of docetaxel, while those receiving TC during the intervention condition completed 3.77 cycles ( p = 0.014). Seventy-eight percent in the control group completed at least 4 cycles of docetaxel, compared to 84% in the intervention group. Those receiving TC during the control condition completed an average of 3.71 cycles of cyclophosphamide, compared to 3.78 cycles in the intervention condition (p = 0.231). Eighty-four percent of patients in the control group and 86% in the intervention group completed at least 4 cycles of cyclophosphamide. Conclusions: Routine PRO surveillance, coupled with guideline-based collaborative care interventions, was associated with completion of a greater number of cycles of docetaxel. These findings suggest that routine symptom surveillance and management may enhance the docetaxel tolerance profile and improve treatment adherence in patients with early-stage breast cancer, allowing for delivery of an optimized treatment course.
Current literature lacks details on the impact of pediatric chronic graft-versus-host disease (cGVHD) on long-term survivorship after allogeneic hematopoietic cell transplantation (HCT). Nonetheless, cGVHD remains a leading cause of post-transplant morbidity and mortality in children and adolescents, which is particularly relevant given the longer life-expectancy after HCT (measured in decades) compared to older adults. To address this knowledge gap, leaders of the Pediatric Transplant and Cellular Therapy Consortium convened a multidisciplinary taskforce of experts in pediatric cGVHD and HCT late effects known as RESILIENT after Chronic GVHD (Research and Education towards Solutions for Late effects to Innovate, Excel, and Nurture after cGVHD). Our goals were to define: (1) the current state of understanding about how cGVHD impacts long-term survivorship in children transplanted <18 yr of age; (2) practical aspects of care to help clinicians managing long-term pediatric cGVHD survivors; and (3) develop a research framework for the next decade to further our knowledge. Four working groups were formed, each tasked with addressing a unique theme: (1) cGVHD natural history (phases of cGVHD) and its impact on clinicians' ability to taper and durably discontinue systemic therapy; (2) organ dysfunction and immune reconstitution in relation to survivorship; (3) how cGVHD and its treatment impact growth, metabolism, and development in children; and (4) psychosocial health and patient reported outcomes. The 4 groups met before the 2024 BMT Tandem Meeting in San Antonio, Texas, and then convened a larger in-person RESILIENT conference held on February 20, 2024, at the Tandem meeting to put forth recommendations from their respective working groups and garner feedback. These recommendations are now presented in a series of 4 manuscripts. This current manuscript focuses on the first theme and discusses the phases of cGVHD, challenges in differentiating clinically active from quiescent cGVHD in clinical practice, and the resultant difficulties in determining when and if to taper systemic therapy. To overcome these challenges, we propose revised categorization of long-term cGVHD outcomes and practical recommendations for clinicians and researchers around the long-term follow-up for these patients, including determining when and if to taper systemic therapy, along with the integration of non-immunosuppressive supportive care interventions. (c) 2024 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.