Quality Oncology Research Articles

The Oncology QCARD Initiative: Fostering efficient evaluation of initial real-world data proposals.

The oncology quality, characterization, and assessment of real-world data (Oncology QCARD) Initiative was formed to develop a set of minimum study design and data elements needed to evaluate the fitness of the real-world data (RWD) source(s) proposed in an initial study concept as part of early interaction with scientific reviewers. A multidisciplinary executive committee (EC) was established to guide the Oncology QCARD Initiative. The EC conducted a landscape review of published literature, guidances, and guidelines to evaluate relevant dimensions of data quality measurement. Guided by the review and informed by expert feedback, the Oncology QCARD Initial Protocol Characterization (IPC) provides a summary of minimum elements needed to adequately describe an initial clinical study concept that involves RWD and is intended to support decision-making. Fit-for-use data and fit-for-purpose design emerged as themes from the landscape analysis. Data that are fit-for-use are both relevant (sufficiently capturing exposure, outcomes, and covariates) and reliable (understanding data accrual and quality control and whether the data represent the underlying concepts they are intended to represent) to answer a specific research question. A fit-for-purpose design takes appropriate steps to ensure internal and external validity and allows for transparency in reporting. The QCARD-IPC focuses on high-level characteristics of RWD sources and study design domains including data temporality, population, medical product exposure, comparators, and covariates, endpoints, statistical analysis, and data quality assurance plans. Evaluation of studies including RWD requires understanding the data source, study design, and potential biases to preliminarily evaluate whether selected RWD are fit-for-use for the research question. The Oncology QCARD-IPC provides a structured, transparent approach to facilitate early review and enhanced communication between study sponsors and scientific reviewers of initial study proposals including RWD.

Evaluation of control arm quality in recent radiation oncology randomized clinical trials.

295 Background: Randomized controlled trials (RCTs) are designed to provide the highest levels of evidence for clinical practice; consequently, RCTs are the mainstay for creating guidelines and approving new treatments. It is ethically essential for patients assigned to the control arm in RCTs to receive standard-of-care treatment. This serves to protect patients, optimize adequate treatment, and ensures that RCT findings are compared to current standard-of-care therapy – an ethical imperative of RCT design and implementation. Oncologic medical trials investigating new systemic agents for cancer have a high proportion of RCTs with inadequate control arms (PMID 31046071). It is unknown whether this finding is prevalent in oncologic trials investigating radiation therapy (RT) for cancer. Methods: We identified registered clinical trials investigating RT in patients with cancer over the past decade. ClinicalTrials.gov was queried for RT as the intervention and cancer and other related terms as the condition between 1/1/13 and 1/1/23. Exclusion criteria included trials with incomplete status or non-oncologic indications. Trials were categorized by indication/primary disease site, first posted date, investigational arm, control arm, and sponsor/collaborator. Each control arm was analyzed, and the standard of care was determined according to National Comprehensive Cancer Center Network (NCCN) guidelines at the time of first posting on ClinicalTrials.gov. Results: A total of 508 interventional studies with results registered on ClinicalTrials.gov were included. Of these, 360 single-arm studies were excluded. 116 studies investigating a treatment other than RT were excluded. 20 studies that were not completed were excluded. The remaining 12 studies were included in the final analysis. Of the included trials, 2 each investigated RT usage in central nervous system, prostate, head and neck, and breast disease sites, and 1 each for lung, hepatobiliary, rectal, and bone disease sites. A majority of the trials were industry-funded (83%), and over 2/3 of studies took place in the United States (75%). 100% of the trials were found to have an adequate control arm per the corresponding NCCN guidelines. Conclusions: 100% of oncologic RCTs investigating radiation therapy for cancer were found to have an adequate control arm. This finding contrasts with medical oncology trials, which have been shown to have a high proportion of RCTs with inadequate control arms. This disparity highlights the importance of designing oncologic RCTs with adequate control arms, which is crucial for providing the highest level of evidence to guide optimal clinical practice and ensure the safety of patients. These findings indicate that the field of Radiation Oncology is ensuring ethical trial design with adequate control arm treatments and emphasizes the need for a continued focus on improving the quality of ethical oncologic research trials.

ASCO Domestic Quality Programs.

A growing sense of the need to define good-quality cancer care has emerged in the past decade of the 20th century. The goals were to assess, improve, and reward quality. Animated debates between cancer care delivery academic and community organizations, governmental agencies, and insurance companies have led to multiple initiatives and pilot projects. ASCO was on the cutting edge of quality in oncology movement. We can define three phases, overlapping rather than sequential, in ASCO's journey. The first phase was generating definitions of good-quality care characterized by the publication of ASCO guidelines. The second phase was the creation of the tools to measure the implementation of standards of care with the creation of the Quality Oncology Practice Initiative (QOPI). The third phase was the launch of a comprehensive approach to cancer care quality as illustrated by QOPI Certification, then the more complete iteration, ASCO Certified Program. The latter is the most elaborate program to define quality from the patient and health care providers' perspective on one hand and governmental agencies and insurance providers' perspective on the other. Since the publication of the Ensuring Quality Cancer Care Report in 1998 to the ASCO Certified in 2023, a quarter century has elapsed. ASCO did not operate in a vacuum. Through collaborative efforts, reacting to and interacting with various players, it has advocated for positive change. During this period, ASCO has led the movement of quality in oncology intelligently and with the upmost sense of responsibility toward the patients, health care professionals, and society at large. While many of these efforts began domestically, their reach is extending globally through research, education, and the promotion of equitable care.

Variation in Androgen Deprivation Therapy Use Among Men With Intermediate-Risk Prostate Cancer: Results From a Statewide Radiation Oncology Quality Consortium

PurposeFor men with intermediate risk prostate cancer treated with definitive therapy, the addition of androgen deprivation therapy (ADT) reduces the risk of distant metastasis and cancer-related mortality. However, the absolute benefit of ADT varies by baseline cancer risk. Estimates of prognosis have improved over time, and little is known about ADT decision making in the modern era. We sought to characterize variability and identify factors associated with intended ADT use within the [statewide quality consortium]. Materials and MethodsPatients with localized prostate cancer undergoing definitive radiotherapy were enrolled from 6/9/20 to 6/26/23 (n=815). Prospective data was collected using standardized patient, physician, and physicist forms. Intended ADT use was prospectively defined and is the primary outcome. Associations with patient, tumor, and practice-related factors were tested with multivariable analyses (MVA). Random intercept modeling was used to estimate facility-level variability. ResultsFive-hundred seventy patients across 26 facilities were enrolled with intermediate risk disease. ADT was intended for 46% of men (n=262/570), which differed by NCCN favorable intermediate-risk (FIR) (23.5%, n=38/172) vs unfavorable intermediate-risk (UIR) disease (56.3%, n=224/398), p<0.001. After adjusting for the statewide case mix, the predicted probability of intended ADT use varied significantly across facilities, ranging from 15.4% (95% CI 5.4-37.0%) to 71.7% (95% CI 57.0-82.9%), p<0.01. MVA showed that grade group 3 (OR 4.60 [3.20-6.67]), ≥50% positive cores (OR 2.15 [1.43-3.25]), and PSA 10-20 (OR 1.87 [1.24-2.84]) were associated with ADT use. AUC was improved when incorporating MRI adverse features (0.76) or radiation treatment variables (0.76), but there remained significant facility level heterogeneity in all models evaluated (p<0.05). ConclusionsWithin a state-wide consortium, there is substantial facility-level heterogeneity in intended ADT use for men with intermediate risk prostate cancer. Future efforts are necessary to identify patients who will benefit most from ADT and to develop strategies to standardize appropriate use.

Assessment of endocrine therapy adherence in a nurse-led cancer survivorship clinic: Results from the Linking You to Support and Advice (LYSA) trial.

1627 Background: The care of those living with and beyond a cancer diagnosis requires dedicated cancer survivorship services to ensure optimal symptom control and quality of life. Supporting adherence to adjuvant endocrine therapy is also an essential component of care. We examined endocrine therapy adherence rates, and factors associated with non-adherence, in patients with early-stage breast cancer enrolling in a survivorship trial (LYSA). Methods: Women with early-stage hormone positive breast (n=168) cancers within 12 months of completing primary therapy, were enrolled in a randomized control trial with parallel arms (PMID 36357934). Experimental arm had access to nurse-led symptom management, dietetic consultation, and undertook bimonthly electronic patient reported outcome (ePRO). Active comparator group had access to conventional care and ePRO was completed at beginning and end of study. Endocrine therapy adherence was reported as the ability to take medication as prescribed over prior 4 weeks (Michigan Oncology Quality Consortium Adherence Tool), with response quantified as Excellent (adherence close to 100%), Very Good (80%), Good (60%), Fair (40%) and Poor (20%). Adherence Objective (Secondary) was adherence rate at 12 months after study entry in both arms, and factors associated with non-adherence. Results: A total of 148/168 women with breast cancer who completed the LYSA study reported adjuvant endocrine therapy use (74 experimental arm, 74 active comparator) during study conduct. Therapies included aromatase inhibitors (53%), tamoxifen (39%) and ovarian suppression combinations (8%). At study entry ≥ 80% adherence was reported in 74% of overall cohort (75% experimental, 72% comparator, p=0.7), with 1.6% reporting not taking any medication. By end of study (12 months), ≥ 80% adherence was reported in 74% overall (77% experimental, 71% comparator, p=0.4), while non-adherence rates were 2.9%. Among the pre-specified reasons for non-adherence at study end, “simply missing it” ranked highest (10%), and 5% “experienced side effects”. Post-menopausal patients were more likely than pre-menopausal to report excellent (versus sub-excellent) adherence at study end (OR 4.60, 95%CI 1.45 – 16.13, p = 0.012, adjusted for arm, age, and ECOG). Additional exploration of reasons for non-adherence will be presented. Conclusions: Adjuvant endocrine therapy adherence rates in both arms at 12 months after study entry collected via ePRO were good (≥ 90% reporting excellent or very good adherence). Additional factors potentially associated with non-adherence are being analyzed including self-care agency, symptom burden and quality of life. Clinical trial information: NCT05035173 .

Evaluation of clinical adherence measures for oral oncolytics: A systematic review.

e23130 Background: Despite the critical importance of adherence monitoring for oral oncolytics, there are no standard measures for clinical practice. Methods: We conducted a systematic review using 4 databases aiming to characterize validated adherence monitoring tools utilized in either pre-implementation or evaluation of clinical programs. Various Medical Subject Headings (MeSH) and other search terms related to cancer, oral oncolytics, adherence, metrics, and outcomes were included. Measures used only for research (outside of clinical use) were excluded. Two independent reviewers screened articles with a third reviewer resolving discrepancies. Data extraction and quality assessments concluded the review. Results: Out of 751 screened articles, 73 proceeded to full-text review, with 6 selected for data extraction and quality assessment (Table 1). Two studies focused on the Morisky Medication Adherence Scale-8 (MMAS-8) tool, while others examined Michigan Oncology Quality Consortium Patient Reported Outcome Measure (MOQC PROM), 6-Item Girerd Scale, Medication Adherence Self-Efficacy Scale (MASES), and EXPeriencia con y ADherencia a AntiNEoplasicos Orales (EXPAD-ANEO). Among the five tools, MASES featured the most questions (24). All tools were implemented by healthcare professionals. Girerd and MASES were used specifically in hematologic and solid tumor populations respectively, whereas the remaining tools were applied in both cancer types. MMAS-8 and MASES were employed to evaluate current clinical programs, while MOQC PROM, Girerd, and EXPAD-ANEO were used during pre-implementation for future programs. Common biases from studies included limited generalizability, patient self-reported adherence credibility, and variability in patient baseline characteristics. Conclusions: Our findings highlight the paucity of validated adherence monitoring tools in clinical practice. The five tools discussed above exhibit potential in measuring adherence in a clinical setting; however, small sample size and short duration limit generalizability. Further investigation of new and existing tools in broader settings is needed. [Table: see text]

Compliance of Surgical Care in Patients with Carcinoma Endometrium in a Tertiary Care Centre in South India, to European Society of Gynaecologic Oncology (ESGO) Quality Indicators.

To analyse the compliance of surgical care provided to patients diagnosed with carcinoma endometrium, to the European Society of Gynaeacological Oncology (ESGO) quality indicators. This is a retrospective audit done in the Department of Gynaecologic Oncology. Electronic medical records of patients who underwent surgical management of carcinoma endometrium from January 2020 to December 2021 were assessed. A total of 163 patients had undergone primary surgery, and 2 patients had surgery for recurrence. The audit showed that the target for categories of general indicators and pre-operative work-up was met. There was lack in compliance to the intraoperative management, with only 34% among presumed early-stage disease undergoing successful MIS, 31% undergoing sentinel lymph node procedure and 53% among them being done using indocyanine green with 18% bilateral mapping rate. None of the patients had complete molecular classification. Compliance to adjuvant treatment provided was adequate. Minimal required elements in surgical reports were in 81% and pathological reports in 91% of patients falling short of the set target. The audit helped us identify the need to increase MIS and use and adapt sentinel lymph node procedure with ICG dye more aggressively. There also is a need for improvement in documentation of pertinent information on surgical and pathology reporting. Molecular classification should be routinely incorporated into the diagnostic algorithm to aid in adjuvant therapy.

Ovarian cancer management in an ESGO ovarian cancer center of excellence: a systematic case study of the interprofessional and interdisciplinary interaction

PurposeWith growing knowledge about ovarian cancer over the last decades, diagnosis, evaluation and treatment of ovarian cancer patients have become highly specialized, and an individually adapted approach should be made in each woman by interdisciplinary cooperation. The present study aims to show the variety and extent of medical specialties involved at our institution according to the European Society of Gynecologic Oncology (ESGO) Quality indicators (QI).MethodsA woman, diagnosed with high-grade ovarian cancer, International Federation of Gynecology and Obstetrics (FIGO) class IVb was selected for a single case observational study. The observation period (total = 22d) comprised preoperative diagnostic procedures, including imaging, the in-patient stay for cytoreductive surgery, and the postoperative course and case discussion at our interdisciplinary tumor board. Data were obtained by self-reporting and by patient file review.ResultsPatient tracking demonstrated an interdisciplinary cooperation of 12 medical specialties [62 physicians (63% male, 37% female)], 8 different types of nursing staff [n = 59 (22% male, 78% female)], and 9 different types of perioperative/administrative staff (n = 23; male 17,4%, female n = 19, 82,6%). Contact with the patient was direct (n = 199; 76%) or without face-to-face interaction (n = 63; 24%).ConclusionThe present study demonstrates the high diversity of physicians and the affiliated medical staff, as well as interdisciplinary intersections within teams of a specialized hospital. Matching the ESGO QIs, this report underlines the requirement of an adequate infrastructure for the complex management of advanced ovarian cancer patients.Future prospective studies are warranted to evaluate the specific procedures and actions to optimize the interprofessional and interdisciplinary workflows.

Translation, Cultural Adaptation, and Validation of the Indonesian Version of the Quality of Oncology Nursing Care Scale (QONCS)

A validated instrument is crucial for assessing oncology nursing care in Indonesia. This study focused on translating, adapting, and validating the QONCS among Indonesian cancer patients and families. Initial feedback from nursing academicians and pilot participants guided the adaptation process. Validation involved distributing the instrument via Google Forms to 8 cancer referral hospitals, gathering responses from 148 individuals. Confirmatory factor analysis (CFA) assessed validity, while Cronbach's alpha measured internal consistency. Synonyms and examples were added to enhance item clarity. Eight items were removed due to poor construct validity, resulting in improved statistics (r statistic: 0.653-0.818; average variance extracted: 0.742). The revised instrument demonstrated high reliability (Cronbach's alpha: 0.967). This study confirms the Indonesian QONCS version as a valid and reliable tool for evaluating oncology nursing care. It is recommended for oncology nurses to utilize the QONCS to enhance the quality of care provided.

An observational, cross-sectional study to assess the quality of life (QoL) of family caregivers of patients diagnosed with cancer

Globally, cancer has a major impact on society, and the burden continues to grow by exerting physical, emotional, and financial strain on patients, families, societies, and healthcare systems. Cancer greatly affects not only patients, but also their families. Family caregivers are invisible to healthcare teams, but play an important role in the recovery of cancer patients. Cancer can worsen a family caregiver’s health, impair social life, increase anxiety, and cause depression. It is important to identify and deal with various domains affected by cancer to enhance the quality of life (QoL) of family caregivers. This is a prospective, observational, cross-sectional, questionnaire-based study, to assess the impact of cancer on the quality of life of family caregivers. The primary objective is to measure the effect of cancer diagnosis and its treatment on family caregivers’ quality of life using the CarGOQoL (CareGiver Oncology Quality of Life) questionnaire. The secondary objective is to determine the relationship between quality of life, socio-demographic variables, and cancer disease variables. Family caregivers who are associated with the care of cancer patients for at least two–three hours a day will be recruited in the study after signing the voluntary informed consent form. The CarGOQoL questionnaire will be used to record the responses from the participants. Domains such as psychological well-being, burden, relationship with healthcare, administration and finances, coping, physical well-being, self-esteem, leisure, social support, and private life will be recorded. Approximately 100 participants will be recruited for the study. Data analysis will be performed at the end of participant recruitment. Healthcare and social workers can enhance the quality of life of family caregivers by using the results of the CarGOQoL questionnaire, and better understand the different domains of QoL impacted by cancer.

Cross-Cultural Validation of the Portuguese Version of the Quality of Oncology Nursing Care Scale.

Quality assessment in oncology nursing care has been a growing topic in the literature, gaining relevance as oncological nursing care becomes more complex as the science progresses. However, there are no instruments that assess the perception of the quality of oncology nursing care from the point of view of patients for the Portuguese population. Thus, the cross-cultural translation and validation of the Quality of Oncology Nursing Care Scale (QONCS) was performed for the Portuguese context. This instrument allows nurses to assess patients' self-perception of the quality of nursing care provided in an oncological setting. It also allows researchers to compare the results obtained internationally with the application of this scale. This is a methodological study, with two distinct phases: the first corresponded to the translation and cultural adaptation of the scale to the Portuguese context, and the second consisted of the psychometric validation of the QONCS, which included factor analysis and the evaluation of the psychometric properties of the instrument. We obtained responses from 402 patients from a Portuguese oncology hospital. The Portuguese version of the Quality of Oncology Nursing Care Scale (QONCS_PT) consists of 34 items inserted into a tetra-factorial model, which explains a total variance of the instrument of 69.8%. A Cronbach's alpha of 0.93 was obtained for the complete instrument. QONCS_PT has a competent and reliable structure. The scale's validity was assured and can be used in the Portuguese population, as it is useful for direct care provision but also for researchers and managers.

Microboost dose escalation for localized prostate cancer within a statewide radiation oncology quality consortium.

298 Background: The phase III FLAME trial demonstrated that in localized prostate cancer, an external beam radiotherapy (EBRT) simultaneous integrated microboost to an MRI-defined dominant intraprostatic lesion improves biochemical control without affecting toxicity and quality of life. Given the complexity required to deliver high microboost doses, we hypothesized that practice patterns are variable in clinical practice. We aimed to characterize microboost utilization and evaluate dosimetric parameters within the statewide Michigan Radiation Oncology Quality Consortium (MROQC). Methods: Men with intermediate or high-risk prostate adenocarcinoma treated with curative intent radiotherapy for intact disease were included. Data was prospectively collected, including T/N-category, Gleason score, prostate-specific antigen, and percent positive biopsy cores. Full DICOM files were available for dosimetric data. Multivariable analyses (MVA) were used to evaluate associations between receipt of microboost, known prognostic factors, and fiducial marker and rectal spacer placement (advanced image guided radiation therapy (IGRT)). Results: From 10/26/20 to 06/26/23, 741 patients across 26 centers were enrolled, 71% (n=528) with intermediate-risk and 29% (n=213) with high-risk disease. Androgen deprivation therapy was planned in 61%. EBRT + whole-gland brachytherapy boost was utilized in 29% (n=217/741) of patients. Of those treated with EBRT (71%, n=524/741), 10% received a microboost (n = 53/524). Brachytherapy boost and microboost were used in 9 and 7 centers, respectively. Most patients received either conventional fractionation or moderate hypofractionation- 11% and 66% in EBRT without microboost and 21% and 60% with microboost, respectively. Microboost treatment was associated with use of a planning MRI (91% vs. 62%, p &lt;0.0001) as well as fiducial marker and rectal spacer placement (76% vs. 45%, p &lt;0.0001). Median prostate planning target volume (PTV) was smaller in microboost patients (127 cc vs. 91 cc, p = 0.002); median boost volume was 21 cc. Median boost dose (D0.1cc) was 117% (IQR 115% – 119%) of the PTV prescription. Microboost patients had significantly higher mean bladder D1cc[%] (105.7% vs. 103.4%, p = 0.002) and numerically lower rectal D1cc[%] (90.7% vs. 94.1%, p = 0.065). On MVA, receipt of microboost was significantly associated with grade group 4 or 5 disease, planning MRI use, and fiducial and rectal spacer use. Conclusions: Within a large, diverse prospective cohort of men with prostate cancer treated in both academic and community settings, a microboost was utilized in 10% of EBRT cases. Microboost use was associated with higher grade group, MRI planning, and advanced IGRT. EBRT microboost is an emerging dose escalation strategy and further studies confirming safety and improved clinically meaningful outcomes may increase uptake in routine practice.

Contemporary androgen deprivation therapy practice patterns in locally advanced prostate cancer treated with definitive radiotherapy: Prospective results from a statewide radiation oncology quality consortium.

307 Background: Androgen Deprivation Therapy (ADT) is a critical treatment component for men with locally advanced prostate cancer receiving definitive radiotherapy. National guidelines recommend 18-36 months of ADT for men with high-risk disease, along with androgen receptor signaling inhibitors (ARSI) for those with very high-risk and clinical node positive disease. However, minimal data exist regarding treatment intent in the real-world setting. Given the rapid rate of scientific advances with respect to ADT types and duration, we hypothesized significant practice pattern variation. Using prospectively collected data, we sought to characterize patterns of care within the Michigan Radiation Oncology Quality Consortium (MROQC). Methods: This analysis includes men enrolled in MROQC with intact, non-metastatic, high-risk, or clinical node-positive (cN1) disease. Patient, tumor, and treatment data were prospectively collected at baseline and follow-up using standardized data elements. Physicians prospectively documented intent, type, and duration of ADT. Our primary outcome was guideline-concordant intended use ADT of ≥18 months. Secondary analyses included ARSI use among patients meeting eligibility for STAMPEDE high-risk M0/N1. Univariable (UVA) and multivariable (MVA) analyses were conducted to determine associations with T/N category, grade group, prostate specific antigen (PSA) and practice-related factors. Results: Between 6/9/20 to 6/30/23, 234 men across 26 centers were identified, all of whom should receive ≥18 months of ADT per NCCN guidelines. Eight percent (18/234) had locally advanced T3/4 disease, and 8% (n=18/234) had cN1 disease. Most men had grade group 4 (48%, n=112/234) or 5 (24%, n=56) adenocarcinoma. Intended ADT duration was known for 88% (n=207). ADT use ≥18 months was planned for 56% (n=115/207), &lt;18 months in 30% (n=63/207), and no ADT was intended for 14% (n=29/207) of men. On MVA, grade group 4-5 and PSA &gt;40 were the strongest drivers of guideline-concordant intended ADT. There were no significant associations with comorbidities or race. STAMPEDE M0/cN1 criteria were met for 15% (n=36/234). Intended ARSI use in this subset was 19% (n=7/36), including 26% (n=6/23) of patients treated after publication of STAMPEDE M0/N1. Conclusions: Within a diverse state-wide consortium of academic and community practice, guideline concordant intended ADT use was 56% and was associated with higher risk tumor features. Fewer than 1 in 5 treated with curative intent radiotherapy met STAMPEDE high-risk M0/N1 criteria, and ARSI use among these men was less than 20%. Future work will evaluate patient and practice level drivers of the variation. [Table: see text]

A Multi-Institutional Natural Language Processing Pipeline to Extract Performance Status From Electronic Health Records.

Performance status (PS), an essential indicator of patients' functional abilities, is often documented in clinical notes of patients with cancer. The use of natural language processing (NLP) in extracting PS from electronic medical records (EMRs) has shown promise in enhancing clinical decision-making, patient monitoring, and research studies. We designed and validated a multi-institute NLP pipeline to automatically extract performance status from free-text patient notes. We collected data from 19,481 patients in Harris Health System (HHS) and 333,862 patients from veteran affair's corporate data warehouse (VA-CDW) and randomly selected 400 patients from each data source to train and validate (50%) and test (50%) the proposed pipeline. We designed an NLP pipeline using an expert-derived rule-based approach in conjunction with extensive post-processing to solidify its proficiency. To demonstrate the pipeline's application, we tested the compliance of PS documentation suggested by the American Society of Clinical Oncology (ASCO) Quality Metric and investigated the potential disparity in PS reporting for stage IV non-small cell lung cancer (NSCLC). We used a logistic regression test, considering patients in terms of race/ethnicity, conversing language, marital status, and gender. The test results on the HHS cohort showed 92% accuracy, and on VA data demonstrated 98.5% accuracy. For stage IV NSCLC patients, the proposed pipeline achieved an accuracy of 98.5%. Furthermore, our analysis revealed a documentation rate of over 85% for PS among NSCLC patients, surpassing the ASCO Quality Metrics. No disparities were observed in the documentation of PS. Our proposed NLP pipeline shows promising results in extracting PS from free-text notes from various health institutions. It may be used in longitudinal cancer data registries.

Leveraging oncology collaborative networks and biomedical informatics data resources to rapidly recruit and enroll rural residents into oncology quality of life clinical trials.

This study assesses the feasibility of biomedical informatics resources for efficient recruitment of rural residents with cancer to a clinical trial of a quality-of-life (QOL) mobile app. These resources have the potential to reduce costly, time-consuming, in-person recruitment methods. A cohort was identified from the electronic health record data repository and cross-referenced with patients who consented to additional research contact. Rural-urban commuting area codes were computed to identify rurality. Potential participants were emailed study details, screening questions, and an e-consent link via REDCap. Consented individuals received baseline questionnaires automatically. A sample minimum of n = 80 [n = 40 care as usual (CAU) n = 40 mobile app intervention] was needed. N = 1298 potential participants (n = 365 CAU; n = 833 intervention) were screened for eligibility. For CAU, 68 consented, 67 completed baseline questionnaires, and 54 completed follow-up questionnaires. For intervention, 100 consented, 97 completed baseline questionnaires, and 58 completed follow-up questionnaires. The CAU/intervention reached 82.5%/122.5% of the enrollment target within 2 days. Recruitment and retention rates were 15.3% and 57.5%, respectively. The mean age was 59.5 ± 13.5 years. The sample was 65% women, 20% racial/ethnic minority, and 35% resided in rural areas. These results demonstrate that biomedical informatics resources can be highly effective in recruiting for cancer QOL research. Precisely identifying individuals likely to meet inclusion criteria who previously indicated interest in research participation expedited recruitment. Participants completed the consent and baseline questionnaires with zero follow-up contacts from the research team. This low-touch, repeatable process may be highly effective for multisite clinical trials research seeking to include rural residents.

QOL-08. LONGITUDINAL EFFECTS OF A PSYCHOLOGICAL INTERVENTION FOR CAREGIVERS OF PATIENTS WITH PRIMARY MALIGNANT BRAIN TUMORS: SECONDARY ANALYSIS OF A RANDOMIZED CONTROLLED TRIAL

Abstract BACKGROUND Caregivers of patients with primary malignant brain tumors (PMBT) experience high rates of anxiety. In our randomized controlled trial assessing the effects of a caregiver-directed, telehealth-based psychological intervention (“NeuroCARE”), NeuroCARE participants had significantly lower anxiety symptoms (primary outcome) and depression symptoms, and better self-efficacy and coping immediately post-intervention compared to usual care (UC). We subsequently examined the longitudinal effects of NeuroCARE on caregiver-reported outcomes across all study timepoints. METHODS We enrolled and randomized 120 caregivers of patients with PMBT to NeuroCARE (N = 60) versus usual supportive care (N = 60). Eligible participants had significant baseline anxiety symptoms (Generalized Anxiety Disorder-7 score ≥ 5). We collected caregiver-reported anxiety symptoms (Hospital Anxiety and Depression Scale (HADS)–Anxiety Subscale), depression symptoms (HADS–Depression Subscale), self-efficacy (Lewis Cancer Self-Efficacy scale), coping (Measure of Current Status), quality of life (QOL; CareGiver Oncology Quality of Life survey), caregiver burden (Caregiver Reaction Assessment) and post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for DSM-5) at baseline, 11 weeks (immediately post-intervention) and 16 weeks (one-month post-intervention). We used mixed effects linear regression models to assess longitudinal intervention effects on study outcomes. RESULTS Enrolled caregivers had a mean age of 53 years; the majority were female (99/120; 82.5%) and were the patient’s spouse/partner (84/120; 70%). NeuroCARE participants experienced greater improvement than UC in depression symptoms (change/week [slope]: -0.09 vs. -0.01, p = 0.041), self-efficacy (slope: 0.64 vs. -0.17, p = 0.006) and coping (slope: 0.31 vs. -0.01, p &amp;lt; 0.001). We observed non-statistically significant differences between NeuroCARE and UC for change in anxiety symptoms (slope: -0.13 vs. -0.05, p = 0.059) and QOL (slope: 0.26 vs. 0.04, p = 0.050). Study arms did not differ in longitudinal trajectories for caregiver burden or PTSD symptoms. CONCLUSIONS NeuroCARE participants experienced greater improvements over time in depression symptoms, self-efficacy, and coping than UC participants, highlighting the sustained benefits of this caregiver-directed supportive intervention.

Creation and evaluation of oral anticancer agent (OAA) management resources for a thematic quality improvement program.

380 Background: The Hematology/Oncology Pharmacy Association (HOPA) supported a 6-month American Society of Clinical Oncology (ASCO) Quality Training Program (QTP) for its members focused on oral anticancer agent (OAA) management. HOPA’s Oral Chemotherapy Collaborative (OCC) developed 3 resources for use – an OAA program/practice self-assessment, OAA self-reported adherence guide, and OAA dashboard reporting guide. The purpose of this study is to describe resource development and feedback provided by participants. Methods: Three resources were developed by HOPA OCC. The OAA program/practice self-assessment was created based on Michigan Oncology Quality Consortium (MOQC’s) pre-existing OAA self-assessment with the goal of helping practices assess gaps in care and focus area during quality improvement (QI). The OAA adherence guide focused on the clinic-based patient-facing assessment of OAA adherence that identified three recommended adherence surveys and guidance based on responses. Finally, the OAA dashboard guide was created to help sites track their workload and quality-based metrics and included 2 sections – Administrative and Outcome/Quality Metrics. Resources were provided to teams during the 6-month program and feedback related to their usefulness was requested following programming in June 2023. Results: The sample includes 9 respondents from 7 of 9 participating sites. The majority of respondents found the self-assessment to be useful and would recommend its use (Table). Participants ranked the 1-item adherence question as their top preference for self-reported adherence. Of the dashboard administrative metrics, OAA volume, prescription capture rate, and visits were most selected as useful. For the dashboard outcome/quality metrics, number of interventions, patient reported outcomes, time from OAA prescribed to dispense date, prescribed date to start date, prescribed date to 1st follow-up, percent patients receiving education, percent patients with follow-up within defined time period, and percent patients with OAA adherence assessed were most useful. Resources, priority, information technology, and time were most selected as barriers to implementation of the resources. 100% of survey respondents indicated they were likely to recommend participating in the HOPA-ASCO QTP programming. Conclusions: Overall, the thematic programming with resources from HOPA’s OCC was useful. Multiple barriers exist to incorporate best practice aspects of OAA program implementation.[Table: see text]

Update of ongoing organizational partnership expanding ASCO Quality Training Program to oncology pharmacists.

377 Background: Pharmacists have a recognized role in optimizing medication management and enhancing patient quality of care. The Hematology/Oncology Pharmacy Association (HOPA) partnered with American Society of Clinical Oncology (ASCO) Quality Training Program (QTP) to provide 1-day HOPA sponsored HOPA-ASCO QTP Workshops for HOPA members to enhance knowledge and skills related to oncology quality improvement (QI). The Workshop has been given annually from 2019-2022. Methods: The 1-day Workshop is a condensed overview of foundational quality improvement principles and methodologies consistent with ASCO’s QTP 6-month curriculum. These Workshops were tailored for HOPA members with examples specific to challenges routinely met by oncology pharmacists and leveraged prior HOPA-workshop participants to moderate breakout sessions. Surveys were formulated to assess knowledge pre- and post-participation as well as actionable efforts participants made given knowledge gained from the workshop. Results: A total of 124 HOPA members from 83 different oncology institutions have participated in the four workshops. With a 83% post-participation survey response rate, measures of knowledge and competency increased after participation. Knowledge increased an average of 3.3 points from 3.99 to 7.31 (1-10 scale) and competence increased an average of 3.1 points from 3.82 to 6.91. Ninety-nine percent of respondents were extremely or very likely to recommend someone to participate in the workshop, and 99% were extremely or very likely to continue using the skills gained in their practice. In the 3-month follow-up survey (41% response rate), 84% of respondents indicated they used the skills gained from the program somewhat, very or extremely often and 80% had or were planning to develop a QI project. Top reasons for participation were: content focused on cancer care, ASCO’s reputation, and the comprehensive training in the science of quality improvement. Seven participants completed the ASCO QTP 6-month course after participating in the Workshop. Conclusions: Consistent positive feedback from participants and aligned organizational priorities in improving the quality of care of cancer patients facilitates this continued organizational collaboration. Future workshops will consider feedback from participants to optimize the learning environment and program outcomes. This Workshop is the only quality improvement training program focused specifically on oncology pharmacists providing excellent training and education to HOPA members.

Multisite results from a practice-based self-assessment for oral anticancer agent (OAA) management.

434 Background: The Hematology/Oncology Pharmacy Association (HOPA) supported a 6-month American Society of Clinical Oncology (ASCO) Quality Training Program (QTP) focused on oral anticancer agent (OAA) management. HOPA’s Oral Chemotherapy Collaborative, developed an OAA self-assessment tool to aid in identifying gaps in care regarding OAAs. The purpose of this study is to describe the results of the OAA baseline self-assessment completed by the participating teams. These results will provide insight into areas of future focus for OAA-based quality improvement. Methods: This multisite, retrospective analysis was conducted in September 2022, prior to the HOPA-ASCO QTP program launch. The OAA Self-Assessment was created by HOPA’s Oral Chemotherapy Collaborative utilizing Michigan Oncology Quality Consortium (MOQC’s) pre-existing OAA self-assessment as a guide. The final self-assessment included standards from MOQC, HOPA, and ASCO/ONS and took approximately 10 minutes to complete. Questions were categorized in the following 6 sections: Prescribing (n=25), Education (n=17), Dispensing/Distribution (n=5), Monitoring and Follow-Up (n=8), Practice Management (n=3), and Optimal-State Recommendations (n=4). Team leads from each of 9 participating sites focusing on OAA quality improvement were asked to share the anonymous assessment with team members at their sites who provide care to patients taking OAAs. All response choices were categorized as “never”, “sometimes”, or “always” for the degree to which the OAA standard is followed at the site. Frequency distributions are reported. Results: 105 clinicians (39 pharmacists, 34 nurses, 20 physicians, 10 NP/PAs, and 2 pharmacy technicians) completed the baseline self-assessment from 9 sites. Most standards had a response of “sometimes” or “always”. The area with the largest number of “always” was related to the completion of the OAA prescription. Of the 62 standards, 38 (61%) had at least 1 respondent select “never” and 4.5 respondents/standard (range 1 – 15) selected “never”. Standards that had the highest “never” responses were patient satisfaction monitoring (n=15), use of survivorship program for transition to primary care when appropriate (n=14), use of social determinants of health in OAA treatment decisions (n=13), documentation of treatment consent (n=12), use of therapeutics committee to determine place in therapy of OAAs (n=12), and use of collaborative practice agreements for pharmacists as part of the oncology care team (n=12). Conclusions: Adherence to OAA standards varied between the participating sites. A standardized baseline assessment evaluating current state is helpful in identifying gaps in care and targets for future quality improvement.

Impact and value of olanzapine as part of a 4-drug regimen in patients receiving high emetic risk chemotherapy.

293 Background: The Michigan Oncology Quality Consortium, MOQC, has increased the use of olanzapine as part of a 4-drug antiemetic regimen for high emetic risk chemotherapy in many of its 50 practices across Michigan. The purpose of this project was to estimate the impact of olanzapine prescribing on health care utilization and subsequent savings in healthcare utilization payments in patients with breast cancer on (neo)adjuvant doxorubicin and cyclophosphamide (AC) for breast cancer. Methods: Multipayer claims data were used from the Michigan Value Collaborative (MVC), a collaborative quality initiative of over 100 hospitals and 40 physician organizations with the goal of improving healthcare value. We identified a cohort of female patients with a 90-day episode of care for breast cancer resection between 2016-2021 who received chemotherapy with AC as (neo)adjuvant chemotherapy. Patients were covered by Blue Cross Blue Shield of Michigan insurance plans or Medicare. Each patient was attributed to one practice using National Provider Identifiers on professional claims. Facility claims were used to identify inpatient admissions and emergency department (ED) visits across the patient’s course of chemotherapy, up to 21 days following final chemotherapy. Practice-level use of olanzapine abstracted by MOQC as part of ASCO’s Quality Oncology Practice Initiative (QOPI™) data collection was used to determine whether each patient's chemotherapy treatment began when the practice had “high” (≥25%) or “low” (&lt;25%) rates of olanzapine use for high emetic risk chemotherapy. We compared healthcare utilization among patients treated by high- vs. low-prescriber practices and calculated the estimated differences in price-standardized payments attributed to olanzapine use. Results: We identified 1,891 total patients attributed to 45 MOQC practices; 922 patients were attributed to 15 practices that eventually became high prescribers. Patients treated by a high olanzapine prescribing practice had significantly lower hospitalization rates (10%) during chemotherapy compared to patients treated when their attributed practice was a low olanzapine prescriber (15%, p=0.02). There was no difference in the proportion of patients visiting the ED. The mean per-patient price-standardized insurance payment for inpatient hospitalization for this cohort was $12,007. Increased use of olanzapine led to an estimated payment savings of $334,095 in prevented hospitalizations among 525 patients treated when their attributed practice had a high olanzapine prescribing rate. Conclusions: In this patient sample, practice use of olanzapine in ≥ 25% of patients on high emetic risk chemotherapy was associated with significant reductions in the risk of hospitalization. As the proportion of patients receiving olanzapine increases, we expect even greater reductions in the risk of hospitalization and greater cost savings.