BACKGROUND:The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 Physical Functioning subscale is a widely used patient-reported outcome measure that quantifies cancer patients' physical functioning. Strong floor/ceiling effects can affect a scale's sensitivity to change. The aim of this study was to characterize floor/ceiling effects of the physical functioning domain in patients with advanced/metastatic breast cancer enrolled in commercial clinical trials and a community-based trial. METHODS: The clinical trial cohort comprised patients from 5 registrational trials submitted to the Food and Drug Administration for review (2010)(2011)(2012)(2013)(2014)(2015)(2016)(2017). The community cohort comprised a subgroup of patients from the Alliance Patient Reported Outcomes to Enhance Cancer Treatment (PRO-TECT) trial. The distribution of patient responses to Physical Functioning items and the summed score were assessed at the baseline and 3-month follow-up for both cohorts. Descriptive statistics were used to determine floor/ceiling effects at the item and scale levels. RESULTS: The clinical trial cohort and the community cohort consisted of 2407 and 178 patients, respectively. Twenty-four percent or more of the respondents reported "not at all" for having trouble/needing help with each Physical Functioning item across both cohorts and measurement time points. Fourteen to twenty percent of the patients scored perfectly (100 of 100) on the Physical Functioning subscale summary measure (where higher scores indicated better physical functioning) across both cohorts and time points. CONCLUSIONS: Minor floor effects and notable ceiling effects were found at the item and scale levels of the Physical Functioning subscale, regardless of cohort, and this creates some uncertainty about its ability to detect changes in physical functioning among high-functioning patients. Investigators may consider adding additional high-functioning items from the EORTC's item library to more accurately describe the impact of anticancer treatment on patients' physical functioning.
We thank Vachon and colleagues for their comments on our publication regarding floor and ceiling effects in the European Organisation of Research and Treatment for Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Physical Functioning (PF) domain. 1 In this article, we assessed the QLQ-C30 PF domain for floor and ceiling effects at both the item and scale levels in patients with advanced/ metastatic breast cancer. On the basis of our results, we suggested that the PF domain might have limited sensitivity for detecting changes in PF among patients with advanced/ metastatic breast cancer who are high functioning at the baseline.Vachon et al point out that the definition we used for a ceiling effect at the scale level (≥93.3 of 100) is not conventional. Our selection of this threshold is described in the article, in which we note that patients who scored 93.3 on the summary measure had high functional capacity at the baseline because they reported having no trouble with 4 of 5 PF items and only a little trouble with 1 item. Because almost all items were answered with the best response option and only a single item was answered with the second best response option, we elected to include these patients in our study's definition of having met the ceiling effect. We acknowledge that this is unconventional and state in our article that this definition was limited to our study and not broadly used. We also presented results for both those who scored 93.3 and those who scored 100 separately rather than in aggregate and thus allowed readers the opportunity to interpret our results with either threshold.We agree with Vachon et al that the presence of floor and ceiling effects is not unique to the QLQ-C30 PF domain and is a potential concern for most static questionnaires in which lower and higher bounds exist. We acknowledge that it is impossible for any short form to be fully responsive to the entire spectrum of PF. Instruments like the QLQ-C30 that are designed to be used across a broad range of contexts need to balance coverage of all possible functional levels with the number of questions 2387
180 Background: Patients who engage in decision making are more likely to experience confidence in treatment decisions, satisfaction with treatment, and trust in clinicians. The Association of Community Cancer Centers (ACCC) conducted a survey to explore multidisciplinary team attitudes and practices around shared decision-making (SDM) and health literacy. Methods: ACCC convened a steering committee of multidisciplinary specialists and advocacy representatives to guide this research. The survey included 26 mostly closed-ended questions and was open to multidisciplinary cancer programs from 10/29/19 to 2/20/20. Exploratory analysis was performed on this data set of 305 complete responses. Results: While most respondents reported engaging patients in decision-making to some degree, only 50% reported that SDM is a top organizational priority. 33% reported organizational efforts to formally integrate SDM into the clinical workflow, with only 15% indicating staff opportunities for basic SDM training. The three most frequently cited perceived barriers to engaging in SDM were patients feeling overwhelmed (53%), wanting to defer decisions to clinicians (46%), and having limited health literacy (46%). Only 13% indicated that lack of time was a barrier. Less than half (41%) of respondents reported using patient decision aids to support SDM. Respondents represented a wide range of multidisciplinary team members, though surgical oncologists and general surgeons (20% and 16% respectively) are overrepresented in the results. Conclusions: SDM is commonly accepted as essential to patient engagement but clarity in terminology and prioritizing formal integration of SDM into practice is limited. Strategies to improve integration of SDM into oncology practice should include: 1) Educational initiatives and tools to overcome barriers to SDM, including patient decision aids and SDM training, 2) Initiatives to address health literacy as it relates to patient and caregiver engagement in decision making, 3) Psychosocial support for patients whose emotional upset is a barrier to SDM, 4) Healthcare policies that encourage and incentive providers to engage in SDM. Future analyses will require concurrent assessment of patient, caregiver, healthcare professional, and administrator perspectives.
271 Background: Financial toxicity can be a devastating side effect for patients with cancer and their families, and may impact access to and delivery of care, treatment compliance, and outcomes. Financial advocates mitigate financial toxicity for patients and their families, liaise between payers/providers/pharmacies/patients, support shared decision-making and care planning processes through provision of cost and coverage information, and mitigate institutional financial toxicity. Training on effective financial navigation interventions, financial health literacy, patient engagement, oncology fundamentals, and measurement of impact is critical for advocates. Methods: The Association of Community Cancer Centers (ACCC) Financial Advocacy Boot Camp is a self-paced eLearning program consisting of 9 modules designed to build knowledge and skills of financial advocates. Users interact with education across two levels within the ACCC Learning Management System. To evaluate effectiveness of this content, pre- and post-assessments and evaluation forms for registered learners from 1/1/2020 to 12/31/20 were exported and exploratory analysis was performed on this data set of 538 participants. Results: 51% of respondents are oncology financial advocates; 7% are industry representatives; and the remaining 42% are a mix of patient navigators, nurse navigators, social workers, pharmacists, APPs, and nurses. 363 participants fully completed at least one of two levels. Most participants agreed or strongly agreed that each of the modules improved their knowledge and skills: 94% increased their ability to incorporate effective screening methods to identify patients at risk of financial toxicity, 95% are better able to review the evolving landscape of health insurance provided by public and private payers, and 97% both increased their ability to find patient assistance programs and resources for patients and can describe how to guide patients through the process of improving insurance coverage. 79% identified specific examples of what they will do differently after the training, including implementing screening and follow-up protocols, adjusting communication approaches with patients, proposing quality improvement projects, and accessing resources. Conclusions: Training, such as the Financial Advocacy Boot Camp, that builds knowledge and skills in financial screening, communication, and navigation can help cancer programs improve staffs’ ability to mitigate patient and institutional financial toxicity. Future research efforts should further define financial advocacy competencies, measure patient and institutional impact of financial navigation interventions, and assess effective practices for implementation of financial advocacy training in cancer programs.
307 Background: In the US, more than 12,000 people die from ovarian cancer annually. Although new treatments have recently become available, ovarian cancer care delivery remains suboptimal. The Association of Community Cancer Centers (ACCC) developed a series of initiatives to improve the quality of care for patients with ovarian cancer. In Phase I, ACCC evaluated the needs of cancer programs, conducted 3 quality improvement (QI) workshops, and developed expert-driven Quality of Care recommendations to aid cancer programs in self-assessment and quality improvement. In Phase II, ACCC invited programs to self-assess their level of care using the Quality of Care recommendations. Methods: In 2022, ACCC surveyed 7 ovarian cancer programs across the US. Developed by a multidisciplinary expert steering committee, the 26-question survey assessed the patient populations served, services provided, diagnostic evaluations performed, access to molecular testing, and a self-assessment of quality care delivery and interest in conducting QI projects related to self-identified needs. The survey was administered in Qualtrics and summarized using descriptive statistics. Results: Surveys were completed by 1 community, 2 comprehensive community, 2 hospital-associated, 1 academic comprehensive, and 1 NCI-designated comprehensive cancer programs. The median annual ovarian cases was 40 [range: 2 to 68]. The 7 programs serve diverse racial/ethnic distribution of patients with ovarian cancer ranging from 55% Black to 60% Asian and 30% Pacific Islander. Five programs have a multidisciplinary team for ovarian cancer. All 5 multidisciplinary teams included gynecologic oncology and pathology; 3 teams also included medical oncology and or radiology colleague(s). Sites assessed their level of care for 7 domains of quality care from 1 (lowest) to 5 (highest). The average score was 4.0 for Care Coordination and Patient Education, Treatment Planning, and Disease Surveillance. Diagnosis and Initial Management scored on average 3.8, Equity in Care 3.25, Prevention and Screening 3.25, and Quality of Life 3.2. Sites ranked areas of interest for future QI projects (1 = area of most interest, 7 = area of least interest). The highest ranked domains were Care Coordination and Patient Education as well as Diagnosis and Initial management (average rankings 2.8). These were followed by Quality of Life (average 3.0), Prevention and Screening (Average 3.8), Treatment Planning (Average 4.4), Equity in Care (Average 5.0), and Disease Surveillance (Average 6.2). Conclusions: This assessment will be used to identify 4 additional sites for Phase II QI workshops. Findings from these projects will be combined, summarized, and disseminated to inform future education opportunities and QI initiatives. This initiative aims to help organize and standardize the care of patients with ovarian cancer and improve patient care coordination.
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