Floor and ceiling effects in the EORTC QLQ-C30 Physical Functioning Subscale among patients with advanced or metastatic breast cancer.

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 (2010-2017). 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.

Building Organizational Capacity to Deliver Oncology Financial Advocacy.

Background: Cancer-related financial hardship is linked to poor health outcomes and early mortality. Oncology financial advocacy (OFA) aims to prevent cancer-related financial hardship in oncology settings by assessing patients' needs and connecting them to available financial resources. Despite promising evidence, OFA remains underutilized. Objectives: Describe oncology financial advocates' perceptions about the challenges to and opportunities for implementing oncology financial advocacy (OFA) in community cancer centers. Methods: Nine virtual focus groups were conducted with 45 oncology financial advocates. Focus group transcripts were analyzed using template-based thematic analysis informed by the Consolidated Framework for Implementation Research (CFIR); two study team members coded each transcript and all six team members identified emergent themes. Results: Salient themes were identified across all five domains of the CFIR framework: (1) intervention characteristics: participants described challenges of adapting OFA to meet the needs of the medical system instead of needs of the patients; (2) outer setting: growing awareness of health and cancer disparities could bring more attention to and investment in OFA; (3) inner setting: programs are under-resourced to assist all at-risk patients, staffing, technology integration, and network/communication workflows are needed; (4) characteristics of individuals: advocates believe strongly in the effectiveness and would like to see their credibility enhanced with professional certification; (5) process: implementation strategies that target the engagement of leadership, key stakeholders, and patients to increase program reach are needed. Conclusions: OFA cannot reach all at-risk patients because of understaffing, poor communication between departments, and a lack of understanding OFA as an intervention among colleagues, key stakeholders, and patients. To reach full implementation, advocates need assistance in making the case for more resources, research on patient outcomes, professional certification, and the use of policy to incentivize financial advocacy as a standard of care in medicine.