A qualitative evaluation of factors influencing Tumor Treating fields (TTFields) therapy decision making among brain tumor patients and physicians.

BACKGROUND: Tumor Treating Fields (TTFields) Therapy is an FDA-approved therapy in the first line and recurrent setting for glioblastoma. Despite Phase 3 evidence showing improved survival with TTFields, it is not uniformly utilized. We aimed to examine patient and clinician views of TTFields and factors shaping utilization of TTFields through a unique research partnership with medical neuro oncology and medical social sciences. METHODS: Adult glioblastoma patients who were offered TTFields at a tertiary care academic hospital were invited to participate in a semi-structured interview about their decision to use or not use TTFields. Clinicians who prescribe TTFields were invited to participate in a semi-structured interview about TTFields. RESULTS: Interviews were completed with 40 patients with a mean age of 53 years; 92.5% were white and 60% were male. Participants who decided against TTFields stated that head shaving, appearing sick, and inconvenience of wearing/carrying the device most influenced their decision. The most influential factors for use of TTFields were the efficacy of the device and their clinician's opinion. Clinicians (N = 9) stated that TTFields was a good option for glioblastoma patients, but some noted that their patients should consider the burdens and benefits of TTFields as it may not be the desired choice for all patients. CONCLUSIONS: This is the first study to examine patient decision making for TTFields. Findings suggest that clinician support and efficacy data are among the key decision-making factors. Properly understanding the path to patients' decision making is crucial in optimizing the use of TTFields and other therapeutic decisions for glioblastoma patients.

Development and initial testing of TOGETHER-YA: an eHealth-delivered and group-based psychosocial intervention for young adult cancer survivors.

PURPOSE: This study aimed to (1) develop TOGETHER-YA, an e-Health-delivered and group-based health-related quality of life (HRQOL) intervention for young adult (YA) cancer survivors aged 18-39 (Part 1), and (2) determine its initial feasibility and acceptability in a single-arm pilot trial (Part 2). METHODS: TOGETHER-YA is a manualized, 10-week intervention for YA survivors that includes elements of relaxation training, cognitive-behavioral therapy, and health education. In Part 1, content was adapted from existing evidence-based interventions with feedback from YAs (N = 22) in four iterative focus groups. In Part 2, YA survivors (N = 11) participated in a single-arm pilot trial of TOGETHER-YA. Intervention groups were led by a trained facilitator over videoconference. Primary outcomes were feasibility (i.e., recruitment, session attendance, retention) and acceptability (i.e., participant satisfaction). RESULTS: Focus groups reacted positively to TOGETHER-YA and provided actionable recommendations for enhancing its relevance and acceptability, which were implemented. In initial testing, all feasibility and acceptability benchmarks were met; 58% of eligible YAs were recruited, participants attended M = 6 intervention sessions (SD = 3), and 82% of participants were retained post-intervention. On average, participants "agreed" to "strongly agreed" with positive statements about the weekly sessions and the overall program. CONCLUSION: TOGETHER-YA was developed in collaboration with YA cancer survivors and found to be feasible and acceptable in initial testing. TOGETHER-YA is the first HRQOL intervention for a broad range of YA survivors that is eHealth-delivered for convenience and group-based for peer support. Future large-scale trials should test its efficacy for improving HRQOL. TRIAL REGISTRATION: NCT05048316, September 17, 2021; NCT05054569, September 23, 2021.

A qualitative exploration of the challenges providers experience during peripartum management of patients with a body mass index ≥ 50 kg/m2 and recommendations for improvement.

BACKGROUND: The objective of this research was to conduct a qualitative study among a diverse group of providers to identify their clinical needs, barriers, and adverse safety events in the peripartum care of people with a body mass index (BMI) ≥ 50 kg/m2. METHODS: Obstetricians, anesthesiologists, certified nurse midwives, nurse practitioners, and nurses were invited to participate in focus group discussions if they were employed at the hospital for >6 months. Key concepts in the focus group guide included: (1) Discussion of challenging situations, (2) Current peripartum management approaches, (3) Patient and family knowledge and counseling, (4) Design and implementation of a guideline (e.g., checklist or toolkit) for peripartum care. The audiotaped focus groups were transcribed verbatim, uploaded to a qualitative analysis software program, and analyzed using inductive and constant comparative approaches. Emerging themes were summarized along with representative quotes. RESULTS: Five focus groups of 27 providers were completed in 2023. The themes included staffing (level of experience, nursing-patient ratios, safety concerns), equipment (limitations of transfer mats, need for larger sizes, location for blood pressure cuff, patient embarrassment), titrating oxytocin (lack of guidelines, range of uses), monitoring fetal heart rate and contractions, patient positioning, and communication (lack of patient feedback, need for bias training, need for interdisciplinary relationships). Providers gave examples of items to include in a "BMI cart" and suggestions for a guideline including designated rooms for patients with a BMI ≥ 50 kg/m2, defining nursing ratios and oxytocin titration plans, postpartum incentive spirometer, and touch points with providers (nursing, physicians) at every shift change. CONCLUSIONS: Providers discussed a range of challenges and described how current approaches to care may negatively affect the peripartum experience and pose threats to safety for patients with a BMI ≥ 50 kg/m2 and their providers. We gathered information on improving equipment and communication among providers.

Uncertainty in Postpartum Permanent Contraception Decision-Making: Physician and Patient Perspectives.

PURPOSE: We sought to understand how patients and physicians conceptualize uncertainty in the permanent contraception decision-making process. BASIC PROCEDURES: In 2022-2023, we interviewed postpartum patients with a documented desire for permanent contraception (n = 81) and their delivering physicians (n = 67). Eligible patients gave birth at one of our four study hospitals in California, Ohio, Illinois, and Alabama. We used rapid content analysis and thematic content analysis to develop and refine themes related to uncertainty in permanent contraceptive decision-making. MAIN FINDINGS: Most patients reported full certainty in their decision regarding permanent contraception, although some expressed doubts. After receiving permanent contraception, some patients discussed grief but overall affirmed their decision. One patient said they wished they had considered other contraceptive options. Physicians reported using a range of strategies to safeguard from patient regret, including ensuring patients were 100% certain with their decision, inferring certainty based on their characteristics, asking patients to think through all scenarios that could affect decision-making, and repeat counseling during multiple interactions. PRINCIPAL CONCLUSIONS: Patient experiences reveal the depth, fluidity, and nuance of patients' contraceptive decision-making processes. Physicians sometimes failed to grapple with this nuance by centering potential regret in their counseling. Personalized and supportive contraceptive counseling that acknowledges the complexity of contraceptive decision-making is imperative. Shared decision-making can help ensure patients can make informed and autonomous decisions about their reproductive lives.

A mixed methods evaluation of patient perspectives on the implementation of an electronic health record-integrated patient-reported symptom and needs monitoring program in cancer care.

BACKGROUND: As cancer centers have increased focus on patient-centered, evidenced-based care, implementing efficient programs that facilitate effective patient-clinician communication remains critical. We implemented an electronic health record-integrated patient-reported symptom and needs monitoring program ('cPRO' for cancer patient-reported outcomes). To aid evaluation of cPRO implementation, we asked patients receiving care in one of three geographical regions of an academic healthcare system about their experiences. METHODS: Using a sequential mixed-methods approach, we collected feedback in two waves. Wave 1 included virtual focus groups and interviews with patients who had completed cPRO. In Wave 2, we administered a structured survey to systematically examine Wave 1 themes. All participants had a diagnosed malignancy and received at least 2 invitations to complete cPRO. We used rapid and traditional qualitative methods to analyze Wave 1 data and focused on identifying facilitators and barriers to cPRO implementation. Wave 2 data were analyzed descriptively. RESULTS: Participants (n = 180) were on average 62.9 years old; were majority female, White, non-Hispanic, and married; and represented various cancer types and phases of treatment. Wave 1 participants (n = 37) identified facilitators, including cPRO's perceived value and favorable usability, and barriers, including confusion about cPRO's purpose and various considerations for responding. High levels of clinician engagement with, and patient education on, cPRO were described as facilitators while low levels were described as barriers. Wave 2 (n = 143) data demonstrated high endorsement rates of cPRO's usability on domains such as navigability (91.6%), comprehensibility (98.7%), and relevance (82.4%). Wave 2 data also indicated low rates of understanding cPRO's purpose (56.7%), education from care teams about cPRO (22.5%), and discussing results of cPRO with care teams (16.3%). CONCLUSIONS: While patients reported high value and ease of use when completing cPRO, they also reported areas of confusion, emphasizing the importance of patient education on the purpose and use of cPRO and clinician engagement to sustain participation. These results guided successful implementation changes and will inform future improvements.

Development of an electronic health record-integrated patient-reported outcome-based shared decision-making dashboard in oncology.

Objectives: Patient-reported outcomes (PROs) describe a patient's unique experiences with disease or treatment, yet effective use of this information during clinical encounters remains challenging. This project sought to build a PRO based dashboard within the electronic health record (EHR), prioritizing interpretability and utility of PROs for clinical decision-making. Materials and Methods: Codesign principles were used to define the goal, features, and visualization of the data elements on the dashboard. Codesign sessions occurred between February 2019 and May 2020 and involved a diverse group of stakeholders. Pilot evaluation of dashboard usability was performed with patients and clinicians not involved in the codesign process through qualitative interviews and the Systems Usability Scale. Results: The dashboard was placed into a single tab in the EHR and included select PROM scores, clinical data elements, and goals of care questions. Real-time data analytics and enhanced visualization of data was necessary for the dashboard to provide meaningful feedback to clinicians and patients for decision-making during clinic visits. During soft launch, the dashboard demonstrated "good" usability in patients and clinicians at 3 and 6 months (mean total SUS score >70). Discussion: The current dashboard had good usability and made PRO scores more clinically understandable to patients and clinicians. This paper highlights the development, necessary data elements, and workflow considerations to implement this dashboard at an academic cancer center. Conclusion: As the use of PROs in clinical care is increasing, patient- and clinician-centered tools are needed to ensure that this information is used in meaningful ways.

Venous thromboembolism prevention in cancer care: implementation strategies to address underuse.

Background: Evidenced-based interventions have been developed to prevent venous thromboembolism (VTE) in ambulatory patients with cancer, including VTE-risk assessment for all patients and targeted primary thromboprophylaxis for high-risk patients. Despite supportive evidence and recommendations, oncologists rarely assess VTE risk or provide primary prophylaxis. Our previous work identified barriers and facilitators to using VTE prevention interventions in oncology practice. Objectives: To identify potential strategies that address the identified barriers and leverage facilitators to achieve successful implementation of evidence-based interventions for VTE prevention in oncology practice. Methods: We used the Implementation Research Logic Model, an implementation science framework, to map the relationships among barriers and facilitators, feasible and effective implementation strategies, and implementation and clinical outcomes that will be used to evaluate the implementation strategies. Results: We identified 12 discrete implementation strategies (eg, conducting clinician education and training and staged implementation scale-up) that address barriers and leverage facilitators through their mechanisms of action (eg, increased clinician awareness of evidence and targeting the highest effectiveness). We identified key implementation (eg, penetration, adoption, acceptability, fidelity, appropriateness, and sustainability), system (eg, integration of VTE-risk assessment into clinical workflow), and clinical (eg, lower VTE rates) outcomes targeted by the selected strategies. Conclusion: Using the Implementation Research Logic Model framework and building on our knowledge of barriers and facilitators, we identified implementation strategies and important outcomes to evaluate these strategies. We will use these results to test and measure the strategies to improve the uptake of evidence-based recommendations for VTE prevention in oncology practice.

Protocol for a type 2 hybrid effectiveness-implementation study expanding, implementing and evaluating electronic health record-integrated patient-reported symptom monitoring in a multisite cancer centre.

INTRODUCTION: Cancer symptom monitoring and management interventions can address concerns that may otherwise go undertreated. However, such programmes and their evaluations remain largely limited to trials versus healthcare systemwide applications. We previously developed and piloted an electronic patient-reported symptom and need assessment ('cPRO' for cancer patient-reported outcomes) within the electronic health record (EHR). This study will expand cPRO implementation to medical oncology clinics across a large healthcare system. We will conduct a formal evaluation via a stepped wedge trial with a type 2 hybrid effectiveness-implementation design. METHODS AND ANALYSIS: Aim 1 comprises a mixed method evaluation of cPRO implementation. Adult outpatients will complete cPRO assessments (pain, fatigue, physical function, depression, anxiety and supportive care needs) before medical oncology visits. Results are available in the EHR; severe symptoms and endorsed needs trigger clinician notifications. We will track implementation strategies using the Longitudinal Implementation Strategy Tracking System. Aim 2 will evaluate cPRO's impact on patient and system outcomes over 12 months via (a) a quality improvement study (n=4000 cases) and (b) a human subjects substudy (n=1000 patients). Aim 2a will evaluate EHR-documented healthcare usage and patient satisfaction. In aim 2b, participating patients will complete patient-reported healthcare utilisation and quality, symptoms and health-related quality of life measures at baseline, 6 and 12 months. We will analyse data using generalised linear mixed models and estimate individual trajectories of patient-reported symptom scores at baseline, 6 and 12 months. Using growth mixture modelling, we will characterise the overall trajectories of each symptom. Aim 3 will identify cPRO implementation facilitators and barriers via mixed methods research gathering feedback from stakeholders. Patients (n=50) will participate in focus groups or interviews. Clinicians and administrators (n=40) will complete surveys to evaluate implementation. We will graphically depict longitudinal implementation survey results and code qualitative data using directed content analysis. ETHICS AND DISSEMINATION: This study was approved by the Northwestern University Institutional Review Board (STU00207807). Findings will be disseminated via local and conference presentations and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04014751; ClinicalTrials.gov.

Neuropathy experienced by colorectal cancer patients receiving oxaliplatin: A qualitative study to validate the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity scale.

BACKGROUND: Although oxaliplatin is widely established as a standard treatment in colorectal cancer (CRC), oxaliplatin-induced neuropathy has emerged as a prominent dose-limiting side effect associated with quality of life decrements. Ongoing monitoring and management of neuropathy is important for CRC patient quality of life and adherence to treatment. Therefore, a validated self-reported measure of neuropathy would aid in the management and assessment of oxaliplatin-induced neuropathy in clinical practice and research. We sought to evaluate the content validity of the 13-item Functional Assessment of Cancer Therapy/Gynecologic Oncology Group- Neurotoxicity subscale (FACT/GOG-Ntx) for CRC patients receiving oxaliplatin. AIM: To understand the neuropathy experiences of CRC patients and assess content validity of the FACT/GOG-Ntx. METHODS: Semi-structured concept elicitation and cognitive debriefing interviews were conducted with 31 CRC patients experiencing peripheral neuropathy from current or previous oxaliplatin treatment. Interview data were analyzed using a constant comparative approach, and data were mapped to the FACT/GOG-Ntx to assess content validity. RESULTS: Mean age of the sample was 54 (range 34-82). The sample was primarily Caucasian (84%) and consisted of nearly equal numbers of men and women. Participants described 28 unique neuropathy symptoms; hand tingling (experienced by 87% of respondents); feet tingling (81%); hand numbness (68%); and feet numbness (84%) were most frequently mentioned. Neuropathy symptoms occurring on the feet were most often identified as most bothersome by participants. Eleven of the 13 FACT/GOG-Ntx items exhibited moderate to strong evidence of content validity. Two items related to trouble hearing and ringing in the ears had weak support; however, these items represent severe neuropathy and could be useful for a patient reported outcome measure. CONCLUSION: The FACT/GOG-Ntx represents the key neuropathy experiences of CRC patients treated with oxaliplatin.

Piloting a Financial Counseling Intervention for Patients With Cancer Receiving Chemotherapy.

PURPOSE: National organizations encourage communication about costs of cancer care; however, few data are available on health system models for identifying and assisting patients with financial distress (FD). We report the feasibility and acceptability of a financial counseling (FC) intervention for patients who receive chemotherapy at a comprehensive cancer center. MATERIALS AND METHODS: Patients were randomly assigned 1:1 to FC or standard care. The FC arm received education, financial assistance screening, and an estimation tool with total billed charges and out-of-pocket (OOP) cost of one cycle of chemotherapy from a financial counselor through phone call and in-person visit. Participants completed measures of FD, health-related quality of life, and acceptability. RESULTS: Ninety-five participants enrolled (mean age, 61 years; 72% white; 50% commercially insured), with a 32% attrition rate between assessments. Rates of completion for the phone call, in-person, and entire intervention were 98%, 47%, and 30%, respectively. The OOP estimation tool was considered understandable and acceptable to the majority of participants. No significant changes in FD were found between arms. Emotional functioning was negatively associated with having high FD (95% CI, -0.13379 to -0.013; P = .0189). Being married was associated with a decrease in log-odds of having high FD (ß = -1.916; 95% CI, -3.358 to -0.475; P = .0092). CONCLUSION: Implementation of an FC program that provides transparent cost data is feasible and acceptable. Incorporation of FC into clinical workflow, including phone counseling, is important to improve feasibility. Additional work is needed to develop tailored educational materials that are patient specific.