bluuebunny/crossref_metadata_2025 huggingface dataset:
Toxicity surveillance in FDA pivotal registration trials for immune checkpoint inhibitors: Are we missing the mark?
Authors: Hadfield Matthew James , VanHelene Alex , Jain Sandeep Kumar , Lythgoe Mark , Durbin Sienna , Wu Chia-Yun , Vilbert Maysa , Carneiro Benedito A. , Sullivan Ryan J. , Warner Jeremy Lyle , Reynolds Kerry Lynn
Published: September 2024

215

Background:
Immune checkpoint inhibitors (ICIs) have changed the treatment landscape for a multitude of malignancies, leading to prolonged survival and durable responses. Despite this, a significant number of patients will develop immune-related adverse events (irAEs) with significant associated morbidity and mortality. A retrospective study has previously demonstrated that 28% of patients can develop IrAEs from 6 months up to 2 years after starting therapy (1). Surveillance for toxicity is essential for understanding the long-term risk associated with ICIs. We aimed to analyze the reporting timeframes used in clinical trials of immuno-oncology agents leading to FDA approval.
Methods:
In this retrospective study, we interrogated the HemeOnc knowledgebase to curate a list of all clinical trial publications leading to FDA approval from 2011 to 2024. We manually selected from this list any trial including an immune checkpoint inhibitor either as monotherapy or in combination with another systemic therapy. The adverse event follow-up time was then extrapolated by manually reviewing the trial publication, supplemental materials or the trial protocol depending on where this information was listed. All trials were categorized based on trial initiation dates.
Results:
We identified 175 clinical trials leading to FDA approvals, with trial initiation dates ranging from 2004 to 2019. 165 trials were included in the analysis with 10 being excluded due to lack of language regarding follow-up. 62% of the trials included were Phase III trials with the remaining 38% Phase I/II trials. The median follow-up days for all trials across this timeframe was 90, with a range of 28 to 135. The median follow-up time for AE monitoring increased by nearly 30%, rising from 70 days in 2004 to 90 days in 2013. Subsequently, we observed a consistent median follow-up time of 90 days (28 to 130 days) from that point onward, with no further increase.
Conclusions:
To our knowledge this is the first systematic review of IrAE monitoring in clinical trials leading to FDA approval. In our study we revealed that, despite advancements in the understanding of IrAEs and their potential for late presentation, registration trials leading to regulatory approval remain inadequately designed to capture chronic and delayed immunotherapy toxicities. As these therapies advance into earlier stages of disease with longer life expectancy, it will be critical for regulatory bodies, study sponsors, and trial investigators to either redesign clinical trials or for there to be an alternative method that comprehensively captures the incidence and pattern of late-presenting toxicities. 1. Durbin, ASCO 2023.
Associations between acupuncture and uses of opioids and neuropsychiatric medication following chemotherapy-induced peripheral neuropathy among patients with breast cancer.
Authors: Lu Chuan , Pan Xiaoyu , Hsieh Tina Yi Jin , Wei James Chung-Chung
Published: September 2024

216

Background:
Chemotherapy-induced peripheral neuropathy (CIPN) features debilitative neuropathic pain and neurologic deficits, commonly present in breast cancer population exposed to certain chemo-agents. Given suboptimal effects often rendered by limited therapeutic options, CIPN is associated to psychological distress and drug-seeking behaviors, which leads to heightened functional impairment and disease burden. Acupuncture has gained clinical recognitions for alleviating pain and mental distress, but its impact on medication uses for pain or psychiatric disorders in CIPN remains unclear. As such, this study aims to investigate the association between acupuncture and use of these medications among breast cancer patients experiencing CIPN.
Methods:
This survival analysis utilized data from the TriNetX Network comprising real-time electronic health records from over 60 healthcare organizations across the United States. Breast cancer patients over 18 at the index date within 01/01/1997 (inception of acupuncture practice in US) and 05/10/2023, diagnosed with CIPN after exposure to chemo-agents such as taxane, platinum, vinca alkaloids, thalidomide, or bortezomib, were identified as the baseline cohort. Patients who received at least three acupuncture sessions post CIPN diagnosis were compared to those without any acupuncture record. Endpoints included prescription of sedative/hypnotics, anti-depressants, anti-psychotics, anti-convulsant agents, and opioid analgesics, within a twelve-month follow-up period after index date. Antibiotics use was the negative control outcome. A 1:1 propensity-score-matching (PSM) method was applied for between-group balance of demographics, BMI, cancer treatment history, health comorbidities, and concurrent medications, followed by hazard ratios and 95% CI calculation using Cox regression model.
Results:
Among 398 PSM pairs, acupuncture group demonstrated significantly lower hazards of sedative/hypnotics (HR= 0.74, 95% CI 0.61-0.9), anti-depressants (HR= 0.75, 95% CI 0.61-0.93), anti-psychotics (HR= 0.74, 95% CI 0.58-0.96), anticonvulsants (HR= 0.48, 95% CI 0.27-0.87), and opioids (HR= 0.78, 95% CI 0.65-0.94) use, whereas antibiotics showed insignificant result (HR= 0.75, 95% CI 0.55-1.02). The significance sustained after sensitivity analyses, excluding patients with concurrent other cancers, and narrowing follow-up period down to the last nine months to concentrate on treatment effects.
Conclusions:
Our study suggests a decreased need of opioids and neuropsychiatric medication associated with acupuncture treatment among breast cancer patients endorsing CIPN. Rigorous clinical studies are warranted to validate the causal underpinnings.
Perioperative interventions to enhance surgical outcomes for older adults with cancer: A systematic review.
Authors: Sorensen Luke , Lam Anh B. , Moore Vanessa Ann , Bouvette Max , Wismann Andrea , Diaz Adolfo , Clifton Shari , Keyser Katie , Shinall Myrick C. , Nipp Ryan David
Published: September 2024

219

Background:
Older adults with cancer have unique needs, particularly in the perioperative setting, which likely influence surgical outcomes in the geriatric oncology population. Little work has sought to describe available literature investigating perioperative interventions to enhance surgical outcomes for these individuals. Our systematic review sought to describe the literature on perioperative interventions in older adults with cancer undergoing surgery.
Methods:
Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we performed a comprehensive search using the Ovid MEDLINE, CINAHL, and Embase databases, searching for literature published from 1/2010-10/2023 (search terms used relevant terminology for geriatric oncology in the perioperative setting). We included randomized controlled trials (RCT) focusing on patient-centered interventions that enrolled adults >60 years old with cancer, excluding studies with pharmacologic, procedural, and radiographic interventions.
Results:
We included 11 RCTs with 2,177 patients. Patients’ age ranged from 60-95, and median number of patients per study was 147 (range: 44-690). Most studies included patients with colorectal cancer (81.8% [9/11]), all involving non-emergent elective surgeries. Half the studies (54.5% [6/11]) evaluated exercise interventions, and the remaining assessed geriatric assessment-guided interventions (27.2% [3/11]), nutrition optimization (9.1% [1/11]), and patient empowerment (9.1% [1/11]). Primary outcomes were as follows: postoperative complications, quality of life, feasibility of exercise programs, delirium incidence, inspiratory muscle endurance, hospital length of stay, and consistency of nutritional management. All studies had postoperative complications as a primary or secondary outcome. In studies with exercise-based interventions, all but one (83.3% [5/6]) found reduction in postoperative complications, and one showed improvement in quality of life (16.7% [1/6]). Studies focusing on geriatric assessment did not achieve significant differences in outcomes. We found implementation challenges that influenced several studies, including high drop-out rates and intervention fidelity.
Conclusions:
In this review, we found 11 studies focused on perioperative interventions in older adults with cancer undergoing surgery. Notably, interventions involved exercise, geriatric assessment-guided care, nutrition optimization, and patient empowerment. RCTs to date seem to primarily focus on exercise interventions and geriatric assessment-guided strategies. Although most studies met their primary endpoint, we found heterogeneity in intervention modality and outcome assessment, thus demonstrating a need for ongoing work to address the unique needs of the geriatric oncology population.
Improving the assessment and documentation of systemic cancer therapy–related toxicity in the ambulatory oncology setting.
Authors: Hurtado Castillo Marisabel , Sessions William Steele , O'Neill Colleen Alice , Zhou Yuhang , Fitzpatrick Madeline Campbell , Goodgame Boone Wilder
Published: September 2024

221

Background:
Accurate documentation of systemic cancer therapy toxicity is crucial for patient safety and effective treatment management. However, achieving consistent and comprehensive documentation remains challenging. While the use of electronic patient-reported outcomes (ePROs) is becoming standard in clinical practice, small community-based practices lack the resources to implement this strategy. This project aims to offer alternative methods for implementing patient-reported outcomes in such practices and utilize this information to enhance the documentation of systemic cancer therapy toxicities using the CTCAE (Common Terminology Criteria for Adverse Events).
Methods:
We conducted a quality improvement project targeting the adequate assessment and documentation of graded toxicity assessments among healthcare providers. Interventions included implementing a patient-reported outcome survey created using the National Cancer Institute PRO-CTCAE form builder, which patients completed while waiting to be seen by the provider. Additionally, we educated providers on how to use the CTCAE grading tool available in Cerner. Rates of documented graded toxicity assessment using the CTCAE system were evaluated among 71 patients aged 18 years or older receiving systemic cancer therapy and attending follow-up appointments at the Seton Cancer Clinic. Data were collected from electronic medical records both before and after the intervention, with 50 patients assessed pre-intervention and 21 patients assessed post-intervention.
Results:
The implementation of the patient-reported outcome survey and the utilization of the CTCAE grading tool available in Cerner facilitated a more consistent and comprehensive assessment and documentation process. Post-intervention, the rate of documented graded toxicities increased significantly; the percentage of patients with documented graded toxicities increased from 4% pre-intervention to 80% post-intervention. The intervention also improved the workflow efficiency and the accuracy of toxicity assessments in the oncology clinic.
Conclusions:
These findings highlight the importance of implementing strategies to improve the assessment and documentation of systemic cancer therapy-related toxicity, especially in small community-based practices where resources may be limited. Continued monitoring and periodic data collection will be essential for sustaining these improvements.
Pilot to scale: Implementing a digital triage solution across a large comprehensive cancer centre.
Authors: Lovas Mike , Devonish Shayla , Somji Faiza , Carey Stacie , Carvalho Maritza , Tymoshyk Iryna , Badzynski Adam , Bravo Ana , Lane Kelly , Truong Tran , Krzyzanowska Monika K. , Berlin Alejandro
Published: September 2024

225

Background:
Princess Margaret Cancer Centre (PM) sees over 80,000 patients annually and primarily operates using an outpatient model. Historically patients use a phone/voicemail triage service to communicate with their care team between scheduled visits. Many patient queries lack critical information necessary for effective screening, assessment, and processing. In turn leading to delays or missed calls that negatively impact patient experience, system efficiency, and safety. To address these challenges, we piloted a digital triage service and subsequently implemented in sixteen clinics. This project evaluated initial adoption, usage, care patterns and satisfaction in the first 5 months post-implementation.
Methods:
We used human-centred service design to develop the digital triage service within the EMR (Epic). Implementation strategies to scale across all outpatient clinics included leadership buy-in, co-design with key stakeholders, a phased implementation approach, and improvement cycles. To evaluate initial adoption, usage and care patterns, we used EMR system data. To assess patient satisfaction, we surveyed patients who used the service during the first three months. We conducted semi-structured interviews with staff to understand their experience integrating digital triage into their workflow.
Results:
Following the go-live period, patients sent an average of 1096 digital requests per month, representing 16% of all triage requests (phone + digital). The most common requests were symptom management (36% of nursing requests) and appointment change requests (40% of administrative requests). The algorithm automatically routed 93% of requests to the most appropriate care team member, compared to 74% pre-implementation. When asked if they were satisfied with their experience, most patients agreed or were neutral (69% and 10%, respectively), while 21% disagreed. In semi-structured interviews, nurses and administrative staff described improved efficiency by having triage requests integrated within the EMR, while have challenges related to prioritizing requests across multiple channels (e.g. digital, phone, others).
Conclusions:
Digital triage is foundational for better cataloguing and understanding our patients' unmet needs at home and between visits, enabling a continuous learning process to understand when and why people struggle throughout their care journey. Ongoing analyses will explore disease site-specific trends, compare phone to digital triage, and identify differences between users of each method. The data will inform further improvement cycles on the build and workflows, while enabling appropriate resourcing of this critical service and shifts towards proactive care.
A TED Talk style patient video education intervention to improve care coordination for rural patients with early-stage cancer: A feasibility study.
Authors: Okado Izumi , Braun-Inglis Christa M. , Matsumoto Kehau , Chang Shin , Elhajj Carry , Cassel Kevin , Berenberg Jeffrey L. , Holcombe Randall F.
Published: September 2024

236

Background:
Effective care coordination is a key component of high-quality, patient-centered cancer care. However, cancer patients residing in rural areas often experience substantial barriers to care and suboptimal care coordination. To date, there is a paucity of interventions to improve care coordination for rural cancer patients. In this pilot trial, we assessed the feasibility and preliminary efficacy of a remote, tablet-based patient video education intervention focused on cancer care coordination among rural patients in Hawaii.
Methods:
We conducted a single-arm pilot study to assess the preliminary effects of a novel, TED-talk style patient video education intervention presented by clinicians and a patient advocate. Video content focused on cancer basics, care coordination, and self-advocacy. Eligible participants were newly diagnosed with early-stage cancer (I-III), within one month of starting adjuvant chemotherapy, able to speak/read English, and residing in rural areas (defined as RUCA ≥ 4). We assessed the feasibility and patient-reports of acceptability and satisfaction using semi-structured interviews. Validated instruments were administered at baseline and post-intervention and used to assess the preliminary effects of the intervention on patients’ perceptions of care coordination (CCI; Care Coordination Instrument) and self-advocacy (adapted Cancer Self-Advocacy Scale; Hagan et al. 2018). Descriptive statistics were used to assess study outcomes.
Results:
From 01/2022 to 12/2022, 19 patients enrolled on the study (21 approached); 74% were female, 42.1% identified as two or more races, 26.3% Asian, and 21.1% White. Mean age was 52.2. The majority of participants were receiving treatment for breast cancer. Five patients became ineligible after enrolling on the study (disease progression, relocation). 71.4% of eligible patients completed all assessments. No changes were observed in the overall perceptions of care coordination. Improved scores were observed for the CCI communication domain (+4.5; Cohen’s
d
= -0.76, 95% CI: -1.45, -0.03). For self-advocacy, there was an overall trend for improved scores for the informed decision making and connected strengths subscales. All participants reported high satisfaction with the intervention.
Conclusions:
Results support the preliminary feasibility, satisfaction, and acceptability of this intervention for rural patients. Although the effects on the overall perceptions of care coordination are unclear, preliminary data suggest that the intervention may improve communication aspects of care coordination and self-advocacy. Further study is needed to evaluate the intervention in other rural areas. Funding support: The HOPE Foundation for Cancer Research/SWOG.

Clinical trial information:
NCT05162404

.
Health insurance plans from NCI-designated public and private cancer centers versus federal health insurance plans.
Authors: Xing Jiazhang , Moore Vanessa Ann , Bouvette Max , Lam Anh B. , Jiang Changchuan , Nipp Ryan David , Choradia Nirmal
Published: September 2024

24

Background:
Understanding health insurance plans is crucial for making informed financial decisions and ensuring equitable access to healthcare. While physicians are directly involved in healthcare, the plans available to them are poorly understood. This study compared plans offered at NCI-designated cancer centers with federal plans to better understand and further investigate the differences in beneficiary costs.
Methods:
We collected data on health plans from 65 cancer centers and federal plans from 5 major insurers by reviewing their websites from 11/2023 - 03/2024. We included up to 3 plans (regardless of insurer) per cancer center and up to 6 federal plans per insurer. We abstracted cost data on premium, deductible, co-pay for physician visits, out-of-pocket (OOP) maximum, and coinsurance for hospitalizations. We compared HMO and PPO plans between public and private cancer centers, as well as with federal plans.
Results:
We obtained data of 153 plans from 39 public and 26 private cancer centers to compare with 18 federal plans. In the comparison of plans offered at public and private cancer centers, private cancer centers had significantly higher deductible ($597.6 vs $225.9, p=0.03), specialist visit co-pays ($36.1 vs $27.1, p=0.01), and inpatient stay co-insurance ($1281.0 vs $582.9, p=0.02) in HMO plans compared to public cancer centers. For PPO plans, private cancer centers had higher inpatient stay co-insurance ($2,100.5 vs $1,526.3, p=0.03). The premiums of private cancer centers are lower than those in public centers for both HMO plans ($113.5 vs $139.5, p=0.43) and PPO plans ($140.8 vs $190.2, p=0.33), although these differences were not statistically significant. Compared to federal plans, cancer centers plans had significantly higher HMO deductibles ($387.8 vs $100, p=0.02), lower PPO specialist visit co-pays ($30.4 vs $40.5, p=0.05), and lower OOP maximum ($3,823.8 vs $6,554.6, p<0.001) (Table).
Conclusions:
Our research reveals differences in beneficiary costs between health plans offered by cancer centers and federal plans, as well as among different types of cancer centers. Notably, private cancer centers had higher average costs for deductible, specialist visit, and inpatient stays compared to public cancer centers, likely as a tradeoff to offer a lower premium. These findings underscore the complexities within health plans offered to physicians, emphasizing the necessity for a more comprehensive understanding.

Comparison of health plans.

Average costs ($)
Cancer centers HMO
Federal HMO
p
Cancer Centers PPO
Federal PPO
p

Premium
133.6
425.1
0.1
176.8
259.3
0.1

Deductible
387.8
100
0.02*
906.2
768.2
0.52

Co-pay of PCP visit
20
21.7
0.52
19.7
18.8
0.78

Co-pay of specialist visit
29.4
36.7
0.14
30.4
40.5
0.05*

Co-insurance for inpatient stay
955.2
1231.6
0.53
1712
1957.9
0.48

OOP Maximum
3300.2
4416.7
0.24
3823.8
6554.6
<0.001*

*p-value < 0.05.
Measuring what really matters: Advocacy-led co-creation and accrual of a pan-cancer QoL survey.
Authors: Tinianov Stacey , Feldman Jill E. , Shah Dimpy P , Shanahan Kelly , Cowden Janice
Published: September 2024

240

Background:
Implementing co-creation methods in research may provide vital input to improve accrual, retention, and research value.
Advocates for Collaborative Education
(ACE), a global coalition of patient, community, research, and policy advocates, used co-creation methodology with patients, survivors, and metavivors to
Design, Develop
, and
Deploy
a survey to define and quantify QoL impacts across a large sample of individuals with a diagnosis or history of cancer.
Methods:
With a defined primary objective to “gain insight into challenges faced by individuals with a history or diagnosis of cancer and how these challenges impact their life and quality of life,” a co-creation team of individuals with lived experience in early stage or metastatic cancers was established. In the
Design
phase, co-creation team members were interviewed and engaged in discussions on side effect measurement and impact. They were asked a variety of questions, including what side effects they believed were most impactful to QoL, what elements they felt were missing in conversations around QoL, and how accurately they felt QoL was measured in the clinical setting. In the
Develop
phase, survey questions were developed and vetted with the co-creation team. In the
Deploy
phase, co-creation team members, advocate members of the ACE community, and aligned advocacy groups, were key to recruiting a broad audience via electronic distribution and social media platforms.
Results:
Efforts resulted in the co-creation of a six-section, 93 question, IRB-exempt survey. The co-creation team identified 17 treatment-related side effects that were incorporated into the survey. Survey questions asked respondents about perceived severity of side effects, how well informed they felt about possibilities of experiencing these side effects, access to supportive care, side effects of supportive care therapies, and personal preferences for receiving cancer-related information. A unique measurement scale was shaped by the co-creation team to be more reflective of side effect impact on QoL. In five weeks, the survey accrued over 500 responses across a variety of cancer types (15+), stages (0 - IV), ages, statuses, and racial groups.
Conclusions:
Co-creation methods were used in
Design
to identify side effect experiences in cancer treatment and validate what matters most to individuals with cancer; in
Develop
to validate a pan-cancer survey examining what mattered to the audience of interest; and in
Deploy
to rapidly accrue a large and diverse set of responses through advocacy partnerships. Co-creation also identified layers of side effect management challenges that cannot be reflected in current rubrics for QoL measurement. While co-creation may seem daunting, this study provides a template for effective, quality partnerships between study teams, advocates, and advocacy groups for implementing co-creation methods in the cancer setting.
Exploring the meaning of “a good day” for individuals living with advanced cancer: A qualitative interview study.
Authors: Cheng Svea , Lazris David , Bartel Christianna , Durica Krina , Chen Leeann , Fedor Jennifer , Low Carissa A.
Published: September 2024

249

Background:
More people are living longer with stage IV cancer due to advances in cancer treatments. However, individuals living with advanced cancer must navigate dynamic treatment schedules, side effects, fear of progression, and uncertainty, resulting in unique day-to-day experiences that may be poorly understood by their health care team. The goal of this project was to better understand the activities, behaviors, and experiences that characterize a “good day” versus a “bad day” among individuals living with advanced cancer.
Methods:
Twenty participants with stage IV cancer were enrolled (mean 63 years old, range 41-75; 65% female; 65% White and 35% Black; mean 1.5 years since Stage IV diagnosis, range 9 days to 7.5 years). Participants completed semi-structured interviews which involved rating the quality of their day yesterday from 1-5 (1 = very bad and 5 = very good) and characterizing their experiences and activities during the day. Participants were also asked to describe a theoretical ‘very good day’ versus a ‘very bad day’ for them personally, as well as advice they would give to another patient with advanced cancer about how to make a day better. Interview transcripts were reviewed to identify common themes across participants.
Results:
Interviews revealed that “good days” were associated with feeling like oneself (feeling symptom-free, in control, like pre-cancer self), bringing oneself to engage in activities that bring personal wellness, feeling connected to others (spending quality time with others, helping others, feeling supported and understood by others), feeling accomplished (getting things done, reaching goals), and practicing positive thought patterns (gratitude, reframing success, letting go). On the other hand, loss of control, uncertainty/unpredictability, disruptive physical symptoms, negative experiences with health care, and inability to reach one’s goals were common on “bad days.” When asked what they felt most grateful for yesterday, some participants cited their support system, kids, and grandkids, but the majority of participants reported feeling most grateful for simply living another day, good or bad.
Conclusions:
Preliminary findings suggest that days on which individuals with advanced cancer are able to engage in activities that give them a sense of normalcy, control, self-identity, and connection to others are better than days without these activities. Findings also suggest that what defines a “good day” looks different between individuals with stage IV cancer. Understanding these individuals’ values and priorities may help care teams support people with advanced cancer to optimize their quality of life and functioning and navigate treatment decisions.
Understanding the causes of nonadherence to chronic medications among patients with cancer and multimorbidity: A qualitative study.
Authors: Kaye Deborah , Varma Roshni , Roud Sophia , Parnell Heather E. , Zullig Leah L. , Shenoy Devika , Ubel Peter A. , Fish Laura J. , Sloan Caroline
Published: September 2024

252

Background:
Patients with active cancer and multimorbidity (≥2 chronic conditions) are at increased risk of disease progression, hospitalization and death compared to patients without concomitant chronic conditions. Adherence to chronic medications is imperative in this patient population, but frequently declines after the initial cancer diagnosis. Reasons for this declining adherence are not well understood. We aimed to explore barriers and facilitators of chronic medication adherence among patients with multimorbidity and a recent cancer diagnosis.
Methods:
We conducted a qualitative study of patients with active solid organ cancer and multimorbidity receiving care at one academic health system in March-November 2023. We used purposive sampling to include balanced numbers of advanced (stage 3-4) and non-advanced (stage 1-2) cancers and perceived change in chronic medication adherence after cancer diagnosis (same/better vs worse). We asked participants to describe their perceptions of and experiences with balancing their cancer and non-cancer symptoms, medications, and medical appointments, as well as barriers to adherence and strategies used to help with adherence. We analyzed transcripts using thematic analysis.
Results:
We interviewed 20 patients aged ≥50 who had an average of 3 chronic conditions and took an average of 3 chronic medications. Three themes emerged. First, patients made decisions about which diseases, medications, and medical appointments to prioritize. Many focused their energy on their cancer treatment and appointments, putting management of their chronic conditions on pause. In contrast, patients with severe chronic conditions (e.g., heart failure, diabetes) prioritized avoiding hospitalizations for their chronic conditions so that they could continue their cancer treatment uninterrupted. Patients based their decisions on prior experience, as well as advice from caregivers and clinicians. Second, adherence fluctuated in response to drug side effects (e.g., nausea/vomiting), drug-disease interactions (e.g., weight loss reducing need for antihypertensives), drug-drug interactions, and conflicting recommendations from cancer and non-cancer care teams. Patients often most closely followed the recommendations of the clinician they viewed as being “in charge” of their care. Third, patients’ trust in caregivers, medical teams, and their own self-efficacy influenced their motivation to adhere to medications.
Conclusions:
Patients with cancer and multimorbidity must balance competing priorities, interactions between their cancer and non-cancer conditions, relationships with care teams and caregivers, and their own sense of self-efficacy. Further work is needed to devise strategies to address barriers to chronic medication adherence in this population and thus improve short- and long-term health outcomes.
A qualitative study identifying the navigation needs of patients with HCC.
Authors: Jones Patricia Denise , Hon Sai Sophia , Prieto-Bello Daniela , Lee Debbiesiu
Published: September 2024

263

Background:
Hepatocellular carcinoma (HCC), the 2
nd
leading cause of cancer mortality, disproportionately affects racial and ethnic minorities. Disparities in risk are compounded by profound differences in HCC treatment and survival. Black patients are consistently diagnosed at more advanced stages, least likely to receive treatment, and have the lowest survival. In other cancer types, navigation facilitates successful treatment and improves outcomes. To inform development of a longitudinal navigation program, we aimed to ascertain the needs of HCC patients, and identify obstacles limiting access to cancer treatment and supports needed for successful HCC treatment from the vantage point of patients and other stakeholders.
Methods:
In-depth, one-hour qualitative interviews were conducted with 40 individuals (14 patients, 7 caregivers, 8 advocates, and 11 providers) in English or Spanish. Providers included physicians, advanced practice providers, social workers, nurse navigators, and transplant coordinators involved in HCC care. We recruited patients, caregivers, and providers from the Sylvester Comprehensive Cancer Center and Jackson Health System; advocates were recruited through partnerships with Global Liver Institute and the Hepatitis B Foundation.
Results:
The interviews identified five overarching themes representing navigation needs of HCC patients: (1) Education/ Health Literacy, (2) Financial Resources, (3) Coordination of Care, (4) Emotional Management, and (5) Social Support. The table displays the themes and subthemes.
Conclusions:
This study provides valuable insight into the needs of HCC patients at the institutional and national levels. Successful navigation must include interventions that address these needs; study findings have informed our pilot navigation intervention.

Navigation needs of HCC patients.

Themes
Subthemes

Education
Disease progression and prognosisTreatment optionsPreparation for various stages of disease and treatmentEducation and preparation for upcoming visitsImportance of follow-upNutrition and other health behaviors

Financial Resources
Insurance–treatment/medication coverage andcopaymentsTransportationHousing/ RentFoodConnection to other agencies/ community resources (Medicare/ Medicaid, funding programs, foundations/ non-profits targeting HCC, advocacy)

Coordination of Care
Scheduling multiple doctor/lab visitsFollow-up for attendance to visitsMedical records ordered and receivedImaging done correctly and receivedServices to manage symptoms (Nutrition, acupuncture, massage, etc.)

Emotional Management
Manage anxiety/ depression/ overwhelm/ confusion/ denial/ fatiguePsycho-oncology/psychiatrist referralAlcohol and substance abuse treatmentSupport groupsStress reduction/ coping strategiesMindfulness/ meditationYoga/ Movement

Limited Social Support
Mental healthTransportationTreatment adherence
Evaluating the readability of online patient information for cholangiocarcinoma.
Authors: Patel Rishi , Paschke Alexander , Grewal Udhayvir Singh
Published: September 2024

264

Background:
The digital age has facilitated the dissemination of free comprehensive information regarding the diagnosis and treatment of various cancers. Especially for rarer cancers, such as cholangiocarcinoma, patients heavily rely on online patient information (OPI) as a primary source of information. However, the usefulness of these websites is dependent on the readability of the information. The National Institute of Health (NIH) recommends OPI have a readability level of grade 8 or lower. We sought to assess the readability of OPI for cholangiocarcinoma.
Methods:
We utilized Google to identify the top ten websites utilizing the search query "cholangiocarcinoma". The readability score of each website was defined as the median of ten popular standardized readability scales - Flesch–Kincaid, Gunning Fog, Coleman–Liau, Simple Measure of Gobbledygook, Automated Readability Index, FORCAST, Raygor, Fry Graph, and New Dale Chall. These readability scales were obtained using www.readable.com. Group comparisons of readability score were performed for affiliation (i.e., academic, non-profit, or government) and website content (i.e., treatment modalities, complications, clinical trials, supportive care, and survivorship). Statistical analysis was done in RStudio. Pairwise comparisons were performed using the Wilcoxon rank sum test.
Results:
A total of 10 websites were analyzed with 4/10 (40%) affiliated with academic institutions, 3/10 (30%) affiliated with non-profit organization, and 3/10 (30%) affiliated with government websites. The median readability score for all 10 websites was 9.95 (IQR 9.15-10.75). The majority of the websites (9/10, 90%) websites had readability scores that did not satisfy the NIH recommendation for readability. Readability scores did not differ significantly between academic, government, and nonprofit websites (p=0.68). Readability also did not differ by website content. The correlation between word count and readability score was not statistically significant (r = 0.03, p = 0.92).
Conclusions:
We performed a first of its kind analysis to assess the readability of OPI for cholangiocarcinoma. The median readability of OPI for cholangiocarcinoma was at a 10th grade level and the majority of the websites did not satisfy the NIH guideline for readability. Surprisingly, government websites were not simpler to read than their academic and nonprofit counterparts. Our study underscores the need to develop OPI for cholangiocarcinoma that is easily readable for patients and their caregivers. Organizations publishing OPI may use readability scores to ensure their content is accessible for the general population.
The impact of COVID-19 on time toxicity in patients with advanced cancer.
Authors: Duffens Ali , Zhu Shiyun , Shirazi Aida , Liu Raymond
Published: September 2024

267

Background:
The COVID-19 pandemic necessitated the rapid adoption of telemedicine but little is known about whether the changes in care delivery has led to differences in time toxicity for patients with advanced cancer. This study examines the impact of the pandemic on time toxicity, defined as the time burden of interacting with the healthcare system, by comparing healthcare contact days between pre-COVID and post-COVID periods.
Methods:
A retrospective cohort study was performed on patients with advanced (stage 4) cancer who died within one year of diagnosis at Kaiser Permanente Northern California between January 1, 2015 and June 30, 2023. Time toxicity was defined as the percentage of healthcare contact days over the course of survival period between cancer diagnosis and death (contact days/survival days). We included outpatient days (imaging, labs, treatment, provider visits), inpatient stays (emergency department, acute inpatient, non-acute institutional stays), and in-home days (in-home care, virtual care, home hospice). Differences between pre-COVID (diagnosed and died before March 1, 2020) and post-COVID (diagnosed after March 1, 2020) periods were analyzed using Wilcoxon tests.
Results:
The cohort included 9643 patients, with 6558 pre-COVID and 3085 post-COVID. Median age at diagnosis was 74 years, and the cohort was 46.9% female, largely white (64.5%), with a high comorbidity score (median Elixhauser score: 4). Post-COVID, there was an increase in institutional stay (8.7% vs. 9.3%) and outpatient service (imaging and labs) (4.4% vs. 3.1%), while in-person outpatient visits decreased (5.9% vs. 8.7%, p<0.0001). Additionally, in-home days increased (25.0% vs. 20.8%), with a significant rise in in-home virtual care (3.9% vs. 1.8%, all p<0.01).
Conclusions:
The COVID-19 pandemic led to notable shifts in healthcare utilization for patients with advanced cancer in the last year of life. The increase in telehealth and in-home services in the post-COVID era was accompanied by a slight increase in emergency and ancillary services. Further understanding patient experiences around these shifts is crucial for optimizing care and managing time toxicity in the evolving healthcare landscape.

Description of outcomes pre and post-COVID-19 pandemic.

Total
Pre-COVID
Post-COVID
P-value

Survival Days, median
86.0
84.0
89.0
0.02

Percentage of Contact, median (interquartile range)

Comprehensive Contact
63.3 (41.0-92.0)
62.5 (40.7-91.0)
65.2 (41.7-94.1)
0.01

Institutional stay
9.0 (2.7-26.2)
8.7 (2.7-25.9)
9.3 (2.9-26.8)
0.11

Outpatient
12.4 (5.3-19.8)
12.9 (5.6-20.6)
11.2 (4.8-18.1)
<.001

Outpatient visit
7.7 (2.8-13.4)
8.7 (3.5-14.6)
5.9 (1.6-10.7)
<.0001

Outpatient service
3.5 (0.8-6.3)
3.1 (0.4-5.8)
4.4 (1.5-7.1)
<.0001

In-home
22.2 (7.4-50.0)
20.8 (6.0-48.4)
25.0 (10.4-51.7)
<.001

In-home care
18.1 (1.7-46.6)
17.4 (1.2-46.2)
19.2 (2.4-47.2)
0.03

In-home virtual care
2.2 (0.0-4.8)
1.8 (0.0-3.8)
3.9 (0.7-7.0)
<.0001
Diagnostic evaluation for abnormal uterine bleeding at emergency departments in the United States.
Authors: Huang Wanyi , Ma Xiaomei , Clark Mitchell , Xu Xiao
Published: September 2024

269

Background:
Uterine cancer is the most common gynecologic malignancy in the U.S. with well-documented racial disparity in stage at diagnosis (more advanced stage among Black women). As there is no routine screening for uterine cancer, timely and proper evaluation of relevant symptoms is important for early diagnosis. Abnormal uterine bleeding (AUB) is a prominent symptom of uterine cancer, yet data on the quality of care around AUB evaluation are sparse, especially among patients presenting to the emergency departments (ED) who are particularly at risk for delayed diagnosis due to lack of access to primary care. This study aimed to examine the pattern of diagnostic evaluation for AUB in a national sample of women seeking care at EDs and potential racial and ethnic differences.
Methods:
Using the 2014-2021 National Hospital Ambulatory Medical Care Survey (NHAMCS) data, we identified 7,900,653 (weighted) women without previous cancer diagnosis who visited ED for non-pregnancy related AUB. The primary outcomes were whether an ultrasound was performed/ordered at the ED visit and whether a referral/return to a physician or clinic for follow-up consultation was recommended. Multivariable logistic regressions were fit to assess the association of race and ethnicity with these diagnostic evaluations, while accounting for other characteristics of the ED visit (e.g. patient age, comorbidities, involvement of a consulting physician, type of insurance, geographic region, and metropolitan area location). All analyses accounted for the NHAMCS complex sample design and sampling weight to generate nationally representative estimates.
Results:
Non-Hispanic Black women were less likely than non-Hispanic White women to receive or have an ultrasound ordered (34.9% vs 42.5%, P = 0.004), which remained statistically significant after adjusting for other characteristics of the visit in multivariable analysis (adjusted OR = 0.58, 95% CI 0.36-0.92). Multivariable analysis also showed a lower likelihood of non-Hispanic Black women receiving referral or recommendation for follow-up consultation, compared to non-Hispanic White women (adjusted OR = 0.54, 95% CI 0.31-0.94). Hispanic women did not differ significantly from non-Hispanic White women in these measures. Perimenopausal age (45-54 years) and location in a non-metropolitan area were associated with a lower likelihood of having an ultrasound performed/ordered or a referral/follow-up consultation recommended. Involvement of a consulting physician at the ED visit increased the likelihood of having an ultrasound performed/ordered while reducing the likelihood of referral/recommendation for follow-up consultation.
Conclusions:
There is racial disparity in the diagnostic evaluation of AUB among women seeking care at EDs. Future efforts to improve care quality and equity in this area may help reduce disparities in early diagnosis of uterine cancer.
A comparative analysis of supportive care service needs in patients with pancreas versus other gastrointestinal cancers.
Authors: Coveler Andrew L. , Sham Jonathan G , Sandoval Madeline V , Britton Thom , Tate John , Stricker Carrie Tompkins , McMillen Kerry K
Published: September 2024

272

Background:
Pancreatic ductal adenocarcinoma (PDAC) is the third leading cause of cancer death and presents with advanced incurable disease approximately 75% of the time, contributing to the lowest survival rate and worst multidimensional quality of life (QOL) compared to other adult solid tumors. Standardized screening for early integration of interdisciplinary care (IDC) services, advance care planning, and utilization of electronic patient-reported outcomes (ePROs) for improved QOL and symptom management are recommended, yet the literature is lacking in rigorously-conducted PDAC needs assessments, an important prerequisite to care model design.
Methods:
Between September 12, 2023 and May 7, 2024, 525 patients with gastrointestinal (GI) malignancies were sent a Supportive Care Questionnaire (SCQ), an ePRO survey assessing multi-dimensional IDC needs prior to first visit at an NCI-designated comprehensive cancer center in the Pacific Northwest. The SCQ includes validated surveys and a total of 12 domains chosen by the IDC service responsible for management of the given need(s), who also set trigger thresholds for referral to the IDC service. Rates of positive screens for each service were compared by cancer type (PDAC, Colorectal [CRC], gastroesophageal [GE]).
Results:
340 (65%) SCQs were completed (57% via MyChart, 43% in person) similarly across disease groups; with an average of 10 mins to complete. Respondents were 49% female/59% male (Race: White (76.5%), Asian (10%), Black/African-American (4.5%), Other/Unknown (9%)/Ethnicity Non-Hispanic (90%, Hispanic 7.6%), Other/Declined/Unknown 2.4%), with primary language spoken being English (92%), Spanish (3.5%), simplified Chinese (1.5%) and Other (2.5%). Table 1 shows – by GI cancer type –the total number of responses and the proportion of patients who screened positive for one or more IDC services.
Conclusions:
Patients with PDAC had the greatest need for IDC services with most frequent positive screens indicating need for nutrition, social work, palliative care and patient navigation services when surveyed in our institution-wide program of SC screening for all new GI cancer patients. Results will inform further development of IDC services in PDAC and other GI cancers, including via staff prediction modeling. The SCQ is also being considered for SC screening and management across the Canopy Cancer Collective, a nationwide learning health network of pancreas cancer programs.

PDAC
CRC
GE

Surveyed
187
237
101

Completed
122 (65%)
153 (65%)
65 (64%)

Positive Screen
68 (56%)
70 (46%)
26 (40%)
Alopecia as an uncommon side effect of single postoperative instillation of gemcitabine in patients with non-muscle-invasive urothelial carcinoma of the bladder.
Authors: Dadabhoy Anosh , Ladi Seyedian Seyedeh Sanam , Doshi Chirag , Schuckman Anne K. , Daneshmand Siamak
Published: September 2024

274

Background:
Single-dose administration of intravesical gemcitabine is a common part of clinical practice following transurethral resection (TURBT) of non-muscle invasive bladder cancer (NMIBC). Although the side effect profile for gemcitabine is well characterized in systemic and local therapy, rare side effects continue to be identified with ongoing use. Here we identify several cases of treatment-related alopecia with adjuvant single dose intravesical administration for NMIBC after TURBT.
Methods:
Using our single-institutional IRB-approved Cysview registry database, we identified patients who underwent TURBT for NMIBC and received a single dose of intravesical gemcitabine post-TURBT between January 2020 and June 2023 at Keck Hospital of USC. Patients with a history of low grade NMIBC or those undergoing their first TURBT received 2g of gemcitabine dissolved in 100 cc of saline 1h after tumor resection. We reviewed patient-reported adverse events and included patients who reported alopecia following gemcitabine instillation. Patients were questioned on the degree and length of hair loss and information was collected from patient charts.
Results:
Overall, 9 patients (2 male, 7 female) reported hair loss following single dose intravesical gemcitabine after the TURBT. One patient had an autoimmune disease. The hair loss started within a few days of gemcitabine instillation and resolved spontaneously. The table shows the clinicopathologic characteristics of this cohort in detail. Three patients experienced severe hair loss. The resection extent during TURBT was classified as small (<2 cm), medium (2-5 cm), or large (>5 cm). Three patients had a large resection, 2 patients a medium one and 3 patients a small resection. None of the patients had previous intravesical gemcitabine; however, 2 patients had a history of intravesical BCG and 1 had intravesical mitomycin before.
Conclusions:
This study demonstrates that hair loss is a rare but possible adverse effect of intravesical gemcitabine after TURBT. Prior to surgery, patients should be counseled regarding this potential side-effect. Additional research and multicenter studies are required to describe the occurrence and cause of this adverse event.

Demographic, clinical, and pathologic characteristics of patients.

Patient ID
Age
Sex
History of other IVT
Pathology of TURBT
Number of prior TURBT
Resection extent
Severity of hair loss
Prior UBC

1
73
M
None
LGTa
1
large
moderate
LGTa

2
88
M
MMC
LGTa
multiple
large
severe
LGTa

3
76
F
BCG
CIS
multiple
small
moderate
HGT1 in upper tract,HGTa & LGTa in bladder

4
56
F
BCG
HGTa
multiple
large
severe
LG+HGTa

5
66
F
None
HGTa
none
small
moderate
None

6
84
F
None
LGTa
none
small
severe
None

7
62
F
None
LGTa
1
medium
moderate
LGTa

8
68
F
None
HGTa
multiple
medium
mild
LGTa

9
64
F
None
LGTa
none
medium
severe
None

LG= Low Grade, HG = High Grade.