Experiences of patients with peritoneal carcinomatosis-related complex care needs and their caregivers.

BACKGROUND: Patients with peritoneal carcinomatosis (PC) frequently undergo palliative procedures, yet these patients and their caregivers report being unprepared to manage ostomies, drains, and other complex care needs at home. The purpose of this study was to characterize the unique needs of these patients and their caregivers during care transitions. METHODS: Patients completed measures of health status and advance care planning, caregivers completed measures of preparedness and burden, and all participants completed measures of depression and anxiety. Participants detailed their experiences in individual, semi-structured interviews. We analyzed data using descriptive statistics and conventional content analysis. RESULTS: Sixty-one patients and 39 caregivers completed baseline measures. Twenty-four (39.3%) patients acknowledged their terminal illness and seven (11.5%) had discussed end-of-life care preferences with clinicians. Most (26/39, 66.7%) caregivers provided daily care. Among caregivers who managed symptoms, few were taught how to do so (6/20, 30%). Seven patients (11.5%) and seven caregivers (17.9%) met case criteria for anxiety, while 15 patients (24.6%) and two caregivers (5.1%) met case criteria for depression. Interview participants described a diagnosis of PC as a turning point for which there is no road map and identified the need for health systems change to minimize suffering. CONCLUSION: Patients with PC and their caregivers are highly burdened by symptoms and care needs. Patients' prognostic understanding and advance care planning are suboptimal. Interventions that train patients with PC and their caregivers to perform clinical care tasks, facilitate serious illness conversations, and provide psychosocial support are needed.

Improving the palliative-procedure decision-making process for patients with peritoneal carcinomatosis: A secondary analysis.

BACKGROUND: Peritoneal carcinomatosis (PC) is common in patients with advanced gynecologic and gastrointestinal cancers. Frequently, patients with PC undergo palliative surgery or procedures to manage disease-related complications and side effects. However, there are limited data regarding patients' and family caregivers' decision-making processes about these procedures. Thus, we sought to describe the decision-making experiences of patients with PC who elect to pursue palliative surgical procedures and their family caregivers. METHODS: We conducted a secondary analysis of qualitative data collected during a pilot randomized controlled trial of BOLSTER, a nurse-led telehealth intervention for patients with PC and their caregivers after an acute hospitalization and palliative procedure. Participants in both study arms described their experiences in semi-structured interviews. We re-analyzed coded qualitative data with a focus on understanding decision-making experiences surrounding palliative surgery and procedures using conventional content analysis. RESULTS: Interviews from 32 participants, 23 patients and 9 caregivers, were analyzed. Participants reported their decision-making was complicated by illness uncertainty and a desire for clear, effective communication with surgical and medical oncology teams. Participants requested more information about the impact of palliative procedures on their daily life. Several also noted that, without improved understanding, a misalignment between patient and family caregiver goals and palliative procedures may inadvertently increase suffering. CONCLUSION: Discussions related to patients' goals and preferences can improve the quality of treatment decision-making in patients with PC and their caregivers. Future research should test interventions to improve advanced cancer patients' illness understanding and decision-making surrounding palliative surgery and procedures.

Feasibility and acceptability of a nurse-led telehealth intervention (BOLSTER) to support patients with peritoneal carcinomatosis and their caregivers: A pilot randomized clinical trial.

OBJECTIVE: Patients with advanced gynecologic (GYN) and gastrointestinal (GI) cancers frequently develop peritoneal carcinomatosis (PC), which limits prognosis and diminishes health-related quality of life (HRQoL). Palliative procedures may improve PC symptoms, yet patients and caregivers report feeling unprepared to manage ostomies, catheters, and other complex needs. Our objectives were to (1) assess the feasibility of an efficacy trial of a nurse-led telehealth intervention (BOLSTER) for patients with PC and their caregivers; and (2) assess BOLSTER's acceptability, potential to improve patients' HRQoL and self-efficacy, and potential impact on advance care planning (ACP). METHODS: Pilot feasibility RCT. Recently hospitalized adults with advanced GYN and GI cancers, PC, and a new complex care need and their caregivers were randomized 1:1 to BOLSTER or enhanced discharge planning (EDP). We defined feasibility as a ≥ 50% approach-to-consent ratio and acceptability as ≥70% satisfaction with BOLSTER. We assessed patients' HRQoL and self-efficacy at baseline and six weeks, then compared the proportion experiencing meaningful improvements by arm. ACP documentation was identified using natural language processing. RESULTS: We consented 77% of approached patients. In the BOLSTER arm, 91.0% of patients and 100.0% of caregivers were satisfied. Compared to EDP, more patients receiving BOLSTER experienced improvements in HRQoL (68.4% vs. 40.0%) and self-efficacy for managing symptoms (78.9% vs. 35.0%) and treatment (52.9% vs. 42.9%). The BOLSTER arm had more ACP documentation. CONCLUSIONS: BOLSTER is a feasible and acceptable intervention with the potential to improve patients' HRQoL and promote ACP. An efficacy trial comparing BOLSTER to usual care is underway. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03367247; PI: Wright.

Pain coping, multidisciplinary care, and mHealth: Patients' views on managing advanced cancer pain.

OBJECTIVE: Pain is common among people with advanced cancer. While opioids provide significant relief, incorporating psycho-behavioral treatments may improve pain outcomes. We examined patients' experiences with pain self-management and how their self-management of chronic, cancer-related pain may be complemented by behavioral mobile health (mHealth) interventions. METHODS: We conducted semi-structured qualitative interviews with patients with advanced cancer and pain. Each participant reviewed content from our behavioral mHealth application for cancer pain management and early images of its interface. Participants reflected on their experiences self-managing cancer pain and on app content. Interviews were transcribed verbatim and analyzed using a combination of inductive and deductive thematic analysis. RESULTS: Patients (n = 28; 54% female; mean age = 53) across two geographic regions reported using psychological strategies (e.g., reframing negative thoughts, distraction, pain acceptance, social support) to manage chronic cancer-related pain. Patients shared their perspectives on the integration of psycho-behavioral pain treatments into their existing medical care and their experiences with opioid hesitancy. Patient recommendations for how mHealth interventions could best support them coalesced around two topics: 1.) convenience in accessing integrated pharmacological and psycho-behavioral pain education and communication tools and 2.) relevance of the specific content to their clinical situation. CONCLUSIONS: Integrated pharmacological and psycho-behavioral pain treatments were important to participants. This underscores a need to coordinate complimentary approaches when developing cancer pain management interventions. Participant feedback suggests that an mHealth intervention that integrates pain treatments may have the capacity to increase advanced cancer patients' access to destigmatizing, accessible care while improving pain self-management.

Development and pre-pilot testing of STAMP + CBT: an mHealth app combining pain cognitive behavioral therapy and opioid support for patients with advanced cancer and pain.

PURPOSE: We developed and piloted a mobile health app to deliver cognitive behavioral therapy for pain (pain-CBT), remote symptom monitoring, and pharmacologic support for patients with pain from advanced cancer. METHODS: Using an iterative process of patient review and feedback, we developed the STAMP + CBT app. The app delivers brief daily lessons from pain-CBT and pain psychoeducation, adapted for advanced cancer. Daily surveys assess physical symptoms, psychological symptoms, opioid utilization and relief. Just-in-time adaptive interventions generate tailored psychoeducation in response. We then conducted a single-arm pilot feasibility study at two cancer centers. Patients with advanced cancer and chronic pain used the app for 2 or 4 weeks, rated its acceptability and provided feedback in semi-structured interviews. Feasibility and acceptability were defined as ≥ 70% of participants completing ≥ 50% of daily surveys, and ≥ 80% of acceptability items rated ≥ 4/5. RESULTS: Fifteen participants (female = 9; mean age = 50.3) tested the app. We exceeded our feasibility and accessibility benchmarks: 73% of patients completed ≥ 50% of daily surveys; 87% of acceptability items were rated ≥ 4/5. Participants valued the app's brevity, clarity, and salience, and found education on stress and pain to be most helpful. The app helped participants learn pain management strategies and decrease maladaptive thoughts. However, participants disliked the notification structure (single prompt with one snooze), which led to missed content. CONCLUSION: The STAMP + CBT app was an acceptable and feasible method to deliver psychological/behavioral treatment with pharmacologic support for cancer pain. The app is being refined and will be tested in a larger randomized pilot study. TRN: NCT05403801 (05/06/2022).

Adaptation of a Multimedia Chemotherapy Educational Intervention for Latinos: Letting Patient Narratives Speak for Themselves.

This study aims to adapt a video-based, multimedia chemotherapy educational intervention to meet the needs of US Latinos with advanced gastrointestinal malignancies. A five-step hybrid adaptation process involved (1) creating a multidisciplinary team with diverse Latino subject experts, (2) appraising the parent intervention, (3) identifying key cultural considerations from a systematic literature review and semi-structured Latino patient/caregiver interviews, (4) revising the intervention, highlighting culturally relevant themes through video interviews with Latino cancer patients, and (5) target population review with responsive revisions. We developed a suite of videos, booklets, and websites available in English and Spanish, which convey the risks and benefits of common chemotherapy regimens. After revising the English materials, we translated them into Spanish using a multi-step process. The intervention centers upon conversations with 12 Latino patients about their treatment experiences; video clips highlight culturally relevant themes (personalismo, familismo, faith, communication gaps, prognostic information preferences) identified during the third adaptation step. The adapted intervention materials included a new section on coping, and one titled "how to feel the best you can feel," which reviews principles of side effect management, self-advocacy, proactive communication, and palliative care. Ten Latinos with advanced malignancies reviewed the intervention and found it to be easily understandable, relatable, and helpful. A five-step hybrid model was successful in adapting a chemotherapy educational intervention for Latinos. Incorporation of video interviews with Latino patients enabled the authentic representation of salient cultural themes. Use of authentic patient narratives can be useful for cross-cultural intervention adaptations.

Racial and ethnic disparities in cancer caregiver burden and potential sociocultural mediators.

PURPOSE: Black and Hispanic cancer patients experience many worse care quality and health outcomes than non-Hispanic White patients, yet less is known about disparities in caregiving responsibilities and burden among cancer caregivers. METHODS: We analyzed cross-sectional data from Cancer Care Outcomes Research and Surveillance consortium, a large multi-regional, population-based study of colorectal and lung cancer patients and their caregivers. Bivariate and multivariable regression models assessed differences by racial and ethnic groups in caregiving responsibilities and social/emotional, financial, and health burdens. Structural equation models estimated whether sociocultural resources (social support, caregiving preparedness, caregiver-patient communication) mediated racial and ethnic differences in caregiver burden. RESULTS: Compared with non-Hispanic White caregivers (N = 1,169), Black (N = 220) and Hispanic (N = 84) caregivers spent more time caregiving (18 vs. 26 vs. 26 h/week; P < 0.001), completed more tasks (6.8 vs. 7.6 vs. 8.7; P < 0.05), and reported greater financial burden (P = 0.02). Yet, compared to non-Hispanic Whites, Hispanic caregivers reported similar social/emotional and health burdens, while Black caregivers reported lower levels (P < 0.01). In adjusted models, disparities in financial burden disappeared, and Hispanic caregivers had less health burden than non-Hispanic White caregivers (P = 0.01). Social support and/or caregiving preparedness partially mediated the Black-White gap for all three types of burdens. CONCLUSIONS: Black and Hispanic cancer caregivers perform more caregiving and report greater financial burden than non-Hispanic White caregivers, but experience lower or equivalent social/emotional and health burdens. Racial differences in caregivers' social support and caregiving preparedness levels partially explain Black-White burden differences. Research and policy should address Black and Hispanic caregivers' increased financial burden.

Cancer pain self-management in the context of a national opioid epidemic: Experiences of patients with advanced cancer using opioids.

BACKGROUND: The US opioid epidemic has prompted dramatic changes in public attitudes and regulations governing opioid prescribing. Little is known about the experiences of patients with advanced cancer using opioids in the context of the epidemic. METHODS: Semistructured interviews of 26 patients with advanced cancer were conducted between May 2019 and April 2020; their experiences self-managing chronic pain with opioids were evaluated. RESULTS: Patients consistently described the negative impact of the opioid epidemic on their ability to self-manage pain. Negative media coverage and personal experiences with the epidemic promoted stigma, fear, and guilt surrounding opioid use. As a result, many patients delayed initiating opioids and often viewed their decision to take opioids as a moral failure-as "caving in." Patients frequently managed this internal conflict through opioid-restricting behaviors (eg, skipping or taking lower doses). Stigma also impeded patient-clinician communication; patients often avoided discussing opioids or purposely conveyed underusing them to avoid being labeled a "pill seeker." Patients experienced structural barriers to obtaining opioids such as prior authorizations, delays in refills, or being questioned by pharmacists about their opioid use. Barriers were stressful, amplified stigma, interfered with pain control, and reinforced ambivalence about opioids. CONCLUSIONS: The US opioid epidemic has stigmatized opioid use and undermined pain management in individuals with advanced cancer. Interventions seeking to alleviate cancer pain should attend to the multiple, negative influences of the opioid crisis on patients' ability to self-manage. LAY SUMMARY: Patients with advanced cancer suffer from significant pain and frequently receive opioids to manage their pain. Of the 26 patients with advanced cancer interviewed, the majority of patients experienced stigma about their opioid use for cancer pain management. All patients felt that the opioid epidemic fostered this stigma. Several struggled to use opioids for pain because of this stigma and the logistical complications they experienced with pharmacies and insurance coverage. Many were afraid to share their concerns about opioids with their providers. ​.

Chronic pain severity, impact, and opioid use among patients with cancer: An analysis of biopsychosocial factors using the CHOIR learning health care system.

BACKGROUND: Despite the biopsychosocial underpinnings of chronic noncancer pain, relatively little is known about the contribution of psychosocial factors to chronic cancer pain. The authors aimed to characterize associations between biopsychosocial factors and pain and opioid use among individuals with chronic pain and cancer. METHODS: The authors conducted a retrospective, cross-sectional study of 700 patients with chronic pain and cancer seeking treatment at an academic tertiary pain clinic. Patients completed demographic questionnaires and validated psychosocial and pain measures. Multivariable, hierarchical linear and logistic regressions assessed the relative contributions of biopsychosocial factors to the primary dependent variables of pain severity, pain interference, and opioid use. RESULTS: Participants were 62% female and 66% White with a mean age of 59 ± 15 years, and 55% held a college degree or higher. Older age, African American or "other" race, sleep disturbance, and pain catastrophizing were significantly associated with higher pain severity (F(5,657) = 22.45; P ≤ .001; R2 = 0.22). Depression, sleep disturbance, pain catastrophizing, lower emotional support, and higher pain severity were significantly associated with pain interference (F(5,653) = 9.47; P ≤ .001; R2 = 0.44). Lastly, a poor cancer prognosis (Exp(B) = 1.62) and sleep disturbance (Exp(B) = 1.02) were associated with taking opioids, whereas identifying as Asian (Exp(B) = 0.48) or Hispanic (Exp(B) = 0.47) was associated with lower odds of using opioids. CONCLUSIONS: Modifiable psychological factors-specifically sleep disturbance, depression, and pain catastrophizing-were uniquely associated with pain and opioid use in patients with chronic pain and diverse cancer diagnoses. Future behavioral pain interventions that concurrently target sleep may improve pain among patients with cancer. LAY SUMMARY: Feeling depressed, worrying about pain, and bad sleep are related to higher pain symptoms in individuals with chronic pain and cancer. Specifically, those who struggle to sleep have worse pain and use more opioids. Also, individuals who have a bad prognosis for their cancer are more likely to be using opioid pain medications. Although race and cancer are related to chronic pain in patients, psychological well-being is also strongly related to this same pain.

Leveraging mobile health technology and research methodology to optimize patient education and self-management support for advanced cancer pain.

PURPOSE: Patient education is critical for management of advanced cancer pain, yet the benefits of psychoeducational interventions have been modest. We used mobile health (mHealth) technology to better meet patients' needs. METHODS: Using the Agile and mHealth Development and Evaluation Frameworks, a multidisciplinary team of clinicians, researchers, patients, and design specialists followed a four-phase iterative process to develop comprehensive, tailored, multimedia cancer pain education for a patient-facing smartphone application. The target population reviewed the content and provided feedback. RESULTS: The resulting application provides comprehensive cancer pain education spanning pharmacologic and behavioral aspects of self-management. Custom graphics, animated videos, quizzes, and audio-recorded relaxations complemented written content. Computable algorithms based upon daily symptom surveys were used to deliver brief, tailored motivational messages that linked to more comprehensive teaching. Patients found the combination of pharmacologic and behavioral support to be engaging and helpful. CONCLUSION: Digital technology can be used to provide cancer pain education that is engaging and tailored to individual needs. A replicable interdisciplinary and patient-centered approach to intervention development was advantageous. mHealth interventions may be a scalable approach to improve cancer pain. Frameworks that merge software and research methodology can be useful in developing interventions.

Meeting the guidelines: Implementing a distress screening intervention for veterans with cancer.

BACKGROUND: Guidelines recommend systematic evaluation of distress screening and referral for cancer patients. Implementation remains a notable gap for cancer centers serving disadvantaged communities. We present the implementation of a distress screening program within a Veterans Affairs hospital oncology clinic, serving a majority African American (AA) male population of low socioeconomic status (SES). METHODS: The Coleman Foundation funded this program supporting a palliative care physician and psychologist to implement screening in a phased approach as follows: (1) Organizing key stakeholders, (2) educating clinical staff, (3) delivering distress screening, (4) generating documentation, and (5) implementing clinical action and referral pathways. We utilized validated measures in the "Patient Screening Questions for Supportive Care" screening tool. RESULTS: This program was unsuccessful in screening all veterans with cancer; however, we were able to implement 3 years of longitudinal screening. In distress screens from the initial program period (n = 253), patients were primarily males (95.6%) of older age (m = 70, standard deviation = 9.45), AA (76.4%), with various cancers of advanced disease (69%). Males reported moderate psychosocial distress and elevated financial needs. For males with elevated psychosocial distress (n = 63, PHQ-4 ≥3), 36% were previously connected with psychosocial services. Following screening, engagement increased as the majority (77%) established psychosocial care. CONCLUSIONS: This screening program had mixed success. Centralized program staff and available supportive care referrals were critical for program implementation. Screening may have increased engagement in social work/mental health services for males of low SES. Screening programs should be tailored to the needs of underserved communities with accessible housing/food subsidies.

A scale to assess religious beliefs in end-of-life medical care.

BACKGROUND: Studies postulate that certain religious beliefs related to medical care influence the end-of-life (EOL) medical decision making and care of patients with advanced cancer. Because to the best of the authors' knowledge no current measure explicitly assesses such beliefs, in the current study the authors introduced and evaluated the Religious Beliefs in EOL Medical Care (RBEC) scale, a new measure designed to assess religious beliefs within the context of EOL cancer care. METHODS: The RBEC scale consists of 7 items designed to reflect religious beliefs in EOL medical care. Its psychometric properties were evaluated in a sample of 275 patients with advanced cancer from the Coping With Cancer II study, a National Cancer Institute-funded, multisite, longitudinal, observational study of communication processes and outcomes in EOL cancer care. RESULTS: The RBEC scale proved to be internally consistent (Cronbach α, .81), unidimensional, positively associated with other indicators of patients' religiousness and spirituality (establishing its convergent validity), and inversely associated with patients' terminal illness understanding and acceptance (establishing its criterion validity), suggesting its potential clinical usefulness in promoting informed EOL decision making. The majority of patients (87%) reported some ("somewhat," "quite a bit," or "a great deal") endorsement of at least 1 RBEC item and a majority (62%) endorsed ≥3 RBEC items. CONCLUSIONS: The RBEC scale is a reliable and valid tool with which to assess religious beliefs within the context of EOL medical care, beliefs that frequently are endorsed and inversely associated with terminal illness understanding.

Effects of a change in recall period on reporting severe symptoms: an analysis of a pragmatic multisite trial.

BACKGROUND: Optimal methods for deploying electronic patient-reported outcomes to manage symptoms in routine oncologic practice remain uncertain. The electronic symptom management (eSyM) program asks chemotherapy and surgery patients to self-report 12 common symptoms regularly. Feedback from nurses and patients led to changing the recall period from the past 7 days to the past 24 hours. METHODS: Using questionnaires submitted during the 16 weeks surrounding the recall period change, we assessed the likelihood of reporting severe or moderate and severe symptoms across 12 common symptoms and separately for the 5 most prevalent symptoms. Interrupted time-series analyses modeled the effects of the change using generalized linear mixed-effects models. Surgery and chemotherapy cohorts were analyzed separately. Study-wide effects were estimated using a meta-analysis method. RESULTS: In total, 1692 patients from 6 institutions submitted 7823 eSyM assessments during the 16 weeks surrounding the recall period change. Shortening the recall period was associated with lower odds of severe symptom reporting in the surgery cohort (odds ratio = 0.65, 95% confidence interval = 0.46 to 0.93; P = .02) and lower odds of moderate and severe symptom reporting in the chemotherapy cohort (odds ratio = 0.83, 95% confidence interval = 0.71 to 0.97; P = .02). Among the most prevalent symptoms, 24-hour recall was associated with a lower rate of reporting postoperative constipation but no differences in reporting rates for other symptoms. CONCLUSION: A shorter recall period was associated with a reduction in the proportion of patients reporting moderate-severe symptoms. The optimal recall period may vary depending on whether electronic patient-reported outcomes are collected for active symptom management, as a clinical trial endpoint, or another purpose. ClinicalTrials.gov ID NCT03850912.

Racial and Ethnic Disparities in Opioid Access and Urine Drug Screening Among Older Patients With Poor-Prognosis Cancer Near the End of Life.

PURPOSE: To characterize racial and ethnic disparities and trends in opioid access and urine drug screening (UDS) among patients dying of cancer, and to explore potential mechanisms. METHODS: Among 318,549 non-Hispanic White (White), Black, and Hispanic Medicare decedents older than 65 years with poor-prognosis cancers, we examined 2007-2019 trends in opioid prescription fills and potency (morphine milligram equivalents [MMEs] per day [MMEDs]) near the end of life (EOL), defined as 30 days before death or hospice enrollment. We estimated the effects of race and ethnicity on opioid access, controlling for demographic and clinical factors. Models were further adjusted for socioeconomic factors including dual-eligibility status, community-level deprivation, and rurality. We similarly explored disparities in UDS. RESULTS: Between 2007 and 2019, White, Black, and Hispanic decedents experienced steady declines in EOL opioid access and rapid expansion of UDS. Compared with White patients, Black and Hispanic patients were less likely to receive any opioid (Black, -4.3 percentage points, 95% CI, -4.8 to -3.6; Hispanic, -3.6 percentage points, 95% CI, -4.4 to -2.9) and long-acting opioids (Black, -3.1 percentage points, 95% CI, -3.6 to -2.8; Hispanic, -2.2 percentage points, 95% CI, -2.7 to -1.7). They also received lower daily doses (Black, -10.5 MMED, 95% CI, -12.8 to -8.2; Hispanic, -9.1 MMED, 95% CI, -12.1 to -6.1) and lower total doses (Black, -210 MMEs, 95% CI, -293 to -207; Hispanic, -179 MMEs, 95% CI, -217 to -142); Black patients were also more likely to undergo UDS (0.5 percentage points; 95% CI, 0.3 to 0.8). Disparities in EOL opioid access and UDS disproportionately affected Black men. Adjustment for socioeconomic factors did not attenuate the EOL opioid access disparities. CONCLUSION: There are substantial and persistent racial and ethnic inequities in opioid access among older patients dying of cancer, which are not mediated by socioeconomic variables.

Cancer Caregivers' Prognostic and End-of-Life Communication Needs and Experiences and their Impact.

CONTEXT: Family caregivers of patients with advanced cancer are integrally involved in communications regarding prognosis and end-of-life (EOL) planning and care. Yet little research has examined caregivers' communication experiences or the impact of these experiences on patients and caregivers at EOL. OBJECTIVES: Investigate cancer caregivers' communication experiences and potential impact on patient and caregiver outcomes. METHODS: Semistructured interviews with bereaved family cancer caregivers (N=19) about their communication needs and experiences as their loved one approached EOL and died. Audiotaped interviews were transcribed and thematically analyzed for communication-related themes. RESULTS: Caregivers described fulfilling many important communication roles including information gathering and sharing, advocating, and facilitating-often coordinating communication with multiple partners (e.g., patient, family, oncology team, hospital team). Caregivers reported that, among the many topics they communicated about, prognosis and EOL were the most consequential and challenging. These challenges arose for several reasons including caregivers' and patients' discordant communication needs, limited opportunity for caregivers to satisfy their personal communication needs, uncertainty regarding their communication needs and responsibilities, and feeling unacknowledged by the care team. These challenges negatively impacted caregivers' abilities to satisfy their patient-related communication responsibilities, which shaped many outcomes including end-of-life decisions, care satisfaction, and bereavement. CONCLUSION: Caregivers often facilitate essential communication for patients with advanced cancers yet face challenges successfully fulfilling their own and patients' communication needs, particularly surrounding prognostic and end-of-life conversations. Future research and interventions should explore strategies to help caregivers navigate uncertainty, create space to ask sensitive questions, and facilitate patient-caregiver discussions about differing informational needs.

Daily pain and opioid administration in hospitalized patients with cancer: the importance of psychological factors, recent surgery, and current opioid use.

ABSTRACT: Pain is common and variable in its severity among hospitalized patients with cancer. Although biopsychosocial factors are well established as modulators of chronic pain, less is known about what patient-level factors are associated with worse pain outcomes among hospitalized cancer patients. This prospective cohort study included patients with active cancer presenting to the emergency department (ED) with pain severity of ≥4/10 and followed pain outcomes longitudinally throughout hospital admission. Baseline demographic, clinical, and psychological factors were assessed on ED presentation, and daily average clinical pain ratings and opioid consumption during hospitalization were abstracted. Univariable and multivariable generalized estimating equation analyses examined associations of candidate biopsychosocial, demographic, and clinical predictors with average daily pain and opioid administration. Among 113 hospitalized patients, 73% reported pain as the primary reason for presenting to the ED, 43% took outpatient opioids, and 27% had chronic pain that predated their cancer. Higher pain catastrophizing ( B = 0.1, P ≤ 0.001), more recent surgery ( B = -0.2, P ≤ 0.05), outpatient opioid use ( B = 1.4, P ≤ 0.001), and history of chronic pain before cancer diagnosis ( B = 0.8, P ≤ 0.05) were independently associated with greater average daily pain while admitted to the hospital. Higher pain catastrophizing ( B = 1.6, P ≤ 0.05), higher anxiety ( B = 3.7, P ≤ 0.05), lower depression ( B = -4.9, P ≤ 0.05), metastatic disease ( B = 16.2, P ≤ 0.05), and outpatient opioid use ( B = 32.8, P ≤ 0.001) were independently associated with higher daily opioid administration. Greater psychological distress, especially pain catastrophizing, as well as pain and opioid use history, predicted greater difficulty with pain management among hospitalized cancer patients, suggesting that early assessment of patient-level characteristics may help direct consultation for more intensive pharmacologic and nonpharmacologic interventions.

Programmatic Precision Oncology Decision Support for Patients With Gastrointestinal Cancer.

PURPOSE: With the growing number of available targeted therapeutics and molecular biomarkers, the optimal care of patients with cancer now depends on a comprehensive understanding of the rapidly evolving landscape of precision oncology, which can be challenging for oncologists to navigate alone. METHODS: We developed and implemented a precision oncology decision support system, GI TARGET, (Gastrointestinal Treatment Assistance Regarding Genomic Evaluation of Tumors) within the Gastrointestinal Cancer Center at the Dana-Farber Cancer Institute. With a multidisciplinary team, we systematically reviewed tumor molecular profiling for GI tumors and provided molecularly informed clinical recommendations, which included identifying appropriate clinical trials aided by the computational matching platform MatchMiner, suggesting targeted therapy options on or off the US Food and Drug Administration-approved label, and consideration of additional or orthogonal molecular testing. RESULTS: We reviewed genomic data and provided clinical recommendations for 506 patients with GI cancer who underwent tumor molecular profiling between January and June 2019 and determined follow-up using the electronic health record. Summary reports were provided to 19 medical oncologists for patients with colorectal (n = 198, 39%), pancreatic (n = 124, 24%), esophagogastric (n = 67, 13%), biliary (n = 40, 8%), and other GI cancers. We recommended ≥ 1 precision medicine clinical trial for 80% (406 of 506) of patients, leading to 24 enrollments. We recommended on-label and off-label targeted therapies for 6% (28 of 506) and 25% (125 of 506) of patients, respectively. Recommendations for additional or orthogonal testing were made for 42% (211 of 506) of patients. CONCLUSION: The integration of precision medicine in routine cancer care through a dedicated multidisciplinary molecular tumor board is scalable and sustainable, and implementation of precision oncology recommendations has clinical utility for patients with cancer.

Combined PD-1, BRAF and MEK inhibition in BRAFV600E colorectal cancer: a phase 2 trial.

While BRAF inhibitor combinations with EGFR and/or MEK inhibitors have improved clinical efficacy in BRAFV600E colorectal cancer (CRC), response rates remain low and lack durability. Preclinical data suggest that BRAF/MAPK pathway inhibition may augment the tumor immune response. We performed a proof-of-concept single-arm phase 2 clinical trial of combined PD-1, BRAF and MEK inhibition with sparatlizumab (PDR001), dabrafenib and trametinib in 37 patients with BRAFV600E CRC. The primary end point was overall response rate, and the secondary end points were progression-free survival, disease control rate, duration of response and overall survival. The study met its primary end point with a confirmed response rate (24.3% in all patients; 25% in microsatellite stable patients) and durability that were favorable relative to historical controls of BRAF-targeted combinations alone. Single-cell RNA sequencing of 23 paired pretreatment and day 15 on-treatment tumor biopsies revealed greater induction of tumor cell-intrinsic immune programs and more complete MAPK inhibition in patients with better clinical outcome. Immune program induction in matched patient-derived organoids correlated with the degree of MAPK inhibition. These data suggest a potential tumor cell-intrinsic mechanism of cooperativity between MAPK inhibition and immune response, warranting further clinical evaluation of optimized targeted and immune combinations in CRC. ClinicalTrials.gov registration: NCT03668431.

Deep Learning for Cancer Symptoms Monitoring on the Basis of Electronic Health Record Unstructured Clinical Notes.

PURPOSE: Symptoms are vital outcomes for cancer clinical trials, observational research, and population-level surveillance. Patient-reported outcomes (PROs) are valuable for monitoring symptoms, yet there are many challenges to collecting PROs at scale. We sought to develop, test, and externally validate a deep learning model to extract symptoms from unstructured clinical notes in the electronic health record. METHODS: We randomly selected 1,225 outpatient progress notes from among patients treated at the Dana-Farber Cancer Institute between January 2016 and December 2019 and used 1,125 notes as our training/validation data set and 100 notes as our test data set. We evaluated the performance of 10 deep learning models for detecting 80 symptoms included in the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) framework. Model performance as compared with manual chart abstraction was assessed using standard metrics, and the highest performer was externally validated on a sample of 100 physician notes from a different clinical context. RESULTS: In our training and test data sets, 75 of the 80 candidate symptoms were identified. The ELECTRA-small model had the highest performance for symptom identification at the token level (ie, at the individual symptom level), with an F1 of 0.87 and a processing time of 3.95 seconds per note. For the 10 most common symptoms in the test data set, the F1 score ranged from 0.98 for anxious to 0.86 for fatigue. For external validation of the same symptoms, the note-level performance ranged from F1 = 0.97 for diarrhea and dizziness to F1 = 0.73 for swelling. CONCLUSION: Training a deep learning model to identify a wide range of electronic health record-documented symptoms relevant to cancer care is feasible. This approach could be used at the health system scale to complement to electronic PROs.

A Phase II Study of Ziv-Aflibercept in Patients With Advanced Extrapancreatic Neuroendocrine Tumors.

OBJECTIVES: Neuroendocrine tumors (NETs) are characterized by their expression of vascular endothelial growth factor (VEGF). This trial investigated the activity of Ziv-aflibercept, a recombinant protein that binds to and inhibits the activity of VEGF, in patients with advanced NETs (NCT01782443). METHODS: A single-arm, phase II trial enrolling patients with advanced, progressive extrapancreatic NET. Patients were treated with Ziv-aflibercept 4 mg/kg intravenously on day 1 and 15 of a 28-day cycle; the starting dose was reduced to 2 mg/kg on days 1 and 15 of a 28-day cycle because of hypertension-related events. The primary end point was progression-free survival. RESULTS: The trial enrolled 19 patients (13 male:6 female). Patients received a median of 7 cycles (range, 1-18 cycles). The median progression free survival was 11.8 months (95% confidence interval, 3.2-16.1 months), and the median overall survival was 36.4 months (95% confidence interval, 16.1-not reached). Best responses by Response Evaluation Criteria in Solid Tumors 1.1 are as follows: 1 (5%) partial response, 13 (68%) stable disease, 2 (10%) with progressive disease, and 3 (15%) unevaluable. Hypertension occurred in 18 patients (95%), including grade 3-4 hypertension in 12 patients (63%). CONCLUSIONS: Although the progression free survival is similar to other VEGF inhibitors in NET, toxicity may preclude further investigation.