Creating a Palliative Care Clinic for Patients with Cancer Pain and Substance Use Disorder.

BACKGROUND: Opioids are a first-line treatment for severe cancer pain. However, clinicians may be reluctant to prescribe opioids for patients with concurrent substance use disorders (SUD) or clinical concerns about non-prescribed substance use. MEASURES: Patient volume, 60-day retention rate, and use of sublingual buprenorphine to treat opioid use disorder. INTERVENTION: We created the Palliative Harm Reduction and Resiliency Clinic, a palliative care clinic founded on harm reduction principles and including formal collaboration with addiction psychiatry. OUTCOMES: During the first 18 months, patient volume increased steadily; 70% of patients had at least one subsequent visit within 60 days of the initial appointment; and buprenorphine was prescribed for 55% of patients with opioid use disorder. CONCLUSIONS/LESSONS LEARNED: The formal collaboration with addiction psychiatry and the integration of harm reduction principles and practices into ambulatory palliative care improved our ability to provide treatment to a previously underserved patient population with high symptom burden.

Similarities and Differences Between Pragmatic Trials and Hybrid Effectiveness-Implementation Trials.

Pragmatism in clinical trials is focused on increasing the generalizability of research findings for routine clinical care settings. Hybridism in clinical trials (i.e., assessing both clinical effectiveness and implementation success) is focused on speeding up the process by which evidence-based practices are developed and adopted into routine clinical care. Even though pragmatic trial methodologies and implementation science evolved from very different disciplines, Pragmatic Trials and Hybrid Effectiveness-Implementation Trials share many similar design features. In fact, these types of trials can easily be conflated, creating the potential for investigators to mislabel their trial type or mistakenly use the wrong trial type to answer their research question. Blurred boundaries between trial types can hamper the evaluation of grant applications, the scientific interpretation of findings, and policy-making. Acknowledging that most trials are not pure Pragmatic Trials nor pure Hybrid Effectiveness-Implementation Trials, there are key differences in these trial types and they answer very different research questions. The purpose of this paper is to clarify the similarities and differences of these trial types for funders, researchers, and policy-makers. In addition, recommendations are offered to help investigators choose, label, and operationalize the most appropriate trial type to answer their research question. These recommendations complement existing reporting guidelines for clinical effectiveness trials (TIDieR) and implementation trials (StaRI).

Racial and ethnic disparities in genomic testing among lung cancer patients: a systematic review.

INTRODUCTION: Racial and ethnic disparities in genomic testing could exacerbate disparities in access to precision cancer therapies and survival-particularly in the context of lung cancer, where genomic testing has been recommended for the past decade. However, prior studies assessing disparities in genomic testing have yielded mixed results. METHODS: We conducted a systemic review to examine racial and ethnic disparities in the use of genomic testing among lung cancer patients in the U.S. Two comprehensive searches in PubMed, Embase, and Scopus were conducted (September 2022, May 2023). Original studies that assessed rates of genomic testing by race or ethnicity were included. Findings were narratively synthesized by outcome. RESULTS: The search yielded 2,739 unique records, resulting in 18 included studies. All but one study was limited to patients diagnosed with non-small cell lung cancer. Diagnosis years ranged from 2007-2022. Eleven of 18 studies found statistically significant differences in the likelihood of genomic testing by race or ethnicity; in seven of these studies, testing was lower among Black patients compared to White or Asian patients. However, many studies lacked adjustment for key covariates and included patients with unclear eligibility for testing. CONCLUSIONS: A majority of studies, though not all, observed racial and ethnic disparities in the use of genomic testing among patients with lung cancer. Heterogeneity of study results throughout a period of changing clinical guidelines suggests that minoritized populations-Black patients in particular-have faced additional barriers to genomic testing, even if not universally observed at all institutions.

Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Substance Use Disorders Among US Adult Cancer Survivors.

Importance: Some individuals are predisposed to cancer based on their substance use history, and others may use substances to manage cancer-related symptoms. Yet the intersection of substance use disorder (SUD) and cancer is understudied. Because SUD may affect and be affected by cancer care, it is important to identify cancer populations with a high prevalence of SUD, with the goal of guiding attention and resources toward groups and settings where interventions may be needed. Objective: To describe the cancer type-specific prevalence of SUD among adult cancer survivors. Design, Setting, and Participants: This cross-sectional study used data from the annually administered National Survey on Drug Use and Health (NSDUH) for 2015 through 2020 to identify adults with a history of solid tumor cancer. Substance use disorder was defined as meeting at least 1 of 4 Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) criteria for abuse or at least 3 of 6 criteria for dependence. Main Outcomes and Measures: Per NSDUH guidelines, we made adjustments to analysis weights by dividing weights provided in the pooled NSDUH data sets by the number of years of combined data (eg, 6 for 2015-2020). The weighted prevalence and corresponding SEs (both expressed as percentages) of active SUD (ie, within the past 12 months) were calculated for respondents with any lifetime history of cancer and, in secondary analyses, respondents diagnosed with cancer within 12 months prior to taking the survey. Data were analyzed from July 2022 to June 2023. Results: This study included data from 6101 adult cancer survivors (56.91% were aged 65 years or older and 61.63% were female). Among lifetime cancer survivors, the prevalence of active SUD was 3.83% (SE, 0.32%). Substance use disorder was most prevalent in survivors of head and neck cancer (including mouth, tongue, lip, throat, and pharyngeal cancers; 9.36% [SE, 2.47%]), esophageal and gastric cancer (9.42% [SE, 5.51%]), cervical cancer (6.24% [SE, 1.41%]), and melanoma (6.20% [SE, 1.34%]). Alcohol use disorder was the most common SUD (2.78% [SE, 0.26%]) overall and in survivors of head and neck cancer, cervical cancer, and melanoma. In survivors of esophageal and gastric cancers, cannabis use disorder was the most prevalent SUD (9.42% [SE, 5.51%]). Among respondents diagnosed with cancer in the past 12 months, the overall prevalence of active SUD was similar to that in the lifetime cancer survivor cohort (3.81% [SE, 0.74%]). However, active SUD prevalence was higher in head and neck (18.73% [SE, 10.56%]) and cervical cancer survivors (15.70% [SE, 5.35%]). The distribution of specific SUDs was different compared with that in the lifetime cancer survivor cohort. For example, in recently diagnosed head and neck cancer survivors, sedative use disorder was the most common SUD (9.81% [SE, 9.17%]). Conclusions and Relevance: Findings of this study suggest that SUD prevalence is higher among survivors of certain types of cancer; this information could be used to identify cancer survivors who may benefit from integrated cancer and SUD care. Future efforts to understand and address the needs of adult cancer survivors with comorbid SUD should prioritize cancer populations in which SUD prevalence is high.

Embedding implementation science in the research pipeline.

Clinical and health services researchers seek to discover effective programs, practices, and interventions to improve people's health. The current paradigm for evidence generation is incremental and misaligned to translate evidence-based discoveries into real-world settings. This persistent challenge are "valleys of death" that represent missed opportunities and preventable missteps to actually use scientific advancements in real-world clinical settings where they can improve health and well-being (De Geest S, Zúñiga F, Brunkert T et al. Powering Swiss health care for the future: implementation science to bridge "the valley of death". 2020;150:w20323). Only one in seven of evidence-based interventions is ever implemented. It is after an average of 17 years. We propose embedding the principles of implementation science throughout the research pipeline, from discovery to adoption, to efficiently translate discoveries into real-world contexts (Balas EA, Boren SA. Managing clinical knowledge for health care improvement. 2000;9:65-70). We outline implications for capacity building, including composition of the research team, study design, and competencies that could bolster the value proposition of implementation science. We describe a research paradigm that recognizes scientists' responsibility to ensure their discoveries be translated into real-world settings.

Most innovative research is not used in clinical care settings. When it is, it takes a very long time to get into the real world. This means that patients may not get the best care possible to improve their health. The research community has tools that can help design innovative research in ways that it could work in clinical care settings and tools to help that happen faster, so that clinical care teams and patients can use innovative research. This is called implementation science. We outline why it is important to use implementation science ideas and teams earlier and how we can support infrastructure to do so.

Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

PURPOSE: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. METHODS: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). RESULTS: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. CONCLUSION: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

Meaning-centered pain coping skills training for patients with metastatic cancer: Protocol for a randomized controlled efficacy trial.

BACKGROUND: Many patients with advanced cancer describe pain as a debilitating symptom that greatly interferes with daily activities and enjoyment of life. Psychosocial interventions can improve cancer-related pain but rarely address spiritual concerns (e.g., loss of meaning, peace), which can influence the pain experience for those facing life-threatening illness. To address these needs, we systematically developed and pilot tested a novel psychosocial intervention called Meaning-Centered Pain Coping Skills Training (MCPC). In this randomized controlled trial, we aim to determine MCPC's efficacy for reducing pain interference (primary outcome) and improving secondary outcomes. We will also estimate MCPC's cost-effectiveness. METHOD/DESIGN: Patients (target N = 210) with advanced solid tumor malignancies (Stage IV) and clinically-elevated pain interference will be enrolled and block randomized with equal allocation to MCPC + enhanced usual care or enhanced usual care alone. MCPC's four, videoconferenced, 45-60 min weekly sessions will be individually delivered by trained study therapists. Primary (pain interference) and secondary (pain severity, anxiety and depressive symptoms, pain self-efficacy, social support, spiritual well-being) patient-reported outcomes will be assessed at baseline, and 8-weeks (primary endpoint) and 12-weeks after baseline. CONCLUSION: Our MCPC intervention is the first to systematically address the biopsychosocial-spiritual aspects of pain in patients with advanced cancer. If MCPC demonstrates efficacy, next steps will involve hybrid efficacy-effectiveness and implementation work to broaden access to this brief, manualized, remotely-delivered intervention, with the goal of reducing suffering in patients with life-threatening illness.

Meaning-centered pain coping skills training for patients with metastatic cancer: Results of a randomized controlled pilot trial.

OBJECTIVE: For patients with advanced cancer, pain is a common and debilitating symptom that can negatively impact physical, emotional, and spiritual well-being. This trial examined the feasibility and initial effects of Meaning-Centered Pain Coping Skills Training (MCPC), a cognitive-behavioral pain management intervention with an emphasis on enhancing meaning (i.e., a personal sense of purpose, worth, and significance) and peace. METHODS: We enrolled 60 adults with stage IV solid tumor cancers and moderate-severe pain between February 2021 and February 2022. Participants were randomized 1:1 to MCPC + usual care or usual care alone. Meaning-Centered Pain Coping Skills Training consisted of four weekly 60-min individual sessions via videoconference or telephone, delivered by a trained therapist using a manualized protocol. Participants completed validated measures of pain severity, pain interference, pain self-efficacy, spiritual well-being (i.e., meaning, peace, and faith), and psychological distress at baseline and 5-week and 10-week follow-ups. RESULTS: All feasibility metrics exceeded prespecified benchmarks. Fifty-eight percent of screened patients were eligible, and 69% of eligible patients consented. Of those assigned to MCPC, 93% completed all sessions and 100% of those who completed follow-ups reported using coping skills weekly. Retention was strong at 5-week (85%) and 10-week (78%) follow-ups. Meaning-Centered Pain Coping Skills Training participants reported better scores than control participants across outcome measures, including moderate-to-large sized differences at 10-week follow-up in pain severity (Cohen's d = -0.75 [95% confidence interval: -1.36, -0.14]), pain interference (d = -0.82 [-1.45, -0.20]), and pain self-efficacy (d = 0.74 [0.13, 1.35]). CONCLUSIONS: MCPC is a highly feasible, engaging, and promising approach for improving pain management in advanced cancer. Future efficacy testing is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04431830, registered 16 June 2020.

The Use of Templates for Documenting Advance Care Planning Conversations: A Descriptive Analysis.

CONTEXT: While professional societies and expert panels have recommended quality indicators related to advance care planning (ACP) documentation, including using structured documentation templates, it is unclear how clinicians document these conversations. OBJECTIVE: To explore how clinicians document ACP, specifically, which components of these conversations are documented. METHODS: A codebook was developed based on existing frameworks for ACP conversations and documentation. ACP documentation from a hospital medicine quality improvement project conducted from November 2019 to April 2021 were included and assessed. Documentation was examined for the presence or absence of each component within the coding schema. Clinician documented ACP using three different note types: template (only template prompts were used), template plus (authors added additional text to the template), and free text only. ACP note components were analyzed by note type and author department. RESULTS: A total of 182 ACP notes were identified and reviewed. The most common note type was template plus (58%), followed by free text (28%) and template (14%). The most frequent components across all note types were: important relationships to patient (92%), and discussion of life-sustaining treatment preferences (87%). There was considerable heterogeneity in the components across note types. The presence of components focused on treatment decisions and legal paperwork differed significantly between note types (P < 0.05). Components on preference for medical information, emotional state, or spiritual support were rarely included across all note types. CONCLUSION: This study provides a preliminary exploration of ACP documentation and found that templates may influence what information is documented after an ACP conversation.

Factors Associated With Receipt of Molecular Testing and its Impact on Time to Initial Systemic Therapy in Metastatic Non-Small Cell Lung Cancer.

BACKGROUND: Despite recommendations for molecular testing irrespective of patient characteristics, differences exist in receipt of molecular testing for oncogenic drivers amongst metastatic non-small cell lung cancer (mNSCLC) patients. Exploration into these differences and their effects on treatment is needed to identify opportunities for improvement. PATIENTS AND METHODS: We conducted a retrospective cohort study of adult patients diagnosed with mNSCLC between 2011 and 2018 using PCORnet's Rapid Cycle Research Project dataset (n = 3600). Log-binomial, Cox proportional hazards (PH), and time-varying Cox regression models were used to ascertain whether molecular testing was received, and time from diagnosis to molecular testing and/or initial systemic treatment in the context of patient age, sex, race/ethnicity, and multiple comorbidities status. RESULTS: The majority of patients in this cohort were ≤ 65 years of age (median [25th, 75th]: 64 [57, 71]), male (54.3%), non-Hispanic white individuals (81.6%), with > 2 comorbidities in addition to mNSCLC (54.1%). About half the cohort received molecular testing (49.9%). Patients who received molecular testing had a 59% higher probability of initial systemic treatment than patients who were yet to receive testing. Multiple comorbidity status was positively associated with receipt of molecular testing (RR, 1.27; 95% CI 1.08, 1.49). CONCLUSION: Receipt of molecular testing in academic centers was associated with earlier initiation of systemic treatment. This finding underscores the need to increase molecular testing rates amongst mNSCLC patients during a clinically relevant period. Further studies to validate these findings in community centers are warranted.

"It Is So Easy For Them to Dismiss": A Phenomenological Study of Cancer Survivors With Chronic Cancer-Related Pain.

Background: For many cancer survivors post-cure, chronic pain is a devastating complication of cancer treatment. The prevalence of chronic pain among cancer survivors is double that of the general population. However, little is known about the pain experience of cancer survivors who may have a different perspective than people with advanced cancer or people with noncancer pain. Objective: To understand the lived experience of chronic cancer-related pain in cancer survivors. Methods: We used a qualitative design with a descriptive phenomenological method to conduct in-depth interviews of 13 cancer survivors residing in the United States who completed curative cancer therapy, were at least three months from treatment, and experienced pain attributable to cancer. Data collection was focused on the lived experience and management of chronic cancer-related pain and a deep understanding of how the experience of chronic cancer-related pain shapes pain management choices. Results: The participants had a variety of primary cancer types and cancer pain syndromes. Three essential themes epitomized the experience of living with chronic cancer-related pain: invisible suffering at the cost of survival, an opioid paradox, and a lack of answers on what to expect and what might help. Conclusion and Implications: The results highlight an opportunity for pain self-management, education, and psychosocial interventions to optimize pain in cancer. Participants' experiences identify several opportunities to improve chronic cancer-related pain. Future efforts should prioritize access to multimodal pain treatments, high-quality communication, and expand clinicians' knowledge and skills to manage chronic pain.

Clinician Perspectives on Managing Chronic Pain After Curative-Intent Cancer Treatment.

PURPOSE: Among cancer survivors who have completed curative-intent treatment, the high prevalence and adverse consequences of chronic pain are well documented. Yet, research on clinicians' experiences with and perspectives on managing chronic pain among cancer survivors is critically lacking. METHODS: We conducted semistructured interviews with 17 clinicians (six oncology, three palliative care, and eight primary care) affiliated with an academic medical center. Interview questions addressed clinicians' experiences with and perspectives on managing chronic pain (with or without opioid therapy) during the transition from active treatment to survivorship. A multidisciplinary team conducted content analysis of interview transcripts to identify and refine themes related to current practices and challenges in managing chronic pain in this context. RESULTS: Overall, clinicians perceived chronic pain to be relatively uncommon among cancer survivors. Identified challenges included a lack of clarity about which clinician (or clinicians) are best positioned to manage chronic pain among cancer survivors, and (relatedly) complexities introduced by long-term opioid management, with many clinicians describing this practice as outside their skill set. Additionally, although most clinicians recognized chronic pain as a biopsychosocial phenomenon, they described challenges with effectively managing psychosocial stressors, including difficulty accessing mental or behavioral health services for cancer survivors. CONCLUSION: Discovered challenges highlight unmet needs related to cancer survivor-clinician communication about chronic pain and the absence of a chronic pain management home for cancer survivors, including those requiring long-term opioid therapy. Research evaluating routine pain monitoring and accessible, tailored models of multimodal pain care in survivorship may help to address these challenges.

Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity.

BACKGROUND: Conducting an embedded pragmatic clinical trial in the workflow of a healthcare system is a complex endeavor. The complexity of the intervention delivery can have implications for study planning, ability to maintain fidelity to the intervention during the trial, and/or ability to detect meaningful differences in outcomes. METHODS: We conducted a literature review, developed a tool, and conducted two rounds of phone calls with NIH Pragmatic Trials Collaboratory Demonstration Project principal investigators to develop the Intervention Delivery Complexity Tool. After refining the tool, we piloted it with Collaboratory demonstration projects and developed an online version of the tool using the R Shiny application (https://duke-som.shinyapps.io/ICT-ePCT/). RESULTS: The 6-item tool consists of internal and external factors. Internal factors pertain to the intervention itself and include workflow, training, and the number of intervention components. External factors are related to intervention delivery at the system level including differences in healthcare systems, the dependency on setting for implementation, and the number of steps between the intervention and the outcome. CONCLUSION: The Intervention Delivery Complexity Tool was developed as a standard way to overcome communication challenges of intervention delivery within an embedded pragmatic trial. This version of the tool is most likely to be useful to the trial team and its health system partners during trial planning and conduct. We expect further evolution of the tool as more pragmatic trials are conducted and feedback is received on its performance outside of the NIH Pragmatic Trials Collaboratory.

Concurrent prescribing of opioids with other sedating medications after cancer diagnosis: a population-level analysis.

PURPOSE: Cancer is a major reason for concurrent prescription of opioids with other sedating medications-particularly benzodiazepines and gabapentinoids-yet population-based assessments of the extent and predictors of concurrent prescribing among clinically and demographically diverse patients with cancer are lacking. METHODS: We conducted a retrospective cohort study of patients with non-metastatic cancer using North Carolina cancer registry data linked with Medicare and private insurance claims (2013-2016). We used modified Poisson regression to assess associations of patient characteristic with adjusted relative risk (aRR) of new concurrent prescribing of opioids with benzodiazepines or gabapentinoids after diagnosis. RESULTS: Overall, 15% of patients were concurrently prescribed opioids with benzodiazepines or gabapentinoids. Characteristics independently associated with an increased risk of concurrent prescribing included cancer type (e.g., aRR cervical vs. colorectal cancer: 1.55, 95% CI: 1.12-2.14); prior use of opioids (aRR: 2.43, 95% CI:2.21-2.67), benzodiazepines (aRR: 4.08, 95% CI: 3.72-4.48), or gabapentinoids (3.82, 95% CI: 3.31-4.39), and premorbid mental health conditions, including substance use disorder (aRR: 1.27, 95% CI: 1.05-1.54). Black and Hispanic patients were less likely to experience concurrent prescribing (aRR, Black vs. White: 0.35, 95% CI: 0.15-0.83; aRR, Hispanic vs. White: 0.75, 95% CI: 0.66-0.85). CONCLUSION: Approximately 1 in 7 patients with cancer was concurrently prescribed opioids with other sedating medications. Associations between patient characteristics and risk of concurrent prescribing highlight predictors of concurrent prescribing and suggest a rationale for systematic assessment of substance use history at diagnosis. Future research could explore inequitable pain and symptom management and investigate risk of adverse medication-related events.

Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial.

BACKGROUND: For patients and their intimate partners, advanced cancer poses significant challenges that can negatively impact both individuals and their relationship. Prior studies have found evidence that couple-based communication skills interventions can to be beneficial for patients and partners. However, these studies have been limited by reliance on in-person treatment delivery and have not targeted couples at high risk for poor outcomes. This study tests the efficacy of a Couples Communication Skills Training (CCST) intervention delivered via videoconference for couples reporting high levels of holding back from discussing cancer-related concerns, a variable associated with poorer psychological and relationship functioning. METHODS: This RCT is designed to evaluate the efficacy of CCST in improving patient and partner relationship functioning (primary outcome). Secondary outcomes include patient and partner psychological functioning and patient symptoms and health care use. We also examine the role of objective and self-reported communication behaviors as mediators of treatment effects. Two hundred thirty patients with advanced lung, gastrointestinal, genitourinary, and breast cancer and their partners will be randomized to CCST or an education control intervention. Participants in both conditions complete self-reported outcome measures at baseline, mid-treatment, post-treatment, and 3 months post-treatment. Objective measures of communication are derived from video-recorded couple conversations collected at baseline and post-treatment. An implementation-related process evaluation (assessing implementation outcomes and potential barriers to/facilitators of implementation) will be conducted to inform future efforts to implement CCST in real-world settings. DISCUSSION: This trial can yield important new knowledge about effective ways to improve patient and partner adjustment to advanced cancer. TRIAL REGISTRATION: This study trial is registered at clinicaltrials.gov (Trial # NCT04590885); registration date: October 19, 2020.

Financial Burden of Drugs Prescribed for Cancer-Associated Symptoms.

PURPOSE: The financial toxicity of anticancer drugs is well-documented, but little is known about the costs of drugs used to manage cancer-associated symptoms. METHODS: We reviewed relevant guidelines and compiled drugs used to manage seven cancer-associated symptoms (anorexia and cachexia, chemotherapy-induced peripheral neuropathy, constipation, diarrhea, exocrine pancreatic insufficiency, cancer-associated fatigue, and chemotherapy-induced nausea and vomiting). Using GoodRx website, we identified the retail price (cash price at retail pharmacies) and lowest price (discounted, best-case scenario of out-of-pocket costs) for patients without insurance for each drug or formulation for a typical fill. We describe lowest prices here. RESULTS: For anorexia and cachexia, costs ranged from $5 US dollars (USD; generic olanzapine or mirtazapine tablets) to $1,156 USD (brand-name dronabinol solution) and varied widely by formulation of the same drug or dosage: for olanzapine 5 mg, $5 USD (generic tablet) to $239 USD (brand-name orally disintegrating tablet). For chemotherapy-induced peripheral neuropathy, costs of duloxetine varied from $12 USD (generic) to $529 USD (brand-name). For constipation, the cost of sennosides or polyethylene glycol was <$15 USD, whereas newer agents such as methylnaltrexone were expensive ($1,001 USD). For diarrhea, the cost of generic loperamide or diphenoxylate-atropine tablets was <$15 USD. For exocrine pancreatic insufficiency, only brand-name formulations were available, range of cost, $1,072 USD-$1,514 USD. For cancer-associated fatigue, the cost of generic dexamethasone or dexmethylphenidate was <$15 USD, whereas brand-name modafinil was more costly ($1,284 USD). For a 4-drug nausea and vomiting prophylaxis regimen, costs ranged from $181 USD to $1,430 USD. CONCLUSION: We highlight the high costs of many symptom control drugs and the wide variation in the costs of these drugs. These findings can guide patient-clinician discussions about cost-effectively managing symptoms, while promoting the use of less expensive formulations when possible.

Opioid Prescribing and Use Among Cancer Survivors: A Mapping Review of Observational and Intervention Studies.

CONTEXT: Recent years show a sharp increase in research on opioid use among cancer survivors, but evidence syntheses are lacking, leaving knowledge gaps. Corresponding research needs are unclear. OBJECTIVES: To provide an evidence synthesis. METHODS: We searched PubMed and Embase, identifying articles related to cancer, and opioid prescribing/use published through September 2020. We screened resulting titles/abstracts. Relevant studies underwent full-text review. Inclusion criteria were quantitative examination of and primary focus on opioid prescribing or use, and explicit inclusion of cancer survivors. Exclusion criteria included end-of-life opioid use and opioid use as a secondary or downstream outcome (for intervention studies). We extracted information on the opioid-related outcome(s) examined (including definitions and terminology used), study design, and methods. RESULTS: Research returned 16,591 articles; 296 were included. Only 22 of 296 studies evaluated an intervention. There were 105 studies evaluating outcomes indicative of potentially high-risk, nonrecommended, or avoidable opioid use, e.g., continuous use-described as chronic use, prolonged use, and persistent use (n = 17); use after completion of curative-intent treatment-described as chronic opioid use, long-term opioid use, persistent opioid use, prolonged opioid use, continued opioid use, late opioid use, post-treatment opioid use (n = 27); use of opioids concurrent with other potentially high-risk medications (n = 13), and opioid misuse (n = 14). CONCLUSIONS: We found lack of consistency in the measurement of and terms used to describe similar opioid use outcomes, and a lack of interventional research targeting well-documented patterns of potentially nonrecommended, potentially avoidable, or potentially high-risk opioid prescribing or use.

Inpatient palliative care utilization for patients with brain metastases.

INTRODUCTION: Given the high symptom burden and complex clinical decision making associated with a diagnosis of brain metastases (BM), specialty palliative care (PC) can meaningfully improve patient quality of life. However, no prior study has formally evaluated patient-specific factors associated with PC consultation among BM patients. METHODS: We examined the rates of PC consults in a cohort of 1303 patients with BM admitted to three tertiary medical centers from October 2015 to December 2018. Patient demographics, surgical status, 30-day readmission, and death data were collected via retrospective chart review. PC utilization was assessed by identifying encounters for which an inpatient consult to PC was placed. Statistical analyses were performed to compare characteristics and outcomes between patients who did and did not receive PC consults. RESULTS: We analyzed 1303 patients admitted to the hospital with BM. The average overall rate of inpatient PC consultation was 19.6%. Rates of PC utilization differed significantly by patient race (17.5% in White/Caucasian vs 26.0% in Black/African American patients, P = .0014). Patients who received surgery during their admission had significantly lower rates of PC consultation (3.9% vs 22.4%, P < .0001). Patients who either died during their admission or were discharged to hospice had significantly higher rates of PC than those who were discharged home or to rehabilitation (P < .0001). CONCLUSIONS: In our dataset, PC consultation rates varied by patient demographic, surgical status, discharging service, and practice setting. Further work is needed to identify the specific barriers to optimally utilizing specialty PC in this population.

Predictors of Chronic Opioid Use: A Population-Level Analysis of North Carolina Cancer Survivors Using Multi-Payer Claims.

BACKGROUND: No population-based studies have examined chronic opioid use among cancer survivors who are diverse with respect to diagnosis, age group, and insurance status. METHODS: We conducted a retrospective cohort study using North Carolina cancer registry data linked with claims from public and private insurance (2006-2016). We included adults with nonmetastatic cancer who had no prior chronic opioid use (n = 38 366). We used modified Poisson regression to assess the adjusted relative risk of chronic opioid use in survivorship (>90-day continuous supply of opioids in the 13-24 months following diagnosis) associated with patient characteristics. RESULTS: Only 3.0% of cancer survivors in our cohort used opioids chronically in survivorship. Predictors included younger age (adjusted risk ratio [aRR] 50-59 vs 60-69 = 1.23, 95% confidence interval [CI] = 1.05 to 1.43), baseline depression (aRR = 1.22, 95% CI = 1.06 to 1.41) or substance use (aRR = 1.43, 95% CI = 1.15 to 1.78) and Medicaid (aRR vs private = 1.93, 95% CI = 1.56 to 2.40). Survivors who used opioids intermittently (vs not at all) before diagnosis were twice as likely to use opioids chronically in survivorship (aRR = 2.62, 95% CI = 2.28 to 3.02). Those who used opioids chronically (vs intermittently or not at all) during active treatment had a nearly 17-fold increased likelihood of chronic use in survivorship (aRR = 16.65, 95% CI = 14.30 to 19.40). CONCLUSIONS: Younger and low-income survivors, those with baseline depression or substance use, and those who require chronic opioid therapy during treatment are at increased risk for chronic opioid use in survivorship. Our findings point to opportunities to improve assessment of psychosocial histories and to engage patients in shared decision-making around long-term pain management, when chronic opioid therapy is required during treatment.