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Objective: Chemotherapy-induced neuropathy (CIN) significantly impacts cancer patients, leading to functional disability, diminished quality of life, and increased healthcare costs amid the ongoing opioid crisis. Auricular point acupressure (APA), a non-invasive and non-pharmacological alternative, has shown potential for alleviating the pain, numbness, and tingling associated with CIN. This study aims to assess the efficacy of APA for CIN symptoms and physical function and to examine the mechanisms underlying APA's effects on CIN., Methods: This is a three-arm randomized controlled clinical trial protocol. Patients aged 18 and older who are experiencing CIN are randomly assigned to one of the three groups: an APA group (in-person APA; mAPA), a sham control group (virtual APA; vAPA), and a wait-list usual care control group (UC). During the four-week program, participants in the mAPA receive an in-person APA treatment and training; the sham control participants (vAPA) receive a self-guided smartphone APA application with APA demonstration videos; and the UC participants will continue with the usual care and be re-randomized into one of the APA groups. The primary outcomes are changes in CIN symptoms and physical function. Secondary outcomes include evaluating pain sensory thresholds, motor and cognitive functioning, inflammatory signaling, brain connectivity, opioid use, and quality of life. The outcomes are measured at baseline, program completion (4 weeks), and at monthly follow-up for 3 months post-intervention., Discussion: This study will provide evidence supporting the potential viability of APA as an intervention for CIN., Trial Registration: ClinicalTrials.gov, ID NCT04920097 registered on 3 June 2021., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Lukkahatai et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: The experience of living with cancer is marked by suffering and loss, which creates a need for healing. Understanding what healing means to patients and how clinicians can play a role in the healing process is essential to holistic cancer care., Objective: The aim of this study was to explore the perspectives of cancer patients on the meaning and experiences of healing and the qualities of a clinician and the clinician-patient relationship that are healing., Methods: A qualitative study was conducted using semi-structured interviews with 14 cancer patients. Participants were asked about their illness experience, definition of healing, qualities of a healer, and relationships with clinicians that were healing. Interview transcripts were coded, and qualitative analysis was conducted to identify major themes., Results: Participants defined the nature of healing as comprising aspects of physical, mental, emotional, and spiritual well-being. Participants described healing as alleviating pain and symptoms; promoting mental strength, emotional comfort, and spiritual connection; restoring and adapting to losses; and improving quality of life. The qualities of a clinician that contributed to a healing relationship included listening, empathy and compassion, understanding patients' values and goals, and caring for the patient as a whole person., Conclusion: Participants viewed healing as physical, psychosocial, and spiritual in nature and an important part of their cancer experience with an emphasis on quality of life. Clinicians played an important role beyond treating the cancer by helping in the healing process through their humanistic qualities and holistic approach to patient care., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Importance: Guidelines recommend early specialty palliative care for all patients with advanced cancer, but most patients lack access to such services., Objective: To assess the effect of CONNECT (Care Management by Oncology Nurses to Address Supportive Care Needs), a primary palliative care intervention delivered by oncology nurses, on patient outcomes., Design, Setting, and Participants: This cluster randomized clinical trial of the CONNECT intervention vs standard care was conducted from July 25, 2016, to October 6, 2020. Participants were adult patients with metastatic solid tumors who were undergoing oncological care and for whom an oncologist would agree with the statement "would not be surprised if the patient died in the next year." The trial was conducted at 17 community oncology practices in western Pennsylvania. Data analyses adhered to the intention-to-treat principle., Interventions: The CONNECT intervention included 3 monthly visits with an existing infusion room nurse who was trained to address symptoms, provide emotional support, engage in advance care planning, and coordinate care., Main Outcomes and Measures: The primary outcome was quality of life. At baseline and 3 months, participants completed assessments of quality of life (Functional Assessment of Chronic Illness Therapy-Palliative care: score range, 0-184, with higher scores indicating better quality of life), symptom burden (Edmonton Symptom Assessment Scale: score range, 0-90, with higher scores indicating greater symptom burden), and mood symptoms (Hospital Anxiety and Depression Scale [HADS]: score range, 0-21, with higher scores indicating substantial anxiety and depression). Linear mixed-effects models were used to estimate adjusted mean differences in 3-month outcomes. Preplanned, intensity-adjusted analyses were conducted., Results: A total of 672 patients were enrolled (mean [SD] age, 69.3 [10.2] years; 360 women [53.6%]). The mean (SD) number of CONNECT visits completed was 2.2 (1.0). At 3 months, no difference in mean (SD) quality-of-life score was found between the CONNECT and standard care groups (130.7 [28.2] vs 134.1 [28.1]; adjusted mean difference, 1.20; 95% CI, -2.75 to 5.15; P = .55). Similarly, there was no difference between groups in 3-month mean (SD) symptom burden (23.2 [16.6] vs 24.0 [16.1]; adjusted mean difference, -2.64; 95% CI, -5.85 to 0.58; P = .11) or mood symptoms (HADS depression subscale score: 5.1 [3.4] vs 4.8 [3.7], adjusted mean difference, -0.08 [95% CI, -0.71 to 0.57], P = .82; HADS anxiety subscale score: 5.7 [3.9] vs 5.4 [4.2], adjusted mean difference, -0.31 [95% CI, -0.96 to 0.33], P = .34). Intensity-adjusted analyses revealed a larger estimated treatment effect for patients who received a full dose (3 visits) of the CONNECT intervention., Conclusions and Relevance: This cluster randomized clinical trial found that a primary palliative care intervention that was delivered by oncology nurses did not improve patient-reported outcomes at 3 months. Primary palliative care interventions with a higher dose intensity may be beneficial for most patients with advanced cancer who lack access to palliative care specialists., Trial Registration: ClinicalTrials.gov Identifier: NCT02712229.

Objectives: Family caregiver burden among older adults with advanced cancer remains poorly understood. We sought to (1) identify patient factors associated with caregiver burden and (2) examine how amount of time caregiving modifies these relationships., Methods: Cross-sectional analysis of baseline data from a cluster-randomized palliative care intervention trial including patients with advanced cancer and their family caregivers, recruited from 17 oncology practices in Pennsylvania. Caregiver burden was measured using Zarit Burden Interview (ZBI-12; range 0-48). Patient factors included functional status (Eastern Cooperative Oncology Group), symptom burden (Edmonton Symptom Assessment Scale), anxiety and depression (Hospital Anxiety and Depression Scale), and quality of life (Functional Assessment of Chronic Illness Therapy - Palliative Care). Using adjusted multivariable regression, we analyzed (1) independent associations between patient factors and caregiver burden and (2) how weekly caregiving hours modified these relationships., Results: Among 441 patient-caregiver dyads, mean patient age was 70 ± 10 and caregiver age was 62 ± 13 years. Most caregivers (59%) were patients' partners. Caregivers reported 44.5 ± 53.5 average hours spent caregiving weekly; mean ZBI-12 scores were 10.3 ± 7.3. Worse patient functional status (β = 4.20, p < 0.01), poorer quality of life (β = -0.07, p < 0.01), more anxiety (β = 0.33, p < 0.01) and depression (β = 0.33, p < 0.01) were associated with higher caregiver burden; caregiving hours did not affect these relationships., Conclusions: In advanced cancer, poor patient physical and mental health is associated with higher caregiver burden regardless of hours caregiving; future studies should examine interventions tailored to alleviate caregiver burden for this group., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: Patients with cancer who are at a transition to Phase I investigational treatments have been identified as an underserved population with regard to palliative care. This disease transition is often accompanied by spiritual and existential concerns. The study objective was to conduct a secondary analysis of data from a larger study testing a palliative care intervention. This paper reports the findings of this secondary focus on the spiritual needs of this population., Methods: Patients (n = 479) were accrued to this study prior to initiating a Phase I clinical trial with data collected at baseline, and 4, 12, and 24 week follow-up., Results: Qualitative data revealed that the transition to Phase 1 trial participation is a time of balancing hope for extended life with the reality of advancing disease. Quantitative results demonstrated increased spirituality over time in both religious- and non-religious-affiliated patients., Conclusions: Patients entering Phase I trials have important spiritual needs as they face treatment decisions, advancing disease, and often mortality. Spiritual care should be provided to seriously ill patients as a component of quality care., (© 2020 John Wiley & Sons, Ltd.)

Introduction: Advanced cancer patients participating in phase 1 clinical trials experience considerable symptom burden. Palliative care (PC) may benefit these individuals by providing supportive care during clinical research participation. This study investigates integration of a PC intervention among phase 1 trial participants with advanced cancer., Methods and Materials: This study is a multisite randomized clinical trial testing a concurrent PC intervention among phase 1 trial participants. Baseline demographic and clinical characteristics and descriptive baseline assessment findings were examined for all participants to date. Self-report assessments included quality of life (QOL) using the Functional Assessment of Cancer Therapy-General, spirituality using the Functional Assessment of Chronic Illness Therapy-Spirituality, and overall distress using the Distress Thermometer. Clinical trial retention and healthcare utilization were assessed through chart audit at study completion., Results: The study has enrolled 178 participants to date. The average age is 60.3 years, the majority was Caucasian (57.9%), and participants had an average of 1.7 comorbidities. Overall QOL was 77.6 (±15.1). Responses were most favorable for social/family well-being (22.6 ± 4.6), lowest for emotional well-being (14.9 ± 5.1), and average overall distress was 3.6 (±2.7). Healthcare utilization at study completion (n = 134) identified low rates of supportive care referrals, with approximately half of participants referred to social work (50.8%), and fewer referred for pain (43%), resource centers (44%), and physical therapy (18%)., Conclusion: Phase 1 clinical trial participants experience unmet QOL needs at baseline and levels of distress that merit clinical intervention. Although this study is in progress, initial findings support the potential benefits of PC among this population.

Background: Acute myeloid leukemia (AML) is one of the most common types of leukemia in adults, but there is limited information on survivors' quality of life (QOL) after remission., Objective: We piloted a survey exploring patient-reported outcomes for people with AML in first complete remission (CR1) to determine whether patients felt the survey is relevant to their well-being and to summarize patient characteristics., Design/measurements: Cross-sectional survey of a convenience sample of AML patients in CR1 assessing QOL and functioning (European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 v 3.0), well-being (QOL-cancer survivor [QOL-CS]), fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue]), and anxiety and depression (hospital anxiety and depression scale [HADS]). The survey contained five open-ended questions., Results: Eighteen patients completed the survey. Most felt it was completely or mostly relevant (88.8%) in describing their QOL. Participants scored well on the EORTC QLQ-C30, fatigue being the most common symptom (83%).The FACIT-Fatigue mean score was 28.7 and median score was 33.5 (normal ≥30). Two scored in the abnormal range for anxiety and one for depression on the HADS. On the QOL-CS, participants scored more than 6 out of 10 in most domains, except the subscales of distress and fear., Conclusions: The survey content and length were appropriate. Patients reported ongoing fatigue, fears of future test results, getting a second cancer, and recurrence of cancer. Survivors experience ongoing symptoms, highlighting the importance of providers performing ongoing symptom and needs assessments.

Background: Patients in phase 1 clinical trials often have significant symptom burdens and quality-of-life concerns that increase as they progress along the cancer trajectory and experience drug toxicities from the clinical trial. 
., Objectives: The interdisciplinary intervention described is aimed at providing optimum palliative care to support patients with solid tumors participating in a phase 1 clinical trial.
., Methods: The intervention includes a baseline evaluation using quantitative surveys, a comprehensive palliative care assessment by a research nurse based on patient baseline evaluation, and a goals-of-care discussion by the treating oncologist. The second component includes an interdisciplinary meeting where palliative care recommendations are made, followed by two patient education sessions.
., Findings: The initial experience with the palliative care intervention suggests a need for support for this population, as well as potential benefits from integrating palliative care for patients enrolled in phase 1 clinical trials.

Safe, effective, and evidence-based management of cancer-related pain is a cornerstone of comprehensive cancer care. Despite increasing interest in and efforts to improve its management, pain remains poorly controlled in nearly half of all patients with cancer, with little change in the past 20 years. Limited training in pain assessment and management, overestimation of providers' own skills to treat pain, and failure to refer patients to pain specialists can result in suboptimal pain management with devastating effects on quality of life, physical functioning, and increased psychological distress. From a thorough assessment of cancer-related pain to appropriate treatments that may include opiates, adjuvant medications, nerve blocks, and nondrug interventions, this article is intended as a brief overview of the mechanisms and types of pain as well as a review of current, new, and promising approaches to its management., (Copyright © 2015 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Purpose: The number of patients receiving chemotherapy near the end of life is increasing, as are concerns about goals of treatment, toxicity, and costs. We sought to determine the available sources of knowledge, the choices, and concerns of actual patients, and how patients balanced competing issues., Methods: We used a literature search from 1980 to present., Results: Available patient sources provide little information about prognosis, choices, alternatives, consequences, or how to choose. Many patients would choose chemotherapy for a small benefit in health outcomes, and for a smaller benefit than perceived by their health care providers for their own treatment. Adverse effects are less a concern for patients than for their well health care providers. There are no decision aids to assist patients with metastatic disease in making their choices, such as there are for adjuvant breast therapy., Conclusion: The perspective of the patient is different from that of a well person. Patients are willing to undergo treatments that have small benefits with major toxicity. Receiving realistic information about the different options of care and the likelihood of successful treatment or adverse effects is difficult. These factors may explain some of the increased use of chemotherapy near the end of life. Decision aids and honest, unbiased sources to inform patients of their prognosis, choices, consequences, typical outcomes, and ways to make decisions are needed. More prospective information about how patients make their choices, and what they would consider a good choice, would assist informed decision making.

Even when managed according to guidelines, approximately 14% of cancer patients have unrelieved pain or unacceptable side effects, and there is good evidence that patients still are not receiving optimal therapy. Implantable drug delivery systems (IDDS) administer small amounts of drugs directly to the spinal cord and reduce systemic narcotic exposure by a factor of 300 to one. In a large randomized trial of 202 patients with pain scores of 7.5 or higher, despite 200 mg or more of morphine or equivalent narcotics, IDDS gave better clinical success than comprehensive medical management (84.5% vs 70.8%, P=0.05). Pain scores were reduced by 52% versus 39%, drug toxicity scores were reduced by 50% versus 17%, and IDDS patients lived longer. Even the most refractory pain patients--those failed by a month of comprehensive medical management by experts--when subsequently provided with IDDS, had a 27% reduction in pain scores and a 50% reduction in drug side effects. Given multiple positive small cohort studies and a positive high-power randomized trial, IDDS should be considered as the best treatment for this population.

ContextPalliative care offers patient and family centered approaches that may mitigate risk of caregiver burden and poor mood.ObjectivesTo determine whether a palliative care intervention (CONNECT) improved burden, mood, and self-efficacy among caregivers of patients with advanced cancer.MethodsIn this cluster randomized trial, patients and their caregivers were recruited from 17 Oncology clinics in Pennsylvania. Participants attended nurse-led monthly visits, addressing patient symptoms, goals of care, and advance care planning. At baseline and three months, we measured caregiver burden using Zarit Burden Interview (ZBI-12; range 0-48), caregiver anxiety and depression using Hospital Anxiety and Depression Scales (HADS-A, range 0-21; HADS-D, range 0-21). We measured caregiver self-efficacy at three months using Caregiver Inventory (CGI; range 0-189).ResultsWe enrolled 441 caregivers and 381 completed three-month assessments. We found no significant differences in caregiver burden (adjusted mean difference -0.39; 95% CI -1.07-0.29, P = 0.90), depression (adjusted mean difference -0.22, 95% CI -0.97-0.55, P = 0.26), or anxiety (adjusted mean difference 0.09; 95% CI -1.25-1.43, P = 0.58), between the intervention and standard care at three months. Caregiver self-efficacy was higher at three months in the intervention compared to standard care (adjusted mean difference 9.36; 95% CI 0.95-17.77, P = 0.030).ConclusionCaregivers in CONNECT did not experience improved burden or mood, however, they reported higher self-efficacy compared to caregivers receiving standard care. This study highlights the need for strategies to optimize caregiver outcomes in palliative care interventions.

Complex regional pain syndrome is a chronic debilitating pain disorder that is difficult to manage, in part due to its heterogeneous clinical presentation and lack of clearly defined pathophysiology. Patients usually require a multidisciplinary approach to treatment, which can entail pharmacotherapy, physical therapy, behavioral therapy, and interventional pain procedures, such as sympathetic nerve blocks, spinal cord stimulation, and dorsal root ganglion stimulation. However, many patients continue to experience pain refractory to these multimodal strategies. Scrambler therapy (ST) is a noninvasive method of neuromodulation that is applied through cutaneous electrodes, and can alleviate chronic neuropathic pain by stimulating C-fibers and replacing endogenous pain signals with synthetic non-nociceptive signals. Although the use of ST has been reported for several types of refractory central and peripheral neuropathic pain, there is a paucity of data regarding the use of ST for complex regional pain syndrome. We present two patients with complex regional pain syndrome of the right lower extremity, who each underwent ST and experienced significant pain relief and improvement in function and quality of life. [ABSTRACT FROM AUTHOR]

Adult literacy skills are critical assets of individuals as well as societies in terms of economic (e.g., human capital) and social well-being. Thus, it is important to monitor the long-term trends and sources of skill gain/loss. Yet, temporal sources of adult literacy skill variation are understudied. The current study analyzed three comparable, nationally representative datasets including the 1994 International Adult Literacy Survey; the 2003 International Adult Literacy and Life Skills Survey; and the 2012/2014/2017 Program for the International Assessment of Adult Competencies. Results from the age-period-cohort hierarchical cross-classified random effects model showed significant variation in adult literacy skills across cohorts (1930-1995) and time periods (1994-2017). Possible implications for adult education policies and future research needs were evaluated. [ABSTRACT FROM AUTHOR]

Background: Pancreatic cancer patients often present with complications, which can impact treatment tolerance. Thus, symptom management is a vital component of treatment in addition to traditional chemotherapeutics. Concurrent palliative care with an emphasis on aggressive symptom management may sustain both clinical and patient-centered outcomes during treatment. The purpose of this article is to explore the impact of a concurrent palliative care intervention in patients with pancreatic cancer treated on phase I clinical trials. Materials and Methods: This is a secondary analysis of a National Cancer Institute (NCI)-funded randomized trial of an advanced practice nurse driven palliative care intervention for solid tumor patients treated on phase I clinical trials. Only pancreatic cancer patients were included in the analysis. Patients received two educational sessions around the quality of life (QOL) domains and completed the Functional Assessment of Cancer Therapy—General (FACT-G), patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE), and the psychological distress thermometer at baseline, 4 and 12 weeks. Mixed model with repeated measures analysis was used to explore outcomes by study arm. Results: Of the 479 patients accrued to the study, 42 were diagnosed with pancreatic cancer (26 intervention, 16 usual care). A trend toward improvement in the physical, social, emotional, and functional FACT-G QOL subscales and psychological distress (baseline to 12 weeks) were observed for the intervention arm. Patients reported moderate severity in psychological and physical stress. Conclusions: In this secondary analysis, a nurse-led palliative care intervention may improve the QOL and psychological distress of pancreatic cancer patients. A phase III trial focused on patients with pancreatic cancer is needed to determine the effectiveness of the intervention. [ABSTRACT FROM AUTHOR]

Objective: Patient–oncologist therapeutic alliance is a foundation of quality cancer care, although there is limited research demonstrating its relationship with patient outcomes. We investigated the relationship between therapeutic alliance and patient quality of life with a secondary goal of determining whether the association varied by patients' baseline level of psychological distress. Methods: Cross‐sectional analysis of baseline data from a randomized clinical trial of 672 patients with advanced cancer participating in a primary palliative care intervention trial. Patients completed baseline self‐reported measures of therapeutic alliance (The Human Connection Scale, range: 16–64), overall quality of life (Functional Assessment of Cancer Therapy—Palliative Care, range: 0–184), and psychological distress (Hospital Anxiety and Depression Scale, range: 0–42). First, we determined the relationship between therapeutic alliance and quality of life using multivariable regression adjusting for confounders. We then examined if psychological distress was an effect modifier in this relationship by adding interaction effects of depression and anxiety symptoms on therapeutic alliance into the regression model. Results: Patients reported high levels of therapeutic alliance (56.4 ± 7.4) and moderate quality of life (130.3 ± 25.5). Stronger therapeutic alliance was associated with better quality of life after adjusting for other confounding factors (β = 3.7, 95% confidence interval = 2.1, 5.3, p < 0.01). The relationship between therapeutic alliance and quality of life was generally consistent regardless of psychological distress. Conclusions: Collaborative, trusting relationships between patients with advanced cancer and their oncologists are associated with better patient quality of life. Future research should investigate the causal, longitudinal nature of these relationships. [ABSTRACT FROM AUTHOR]

Background: Phase 1 clinical trials remain vital for oncology care. Patients on these trials require supportive care for quality-of-life (QOL) concerns. Objective: To test a Palliative Care Intervention (PCI) for patients with solid tumors enrolled in Phase I therapeutic trials with a priori hypothesis that psychological distress, QOL, satisfaction, symptoms, and resource utilization would be improved in the PCI group. Design: This unblinded randomized trial compared the PCI with usual care in patients accrued to Phase I Clinical Trials. Subjects (n = 479) were followed for 24 weeks, with 12 weeks as the primary outcome. Setting: Two Comprehensive Cancer Centers in the United States. Subjects: A consecutive sample, 21 years or older, English fluency, with solid tumors initiating a Phase 1 trial. Measurements: Psychological Distress (Distress Thermometer), QOL total and subscales (FACT-G), satisfaction (FAM-CARE), survival, and resource utilization (chart audit). Results: PCI subjects showed improved Psychological Distress (−0.47, p = 0.015) and Emotional Well-Being (0.81, p = 0.045), with differences on variables of QOL and distress between sites. High rates of symptom-management admissions (41.3%) and low rates of Advance Directive completion (39.0%), and hospice enrollment (30.7%), despite a median survival in both groups of 10.1 months from initiating a Phase 1 study. Conclusions: A nurse-delivered PCI can improve some QOL outcomes and distress for patients participating in Phase 1 trials. Greater integration of PC is needed to provide quality care to these patients and to support transitions from treatment to supportive care, especially at the end of life. ClinicalTrials.gov Identifier: NCT01612598. [ABSTRACT FROM AUTHOR]

Introduction: Chemotherapy-induced peripheral neuropathy (CIPN) is a prominent clinical problem, with limited effective therapies. Preliminary non-randomized clinical trial data support that Scrambler Therapy is helpful in this situation.Methods: Patients were eligible if they had CIPN symptoms for at least 3 months and CIPN-related tingling or pain at least 4/10 in severity during the week prior to registration. They were randomized to receive Scrambler Therapy versus transcutaneous electrical nerve stimulation (TENS) for 2 weeks. Patient-reported outcomes (PROs) were utilized to measure efficacy and toxicity daily for 2 weeks during therapy and then weekly for 8 additional weeks.Results: This study accrued 50 patients, 25 to each of the 2 study arms; 46 patients were evaluable. There were twice as many Scrambler-treated patients who had at least a 50% documented improvement during the 2 treatment weeks, from their baseline pain, tingling, and numbness scores, when compared with the TENS-treated patients (from 36 to 56% compared with 16-28% for each symptom). Global Impression of Change scores for "neuropathy symptoms," pain, and quality of life were similarly improved during the treatment weeks. Patients in the Scrambler group were more likely than those in the TENS group to recommend their treatment to other patients, during both the 2-week treatment period and the 8-week follow-up period (p < 0.0001). Minimal toxicity was observed.Conclusions: The results from this pilot trial were positive, supporting the conduct of further investigations regarding the use of Scrambler Therapy for treating CIPN. [ABSTRACT FROM AUTHOR]

Background: Despite positive outcomes associated with specialist palliative care (PC) in diverse medical populations, little research has investigated specialist PC in surgical ones. Although cancer surgery is predominantly safe, operations can be extensive and unpredictable perioperative morbidity and mortality persist, particularly for patients with upper gastrointestinal (GI) cancers. Objectives and Hypotheses: Our objective is to complete a multicenter, randomized controlled trial comparing surgeon-PC co-management with surgeon-alone management among patients pursuing curative-intent surgery for upper GI cancers. We hypothesize that perioperative PC will improve patient postsurgical quality of life. This study and design are based on >8 years of engagement and research with patients, family members, and clinicians surrounding major cancer surgery and advance care planning/PC for surgical patients. Methods: Randomized controlled superiority trial with two study arms (surgeon-PC team co-management and surgeon-alone management) and five data collection points over six months. The principal investigator and analysts are blinded to randomization. Setting: Four, geographically diverse, academic tertiary care hospitals. Data collection began December 20, 2018 and continues to December 2020. Participants: Patients recruited from surgical oncology clinics who are undergoing curative-intent surgery for an upper GI cancer. Interventions: In the intervention arm, patients receive care from both their surgical team and a specialist PC team; the PC is provided before surgery, immediately after surgery, and at least monthly until three months postsurgery. Patients randomized to the usual care arm receive care from only the surgical team. Main Outcomes and Measures: Primary outcome: patient quality of life. Secondary outcomes: patient: symptom experience, spiritual distress, prognostic awareness, health care utilization, and mortality. Caregiver: quality of life, caregiver burden, spiritual distress, and prognostic awareness. Intent-to-treat analysis will be used. Ethics and Dissemination: This study has been approved by the institutional review boards of all study sites and is registered on clinicaltrials.gov (NCT03611309, First received: August 2, 2018). [ABSTRACT FROM AUTHOR]

Introduction: Management of cancer is often characterized by difficult decisions. The National Coalition for Cancer Survivorship (NCCS) has developed the "Know Yourself" tool, a question prompt list (QPL) to enable patients to participate in these decisions. Methods: We investigated the feasibility of using the NCCS tool by oncologists and their patients with cancer in a before-and-after pilot study at a tertiary medical center. We also measured patient reported decision preparedness, anxiety, satisfaction with care, trust in physician, discussion of care with their primary care physician (PCP), and general state of health, and solicited feedback from clinicians and patients on use of the form. Results: Ninety patients and fifteen clinicians participated. Most patients reported the Tool was easy to use (91%) and would recommend it to others (73%) however fewer reported discussing the Tool at the visit (31%) or felt that it improved the quality of care (45%) or communication with the oncologist (56%). Clinicians reported Tool use in only 16 of 60 visits (27%); in these visits the Tool was helpful in identifying areas of concern (74%), guiding the clinical interaction (67%), promoting communication (62%), identifying areas of need (70%), and improving quality of care (71%). Decision preparedness, trust in physicians, uncertainty about care, anxiety, patient satisfaction and discussion of care with the PCP was unchanged with Tool use compared to non-use. Conclusions: The Know Yourself tool had poor uptake but was favorably received among both patients and clinicians who used it. These findings suggest some patients could benefit from QPLs. Future work should test how implementation strategies might achieve greater use. [ABSTRACT FROM AUTHOR]

This commentary discusses evidence supporting the importance of full palliative care dose intensity in outcomes for patients with cancer. [ABSTRACT FROM AUTHOR]

Background: Although mounting evidence supports the use of palliative care (PC) to improve care experiences and quality of life for oncology patients, the frequency of and factors associated with PC use during oncology-related hospitalizations remain unknown. Materials and Methods: Using the National Inpatient Sample dataset, hospitalizations during 2012–2014 for a primary diagnosis of cancer with high risk of in-hospital mortality were identified. PC use was identified using the V66.7 ICD-9 code. Factors associated with the cost of hospitalization were identified using multivariable gamma regression. Results: During the study period, 124,186 hospitalizations were identified with a primary diagnosis of malignancy (melanoma, breast, colon, gynecologic, prostate, male genitourinary, head/neck, urinary tract, noncolon gastrointestinal, lung, brain, bone/soft tissue, endocrine, or nonlung thoracic). Most patients were treated at a teaching hospital (51–77% by cancer type), and use of PC ranged from 10% for patients with endocrine cancers to 31% for patients with melanoma. Patients utilizing PC had a lower frequency of operative procedures (4–33% vs. 34–79% by cancer type, all p ≤ 0.001), a higher rate of in-hospital death (30–45% vs. 4–10% by cancer type, all p < 0.001), and a lower total hospitalization cost (median: $5076–17,151 vs. $10,918–29,287 by cancer type, p ≤ 0.01 except male genitourinary). In an adjusted analysis, the cost of hospitalization was significantly associated (all p < 0.001) with patient gender, race, age, operative, in-hospital death, extended length of stay, and PC. Conclusions: In summary, inpatient PC utilization varied by cancer type. PC was associated with lower utilization of surgical procedures, shorter length of stay, and lower hospitalization cost. Lower hospitalization cost was also seen for patients who were older, female, or African American. [ABSTRACT FROM AUTHOR]

Background: Cancer patients with advanced disease who have exhausted most treatment options are often offered participation in Phase I clinical trials. To date, studies that assess the benefits of palliative care provided concurrently in Phase I clinical trial settings are lacking. The overall purpose of this study was to test the feasibility of a palliative care intervention administered concurrently to cancer patients receiving treatment in a Phase I clinical trial. Methods: Cancer patients enrolling in a Phase I clinical trial were invited to participate in this study. Patients completed baseline questionnaires prior to treatment initiation that assessed quality of life (QOL), symptom distress, psychological distress, and satisfaction with care. Patients then received the palliative care intervention (PCI), which consisted of comprehensive QOL assessment, care planning for the patient during an interdisciplinary team meeting, and two patient education sessions. Patients were surveyed again at 1 and 2 months following treatment initiation. Results: A total of 14 patients were accrued to the pilot over a 3-month time period, representing 70% of eligible patients. Patient retention was high at 1 month (75%), and had declined at 2 months (50%). Patient outcome measure scores, including symptom distress, psychological distress, and satisfaction with care, were relatively stable over time, except for overall QOL, which declined over time. Conclusions: Concurrent palliative care is feasible for cancer patients treated in Phase I clinical trial settings. A large, multisite randomized controlled trial based on this pilot will be launched to test the efficacy of the intervention in this understudied cancer population. [ABSTRACT FROM AUTHOR]

This study uses focus group methodology to examine supportive and unsupportive responses experienced by African American and Caucasian cancer patients. Supportive responses included practical assistance, as well as people's willingness to listen, maintain a positive attitude, and pray. Unsupportive responses included others' withdrawal behaviors, patients having to support friends/family as they coped, and family/friends limiting patients' independence. Results reflect ways in which mental health providers, social workers, and health care providers can help patients express support needs, as well as how social networks can be better educated about the types of support valued by patients. [ABSTRACT FROM AUTHOR]

Projections for the future suggest that the United States population will grow by 10-15% by the year 2000, but the number of people over the age of 80 will increase by 66%. As a result, the increase that has already been observed in the number of elderly patients requiring major medical attention can only be expected to grow. This study reviews the admissions to the intensive care unit (ICU) over the last 5 years by age to analyze whether the ICU admissions are higher for the patients older than 60 years of age. We considered all the admissions to the surgical (SICU) and medical (MICU) intensive care units at Morristown Memorial Hospital from January 1, 1992, to December 31, 1996. Patients were divided into age brackets (0-9 years, 10-19 years, 20-29 years,... >90 years) and by gender. Medical and surgical admissions were analyzed including the average length of stay in the ICU. Daily charge for bed occupancy was reviewed based on the hospital data reported in 1995. The death rate was also considered. Fisher-corrected χ2 and a Student t test were used for statistical analysis. A total of 6243 patients (2926 female and 3317 male) were admitted to the ICU over the 5-year period. The ICU admissions rate was higher in patients above 60 years of age compared with those below 60 (60% versus 30%, respectively). The age group with the highest admissions rate was between 70 and 79 years, followed by the 60-69-year group. These two groups had significantly more admission than all other groups (P < 0.001). Medical patients' length of stay was shorter than the surgical group, and they had a lower rate of admission to the ICU. The death rate was higher in the group older than 60 years. They also spent a longer time in ICU compared with the younger group (22 ± 7 days versus 12 ± 8 days). The charge per day per bed was $2100 in the ICU, $1600 in a telemetry floor, and $950 in a regular floor. The charge per bed in the group above 60 years old was double compared with the one for the younger group. Older patients were admitted to the ICU with a significantly higher frequency than was the younger group. There were more surgical than medical patients admitted to the ICU. The mortality rate and the daily cost, based on daily bed charge, was significantly higher in the older group. Based on our experience, older people had a more difficult recovery in ICU than did the younger people. In our opinion we should treat acute critical illness but not terminal pathology. A problem ex ists in educating physicians about which patients will de rive no benefit from the ICU. This will determine if we can decrease or avoid the use of the ICU and its accom panying expense, in situations where it does not signif icantly increase survival and the quality of life. [ABSTRACT FROM PUBLISHER]

Context: Preliminary trials report that Scrambler Therapy, a form of electroanalgesia, may improve discomfort from chemotherapy-induced peripheral neuropathy (CIPN).Objective: The objective of this phase II, randomized controlled trial was to evaluate the efficacy of Scrambler therapy vs. transcutaneous electrical nerve stimulation (TENS) in treating CIPN.Methods: Fifty patients were accrued for the first half of this two-part, crossover trial consisting of a 2-week treatment period with either Scrambler or TENS, followed by an 8-week observation period, and then crossover treatment. Twenty-two patients proceeded to the crossover phase. The primary means of assessment was patient-reported outcomes, including symptom severity scales and Global Impression of Change questionnaires. Symptoms were assessed daily during the treatment period and weekly during an 8-week observation period.Results: A 50% or greater reduction in primary symptom (pain or tingling) score on the last day of treatment was achieved by 6 of 10 Scrambler-treated patients (60%) and 3 of 12 TENS-treated patients (25%) after crossover (P = 0.11). By day 4 of treatment, the two arms diverged with respect to mean change in primary symptom score; this effect was largely carried through to the end of the two-week treatment period. Similarly, Scrambler therapy appeared better than TENS when assessed by Global Impression of Change for neuropathy, pain, and overall quality of life.Conclusions: Similar findings from the initial randomization and crossover phases of this study support further evaluation of the efficacy of Scrambler therapy in alleviating CIPN symptoms. Evaluation in a larger, randomized controlled trial with standardized treatment is warranted. [ABSTRACT FROM AUTHOR]

BACKGROUND: Understanding the experiences of patients with solid tumors who are in phase 1 clinical trials can help nurses to provide optimal care. OBJECTIVES: The purpose of this article is to describe patient perspectives of participating in a phase 1 trial and understanding their disease status and treatment options. In addition, the authors describe the impact of the disease and clinical trial participation on quality of life. METHODS: 30 patients were interviewed and audio recorded; the interviews were transcribed and content analysis methods were used to identify common themes. FINDINGS: Patients reported participating in the phase 1 clinical trial because their doctors informed and encouraged them, they had no other treatment options if they wanted to live longer, or they wanted to help future patients with cancer. Most believed that participation would improve or stabilize their illness and quality of life. They believed that, when the clinical trial ended, there would be new treatments. Participants reported that healthcare providers and family members provided support, and that compassion, cultural awareness, spiritual support, and the need for individual attention were important. [ABSTRACT FROM AUTHOR]

Background The addition of specialty palliative care to standard oncology care improves outcomes for patients with advanced cancer and their caregivers, but many lack access to specialty care services. Primary palliative care—meaning basic palliative care services provided by clinicians who are not palliative care specialists—is an alternative approach that has not been rigorously evaluated. Methods A cluster randomized, controlled trial of the CONNECT (Care management by Oncology Nurses to address supportive care needs) intervention, an oncology nurse-led care management approach to providing primary palliative care for patients with advanced cancer and their family caregivers, is currently underway at 16 oncology practices in Western Pennsylvania. Existing oncology nurses are trained to provide symptom management and emotional support, engage patients and families in advance care planning, and coordinate appropriate care using evidence-based care management strategies. The trial will assess the impact of CONNECT versus standard oncology care on patient quality of life (primary outcome), symptom burden, and mood; caregiver burden and mood; and healthcare resource use. Discussion This trial addresses the need for more accessible models of palliative care by evaluating an intervention led by oncology nurses that can be widely disseminated in community oncology settings. The design confronts potential biases in palliative care research by randomizing at the practice level to avoid contamination, enrolling patients prior to informing them of group allocation, and conducting blinded outcome assessments. By collecting patient, caregiver, and healthcare utilization outcomes, the trial will enable understanding of the full range of a primary palliative care intervention's impact. [ABSTRACT FROM AUTHOR]