Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA (CARES): a randomised, parallel, phase 3 trial.

BACKGROUND: The current standard of care of screening and referring patients for treatment for symptoms, such as depression, pain, and fatigue, is not effective. This trial aimed to test the efficacy of an integrated screening and novel stepped collaborative care intervention versus standard of care for patients with cancer and at least one of the following symptoms: depression, pain, or fatigue. METHODS: This randomised, parallel, phase 3 trial was conducted in 29 oncology outpatient clinics associated with the UPMC Hillman Cancer Center in the USA. Patients (aged ≥21 years) with any cancer type and clinical levels of depression, pain, or fatigue (or all of these) were eligible. Eligible family caregivers were aged 21 years or older and providing care to a patient diagnosed with cancer who consented for this study. Patients were randomly assigned (1:1) to stepped collaborative care or standard of care using a central, permuted block design (sizes of 2, 4, and 6) stratified by sex and prognostic status. The biostatistician, oncologists, and outcome assessors were masked to treatment assignment. Stepped collaborative care was once-weekly cognitive behavioural therapy for 50-60 min from a care coordinator via telemedicine (eg, telephone or videoconferencing). Pharmacotherapy for symptoms might be initiated or changed if recommended by the treatment team or preferred by the patient. Standard of care was screening and referral to a health-care provider for treatment of symptoms. The primary outcome was health-related quality of life in patients at 6 months. Maintenance of the treatment benefits was assessed at 12 months. Participants included in the primary analysis were per intention to treat, which included patients missing one or both follow-up assessments. This trial was registered with ClinicalTrials.gov (NCT02939755). FINDINGS: Between Dec 5, 2016, and April 8, 2021, 459 patients and 190 family caregivers were enrolled. 222 patients were assigned to standard of care and 237 to stepped collaborative care. Of 459 patients, 201 (44%) were male and 258 (56%) were female. Patients in the stepped collaborative care group had a greater 0-6-month improvement in health-related quality of life than patients in the standard-of-care group (p=0·013, effect size 0·09). Health-related quality of life was maintained for the stepped collaborative care group (p=0·74, effect size 0·01). Patients in the stepped collaborative care group had greater 0-6-month improvements than the standard-of-care group in emotional (p=0·012), functional (p=0·042), and physical (p=0·033) wellbeing. No adverse events were reported by patients in either group and deaths were considered unrelated to the study. INTERPRETATION: An integrated screening and novel stepped collaborative care intervention, compared with the current standard of care, is recommended to improve health-related quality of life. The findings of this study will advance the implementation of guideline concordant care (screening and treatment) and has the potential to shift the practice of screening and treatment paradigm nationwide, improving outcomes for patients diagnosed with cancer. FUNDING: US National Cancer Institute.

Long-term overall survival in patients undergoing liver resection for metastatic anal squamous cell carcinoma.

BACKGROUND AND OBJECTIVES: There is limited research on management of metastatic anal canal squamous cell carcinoma (SCC) to the liver. This study aimed to describe outcomes for patients undergoing liver resection of anal SCC metastases. METHODS: A multicenter, retrospective cohort study was conducted by three tertiary-referral centers. Patients undergoing liver surgery between 2008 and 2022 were included. Cox regression analysis was performed to evaluate predictors of recurrence and survival and Kaplan-Meier analysis was performed for 1-, 3-, and 5-year survival. RESULTS: Twenty-one patients underwent liver resection and/or ablation. None were HIV positive and 24% had known HPV infection. 20/21(95%) patients had undergone Nigro protocol for management of the primary tumor with 12/21 (57%) patients experiencing complete response. 4/21 (19%) patients had synchronous liver metastases at time of diagnosis. Median tumor size was 5.0 cm and median tumor number was one. At analysis, 52% remained alive. Median overall survival was 32.2 months. 5-year overall survival was 50%. Median recurrence-free survival was 7.7 months and 5-year recurrence-free survival was 30%. Need for salvage abdominoperineal resection was negatively associated with recurrence-free survival. The most common site of recurrence was the liver. CONCLUSIONS: Liver resection for metastatic anal SCC can be beneficial for appropriately selected patients.

Pain Interference in End Stage Kidney Disease is Associated with Changes in Gut Microbiome Features Before and After Kidney Transplantation.

BACKGROUND: Pain, a common debilitating symptom among kidney transplant recipients (KTRs), is among the most common and undertreated symptoms after kidney transplantation. AIMS: Characterize associations between gut microbiome features and pain interference before and after kidney transplantation. DESIGN: Longitudinal, repeated measures study, collecting fecal specimens and pain interference data pretransplant and 3 months posttransplant. SETTING: Participants were recruited at the kidney transplant clinic at the University of Illinois Hospital & Health Sciences System. PARTICIPANTS/SUBJECTS: 19 living donor kidney transplant recipients. METHODS: We assessed fecal microbial community structure with shotgun metagenomic sequencing; we used pain interference scores derived from the Patient-Reported Outcomes Measurement Information System-57. RESULTS: We measured a reduction in the Shannon diversity index in both groups after transplantation but observed no significant differences between groups at either time point. We did observe significant differences in fecal microbial Bray-Curtis similarity index among those reporting pain interference pre- transplant versus no pain interference at 3-months posttransplant (R = .306, p = .022), and between pain interference groups at posttransplant (R = .249, p = .041). Pairwise models showed significant differences between groups posttransplant in relative abundances of several taxa, including a 5-fold reduction.ßin Akkermansia among those with pain interference and a higher relative abundance of taxa associated with chronic inflammation in those with pain interference posttransplant. Functional gene analysis identified two features that were significantly enriched in those with pain interference, including a peptide transport system gene. CONCLUSIONS: Gut microbiota community structure differs between groups with and without pain interference at 3 months after kidney transplantation. Several taxa involved in intestinal barrier integrity and chronic inflammation were associated with posttransplant pain.

The benefits and consequences of the COVID-19 pandemic for patients diagnosed with cancer and their family caregivers.

BACKGROUND: The objectives of this study were to examine benefits and consequences of the COVID-19 pandemic for patients diagnosed with cancer and their family caregivers. METHODS: A 23-item questionnaire assessing COVID-19-related issues, the Patient Health Questionnaire-2, Generalized Anxiety Disorder-2, Pittsburgh Sleep Quality Index, and the Perceived Stress Scale (PSS)-4 were administered to patients diagnosed with cancer and their family caregivers. RESULTS: Of the 161 patients and 78 caregivers who participated, 38.1% and 32.8 were male, 95% and 84.6% Caucasian, and the mean age was 66 and 64.6 years, respectively. A total of 16.5% and 15.2% reported depressive symptoms, 18.4% and 19% reported anxiety; 35.5% and 26.6% reported poor sleep quality, and 66% and 63.3% scored one standard deviation above the norms for the PSS, respectively. Predictors of poorer patient- and caregiver-reported outcomes included greater loneliness, worry about self or family being infected by the COVID-19, and worsening relationships with family. The fear of COVID-19 led to 20.8% of patients and 24.4% of family caregivers cancelling medical appointments, procedures, and treatments. A total of 52.5% of patients and 53.2% caregivers reported that the pandemic led to benefit finding but these changes were not associated with any of the measured patient- or caregiver-related outcomes. CONCLUSIONS: Psychological functioning for patients and caregivers was similar to that of pre-pandemic levels, however the decrease in health care utilization secondary to fear of COVID-19 was notable. While there were many negative effects of the pandemic, the majority of patients and caregivers reported some benefit to the pandemic.

Psychosocial outcomes 1-year post total pancreatectomy and autologous islet cell transplant.

BACKGROUND: A paucity of research regarding the psychosocial outcomes after TPIAT exists. METHODS: Adults (>18 years), adolescents (13-18 years), and children (5-12 years) with their parents were administered questionnaires at the time of evaluation for TPIAT and 1-year postsurgery to assess psychosocial outcomes. RESULTS: A total of 13 adults (6 male, 46%; mean age 35.2 years) and 9 children/adolescents (4 female, 44.4%; mean age 11.78 years) with CP were included in the study. A total of 69.2% of the adults and 66.7% of the children and adolescents were insulin dependent at 1-year postsurgery. In adults, improvements on the SF-36 pain (p = .001) and general health (p = .045) subscales were generally observed 1-year postsurgery. Adult patients who underwent robotic-assisted surgery compared to open surgery specifically reported better general health on the SF-36 (p < .05) at 1 year. For children and adolescents, reductions in average pain in the last week (p < .05), pain interference (p < .001), and fatigue were observed (p < .05) at 1-year postsurgery. For the entire sample, using repeated measures ANOVA and covarying for age, significant differences were found 1-year postsurgery in average pain in the last week (p = .034) and pain interference with the following categories: general activity (p < .001), walking (p = .04), normal work (p = .003), sleep (p = .002), and enjoyment in life (p = .007). CONCLUSIONS: While few transplant centers offer this treatment, the improvement in quality of life suggests this may be a viable treatment option for those with CP complicated by intractable pain. (IRB Approval PRO 19080302).

Post-operative outcomes in anonymous living liver donors: What motivates individuals to donate to strangers.

BACKGROUND: Anonymous living donor liver transplantation (LDLT) is a strategy to address the shortage of available transplantable livers; however, few studies have been conducted on this population. The objective of this study was to describe the motivations and medical, psychosocial, and financial outcomes of anonymous living liver donors. METHODS: Between 2010-2019, 116 anonymous living liver donors were evaluated, 59 (51.7%) of whom proceeded to surgery. A subset of 21 anonymous donors were matched to biologically/emotionally related donors according to age, gender, race, and duration since surgery. A medical chart review and post-surgical interviews were performed to assess medical and financial outcomes. RESULTS: The primary motivation for donors was an unselfish desire to help others (43, 72.9%). A total of 13 (22%) anonymous donors experienced complications. Of these, 7 (11.9%) were grade I Clavien-Dindo classification, 5 (8.5%) grade II, 1 was grade III (1.7%); and no patients had grade IV-V Clavien-Dindo complications. Increased anxiety was reported by 3 (5.1%) donors, and one donor reported clinical levels of depression (1.7%). Within the matched controls, anonymous donors were not significantly different to biologically/emotionally related donors with regard to surgical complications, psychosocial, or financial outcomes. CONCLUSIONS: Allowing a greater number of anonymous donors may facilitate the reduction of the waitlist for liver transplant candidates.

Priorities to improve cancer caregiving: report of a caregiver stakeholder workshop.

PURPOSE: Caregivers of people with cancer represent a large, overburdened, and under-recognized part of the cancer care workforce. Research efforts to address the unmet needs of these caregivers are expanding with studies focused on caregivers' skill sets, physical and psychological health, and integration into healthcare delivery. As this field of research continues to expand, integrating caregivers' input is vital to studies to ensure that research aligns with their experiences. METHODS: This is a focus group study of 15 cancer caregivers conducted during a cancer caregiving workshop at the University of Pittsburgh in February 2020. During the workshop, caregivers reviewed, critiqued, and proposed priorities to support caregivers of adults with cancer. We used a multistage consensus building approach to identify priority areas of research and clinical practice to address caregivers' experiences and needs. We used descriptive content analysis to summarize caregivers' priorities. RESULTS: Caregiver-identified priorities included (1) training and information about cancer and treatment, (2) caregiver integration into the patient's healthcare delivery, (3) assistance with navigating the healthcare system, (4) focus on caregiver health and well-being, and (5) policy reform to address caregiver needs. We identified ways in which these priorities can inform cancer caregiving research and practice. CONCLUSION: These recommendations should be considered by researchers, clinicians, cancer center leadership, and policymakers interested in creating caregiver-focused research protocols, interventions, and support systems.

Caregiver-guided pain coping skills training for patients with advanced cancer: Results from a randomized clinical trial.

BACKGROUND: Pain is a major concern among patients with advanced cancer and their family caregivers. Evidence suggests that pain coping skills training interventions can improve outcomes, however they have rarely been tested in this population. AIM: To test the efficacy of a caregiver-guided pain coping skills training intervention. The primary outcome was caregiver self-efficacy for helping the patient manage pain. DESIGN: A randomized controlled trial compared the intervention to an enhanced treatment-as-usual control. Dyads in both conditions received pain education, and those in the intervention received three sessions of pain coping skills training. Caregiver outcomes (self-efficacy; caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy, pain intensity and interference, psychological distress) were collected at baseline and post-intervention. SETTING/PARTICIPANTS: Two hundred two patients with stage III-IV cancer and pain and their family caregivers were enrolled from four outpatient oncology clinics and a free-standing hospice/palliative care organization. RESULTS: Compared to those in the control arm, caregivers in the intervention reported significant increases in caregiving satisfaction (p < 0.01) and decreased anxiety (p = 0.04). In both conditions, caregivers reported improvements in self-efficacy, and patients reported improvements in self-efficacy, pain severity and interference, and psychological distress. CONCLUSIONS: This is the first study to test a pain coping skills intervention targeted to patients and caregivers facing advanced cancer. Findings suggest that pain education provides benefits for patients and caregivers, and coping skills training may be beneficial for caregivers. Further research is needed to optimize the benefits of education and pain coping skills training for improving cancer pain outcomes.Trial registration: ClinicalTrials.gov NCT02430467, Caregiver-Guided Pain Management Training in Palliative Care.

Adverse childhood experiences (ACEs), cell-mediated immunity, and survival in the context of cancer.

PURPOSE: Adverse childhood experiences (ACEs) have been shown to be associated with increased risk of mortality. The biobehavioral mechanisms linking adverse events and survival in cancer patients remain unclear. The aims of the study were to: (1) examine the rates and types of early adverse events in patients diagnosed with cancer; (2) investigate the association of adverse events with circulating cytokines, representing immune status of the patient; and (3) test whether immune markers mediated the association between early adverse events and survival while adjusting for other factors that are associated with immunity (e.g., fatigue) and survival (e.g., depression). PATIENTS AND METHODS: The patients were recruited from an outpatient oncology clinic. Patients were administered a battery of questionnaires including the Traumatic Events Survey and the Center for Epidemiological Studies-Depression scale. Blood was collected and serum levels of cytokines were assessed to characterize immune status. Descriptive statistics, Mann-Whitney U tests and Cox regression were performed to address study aims. RESULTS: Of the 408 patients, 66% reported at least one ACE. After adjusting for demographic, disease-specific factors, and psychological/behavioral factors; having had a major upheaval between parents during childhood or adolescence was associated with poorer survival [ß = -0.702, HR = 0.496, p = 0.034]. Lower levels of interleukin-2 (IL-2) explained, in part, the link between this early adverse event and poorer survival as when IL-2 was entered into the model, a major upheaval between one's parents and survival was no longer significant [ß = -0.612, HR = 0.542, p = 0.104]. CONCLUSION: Having experienced an ACE was associated with lower IL-2 levels-a growth factor for anti-inflammatory T-regulatory lymphocytes-central in contemporary immunotherapy, as well as poorer survival in those diagnosed with cancer. Since lower IL-2 levels also explained, in part, the link between the ACE involving parental upheaval and survival, there is support for a psychoneuroimmunological model of disease course in this vulnerable population.

Health-Related Quality of Life as a Prognostic Factor in Patients After Resection of Hepatic Malignancies.

BACKGROUND: Numerous studies have argued health-related quality of life (HRQoL) measures to be prognostic of survival in patients with chronic disease processes including cancer; however, only a few small studies have evaluated HRQoL changes in the setting of oncologic resections. The objectives of the present study were to investigate factors predicting HRQoL, the change in HRQoL over time, and HRQoL prognostic value in patients undergoing surgical resection of hepatic malignancies. METHODS: We administered the Functional Assessment of Cancer Therapy-Hepatobiliary, Center for Epidemiologic Studies-Depression, Functional Assessment of Cancer Therapy-Fatigue, and Brief Pain Inventory to 128 patients with primary and metastatic hepatic malignancies enrolled between January 2008 to November 2011 and November 2013 to June 2015. Quality of life was obtained at the baseline, 4, 8, and 12 mo, using HRQoL questionnaires. RESULTS: The mean age of all patients included was 61 y, 42.6% had hepatocellular carcinoma, and 50.7% had metastatic colorectal carcinoma. HRQoL decreased from baseline at the 4-mo follow-up but stabilized to preoperative values at 8 and 12 mo. Depressive symptoms (P < 0.001), pain (P = 0.032), and fatigue (P < 0.001) were associated with HRQoL before surgery. Variables associated with HRQoL at 8 mo included extrahepatic recurrence (P = 0.002), depressive symptoms (P < 0.001), pain (P < 0.001), fatigue (P < 0.001), tumor macrovascular (P = 0.011), and microvascular invasion (P = 0.003). Using Cox regression and adjusting for demographics and disease-specific factors, preoperative HRQoL was significantly associated with overall survival. CONCLUSIONS: HRQoL is independently associated with survival in patients with liver malignancies undergoing surgical resection. Major curative liver surgery can be performed with short-term worsening of HRQoL but long-term improvement and stabilization in overall quality of life for patients with cancer.

Sleep problems in advanced cancer patients and their caregivers: Who is disturbing whom?

Background The aims of the study were to understand sleep problems and their effects in advanced cancer patients and spousal and intimate partner caregivers and to examine the directionality of the link between patients' and caregivers' sleep problems. Methods Fifty-four advanced cancer patients and their spousal and intimate partners were administered a battery of questionnaires that included the Pittsburgh Sleep Quality Index and the Center for Epidemiological Studies at the patients' cancer diagnosis and at 2, 4, and 6 months after diagnosis. Results Patients' and caregivers' sleep duration was significantly related. Using cross-lagged panel analyses, caregivers' sleep quality significantly predicted patients' sleep quality and patients' sleep quality subsequently predicted caregivers' sleep quality. Patients' sleep latency significantly was found to significantly predict caregivers' sleep latency. Conclusion Patients diagnosed with cancer and their intimate partners have poor sleep quality and sleep patterns are related.

Socioeconomic disparities of depressive symptoms and cytokines in hepatocellular carcinoma.

OBJECTIVE: To examine the associations among socioeconomic factors, depressive symptoms, and cytokines in patients diagnosed with hepatocellular carcinoma (HCC). METHODS: A total of 266 patients diagnosed with HCC were administered a battery of questionnaires including a sociodemographic questionnaire and the Center for Epidemiologic StudiesDepression (CES-D) scale. Blood samples were collected to assess serum levels of cytokines using Luminex. Descriptive statistics, Mann-Whitney U, Kruskal-Wallis, linear regression, and Bonferroni corrections were performed to test the hypotheses. RESULTS: Of the 266 patients, 24% reported depressive symptoms in the clinical range (CES-D ≥ 22). Females had higher CES-D score than males (Mann-Whitney U = 7135, P = .014, Padj  = .028). Being unemployed/disabled (Kruskal-Wallis = 14.732, P = .001, Padj  = .005) was found to be associated with higher depressive symptoms in males but not in females. Serum level of IL-2 (Kruskal-Wallis = 17.261, P = .001, Padj  = .005) were found to be negatively associated with education level. Gender (ß = .177, P = .035), income (ß = -.252, P = .004), whether the patient's income met their basic needs (ß = .180, P = .035), and IL-1ß (ß = -.165, P = .045) independently predicted depressive symptoms and together explained 19.4% of variance associated with depressive symptoms. CONCLUSIONS: Sociodemographic and socioeconomic factors were predictive of inflammation and depressive symptoms. Recommendations include the development of gender-targeted interventions for patients diagnosed with HCC who have low socioeconomic status (SES) and may suffer from depressive symptoms.

Psychosocial and behavioral pathways of metabolic syndrome in cancer caregivers.

OBJECTIVE: Cancer caregivers are at increased risk for cardiovascular disease (CVD) and mortality. The aims of this study were to examine psychosocial and behavioral predictors of metabolic syndrome, an intermediate endpoint of CVD. METHODS: Cancer caregivers were administered a battery of questionnaires assessing sociodemographic characteristics, depressive symptoms, perceived stress, caregiver quality of life, sleep, physical activity, alcohol and tobacco use, social support, relationship quality, and loneliness. Metabolic syndrome was defined using the American Heart Association guidelines and the National Cholesterol Education Program's Adult Treatment Panel (ATP) III, which includes the presence of at least three of the following abnormalities: blood pressure, glucose, abdominal girth, high-density lipoprotein (HDL), and triglycerides. RESULTS: Of the 104 caregivers, 77% were female, 94% were Caucasian, and the mean age was 59.5 (SD = 12.8). Of the 104 caregivers, 35.6% reported depressive symptoms in the clinical range of the Center for Epidemiologic Studies-Depression (CES-D) and 69.2% reported Perceived Stress Scale scores at least one standard deviation above the general population norms. A total of 16.3% of caregivers currently used tobacco, 28.8% consumed alcohol, and 26.7% were overweight (BMI = 25-29.9) and 48.5% were obese (BMI ≥ 30). Forty-nine percent of the caregivers met the criteria for metabolic syndrome. After age, gender, and race were adjusted, the following remained as significant predictors of metabolic syndrome: low levels of caregiver quality of life (Odds Ratio (OR) = 1.067; 95% CI, 1.019-1.117; P = .006), high levels of hostility (OR = 1.142; 95% CI, 1.030-1.267; P = .012), and current alcohol use (OR = 4.193; 95% CI, 1.174-14.978; P = .027). CONCLUSION: Development of interventions to reduce the risk of metabolic syndrome in cancer caregivers is recommended.

Caregiver-guided pain coping skills training for patients with advanced cancer: Background, design, and challenges for the CaringPals study.

BACKGROUND/AIMS: Pain is a major concern of patients with advanced cancer and their caregivers. There is strong evidence that pain coping skills training interventions based on cognitive-behavioral principles can reduce pain severity and pain interference. However, few such interventions have been tested for patients with advanced cancer and their family caregivers. This study aims to test the efficacy of a caregiver-guided pain coping skills training protocol on patient and caregiver outcomes. METHODS: A total of 214 patients age ≥18 with Stage III-Stage IV cancer and moderate to severe pain, along with their family caregivers, are being identified and randomized with a 1:1 allocation to the caregiver-guided pain coping skills training intervention or enhanced treatment-as-usual. Dyads in both conditions receive educational resources on pain management, and the caregiver-guided pain coping skills training intervention includes three weekly 60-min sessions conducted with the patient-caregiver dyad via videoconference. Measures of caregiver outcomes (self-efficacy for helping the patient manage pain, caregiver strain, caregiving satisfaction, psychological distress) and patient outcomes (self-efficacy for pain management, pain intensity and interference, psychological distress) are collected at baseline and post-intervention. Caregiver outcomes are also collected 3 and 6 months following the patient's death. The study is enrolling patients from four tertiary care academic medical centers and one free-standing hospice and palliative care organization. The primary outcome is caregiver self-efficacy for helping the patient manage pain. RESULTS: This article describes challenges in the design and implementation of the CaringPals trial. Key issues for trial design include the identification and recruitment of patients with advanced cancer and pain, and the follow-up and collection of data from caregivers following the patient's death. CONCLUSION: The CaringPals trial addresses a gap in research in pain coping skills training interventions by addressing the unique needs of patients with advanced cancer and their caregivers. Findings from this study may lead to advances in the clinical care of patients with advanced cancer and pain, as well as a better understanding of the effects of training family caregivers to help patients cope with pain.

Putting the life in lifestyle: Lifestyle choices after a diagnosis of cancer predicts overall survival.

BACKGROUND: The aim of this study was to examine predictors of health behaviors over time and the link between health behaviors and survival after a diagnosis of advanced cancer. METHODS: Patients with a diagnosis of advanced cancer were administered a battery of questionnaires measuring optimism, depressive symptoms, physical activity, intake of fruits and vegetables, and alcohol and tobacco use over an 18-month period. Analyses included generalized linear mixed models and Cox regression survival analyses. RESULTS: Of the 334 patients enrolled in the study, the mean age at cancer diagnosis was 62 years; the majority were male (62.3%) and white (91%). Twenty percent of the patients reported using alcohol, 19% reported using tobacco, 19% reported eating fewer fruits and vegetables than recommended by the Centers for Disease Control and Prevention and 28% reported physical inactivity after the diagnosis of advanced cancer. Clinical levels of depressive symptoms were associated with lower intake of fruits and vegetables (t = 2.67, P = .007) and physical inactivity (t = 2.11, P = .035). Dispositional optimism was positively associated with physical activity (t = -2.16, P = .031) and a lower frequency of tobacco use (Z = -2.42, P = .015). Multivariate analyses revealed that after adjusting for demographic variables (age and sex), depressive symptoms, and disease-specific factors (diagnosis, tumor size, cirrhosis, vascular invasion, and number of lesions), alcohol use (χ2 = 4.1186, P = .042) and physical inactivity (χ2 = 5.6050, P = .018) were linked to an poorer survival. CONCLUSIONS: Greater dissemination and implementation of effective interventions to reduce alcohol use and increase physical activity in cancer patients are recommended.

Prospective Analyses of Cytokine Mediation of Sleep and Survival in the Context of Advanced Cancer.

OBJECTIVE: The aims of this study were to examine the potential association between sleep problems, symptom burden, and survival in patients with advanced cancer. METHODS: A prospective study of 294 patients with gastrointestinal cancer administered questionnaires assessing sleep, depression, anxiety, stress, pain, fatigue, and health-related quality of life. Serum levels of cytokines including interleukin (IL)-1α, IL-1ß, tumor necrosis factor α, IL-10, IL-2, and interferon-γ were measured to assess biological mediation between sleep and survival. Survival was measured as time from diagnosis to death. RESULTS: Fifty-nine percent of patients reported poor sleep quality, 53% reported poor sleep efficiency, 39% reported sleep latency greater than 30 minutes, and 45% reported sleeping less than 6 hours or greater than 10 hours. We found a significant association between sleep duration and symptom burden. Shorter sleep duration was significantly associated with higher levels of fatigue (r = -0.169, p = .01), pain (r = -0.302, p = .01), anxiety (r = -0.182, p = .01), depression (r = -0.172, p = .003), and lower levels of quality of life (r = 0.240, p = .01). After adjustment for demographic, psychological, and disease-specific factors, short sleep duration was associated with reduced survival (hazard ratio [HR] linear = 0.485, 95% confidence interval = 0.275-0.857) and there was also evidence for a quadratic pattern (HR quadrati = 1.064, 95% confidence interval = 1.015-1.115) suggesting a curvilinear relationship between sleep duration and survival. Interleukin 2 was the only cytokine significantly related to survival (HR = 1.01, p = .003) and sleep duration (ß = -30.11, p = .027). When of IL-2 was added to the multivariable model, short and long sleep (ß = -0.557, p = .097; ß = 0.046, p = .114) were no longer significantly related to survival, suggesting mediation by IL-2. CONCLUSION: Sleep duration was associated with symptom burden and poorer survival and IL-2 was found to mediate the association between sleep and survival. Screening and treatment of sleep problems in patients diagnosed with cancer are warranted.

A multicenter study of total pancreatectomy with islet autotransplantation (TPIAT): POST (Prospective Observational Study of TPIAT).

BACKGROUND/OBJECTIVES: Total pancreatectomy with islet autotransplantation (TPIAT) is considered for managing chronic pancreatitis in selected patients when medical and endoscopic interventions have not provided adequate relief from debilitating pain. Although more centers are performing TPIAT, we lack large, multi-center studies to guide decisions about selecting candidates for and timing of TPIAT. METHODS: Multiple centers across the United States (9 to date) performing TPIAT are prospectively enrolling patients undergoing TPIAT for chronic pancreatitis into the Prospective Observational Study of TPIAT (POST), a NIDDK funded study with a goal of accruing 450 TPIAT recipients. Baseline data include participant phenotype, pancreatitis history, and medical/psychological comorbidities from medical records, participant interview, and participant self-report (Medical Outcomes Survey Short Form-12, EQ-5D, andPROMIS inventories for pain interference, depression, and anxiety). Outcome measures are collected to at least 1 year after TPIAT, including the same participant questionnaires, visual analog pain scale, pain interference scores, opioid requirements, insulin requirements, islet graft function, and hemoglobin A1c. Health resource utilization data are collected for a cost-effectiveness analysis. Biorepository specimens including urine, serum/plasma, genetic material (saliva and blood), and pancreas tissue are collected for future study. CONCLUSIONS: This ongoing multicenter research study will enroll and follow TPIAT recipients, aiming to evaluate patient selection and timing for TPIAT to optimize pain relief, quality of life, and diabetes outcomes, and to measure the procedure's cost-effectiveness. A biorepository is also established for future ancillary studies.

Transplant advocacy in the era of the human immunodeficiency virus organ policy equity act.

In 2013, the Human Immunodeficiency Virus Organ Policy Equity (HOPE) Act was passed to permit the conduct of research on the transplantation of organs from donors infected with human immunodeficiency virus (HIV) into recipients who are HIV-positive. The HOPE Act workshop had many objectives including the discussion of the ethical issues involved in HIV-positive to HIV-positive transplantation, the informed consent process, and the role of independent advocates in the context of HIV to HIV transplantation. As of 2018, 22 transplant hospitals are approved, or undergoing approval, to perform HIV-positive to HIV-positive transplant surgeries, and this number is expected to grow. This study aims to: (i) briefly review the history and research of HIV+ transplantation prior to the HOPE Act, (ii) describe the ethical principles supporting the HOPE Act, (iii) characterize the informed consent process, and (iv) provide guidance regarding the role of independent advocates in the context of HIV-positive to HIV-positive transplantation.

Initial Treatment of Unresectable Neuroendocrine Tumor Liver Metastases with Transarterial Chemoembolization using Streptozotocin: A 20-Year Experience.

BACKGROUND: The majority of patients with neuroendocrine tumor liver metastases (NELM) present with multifocal disease and are not surgical candidates. We present our 20-year experience with transarterial chemoembolization (TACE) using streptozotocin (STZ) in patients with initially unresectable NELM. METHODS: Patients with unresectable NELM treated with TACE using STZ at a single institution from 1995 to 2015 were identified after institutional board approval. Imaging was independently reviewed by a radiologist to evaluate for RECIST 1.1 responses. RESULTS: Ninety-one patients with NELM who underwent 474 TACE treatments during the past 20 years were identified. Median age was 62 years, and 54 % of the patients were females. Median number of TACE treatments per patient was four (range 1-22). TACE treatment with STZ was very well tolerated with 10.3 % of treatments being associated with side effects, predominantly transient, including hyper/hypotension, bradycardia, or postembolization syndrome. Median overall survival from the start of TACE was 44 months (5-year OS from TACE 40.8 % and 5-year PFS 20.3 %), and 54 % of the patients who had carcinoid syndrome reported improved symptoms after TACE treatments. Age, grade, liver tumor burden, and ability to undergo multiple TACE treatments were independent predictors of overall survival in multivariable analysis. Chromogranin A levels >115 ng/ml were associated with worse overall survival (p < 0.001). CONCLUSIONS: In patients with unresectable NELM, TACE with STZ is well tolerated with minimal toxicity and can lead to diminished carcinoid syndrome and long-term survival. This is a novel, conservative approach for the initial treatment of unresectable NELM.

Web-based collaborative care intervention to manage cancer-related symptoms in the palliative care setting.

BACKGROUND: The aim of this study was to examine the efficacy of a collaborative care intervention in reducing depression, pain, and fatigue and improve quality of life. METHODS: A total of 261 patients with advanced cancer and 179 family caregivers were randomized to a web-based collaborative care intervention or enhanced usual care. The intervention included the following: 1) a web site with written and audiovisual self-management strategies, a bulletin board, and other resources; 2) visits with a care coordinator during a physician's appointment every 2 months; and 3) telephone follow-up every 2 weeks. Primary patient outcomes included measures of depression, pain, fatigue, and health-related quality of life. Secondary outcomes included Interleukin (IL)-1α, IL-1ß, IL-6, and IL-8 levels, Natural Killer (NK) cell numbers, and caregiver stress and depression. RESULTS: At the baseline, 51% of the patients reported 1 or more symptoms in the clinical range. For patients who presented with clinical levels of symptoms and were randomized to the intervention, reductions in depression (Cohen's d = 0.71), pain (Cohen's d = 0.62), and fatigue (Cohen's d = 0.26) and improvements in quality of life (Cohen's d = 0.99) were observed when compared to those in the enhanced usual car arm at 6 months. Reductions in IL-6 (φ = 0.18), IL-1ß (φ = 0.35), IL-1α (φ = 0.19), and IL-8 (φ = 0.15) and increases in NK cell numbers (φ = 0.23) were observed in comparison with enhanced usual care arm at 6 months. Reductions in caregiver stress (Cohen's d = 0.75) and depression (Cohen's d = 0.37) were observed at 6 months for caregivers whose loved ones were randomized to the intervention arm. CONCLUSIONS: The integration of screening and symptom management into cancer care is recommended.