Patient-reported outcomes after surgery for endometrial carcinoma: Prevalence of lower-extremity lymphedema after sentinel lymph node mapping versus lymphadenectomy.

OBJECTIVE: To compare the prevalence of patient-reported lower-extremity lymphedema (LEL) with sentinel lymph node (SLN) mapping versus comprehensive lymph node dissection (LND) for the surgical management of newly diagnosed endometrial carcinoma. METHODS: Patients who underwent primary surgery for endometrial cancer from 01/2006-12/2012 were mailed a survey that included a validated 13-item LEL screening questionnaire in 08/2016. Patients diagnosed with LEL prior to surgery and those who answered ≤6 survey items were excluded. RESULTS: Of 1275 potential participants, 623 (49%) responded to the survey and 599 were evaluable (180 SLN, 352 LND, 67 hysterectomy alone). Median BMI was similar among cohorts (P = 0.99). External-beam radiation therapy (EBRT) was used in 10/180 (5.5%) SLN and 35/352 (10%) LND patients (P = 0.1). Self-reported LEL prevalence was 27% (49/180) and 41% (144/352), respectively (OR, 1.85; 95% CI, 1.25-2.74; P = 0.002). LEL prevalence was 51% (23/45) in patients who received EBRT and 35% (170/487) in those who did not (OR, 1.95; 95% CI, 1.06-3.6; P = 0.03). High BMI was associated with increased prevalence of LEL (OR, 1.04; 95% CI, 1.02-1.06; P = 0.001). After controlling for EBRT and BMI, LND retained independent association with an increased prevalence of LEL over SLN (OR, 1.8; 95% CI, 1.22-2.69; P = 0.003). Patients with self-reported LEL had significantly worse QOL compared to those without self-reported LEL. CONCLUSIONS: This is the first study to assess patient-reported LEL after SLN mapping for endometrial cancer. SLN mapping was independently associated with a significantly lower prevalence of patient-reported LEL. High BMI and adjuvant EBRT were associated with an increased prevalence of patient-reported LEL.

Psychological correlates of sexual dysfunction in female rectal and anal cancer survivors: analysis of baseline intervention data.

INTRODUCTION: Sexual dysfunction represents a complex and multifactorial construct that can affect both men and women and has been noted to often deteriorate significantly after treatment for rectal and anal cancer. Despite this, it remains an understudied, underreported, and undertreated issue in the field of cancer survivorship. AIM: This study examined the characteristics of women enrolled in an intervention trial to treat sexual dysfunction, and explored the relationship between sexual functioning and psychological well-being. METHODS: There were 70 female posttreatment anal or rectal cancer survivors assessed as part of the current study. Participants were enrolled in a randomized intervention trial to treat sexual dysfunction and completed outcome measures prior to randomization. MAIN OUTCOMES MEASURES: The main outcome measures are quality of life (QOL) (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC-QLQ-C30] and Colorectal Cancer-Specific Module [QLQ-CR38]), sexual functioning (Female Sexual Functioning Index), and psychological well-being (Brief Symptom Inventory Depression/Anxiety, Impact of Events Scale-Revised, CR-38 Body Image). RESULTS: Women enrolled in the study intervention were on average 55 years old, predominantly Caucasian (79%), married (57%), and a median of 4 years postprimary treatment. For those reporting sexual activity at baseline (N=41), sexual dysfunction was associated with a range of specific measures of psychological well-being, all in the hypothesized direction. The Sexual/Relationship Satisfaction subscale was associated with all measures of psychological well-being (r=-0.45 to -0.70, all P<0.01). Body image, anxiety, and cancer-specific posttraumatic distress were notable in their association with subscales of sexual functioning, while a global QOL measure was largely unrelated. CONCLUSIONS: For sexually active female rectal and anal cancer survivors enrolled in a sexual health intervention, sexual dysfunction was significantly and consistently associated with specific measures of psychological well-being, most notably Sexual/Relationship Satisfaction. These results suggest that sexual functioning may require focused assessment by providers, beyond broad QOL assessments, and that attention to Sexual/Relationship Satisfaction may be critical in the development and implementation of interventions for this cohort of patients.

Using R and WinBUGS to fit a generalized partial credit model for developing and evaluating patient-reported outcomes assessments.

The US Food and Drug Administration recently announced the final guidelines on the development and validation of patient-reported outcomes (PROs) assessments in drug labeling and clinical trials. This guidance paper may boost the demand for new PRO survey questionnaires. Henceforth, biostatisticians may encounter psychometric methods more frequently, particularly item response theory (IRT) models to guide the shortening of a PRO assessment instrument. This article aims to provide an introduction on the theory and practical analytic skills in fitting a generalized partial credit model (GPCM) in IRT. GPCM theory is explained first, with special attention to a clearer exposition of the formal mathematics than what is typically available in the psychometric literature. Then, a worked example is presented, using self-reported responses taken from the international personality item pool. The worked example contains step-by-step guides on using the statistical languages r and WinBUGS in fitting the GPCM. Finally, the Fisher information function of the GPCM model is derived and used to evaluate, as an illustrative example, the usefulness of assessment items by their information contents. This article aims to encourage biostatisticians to apply IRT models in the re-analysis of existing data and in future research.

Onset of posttraumatic stress disorder and major depression among refugees and voluntary migrants to the United States.

Although refugees are generally thought to be at increased risk for posttraumatic stress disorder (PTSD) and major depressive episode (MDE), few studies have compared onset of PTSD and MDE between refugees and voluntary migrants. Given differences in migration histories, onset should differ pre- and postmigration. The National Latino and Asian American Survey (NLAAS) is a national representative, complex dataset measuring psychiatric morbidity, mental health service use, and migration history among Latino and Asian immigrants to the United States. Of the 3,260 foreign-born participants, 660 were refugees (a weighted proportion of 9.52%). Refugees were more likely to report a history of war-related trauma, but reports of other traumatic events were similar. Premigration onset of PTSD was statistically higher for refugees than voluntary migrants, odds ratio (OR) = 4.86, 95% confidence interval (CI) [2.01, 11.76], where postmigration onset for PTSD was not, OR = 0.61, 95% CI [0.29, 1.28]; a similar pattern was found for MDE, OR = 1.98, 95% CI [1.11, 3.51]; and OR = 1.02, 95% CI [0.65, 1.62], respectively. Although refugees arrive in host countries with more pressing psychiatric needs, onset is comparable over time, suggesting that postmigration refugees and voluntary migrants may be best served by similar programs.

Cancer surgeons' distress and well-being, II: modifiable factors and the potential for organizational interventions.

PURPOSE: We showed in a companion paper that the prevalence of burnout among surgical oncologists at a comprehensive cancer center was 42% and psychiatric morbidity 27%, and high quality of life (QOL) was absent for 54% of surgeons. Here we examine modifiable workplace factors and other stressors associated with burnout, psychiatric morbidity, and low QOL, together with interest in interventions to reduce distress and improve wellness. METHODS: Study-specific questions important for morale, QOL, and stressors associated with burnout were included in an anonymous Internet-based survey distributed to the surgical faculty at Memorial Sloan-Kettering Cancer Center. RESULTS: Among the 72 surgeons who responded (response rate of 73%), surgeons identified high stress from medical lawsuits, pressure to succeed in research, financial worries, negative attitudes to gender, and ability to cope with patients' suffering and death. Workplace features requiring greatest change were the reimbursement system, administrative support, and schedule. Work-life balance and relationship issues with spouse or partner caused high stress. Strongest correlations with distress were a desire to change communication with patients and the tension between the time devoted to work versus time available to be with family. Surgeons' preferences for interventions favored a fitness program, nutrition consultation, and increased socialization with colleagues, with less interest in interventions conventionally used to address psychological distress. DISCUSSION: Several opportunities to intervene at the organizational level permit efforts to reduce burnout and improve QOL.

Cancer surgeons' distress and well-being, I: the tension between a culture of productivity and the need for self-care.

BACKGROUND: Burnout is a prevalent and important occupational hazard among surgical oncologists. The well-being or distress experienced can have a significant effect on clinicians and their families, the quality of care provided to patients, and the success of the health care organization. METHODS: We aimed to measure the prevalence of burnout, psychiatric morbidity, and quality of life using standardized measures; characterize associated features; and ascertain the surgical faculty's views on potential interventions and obstacles to change. Additional questions about service commitment to well-being, use of annual leave, and attitudes about weekend surgical practice were constructed to guide future targeted interventions. RESULTS: Among the 72 surgeons who responded (response rate of 73%), we found that 42% of surgeons reported burnout and 27% psychiatric levels of distress, while 30% used alcohol and 13% used sleep medications as a possible means to cope. Only one third of surgeons reported high quality of life across physical, emotional, spiritual, and intellectual domains. DISCUSSION: Compared to general surgical practices, cancer surgeons achieved more personal fulfillment and made less use of distancing methods to cope with their patients. Institutional culture contributes to the nonuse of available annual leave, attitudes about weekend operating schedules, and missed opportunities for the leadership to attend to surgeons' well-being.

Oncology Patients' Perspectives on Remote Patient Monitoring for COVID-19.

PURPOSE: Oncology patients are vulnerable to adverse outcomes associated with COVID-19, and clinical deterioration must be identified early. Several institutions launched remote patient monitoring programs (RPMPs) to care for patients with COVID-19. We describe patients' perspectives on a COVID-19 RPMP at a National Comprehensive Cancer Center. METHODS: Patients who tested positive for COVID-19 were eligible. Enrolled patients received a daily electronic COVID-19 symptom assessment, and a subset of high-risk patients also received a pulse oximeter. Monitoring was provided by a centralized team and was discontinued 14 days after a patient's positive test result and following 3 days without worsening symptoms. Patients who completed at least one assessment and exited the program were sent a patient engagement survey to evaluate the patient's experience with digital monitoring for COVID-19. RESULTS: The survey was distributed to 491 patients, and 257 responded (52% completion rate). The net promoter score was 85%. Most patients agreed that the RPMP was worthwhile, enabled better management of their COVID-19 symptoms, made them feel more connected to their healthcare team, and helped prevent emergency room visits. Identified themes regarding patient-perceived value of a RPMP included (1) security: a clinical safety net; (2) connection: a link to their clinical team during a period of isolation; and (3) empowerment: an education on the virus and symptom management. CONCLUSION: RPMPs are perceived to be of value to oncology patients with COVID-19. Policymakers should consider how these programs can be reimbursed to keep vulnerable patients at home and out of the acute care setting.

Personalized electro-acupuncture versus auricular-acupuncture comparative effectiveness (PEACE): A protocol of a randomized controlled trial for chronic musculoskeletal pain in cancer survivors.

INTRODUCTION: Chronic pain is a leading cause of disability and remains under-treated in nearly half of patients with cancer. The opioid crisis has highlighted an urgent public health need for effective nonpharmacological pain management. Electroacupuncture (EA) and Battlefield Acupuncture (BFA) represent nonpharmacological modalities used in clinical practice to manage pain; however, their effectiveness has not been rigorously evaluated in oncology settings. METHODS: We describe the design of a 3-arm, parallel, single-center, multisite randomized controlled trial that investigates EA and BFA versus usual-care wait-list control (WLC) for chronic musculoskeletal pain among 360 patients with diverse cancer types across various stages. The primary aim is to compare effects of EA and BFA versus WLC on pain, physical function, and co-morbid symptoms. The secondary aim is to examine the interaction between patient outcome expectancy and acupuncture modality (EA vs BFA) on pain reduction. The tertiary aim is to evaluate the association between genetic polymorphisms and responses to acupuncture. Patients will be randomized in a 2:2:1 ratio to EA:BFA:WLC. Acupuncture groups will receive weekly treatments over 10 weeks. WLC will receive usual care over the same evaluation period as the acupuncture groups. The primary endpoint will be the change in average pain intensity score from baseline to week 12. We will collect validated patient-reported outcomes and blood/saliva samples at multiple timepoints over 24 weeks. DISCUSSION: Our findings will advance nonpharmacological pain management in oncology and inform personalized treatment approaches that integrate individuals' expectations and genetic biomarkers to deliver "precision" acupuncture to cancer patients with chronic pain. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02979574.

Ethnic differences in delays to treatment for substance use disorders: African Americans, Black Caribbeans and non-Hispanic whites.

Prior research has shown that minority groups experience greater levels of disability associated with psychiatric and substance use conditions due to barriers to treatment. Treatment delays are an important part of the overall problem of service utilization and access to treatment, yet little work has been done to understand the factors associated with treatment delays among ethnic minorities. This study compares African Americans, Caribbean Blacks and non-Hispanic Whites regarding their probability of making treatment contacts over time, using a combined sample of African Americans and Caribbean Blacks from the National Survey of American Life (NSAL) and non-Hispanic Whites from the National Comorbidity Survey-Replication (NCS-R). Alcohol and other drug use disorders (abuse and dependence) were assessed using the World Mental Health Composite International Diagnostic Interview. Cumulative lifetime probability curves were used to examine race differences in treatment contact. Cox regression analysis was used to test the association between race and treatment groups while controlling for other potential confounding variables. Significant delays in making treatment contact were observed across all disorders. However, no evidence of delays was found for racial differences. In the multivariate analysis, race was not significantly associated with delays. However, comorbid anxiety disorders were found to be a consistent factor associated with a faster time to treatment.