A randomized trial comparing live and telemedicine deliveries of an imagery-based behavioral intervention for breast cancer survivors: reducing symptoms and barriers to care.

OBJECTIVE: This multi-site randomized trial evaluates the quality of life (QOL) benefits of an imagery-based group intervention titled 'Envision the Rhythms of Life'(ERL). METHODS: Breast cancer survivors >6 weeks post-treatment were randomized to attend five weekly 4-h group sessions at a community center with therapist present (live delivery (LD), n = 48), therapist streamed via telemedicine (telemedicine delivery (TD), n = 23), or to a waitlist control (WL) group (n = 47). Weekly individual phone calls to encourage at-home practice began at session one and continued until the 3-month follow-up. Seven self-report measures of QOL were examined at baseline, 1-month and 3-month post-treatments including health-related and breast cancer-specific QOL, fatigue, cognitive function, spirituality, distress, and sleep. RESULTS: The Bonferroni method was used to correct for multiple comparisons, and alpha was adjusted to 0.01. Linear multilevel modeling analyses revealed less fatigue, cognitive dysfunction, and sleep disturbance for LD and TD compared with WL across the follow-up (p's < 0.01). Changes in fatigue, cognitive dysfunction, sleep disturbance, and health-related and breast cancer-related QOL were clinically significant. There were no differences between LD and TD. CONCLUSIONS: Both the live and telemedicine delivered ERL intervention resulted in improvements in multiple QOL domains for breast cancer survivors compared with WL. Further, there were no significant differences between LD and TD, suggesting telemedicine delivered ERL intervention may represent an effective and viable option for cancer survivors in remote areas.

Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: a randomized, double-blind, placebo-controlled trial.

OBJECTIVES: Chemotherapy-induced peripheral neuropathy is frequently a dose-limiting factor in cancer treatment and may cause pain and irreversible function loss in cancer survivors. We tested whether alpha-lipoic acid (ALA) could decrease the severity of peripheral neuropathy symptoms in patients undergoing platinum-based chemotherapy. METHODS: Cancer patients 18 years or older were randomly selected to receive either 600 mg ALA or a placebo three times a day orally for 24 weeks while receiving chemotherapy regimens including cisplatin or oxaliplatin. Neuropathy was measured by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scale and the NCI Common Toxicity Criteria for Adverse Events neurotoxicity grades. Results from timed functional tests and the Brief Pain Inventory (BPI) were secondary endpoints. RESULTS: Seventy of 243 (29 %) patients completed the study (24 weeks). Both the ALA and the placebo arms had a comparable drop-out rate. No statistically significant differences were found between the ALA and the placebo groups for FACT/GOG-Ntx scores, BPI scores, and patients' functional outcomes. CONCLUSION: This strategy of oral ALA administration was ineffective at preventing neurotoxicity caused by oxaliplatin or cisplatin. High attrition rates due to poor patient compliance and manner of dosage administration in this trial demonstrated a lack of feasibility for this intervention. Future studies to explore ALA as a neuroprotective agent should take heed of the barriers confronted in this study.

A multicenter survey of Hispanic caregiver preferences for patient decision control in the United States and Latin America.

BACKGROUND: Understanding family caregivers' decisional role preferences is important for communication, quality of care, and patient and family satisfaction. The family caregiver has an important role in a patient's decisional role preferences. There are limited studies on family caregivers' preferences of the patient's decision control at the end of life among Hispanics. AIMS: To identify Hispanic caregivers' preferences of the decision control of patients with advanced cancer and to compare the preferences of caregivers in Hispanic Latin American and Hispanic American caregivers. DESIGN: We surveyed patients and their family caregivers referred to outpatient palliative care clinics in the United States, Chile, Argentina, and Guatemala. Caregiver preferences of patient's decision control were evaluated using the Control Preference Scale. Caregivers' and patients' sociodemographic variables, patient performance status, and Hispanic American patient acculturation level were also collected. PARTICIPANTS: A total of 387 caregivers were surveyed: 100 (26%) in Chile, 99 (26%) in Argentina, 97 (25%) in Guatemala, and 91 (24%) in the United States. The median age was 56 years, and 59% were female. RESULTS: Caregiver preference of patient's decision control was passive, shared, and active for 10 (11%), 45 (52%), and 32 (37%) Hispanic American caregivers and 54 (19%), 178 (62%), and 55 (19%) Hispanic Latin American caregivers (p = 0.0023), respectively. Caregiver acculturation level did not affect the preferences of the Hispanic American sample (p = 0.60). CONCLUSIONS: Most Hispanic family caregivers preferred the patient to make shared decisions. Hispanic Latin American caregivers more frequently preferred patients to assume a passive decisional role. Acculturation did not influence the preferences of Hispanic American caregivers.

Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma.

BACKGROUND: Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients, and available treatments are of little benefit. The objective of this trial was to determine whether acupuncture can prevent xerostomia among head/neck patients undergoing radiotherapy. METHODS: A randomized, controlled trial among patients with nasopharyngeal carcinoma was conducted comparing acupuncture to standard care. Participants were treated at Fudan University Shanghai Cancer Center, Shanghai, China. Forty patients were randomized to acupuncture treatment and 46 to standard care. Patients were treated 3×/wk on the same days they received radiotherapy. Subjective measures included the Xerostomia Questionnaire and MD Anderson Symptom Inventory-Head and Neck (MDASI-HN). Objective measures were unstimulated and stimulated whole salivary flow rates. Patients were followed for 6 months after the end of radiotherapy. RESULTS: Xerostomia Questionnaire scores for acupuncture were statistically significantly lower than for controls starting in week 3 through the 6 months (P = .003 at week 3, all other P < .0001), with clinically significant differences as follows: week 11, relative risk (RR) 0.63 (95% confidence interval [CI], 0.45-0.87); 6 months, RR 0.38 (95% CI, 0.19-0.76). Similar findings were seen for MDASI-HN scores. Group differences emerged as early as 3 weeks into treatment for saliva (unstimulated whole salivary flow rate, P = .0004), with greater saliva flow in the acupuncture group at week 7 (unstimulated whole salivary flow rate, P < .0001; stimulated whole salivary flow rate, P = .002) and 11 (unstimulated whole salivary flow rate, P < .02; stimulated whole salivary flow rate, P < .03) and at 6 months (stimulated whole salivary flow rate, P < .003). CONCLUSIONS: Acupuncture given concurrently with radiotherapy significantly reduced xerostomia and improved quality of life.

Utilization of and Attitudes towards Traditional Chinese Medicine Therapies in a Chinese Cancer Hospital: A Survey of Patients and Physicians.

Background. In China, the use of traditional Chinese medicine (TCM) is very popular, but little is known about how it is integrated with conventional cancer care. We conducted parallel surveys of patients and physicians on TCM utilization. Methods. Two hundred forty-five patients and 72 allopathic physicians at the Fudan University Shanghai Cancer Center completed questions on their use of and attitude towards TCM. Results. Patient mean age was 51, with 60% female. Eighty-three percent of patients had used TCM. Use was greatest for Chinese herbal medicine (CHM; 55.8%). Only 1.3% of patients used acupuncture and 6.8% Qi Gong or Tai Qi. Sixty-three percent of patients notified their oncologist about TCM use. The most common reason for use was to improve immune function. CHM was often used with a goal of treating cancer (66.4%), a use that 57% of physicians agreed with. Physicians were most concerned with interference with treatment, lack of evidence, and safety. Ninety percent of physicians have prescribed herbs and 87.5% have used TCM themselves. Conclusion. The use of TCM by Chinese cancer patients is exceptionally high, and physicians are generally well informed and supportive of patients' use. Botanical agents are much more commonly used than acupuncture or movement-based therapies.

Use of complementary and alternative medications among patients in an obstetrics and gynecology clinic.

OBJECTIVE: To evaluate the current use of complementary and alternative medication (CAM) products among women in obstetrics and gynecology outpatient clinics. STUDY DESIGN: This study was performed at a major academic center among patients seen at either a faculty-led private clinical practice site (n = 250) or a resident-led clinical practice site (n = 250). Patients were requested to bring a written list and the medication bottles (prescriptions, over-the-counter medications and CAM products) to the clinic, where a survey was then administered. RESULTS: Overall, 18.6% of participants were using CAM products. Significantly more patients reported using CAM products in the faculty private practice as compared to the resident clinic practice (28.4% vs. 8.8%, respectively, p value < 0.05). Only 29.0% of CAM products users had spoken to a healthcare provider regarding CAM products. Multivariate logistic regression model determined that older age (p < 0.0001) and Caucasian ethnicity (p = 0.0245) were associated with higher rates of CAM products use. CONCLUSION: In this study CAM products use was not as prevalent as anticipated for this patient population, however it continues to be underreported to providers. Healthcare professionals should continue to increase their knowledge about CAM products, take a proactive role to improve documentation, and develop an open communication with patients regarding appropriate use of CAM products.

Undocumented alcoholism and its correlation with tobacco and illegal drug use in advanced cancer patients.

BACKGROUND: The objectives of this retrospective study were to determine the frequency of undiagnosed alcoholism among patients with advanced cancer who were referred to palliative care and to explore its correlation with alcoholism, tobacco abuse, and use of illegal drugs. METHODS: The authors reviewed 665 consecutive charts and identified 598 patients (90%) who completed a screening survey that was designed to identify alcoholism, the Cut Down, Annoyed, Guilty, Eye Opener (CAGE) questionnaire, including 100 consecutive patients who had CAGE-positive and CAGE-negative results. Data on tobacco and illegal drug use, the Edmonton Symptom Assessment Scale, and the morphine equivalent daily dose were collected. RESULTS: The frequency of CAGE-positive results in this palliative care population was 100 of 598 patients (17%). Only 13 of 100 patients (13%) in that CAGE-positive group had been identified as alcoholics before their palliative care consultation. Compared with CAGE-negative patients, CAGE-positive patients were younger (aged 58.6 years vs 61.3 years; P = .07), predominantly men (68 of 100 patients vs 51 of 100 patients; P = .021), more likely to have a history of tobacco use (86 of 100 patients vs 48 of 100 patients; P < .001), more likely to be actively using nicotine (33 of 100 patients vs 9 of 100 patients; P = .02), and more likely to have a history of illegal recreational drug use (17 of 100 patients vs 1 of 100 patients; P < .001). Pain and dyspnea were worse in patients who had a history of nicotine use. Both CAGE-positive patients and patients who had a history of tobacco use more frequently were receiving strong opioids at the time of their palliative care consultation. CONCLUSIONS: The current findings suggested that alcoholism is highly prevalent and frequently under diagnosed in patients with advanced cancer. CAGE-positive patients were more likely to have a history of, or to actively engage in, smoking and illegal recreational drug use, placing them at risk for inappropriate opioid escalation and abuse.

Factors associated with response to methylphenidate in advanced cancer patients.

BACKGROUND: There has been increasing interest in the use of methylphenidate for cancer-related fatigue (CRF) in patients with advanced cancer. However, there is limited literature on the specific patient characteristics associated with response to methylphenidate. Our objective of this study was to identify the specific patient characteristics associated with response to methylphenidate and to compare day 1 response with day 8 response. METHODS: We retrospectively reviewed the records of patients in two prospective controlled clinical trials that we had conducted who had received methylphenidate for cancer-related fatigue. Baseline patient characteristics, symptoms (as assessed by the Edmonton Symptom Assessment System [ESAS] and Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-F]), and response (change in fatigue) at the end of day 1 treatment were analyzed to determine their association with response to methylphenidate on day 8. RESULTS: A total of 82 patients with advanced cancer who received methylphenidate for CRF were included in our review. The median age was 55 years, 66% were female, 74% were white, and the most common cancer type was breast (37%). Fifty out of 82 patients (61%) responded to methylphenidate (≥ 7 points in FACIT-F). The intensity of baseline fatigue positively correlated with the response to methylphenidate (p < .001). Change in fatigue in response to methylphenidate was not associated with intensity of baseline depression, anxiety, drowsiness, or daily opioid dose. Better improvement of fatigue after treatment on day 1 was associated with more improvement with fatigue on day 8 as assessed by FACIT-F (p = .0004) and ESAS (p = .0001). Day 1 response as a predictor of day 8 response had a sensitivity of 0.84, a positive predictive value of 0.67, and specificity of 0.6. CONCLUSIONS: Response to methylphenidate is associated with higher baseline fatigue but not with higher baseline depression or sedation. Additionally, day 1 improvement is highly sensitive as a predictor of long-term improvement.

Mapping FACT-melanoma quality-of-life scores to EQ-5D health utility weights.

OBJECTIVES: We sought to develop a mapping function from functional assessment of cancer therapy-melanoma (FACT-M) quality of life scores to the EuroQol-5D (EQ-5D) utility scores. METHODS: FACT-M and EQ-5D scores were collected during a prospective study of melanoma-related quality of life at a tertiary cancer care center in the United States. The study sample was divided into development and validation datasets with equal distributions by cancer stage and treatment status. Censored Least Absolute Deviation (CLAD) and Ordinary Least Squares (OLS) regression analyses were performed using the developmental dataset to derive mapping functions, and model performance was examined through comparisons of residuals and measures of fit in the validation dataset. Exploratory analyses examined the predictive ability of clinical factors and individual subscales. RESULTS: Of 273 patients, 75 were undergoing treatment with 198 in follow-up surveillance. Relatively even distributions were observed by melanoma stage: I/II (n = 102), III (n = 100), and IV (n = 71). OLS regression resulted in a mapping function of EQ-5D = 0.0037*FACT-M+0.2238 with an R(2) 0.499. CLAD regression resulted in a mapping function of EQ-5D = 0.0042*FACT-M+0.1648 with pseudo R(2) 0.328. When applied to the validation dataset, correlations between observed and predicted values resulted in identical coefficients (r = 0.824, P < 0.001). Though the mapping functions were similar, residuals were smaller at the 20th, 40th, and 60th percentiles using the OLS model. The CLAD derived mapping function resulted in smaller residuals only for patients whose EQ-5D = 1. CONCLUSIONS: The OLS mapping function demonstrated better predictive ability and will facilitate the derivation of utilities when direct population preference measures are not available.

Assessment of palliative care cancer patients' most important concerns.

AIMS: Patients in the palliative care setting have a number of concerns not necessarily connected to their medical problems, such as spiritual and relationship issues. When these problems are not properly assessed and addressed, they may become a significant source of distress for patients and families. The aims of the present study were to assess the concerns of patients attending a palliative care clinic, to examine physicians' ratings of patient concerns, to access the concordance between patients' and physicians' ratings, and to assess the association between patients' concerns and their level of distress. METHODS: We evaluated 137 patients attending a symptom control and palliative care clinic. Patients completed the Concerns Checklist, Hospital Anxiety and Depression Scale, and Cancer Behavior Inventory at the beginning of their visit. The Concerns Checklist was completed by the patient's clinic physician immediately after the visit and was used to estimate how accurate the physician was in identifying patients' concerns. We examined the correlation between the total number of patient concerns and their levels of anxiety, mood disturbance, and self-efficacy. RESULTS: Patients were most concerned about loss of function, the future, and caring for themselves. Concordance between physician and patient rating of concerns was poor (all kappas, 0.26 or lower). Higher levels of patient concerns were associated with greater anxiety (r = 0.52) and depressive symptoms (r = 0.40) and lower self-efficacy (r = -0.37). CONCLUSIONS: There was generally poor concordance between patients reporting of their concerns and physicians reporting of the patients' concerns. In addition, patients' with more concerns also had higher levels of anxiety and depressive symptoms. Thus, it is important to find strategies to more accurately identify patients' concerns, so that they can be adequately addressed.

Comparison of postoperative rehabilitation in cancer patients undergoing internal and external hemipelvectomy.

OBJECTIVE: To compare postoperative rehabilitation, functional outcome, and pain management in cancer patients who underwent an internal hemipelvectomy versus an external hemipelvectomy. DESIGN: Retrospective study. SETTING: Tertiary cancer center. PARTICIPANTS: Patients (N=60) who underwent a hemipelvectomy between February 1996 and November 2005 were included in this study (30 internal hemipelvectomy patients and 30 external hemipelvectomy patients). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Hospital and rehabilitation length of stay (LOS), percentage of physiatrist consultation and inpatient rehabilitation, functional status of transfers and ambulation, and pain medication utilization. RESULTS: The rate of physiatrist consultation and acute rehabilitation admission were 15 (50%) of 30 and 13 (43%) of 30 for internal hemipelvectomy patients, and 16 (53%) of 30 and 16 (53%) of 30 for external hemipelvectomy patients. Median hospital LOS for external hemipelvectomy patients (37d) was significantly longer than for internal hemipelvectomy patients (19d) (P=0.004); median rehabilitation LOS was similar in both groups (20d for external hemipelvectomy patients versus 22 for internal hemipelvectomy patients; P=0.83). On discharge, 14 (47%) of 30 internal hemipelvectomy patients could ambulate without assistance, whereas only 5 (17%) of 30 external hemipelvectomy patients could do so (P=0.013). The median morphine equivalent daily dose at discharge for external hemipelvectomy patients (150mg) was significantly higher than that for internal hemipelvectomy patients (45mg) (P=0.032). CONCLUSIONS: A similar percentage of internal hemipelvectomy and external hemipelvectomy patients were admitted to inpatient rehabilitation. External hemipelvectomy patients had longer hospital LOS, less favorable functional outcome, and required more intense treatment for pain.

Real-World Outcomes Associated With Methotrexate, Sulfasalazine, and Hydroxychloroquine Triple Therapy Versus Tumor Necrosis Factor Inhibitor/Methotrexate Combination Therapy in Patients With Rheumatoid Arthritis.

OBJECTIVE: Though randomized controlled trials have demonstrated relatively comparable clinical outcomes with triple therapy (methotrexate [MTX], sulfasalazine [SSZ], and hydroxychloroquine [HCQ]) compared to combination therapy (tumor necrosis factor inhibitor [TNFi] and MTX), real-world experiences comparing these strategies have not been well studied. METHODS: We evaluated the clinical effectiveness and effects of medication discontinuation of triple therapy with MTX/SSZ/HCQ versus combination therapy with TNFi/MTX in rheumatoid arthritis (RA) patients enrolled in the Corrona RA Drug Safety & Effectiveness Registry. Propensity score matching was used to match patients up to a ratio of 1:3 to adjust for imbalances between treatment groups, with stratification performed according to biologics-naive or biologics-exposed status of study participants. RESULTS: Patients eligible for analysis in this study included biologics-naive RA patients (3,926 who received combination therapy with TNFi/MTX and 262 who received triple therapy with MTX/SSZ/HCQ) and biologics-exposed RA patients (3,365 who received combination therapy with TNFi/MTX and 130 patients who received triple therapy with MTX/SSZ/HCQ). Before propensity score matching, numerous factors were imbalanced between the treatment groups, with triple therapy patients generally being older, having a longer disease duration of RA and lower RA disease activity, and more likely having a history of malignancy and other comorbidities. After matching, almost all (93-98%) triple therapy patients could be matched to TNFi/MTX therapy patients, and cohort characteristics were generally well balanced. Discontinuation of medication was greater in triple therapy patients referent to TNFi/MTX therapy patients (adjusted hazard ratio [HR] of 2.17 [95% confidence interval 1.63-2.88] in the biologics-naive group; adjusted HR of 1.51 [95% confidence interval 1.06-2.15] in the biologics-exposed group). At 6 months, the proportion of biologics-naive patients attaining low disease activity was significantly greater in the TNFi/MTX treatment group (49.2% in TNFi/MTX therapy patients versus 33.3% in triple therapy patients), as was the mean change in Clinical Disease Activity Index scores (-9.3 units versus -5.5 [95% confidence interval -1.5, -6.1]). Corresponding results in the biologics-exposed patients numerically favored TNFi/MTX therapy compared to triple therapy but did not reach statistical significance. CONCLUSION: Few patients receive triple therapy with MTX/SSZ/HCQ in the US. In the present study, drug persistence and clinical effectiveness outcomes were less favorable in triple therapy patients compared to TNFi/MTX therapy patients.

Availability and integration of palliative care at US cancer centers.

CONTEXT: The current state of palliative care in cancer centers is not known. OBJECTIVES: To determine the availability and degree of integration of palliative care services and to compare between National Cancer Institute (NCI) and non-NCI cancer centers in the United States. DESIGN, SETTING, AND PARTICIPANTS: A survey of 71 NCI-designated cancer centers and a random sample of 71 non-NCI cancer centers of both executives and palliative care clinical program leaders, where applicable, regarding their palliative care services between June and October 2009. Survey questions were generated after a comprehensive literature search, review of guidelines from the National Quality Forum, and discussions among 7 physicians with research interest in palliative oncology. Executives were also asked about their attitudes toward palliative care. MAIN OUTCOME MEASURE: Availability of palliative care services in the cancer center, defined as the presence of at least 1 palliative care physician. RESULTS: A total of 142 and 120 surveys were sent to executives and program leaders, with response rates of 71% and 82%, respectively. National Cancer Institute cancer centers were significantly more likely to have a palliative care program (50/51 [98%] vs 39/50 [78%]; P = .002), at least 1 palliative care physician (46/50 [92%] vs 28/38 [74%]; P = .04), an inpatient palliative care consultation team (47/51 [92%] vs 28/50 [56%]; P < .001), and an outpatient palliative care clinic (30/51 [59%] vs 11/50 [22%]; P < .001). Few centers had dedicated palliative care beds (23/101 [23%]) or an institution-operated hospice (37/101 [37%]). The median (interquartile range) reported durations from referral to death were 7 (4-16), 7 (5-10), and 90 (30-120) days for inpatient consultation teams, inpatient units, and outpatient clinics, respectively. Research programs, palliative care fellowships, and mandatory rotations for oncology fellows were uncommon. Executives were supportive of stronger integration and increasing palliative care resources. CONCLUSION: Most cancer centers reported a palliative care program, although the scope of services and the degree of integration varied widely.

Communicating with cancer patients: what areas do physician assistants find most challenging?

Physician assistants (PAs) and other midlevel practitioners have been taking on increasing clinical roles in oncology settings. Little is known about the communication needs and skills of oncology PAs. PAs working in oncology (n = 301) completed an online survey that included questions about their perceived skill and difficulty on several key communication tasks. Overall, PAs rated these communication tasks as "somewhat" to "moderately" difficult and their skill level in these areas as "average" to "good." Areas of most perceived difficulty were intervening with angry patients or those in denial and breaking bad news. Highest perceived skills were in communicating with patients from cultures and religions different than your own and telling patient he/she has cancer or disease has progressed, and the lowest perceived skills were in discussing do not resuscitate orders. There are areas in which enhancement of communication skills may be needed, and educational opportunities should be developed for PAs working in oncology.

Evaluating minimal important differences for the FACT-Melanoma quality of life questionnaire.

OBJECTIVES: Minimal Important Differences (MIDs) establish benchmarks for interpreting mean differences in clinical trials involving quality of life outcomes and inform discussions of clinically meaningful change in patient status. The purpose of this study was to assess MIDs for the Functional Assessment of Cancer Therapy-Melanoma (FACT-M). METHODS: A prospective validation study of the FACT-M was performed with 273 patients with stages I through IV melanoma. FACT-M, Karnofsky Performance Scales, and Eastern Cooperative Oncology Group Performance Status scores were obtained at baseline and 3 months following enrollment. Anchor- and distribution-based methods for assessing MIDs were compared, and pattern-mixture modeling was employed to derive multivariate adjusted estimates. RESULTS: This study indicates that an approximate range for MIDs of the FACT-M subscales is between 5 to 9 points for the Trial Outcome Index, 4 to 6 points for the Melanoma Combined Subscale, 2 to 4 points for the Melanoma Subscale, and 1 to 2 points for the Melanoma Surgery Subscale. Each method produced similar but not identical ranges of MIDs. CONCLUSIONS: The properties of the anchor instrument employed to derive MIDs directly affect resulting MID ranges and point values. When MIDs are offered as supportive evidence of a clinically meaningful change, the anchor instrument used to derive clinically meaningful thresholds of change should be clearly stated along with information supporting the choice of anchor instrument as the most appropriate for the domain of interest.

Symptom distress in advanced cancer patients with anxiety and depression in the palliative care setting.

BACKGROUND: Mood disorders are among the most distressing psychiatric conditions experienced by patients with advanced cancer; however, studies have not shown a direct association of physical symptoms with depression and anxiety. PURPOSE: The purpose of this study is to determine the relationship between the frequency and intensity of patients' physical symptoms and their expressions of depression and anxiety. PATIENTS AND METHODS: We retrospectively reviewed the records of 216 patients who had participated in three previous clinical trials conducted by our group. We assessed patients' demographic data using descriptive statistics. We analyzed physical symptom frequency and intensity using the Edmonton Symptom Assessment System (ESAS) and anxiety and depression using the respective subscales of the Hospital Anxiety and Depression Scale (HADS-A and HADS-D). RESULTS: Sixty-two percent were male; the median age was 59 years (range 20-91 years). Seventy nine (37%) of the patients had depressive mood (HADS-D > or = 8), and 94 (44%) had anxiety (HADS-A > or = 8). Patients with depressive mood expressed higher frequency of drowsiness (68/78, 64%; p = 0.0002), nausea (52/79, 66%; p = 0.0003), pain (74/79, 94%; p = 0.0101), dyspnea (68/79, 86%; p = 0.0196), worse appetite (72/79, 91%; p = 0.0051), and worse well-being (78/79, 99%; p = 0.0014) and expressed higher intensity of symptoms (ESAS > or = 1) [median (Q1-Q3)] including drowsiness [4 (3-7), p = 0.0174], fatigue [7 (5-8), p < 0.0001], and worse well-being [6 (5-7), p < 0.0001]. Patients with anxiety expressed higher frequency of nausea (59/94, 57%; p = 0.0006), pain (88/94, 89%; p = 0.0031), and dyspnea (84/94, 96%, p = 0.0002) and expressed a higher intensity of pain [6 (3-8), p = 0.0082], fatigue [6 (5-8), p = 0.0011], worse appetite [6 (4-8), p = 0.005], and worse well-being [5 (3-7), p = 0.0007]. Spearman's correlation showed a significant association between HADS-A and HADS-D and other symptoms in the ESAS. Spearman's correlations of HADS with ESAS-Anxiety and ESAS-Depression were 0.56 and 0.39, respectively (p < 0.001). CONCLUSION: Expression of physical symptoms may vary in frequency and intensity among advanced cancer patients with anxiety and depression. Patients expressing high frequency and intensity of physical symptoms should be screened for mood disorders in order to provide treatment for these conditions. More research is needed.

Predictors of Achieving Remission among Patients with Psoriatic Arthritis Initiating a Tumor Necrosis Factor Inhibitor.

OBJECTIVE: To examine predictors of remission among patients with psoriatic arthritis (PsA) initiating a tumor necrosis factor (TNF) inhibitor. METHODS: Patients with PsA enrolled in the Corrona Registry between 2005 and 2013 were followed from initiation of a TNF inhibitor (TNFi; etanercept, adalimumab, infliximab, certolizumab, or golimumab) to the visit closest to 12 months. Additional inclusion criteria included 3 tender or 3 swollen joints. Outcomes of interest were Clinical Disease Activity Index (CDAI) ≤ 2.8 (remission), low disease activity (LDA; CDAI ≤ 10), change in the modified Health Assessment Questionnaire (mHAQ) ≥ 0.35 and achievement of mHAQ < 0.30. Predictors were measured on or before TNFi initiation. Covariates significant in univariable logistic regression models and ≤ 5% missing values were included in a multivariable model and removed individually until all remaining variables were significant (p < 0.05). RESULTS: Among 1832 TNFi initiations, 774 initiations (624 patients) met inclusion criteria. Median age at initiation was 52 years [interquartile range (IQR) 44-60], 56% were female, median PsA duration was 4 years (IQR 2-11), and median CDAI at baseline was 20 (IQR 14.5-28). Remission was achieved by 14% and LDA (or remission) by 37%. Achieving remission was positively associated with college education (OR 1.88, 95% CI 1.11-3.19) but negatively associated with female sex (0.62, 95% CI 0.40-0.97), obese body mass index (0.51, 95% CI 0.32-0.81), hypertension (0.55, 95% CI 0.32-0.95), previous biologic use (0.41, 95% CI 0.26-0.65), and baseline pain (0.80 per 10 mm visual analog scale, 95% CI 0.73-0.87). Predictors for LDA, mHAQ < 0.30, and mHAQ change were similar. CONCLUSION: Few patients with PsA in a US-based registry achieved remission by CDAI criteria. Female sex, obesity, comorbidities, and education influence achievement of remission on a TNFi.

Expressive writing in patients receiving palliative care: a feasibility study.

BACKGROUND: Patients with advanced cancer receiving palliative care often experience severe physical and psychosocial symptoms. However, there are limited resources for psychological and emotional support. Expressive writing has shown decreased anxiety level in young and healthy people suffering from a number of stressors. OBJECTIVE: The purpose of this study was to determine the feasibility of expressive writing in patients receiving palliative care and the most suitable outcomes of expressive writing in this patient population. DESIGN: In this pilot study, patients were randomly assigned to either the expressive writing group (EW) or the neutral writing group (NW). Anxiety level before and after the writing session was compared between the two groups. Writing materials were content analyzed using standard qualitative research methods. RESULTS: A total of 24 patients (12 in EW and 12 in NW) were enrolled in the study between October 2006 and January 2007. Although the majority of patients (83%-100%) were able to complete all baseline assessments, poor adherence was observed during the follow-ups. Only 8% of patients completed the 2-week study. There was no significant difference in the State-Trait Anxiety Inventory (STAI) State-Anxiety scores at baseline, before and after each writing session between the EW and NW groups. DISCUSSION: Our rapid accrual suggests that palliative care patients are interested in participating in studies such as expressive writing. The high level of adherence to the baseline assessments indicates that these assessments were not particularly difficult for our patients to complete. Future studies may need to include patients with better performance status, better patient education, means of emotional expression (i.e., audio recording, telephone interview) and improved adherence. CONCLUSION: We conclude that clinical trials of expressive writing in the palliative care setting are not feasible unless they undergo major modification in methods compared to those previous reported in other patient population. Our findings will hopefully assist researchers considering similar studies.

Interval between first palliative care consult and death in patients diagnosed with advanced cancer at a comprehensive cancer center.

PURPOSE: Most referrals to palliative care and hospice occur late in the trajectory of the disease although an earlier intervention could decrease patients' symptom distress. The purpose of this study was to determine the interval between first palliative care consult (PC1) and death (D) in patients diagnosed with advanced cancer (aCA) at our comprehensive cancer center and if such interval has increased over time. METHODS: The study group was 2868 consecutive patients who had their PC1 during a 30-month period. We reviewed the charts for information about demographics, cancer type, date of cancer (CA) diagnosis, aCA diagnosis, PC1, and D. aCA was defined as locally recurrent or metastatic. RESULTS: One thousand four hundred four patients (49%) were female, 1791 (62%) were less than 65 years old, 2563 (89%) had solid tumors, and 2004 (70%) were white. The median PC1-D, aCA-PC1, aCA-D, and CA-D intervals were 42, 147, 250, and 570 days, respectively. The median PC1-D interval was longer in patients with solid tumors (p < 0.0001), less than 65 years old (p = 0.002), and females (p = 0.004). PC1-D was not affected by ethnicity (p = 0.42). The median PC1-D interval in 5 consecutive half-years was 46, 56, 42, 41, and 34 days, respectively (p = 0.02). The number of PC1 in this period increased from 544 to 654 (20%). The ratio of PC involvement in the aCA-D period (PC1-D/aCA-D) decreased from 0.30 to 0.26 over the 5 half-year periods (p = 0.0004). CONCLUSIONS: The first palliative care consultation to death interval has decreased over time at our center. Education is needed among our referring physicians for earlier access to palliative care. Prospective studies are needed to establish the appropriate timing of the first palliative care consultation.

Characterizing postoperative paralytic ileus as evidence for future research and clinical practice.

Postoperative ileus, a delay of gastrointestinal (GI) motility beyond 3 days, is common in patients after GI surgery. This disorder increases length of hospital stay and costs millions of dollars annually. This study was done to determine clinical factors associated with paralytic ileus. An interdisciplinary team developed a data collection tool based on eight hypotheses derived from a review of literature on factors that contribute to ileus. In a retrospective medical record review of 101 patients who had abdominal surgery, 44 developed postoperative ileus and 57 did not. Data analysis found that three factors were statistically significant in reducing ileus: (1) early postoperative introduction of fluids and food, (2) avoidance of positive fluid balance exceeding 1,000 ml, and (3) avoiding potassium elevations over a 3-day period. A trend identified that the use of nonsteroidal anti-inflammatory drugs could reduce the incidence of ileus. Clinical implications include the importance of encouraging early oral intake, monitoring fluid intake and output in postoperative patients, and identifying positive fluid balance early to prevent it from continuing.