Brief Pain Inventory Short Form Research Articles

860P - Pain evaluation in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223) in the PARABO observation study

BackgroundRa-223 demonstrated a significant overall survival benefit and favourable safety profile in mCRPC in the ALSYMPCA study (Parker C et al. N Engl J Med 2013; 369:213–223). PARABO (NCT02398526) is an ongoing, prospective, observational, non-interventional, single-arm study with a primary objective to evaluate pain response in mCRPC pts treated with Ra-223 in a real-world setting. MethodsThe aim of this interim analysis was to assess the impact of Ra-223 on pain response, with and without the use of opioids. Pain response was determined by the worst pain item on the Brief Pain Inventory–Short Form (BPI-SF) questionnaire. A clinically meaningful pain response was defined as an improvement of≥2 points; a 95% exact (Clopper–Pearson) confidence interval was reported. ResultsOf the 346 pts enrolled, 311 were included in the interim safety analysis set, 49% of whom used opioids at any time in the study. At baseline (BL), 185/311 (59.5%) had an ECOG performance status of 1 and 222/304 (73.0%) had ≥6 metastatic lesions (but not a superscan). Lumbar vertebrae, pelvis and thigh were amongst the most frequently reported areas of most pain at BL. During the observation period after Ra-223 treatment, 126/211 (59.7%) pts had a clinically meaningful pain response. Of the pts who used opioids vs those who did not, 62/113 (54.9%) vs 64/98 (65.3%) had a clinically meaningful pain response, and 28/110 (25.5%) vs 19/127 (15.0%) achieved almost complete relief after the third dose of Ra-223, respectively.Table860PTableRa-223 without opioid use (n=160)Ra-233 with opioid use (n=151)All pts (N=311)BPI-SF change ≥2 at observation,* % (95% CI)(n=98) 65.3 (55.0–74.6)(n=113) 54.9 (45.2–64.3)(n=211) 59.7 (52.8–66.4)Pain relief due to pain medications** at third Ra-223 dose,‡ % 0%–20% (no relief) 30%–70% (some relief) 80%–100% (almost complete relief) Missing data(n=127) 31.5 25.2 15.0 28.417.3 47.3 25.5 10.024.9 35.4 19.8 19.8*QoL-Set-Pain-Response (n=211);**QoL-Set-BPI-SF (n=269); †This time point was chosen due to limited study numbers at later doses;‡According to patients’ answer to the question “In the last 24hours, how much relief have pain treatments or medications provided?” in the BPI-SF questionnaire. ConclusionsIn this study, reflective of real clinical practice, the majority (73.0%) of pts had multiple lesions at BL and almost half (49%) used opioids. Over half (59.7%) of pts reported a decrease in worst pain after Ra-223 treatment, irrespective of opioid use. Of pts who used vs did not use opioids, 54.9% vs 65.3% achieved a clinically meaningful pain response. Overall, a fifth (19.8%) of pts achieved almost complete relief after the third dose of Ra-223. Clinical trial identificationNCT02398526. Editorial acknowledgementJenny Feehan of OPEN Health Medical Communications (London, UK), with financial support from Bayer. Legal entity responsible for the studyBayer Pharma AG. FundingBayer Pharma AG. DisclosureH. Palmedo: Honoraria (self), Travel / Accommodation / Expenses: Bayer Pharmaceuticals. S. Eschmann: Honoraria (self), Travel / Accommodation / Expenses: Bayer Pharmaceuticals. A. Werner: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Bayer Pharmaceuticals; Advisory / Consultancy: Novartis. I. Selinski: Honoraria (self), Travel / Accommodation / Expenses: Bayer Pharmaceuticals. M. Möllers: Honoraria (self), Travel / Accommodation / Expenses: Bayer Pharmaceuticals. J. Kalinovsky: Full / Part-time employment: Bayer Pharmaceuticals. A. Benson: Full / Part-time employment: Bayer Pharmaceuticals. All other authors have declared no conflicts of interest.

851PD - Patient-reported outcomes (PROs) from TITAN: A phase III, randomized, double-blind study of apalutamide (APA) versus placebo (PBO) added to androgen deprivation therapy (ADT) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC)

851PD - Patient-reported outcomes (PROs) from TITAN: A phase III, randomized, double-blind study of apalutamide (APA) versus placebo (PBO) added to androgen deprivation therapy (ADT) in patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC)

Pain-Specific Resilience in People Living With HIV and Chronic Pain: Beneficial Associations With Coping Strategies and Catastrophizing.

ObjectiveChronic pain is increasingly recognized as a common and disabling problem for people living with HIV (PLWH). In a recent systematic review of psychosocial factors associated with chronic pain in PLWH, it was reported that very few studies to date have examined protective psychological factors that might help mitigate chronic pain for PLWH. The current study examined pain-specific resilience in relation to clinical and experimental pain, as well as pain coping in PLWH and chronic pain. Pain-specific resilience specifically refers to the ability to maintain relatively stable, healthy levels of psychological and physical functioning in the face of ongoing and persistent pain.MethodsA total of 85 PLWH (mean CD4 = 643; 13% detectable viral load ≥200; 99% on antiretroviral therapy) who met criteria for chronic pain (>3 consecutive month’s duration) were enrolled. Medical records were reviewed to confirm clinical data. All participants provided sociodemographic information prior to completing the following validated measures: Pain Resilience Scale (PRS), Coping Strategies Questionnaire-Revised (CSQ-R), Center for Epidemiologic Studies – Depression Scale (CES-D), and the Brief Pain Inventory – Short Form (BPI-SF). They then completed a quantitative sensory testing battery designed to assess tolerance for painful heat and cold stimuli.ResultsIn adjusted multiple regression models controlling for covariates, greater pain-specific resilience was significantly associated with less pain interference (p = 0.022) on the BPI-SF, less pain catastrophizing (p = 0.002), greater use of distraction (p = 0.027) and coping self-statements (p = 0.039) on the CSQ-R, as well as significantly greater heat pain tolerance (p = 0.009). Finally, results of a parallel multiple mediation model demonstrated that the effect of pain-specific resilience on heat pain tolerance was indirectly transmitted through less pain catastrophizing (95% confidence interval:0.0042 to 0.0354), but not use of distraction (95% confidence interval: −0.0140 to 0.0137) or coping self-statements (95% confidence interval: −0.0075 to 0.0255).ConclusionThe findings suggest that pain-specific resilience may promote adaptation and positive coping in PLWH and chronic pain.

Health-related quality of life (HRQoL) and pain progression with enzalutamide (ENZ) in metastatic hormone-sensitive prostate cancer (mHSPC) from the ARCHES study.

5044 Background: The Phase 3 ARCHES trial (NCT02677896) evaluated the efficacy and safety of ENZ + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT in 1150 men with mHSPC. Here we report patient-reported outcome (PRO) data using Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory Short Form (BPI-SF). Methods: FACT-P and BPI-SF were assessed at baseline (BL), week (wk) 13, and then every 12 wks until disease progression. Longitudinal changes were assessed using mean scores and mixed-model repeated measures; lower BPI-SF scores represent less pain/interference; higher FACT-P scores represent better HRQoL. Time from BL to first deterioration in PRO score was assessed by Kaplan-Meier estimates and Cox proportional hazards models. Clinically meaningful difference was defined by change from baseline ≥10 for FACT-P total and ≥2 for worst pain/severity. Results: PRO instrument completion rates were high (88−96%) up to wk 73. At BL, men in both arms were generally asymptomatic and reported good HRQoL (FACT-P total: ENZ + ADT, 113.9; PBO + ADT, 112.7) and low pain (worst pain [item 3]: ENZ + ADT, 1.80; PBO + ADT, 1.77). HRQoL and pain scores remained stable over time and there were no clinically meaningful differences between groups in change from BL to wk 73. The proportion of men with no change or improvement in PRO scores (67–88%) was similar in both groups at all time points up to wk 73. There was no significant difference between arms for time to deterioration in FACT-P total (HR 0.90 [95% CI] (0.74, 1.09); p = 0.2998). ENZ + ADT significantly delayed time to pain progression for worst pain (HR 0.82 [0.69, 0.98]; p = 0.0322) and pain severity (HR 0.79 [0.65, 0.97]; p = 0.0209) vs PBO + ADT. Conclusions: Men with mHSPC were generally asymptomatic and had high levels of HRQoL and low levels of pain at BL, likely due to most men initiating ADT several months prior to study entry. No clinically meaningful differences in HRQoL were observed between ENZ and PBO. The prolongation in radiographic progression-free survival observed with ENZ + ADT was accompanied by a significantly prolonged time to progression of worst pain and pain severity vs PBO + ADT. Clinical trial information: NCT02677896.

Health-related quality of life (HRQoL) in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with olaparib in combination with abiraterone.

234 Background: A Phase II trial showed that addition of olaparib (O) to abiraterone (A) led to significant radiographic progression-free survival benefit for patients (pts) with mCRPC vs placebo (P) + A (hazard ratio [HR] 0.65, 95% confidence interval [CI] 0.44–0.97). We report predefined exploratory HRQoL analyses. Methods: This randomized, double-blind trial enrolled pts with mCRPC, post-docetaxel. Pts were randomized (71 per arm) to receive either O (300 mg bd, tablets) + A (1000 mg od) or P + A; all received prednisone (5 mg bd). Pts completed Functional Assessment of Cancer Therapy-Prostate (FACT-P total score [TS]; range 0–156, higher score = better HRQoL), Brief Pain Inventory–Short Form (BPI-SF) and worst bone pain (wbp) questionnaires (both range 0–10, higher score = more severe pain). Adjusted mean change from baseline was analysed using a mixed model for repeated measures, improvement by logistic regression and deterioration by log-rank test. Results: Overall compliance rates (O + A vs P + A) were 97% vs 96%, 92% vs 85%, and 96% vs 92% for FACT-P, BPI-SF and wbp, respectively. Best FACT-P TS response of ‘improved’ (increase ≥6 points from baseline at two consecutive visits) was reported by 22/67 (33%) evaluable pts in the O + A vs 18/64 (28%) pts in the P + A arm; the odds ratio (1.32; 95% CI 0.64–2.78) favored the O + A arm. Best FACT-P TS response of ‘worsened’ (decrease ≥6 points from baseline) was reported by 15 (22%) vs 22 (34%) pts. Adjusted mean change from baseline in FACT-P TS across all visits was -0.60 vs -2.09 in the O + A and P + A arms, respectively (difference 1.48; 95% CI -3.96–6.92). Time to deterioration (TTD) results are shown in the table. Clinical trial information: NCT01972217. Conclusions: Whilst not statistically significant, in this study a higher percentage of pts treated with O + A vs P + A had improved HRQoL, with fewer pts negatively affected. Ongoing phase III studies will help elucidate the impact of O on HRQoL in pts with mCRPC. (NCT01972217)[Table: see text]

Comparison of analgesia, adverse effects, and quality of life in cancer patients during treatment of procedural pain with intravenous morphine, fentanyl nasal spray, and fentanyl buccal tablets.

AimComparison of analgesia, adverse effects, and quality of life (QoL) of cancer patients in the treatment of procedural pain induced by nursing procedures with the use of intravenous morphine, fentanyl nasal spray, and fentanyl buccal tablets.MethodsIn adults with cancer with opioid tolerance and suffering procedural pain, intravenous morphine was used at an inpatient palliative medicine unit (20 patients) and fentanyl by intranasal (15 patients) and buccal routes (nine patients) at home. Five procedural pain episodes were examined: the Mini-Mental State Examination was used to assess cognitive function, the Brief Pain Inventory – short form (BPI-SF) to assess intensity and impact of pain on daily activities, a pain and adverse-effect questionnaire to assess the intensity of pain and adverse effects, and the European Organisation for Research and Treatment of Cancer QLQ-C15-PAL to assess QoL.ResultsAll five procedural pain episodes were completed by 32 patients. Twelve patients stopped treatment due to death or referral to the hospital (four patients in each group), changes in the treatment of background pain (three patients), and intense drowsiness (one patient). Similar beneficial analgesic effects were observed in all patient groups. During fentanyl therapy, a smaller negative effect of pain on patients’ activity, walking, and work (BPI-SF) was observed. Among adverse effects, fewer breaths (10–14 per minute) were observed in 17 patients and slight disturbances of consciousness in seven. For QoL, an improvement in emotional functioning, overall QoL, and fatigue was observed. Patients treated with intranasal and buccal fentanyl had higher physical functioning and were more active.ConclusionIn the treatment of procedural pain induced by nursing procedures in cancer patients, intravenous morphine and rapid-onset fentanyl show similarly high analgesic efficacy, with good tolerance of treatment and improvement in QoL.

Celiac plexus radiosurgery for pain management in advanced cancer patients: An international phase II trial.

TPS466 Background: Many cancer patients, especially those with pancreatic cancer, suffer from severe back/epigastric pain. Contemporary approaches (opioids, celiac blocks, systemic chemotherapy) are often inadequate. This clinical trial investigates a new approach in which high-dose radiation (radiosurgery) is focused on the retroperitoneal celiac plexus nerve bundle. Preliminary results from a single institution pilot trial NCT02356406 are promising: pain relief is substantial and side effects minimal. The main aim of the trial is to establish safety/efficacy in the setting of an international multicenter study. Exploratory analyses will examine the relationship between pain reduction and subjects’ quality-of-life, functionality, and caregiver burden. Methods: Eligibility criteria include a diagnosis of metastatic/unresectable malignancy, uncontrolled pain defined as ≥ 5 on 11-point BPI-SF scale despite analgesic use, typical retroperitoneal pain syndrome, prognosis > 8 weeks, ECOG 0-2, anatomical involvement of the celiac plexus (e.g. any pancreatic cancer, or any other cancer involving the celiac trunk). Exclusion criteria include previous upper abdo. radiation. The intervention consists of a single 25 Gy radiation fraction delivered to the celiac plexus, using anterolateral aspect of the aorta from the 12th thoracic to 2nd lumbar vertebral body as a surrogate structure. The primary tumour may be irradiated at physicians’ discretion. Dose-painting technique limits dose to organs at risk. Pain intensity will be measured using Brief Pain Inventory Short Form (BPI-SF), and quality of life with FACT-Hep. The primary endpoint is complete or partial pain response, defined as a decrease between the score immediately before treatment and 3 weeks’ post-treatment. A change of two or more on the BPI 11-point pain scale is defined as clinically significant. Secondary endpoints include other BPI pain endpoints, pain at 6 weeks, analgesic use, toxicity (CTCAE v4.03), quality of life and functional measures. Analgesia is not restricted. Expected accrual is 100 subjects over three years. Supported by Gateway for Cancer Research, additional support from Israel Cancer Association. Clinical trial information: NCT03323489.

Prevalence of mental health conditions and pain in adults with skeletal dysplasia.

We sought to examine the prevalence of depression and anxiety in adults with skeletal dysplasias, and to assess any correlations with pain. Participation was via an anonymous REDCap survey, which consisted of sociodemographic questions followed by the brief pain inventory-short form (BPI-SF), patient health questionnaire-8 (PHQ-8), and generalized anxiety disorder-7 (GAD-7) questionnaires. These assessed pain, depression, and anxiety respectively. Of the 336 usable responses, 16.1% scored 10 or greater on the PHQ-8 consistent with current depression while 17.3% scored 10 or greater on the GAD-7 consistent with current anxiety. The majority of participants (76.2%) experienced pain, which was significantly associated with prior mental health diagnoses (p < 0.05). A total of 34% reported either a prior diagnosis of depression or scored 10 or greater on the PHQ-8, and 31% reported either a prior diagnosis of anxiety or scored 10 or greater on the GAD-7. This study identified a substantial percentage of individuals with mental health concerns as well as pain in the adult skeletal dysplasia population. Further research is warranted to investigate barriers to service or treatment of mental health disorders as well as pain management.

Pain Severity and Adequacy of Pain Management in Terminally Ill Patients with Cancer: An Experience from North Palestine.

Aim:Chronic pain is common in terminally ill patients with cancer and affects their quality of life. In this study, we wanted to evaluate pain severity and the adequacy of prescribed analgesics in terminally ill patients with cancer in North Palestine.Methods:We conducted a cross-sectional descriptive study in North Palestine on 77 terminally ill patients with cancer. Pain experience was evaluated with Brief Pain Inventory-Short Form (BPI-SF). Pain management index (PMI) was calculated to determine the adequacy of interventions. The relationships between adequacy of pain management and socioeconomic and clinical factors were analyzed by the covariance method. Statistical analyses were performed using Statistical Package for the Social Sciences (SPSS version 15.0 [SPSS Inc., Chicago, USA]).Results:Fifty-nine patients (76.6%) reported moderate-to-severe pain. According to the PMI, only 64.9% of the patients received adequate pain management. Thirty-five patients (45%) wanted additional treatment or an increase in the dose of pain medications. Although men and women reported similar pain severities, women were more likely to be inadequately treated (P = 0.027). Pain severity was significantly less in patients who received health-care services at least once in the last month before the interview, compared to those without recent access to health care (P = 0.024).Conclusion:There is substantial inadequacy in pain management in patients with cancer. The BPI-SF should be routinely used to evaluate pain severity, and analgesics should be prescribed equitably without discrimination with regard to gender and socioeconomic status of patients.

Predictive factors of the neuropathic pain in patients with carpal tunnel syndrome and its impact on patient activity.

To determine the predictive factors of the neuropathic pain in patients with carpal tunnel syndrome (CTS), and the impact of such neuropathic pain on patient's activity. Douleur Neuropathique 4 questionnaire, Short Form-Brief Pain Inventory test and Boston Carpal Tunnel Syndrome Questionnaire were completed and results were stratified according neuropathic pain and work activity of the patients. 69 of 90 patients with CTS had neuropathic pain (76.7%). Increasing by one the scores of numbness/tingling, pain intensity and neurologic affectation of the electromyogram meant increasing 3.3-, 2.7- and 4.4-times the risk of neuropathic pain, respectively. These results will be useful for a better neuropathic pain evaluation in patients with CTS, allowing the appropriate treatment.

Chinese Medicine Yishen Jiangu Granules () on Aromatase Inhibitor-Associated Musculoskeletal Symptoms.

To assess the effectiveness of Yishen Jiangu Granules (, YSJGG) on aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). A single-arm, open-label study was conducted in 34 postmenopausal women with breast cancer who experienced AIMSS. Patients were treated with YSJGG for 12 weeks (12.4 g orally twice daily). The primary outcome was a change in the mean worst pain score of Brief Pain Inventory-Short Form (BPI-SF) over 12 weeks, and the second outcomes included changes in pain severity and pain-related interference of BPI-SF and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the Functional Assessment of Cancer Therapy-Breast (FACT-B), bone mineral density (BMD) and blood indices such as calcium (Ca), phosphate (P), and alkaline phosphatase (ALP). Of 37 women recruited, 30 initiated the therapy and 24 were evaluable at 12 weeks. The primary outcome (BPI-SF worst pain scores) achieved a 2.17-point reduction compared with baseline (5.75±1.87 vs 3.58±2.15, P<0.01). There were reductions in pain severity (decreased 1.65, P<0.01) and pain-related interference (decreased 2.55, P<0.01). The changes in WOMAC and M-SACRAH scores were similar to BPI-SF (P<0.05). In the FACT-B, only physical well-being and functional well-being were improved compared with baseline (P<0.05). No clinical differences were found in BMD, Ca, P and ALP. YSJGG is an effective and well-tolerated agent to reduce AIMSS.

PROMs for Pain in Adult Cancer Patients: A Systematic Review of Measurement Properties.

Pain is one of the most devastating symptoms for cancer patients. One third of patients who experience pain do not receive effective treatment. A key barrier to effective pain management is lack of routine measurement and monitoring of pain. Patient-reported outcome measures (PROMs) are recommended for measuring cancer pain. However, evidence to guide the selection of the most appropriate measure to identify and monitor cancer pain is limited. A systematic review of measurement properties of PROMs for pain in cancer patients is needed to identify the best validated measure for adoption to an electronic platform. To systematically review measurement properties of PROMs used for adult cancer patients to measure pain and, as a secondary goal, to investigate the evidence of validated mobile health (mHealth) applications used to measure pain (registration number: CRD42017065575). Medline, Embase, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL) were systematically searched in March 2018 for studies examining measurement properties for PROMs for pain in adult cancer patients. The methodological quality of the studies and their results were appraised using the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) checklist and specific measurement properties criteria, respectively. Sixteen studies evaluating 8 instruments were included. No studies using a PROM in an mHealth application were identified. The methodological quality of the measurement properties ranged between poor and fair. No instrument showed strong positive evidence for all the evaluated measurement properties. Based on the available evidence, the Brief Pain Inventory-Short Form (BPI-SF) had the strongest evidence to support its selection for the measurement of cancer pain. The BPI-SF was the best performing measure across all properties evaluated through COSMIN. Better quality validation studies of PROMs for cancer pain are needed to explore the full range of measurement properties. Utilizing mHealth applications to measure pain in cancer patients is an innovative approach worthy of further investigation.

Qualitative Research to Explore the Patient Experience of X-Linked Hypophosphatemia and Evaluate the Suitability of the BPI-SF and WOMAC® as Clinical Trial End Points

BackgroundX-linked hypophosphatemia (XLH) is a rare genetic disorder characterized by renal phosphate wasting and defective bone mineralization. Symptoms include bone pain, joint pain, stiffness, and fatigue. Published evidence regarding the patient experience of XLH is sparse and no XLH-specific outcome measures have been validated. ObjectivesTo understand the symptoms, impacts, and patient experience of XLH and to evaluate the face and content validity of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) and the Brief Pain Inventory Short Form (BPI-SF) for use as end points in XLH clinical trials. MethodsFace-to-face, qualitative, semistructured interviews were conducted with 18 adults with XLH in the United States using concept elicitation and cognitive debriefing techniques. Open-ended questioning elicited spontaneous concepts focusing on XLH-associated symptoms and functional limitations. Cognitive debriefing of the WOMAC® and BPI-SF assessed the relevance and patient understanding of item wording, recall period, and response options. ResultsVarious distinct symptom concepts were elicited including pain symptoms, dental symptoms, sensory symptoms, tiredness/fatigue symptoms, and musculoskeletal symptoms. Participants reported experiencing significant bone and joint pain, stiffness, mobility limitations, and an impact on their ability to work. Cognitive interviewing found both instruments to be relevant and well understood by most patients. ConclusionsThe interviews generated rich, qualitative insights into the patient experience of XLH. Cognitive debriefing of the BPI-SF and WOMAC® supported their value as XLH clinical trial end points. Future research will assess the psychometric properties of these instruments for use in the XLH population.

The price of pain in chronic rhinosinusitis.

Chronic rhinosinusitis (CRS) is associated with productivity losses exceeding US$13 billion annually. Although pain is well known to significantly affect patient productivity in other diseases, its economic impact on CRS-related lost productivity has not been examined. The objective of this study was to determine whether CRS-related facial pain correlates with lost productivity in patients with CRS. Seventy patients with CRS were enrolled in a cross-sectional investigation. Patients with a history of systemic inflammatory disease, ciliary dysfunction, chronic pain syndromes, migraines, and fibromyalgia were excluded. Pain was measured using the Brief Pain Inventory Short Form (BPI-SF) and the Short-Form McGill Pain Questionnaire (SF-MPQ). Presenteeism, absenteeism and lost work, and household and overall productivity were assessed. Regression analysis was performed to assess potential confounders, including depression. Pain as measured with BPI-SF and SF-MPQ total scores correlated with all domains of productivity losses. Overall, lost productivity was significantly correlated with pain (R range, 0.354-0.485; p < 0.001). Presenteeism (reduced work efficiency) had the highest correlation with all of the overall pain scores (R range, -0.366 to -0.515; p < 0.001). Lost household productivity time was the least affected by pain (R range, 0.267-0.389; p < 0.05). These correlations remained statistically significant after regression analysis, which accounted for depression (p < 0.05). A significant correlation exists between CRS-related facial pain and productivity losses in patients with CRS that is independent of depression. Facial pain has the strongest correlation with presenteeism, which is the main driver of productivity losses and indirect costs associated with CRS.

Effects of oral vitamin B12 for the treatment of aromatase inhibitors (AI)-related musculoskeletal symptoms in women with early stage breast cancer.

86 Background: Breast cancer patients receiving Aromatase Inhibitor (AI) therapy experience many side effects including arthralgias, myalgias and stiffness of joints. The objective of this study was to evaluate the effect of vitamin B12 supplements on pain related symptoms. Methods: In this study, patients taking AIs and experiencing pain at baseline were given 2500 mcg of vitamin B12 sublingually daily for 90 days. The validated Brief Pain Inventory-Short Form (BPI-SF) questionnaire using a 10 scale rating was evaluated prior and post- intervention. The BPI-SF asseses pain level and its interference with other daily life events on a scale from one to ten, one meaning pain does not interfere. Item 9 from the BPI assesses 7 important dimensions that are reported here. Results: 36 patients were recruited and scores were evaluated at baseline and at 90 days after taking vitamin B12 for general activity, mood, walking ability, normal work, relations with people, and for enjoyment of life post interventions as shown in the table. Conclusions: This study suggests that by taking a high dose of vitamin B12, significant improvement was observed in several dimensions related to pain scales in patients with AI -related musculoskeletal symptoms. Preliminary data confirms that vitamin B12 not only help improve pain, but it also aids in improving patient’s mood, well-being and relations with others. Larger randomized studies are warranted to confirm these promising findings. Clinical trial information: NCT03069313. [Table: see text]

(210) - Understanding pain management strategies within individuals with neuropfibromatosis

Neurofibromatosis Type 1 is an autosomal dominant disease affecting 1 in 3500 individuals. This disease typically presents with plexiform neurofibroma tumors, café au lait mascules, dermal neurofibromas, optic pathway gliomas, and malignant peripheral nerve sheath tumors. The onset of these tumors usually manifests at adolescence, and often produces significant pain and discomfort. Moreover, the limited treatment options, e.g. surgery or opioid medications, can increase pain severity and/or interference. To date, little research has been published evaluating pain symptomology for individuals diagnosed with NF1. In collaboration with the department of Medicine and Public Health at Washington university in St. Louis, Missouri, in June 2017, we recruited individuals from the NF1 Patient Registry Initiative (NPRI, N = 800) through an email solicitation to complete an on-line survey. The survey included items on demographics, medical history, pain characteristics and treatment including medications and alternative and complementary treatments, and substance use. 241 individuals completed the survey of 263 for a response rate of 33%. The Brief Pain Inventory Short Form (BPI-SF) was used to assess pain severity and interference on a scale from 0 to 10. Mean pain interference was 4.87(SD = 2.71) and mean pain severity was 4.6 (SD = 2.24). These findings demonstrate that individuals with NF1 have similar pain scores as prostate and persistent cancer pain patients. Furthermore, most participants reported only using pain medication or surgery (65%). Use of complementary and alternative treatment was rare ranging from 2% for occupational therapy to 20% for massage. Additionally, 9% reported tobacco use, 15% reported using marijuana in the last 30 days, and 3% reported illicit drug use. These preliminary findings reinforce the need to provide more evidence based therapeutic applications for individuals suffering with NF1, while educating individuals about the alternative options for management of chronic pain due to their NF1 symptoms.

Prevalence of Burnout Among Pain Medicine Physicians and Its Potential Effect upon Clinical Outcomes in Patients with Oncologic Pain or Chronic Pain of Nononcologic Origin.

To evaluate the prevalence of burnout among physicians treating patients with chronic pain and to assess the potential relationships between the presence of burnout and patients' clinical outcomes such as pain relief, satisfaction with pain control, and quality of life. An observational, prospective, and noncomparative study. Pain medicine clinics. Physicians from medical departments involved in the management of chronic pain. Patients aged ≥18 years who exhibited moderate chronic pain lasting at least three months. Physicians were evaluated with the Maslach Burnout Inventory-Human Services Survey (MBI-HSS). Patients were evaluated with the Charlson Comorbidity Index, the Brief Pain Inventory-Short Form (BPI-SF), the EuroQol-5D (EQ-5D), and ad hoc instruments for evaluating satisfaction with pain control, the extent to which the treatment met patients' expectations, and subjective impressions of improvement. Of the 301 physician participants, 22 (7.3%, 95% confidence interval [CI] = 4.9 to 10.8) met the criteria of burnout. Burnout was higher among physicians from pain units, while none of the 35 primary care physicians reported burnout. The presence of burnout was positively associated with patients' pain relief (odds ratio [OR] = 1.423, 95% CI = 1.090 to 1.858) but not with satisfaction with pain control or quality of life. Of the remaining independent variables, being treated by pain unit physicians was significantly associated with worse pain relief (OR = 0.592, 95% CI = 0.507 to 0.691), lower satisfaction (β = -0.680, 95% CI = -0.834 to -0.525), and worse quality of life (β = -4.047, 95% CI = -5.509 to -2.585) compared with being treated by physicians from other specialties (e.g., traumatologists, oncologists, etc.). Our study shows a lack of negative or clinically relevant (as shown by the negligible to small effect sizes) impact of burnout on patient-reported outcomes (namely, pain relief, satisfaction, and quality of life) in patients with chronic pain who are treated by pain medicine physicians.

Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial

In the LATITUDE trial, addition of abiraterone acetate plus prednisone to androgen deprivation therapy (ADT) improved overall survival compared with placebos plus ADT in patients with newly diagnosed, high-risk, metastatic castration-naive prostate cancer. Understanding the effects of treatments on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) is important for treatment decisions; therefore we aimed to analyse the effects of ADT plus abiraterone acetate and prednisone versus ADT plus placebos on PROs and HRQOL in patients in the LATITUDE study. In the multicentre, international, randomised, phase 3 LATITUDE trial, eligible patients were aged 18 years or older, had newly diagnosed, high-risk, metastatic castration-naive prostate cancer confirmed by bone scan (bone metastases) or by CT or MRI (visceral, soft tissue, or nodal metastases), and an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less. Patients from 235 clinical sites in 34 countries were randomly assigned (1:1) following a country-by-country scheme done by permuted block randomisation (with two blocks) and stratified by the presence of visceral metastasis and ECOG performance status to receive ADT plus 1000 mg oral abiraterone acetate and 5 mg oral prednisone once daily or ADT plus placebos. Selection of ADT, chemical or surgical, was at the investigator's discretion. The co-primary endpoints of the trial, overall survival and radiographic progression-free survival, have been published. PRO data were collected directly on electronic tablet devices at the clinical sites during screening and before any other visit procedure on day 1 of cycles 1-3, monthly during cycles 4-13, and then every 2 months until the end of treatment, by use of the Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy Prostate scale (FACT-P), and the EuroQol (EQ-5D-5L) questionnaires. PRO analyses were an exploratory endpoint. Analyses were by intention-to-treat. Results from the first pre-planned interim analysis (Oct 31, 2016), are presented here. This ongoing study is registered with Clinicaltrials.gov, number NCT01715285. Between Feb 12, 2013, and Dec 11, 2014, 1199 patients were randomly assigned: 597 to ADT plus abiraterone acetate and prednisone and 602 to ADT plus placebos. Median follow-up was 30·9 months (IQR 21·2-33·2) in the ADT plus abiraterone acetate and prednisone group versus 29·7 months (1·4-43·5; 16·1-31·3) in the ADT plus placebos group. Median time to worst pain intensity progression assessed by the BPI-SF score was not reached in either group (ADT plus abiraterone acetate and prednisone, not reached [95% CI not reached to not reached]; 25th percentile 11·07 months [95% CI 9·23-18·43]; ADT plus placebos group, not reached [95% CI not reached to not reached]; 25th percentile 5·62 [95% CI 4·63-7·39]; hazard ratio [HR] 0·63 [95% CI 0·52-0·77]; p<0·0001). Median time to worst fatigue intensity was not reached in either the ADT plus abiraterone acetate and prednisone group (not reached [95% CI not reached to not reached]; 25th percentile 18·4 months [95% CI 12·9-27·7]) or the ADT plus placebos group (not reached [95% CI not reached to not reached]; 25th percentile 6·5 months [95% CI 5·6-9·2]; HR 0·65 [95% CI 0·53-0·81], p=0·0001). Median time to deterioration of functional status assessed by the FACT-P total score scale was 12·9 months (95% CI 9·0-16·6) in the ADT plus abiraterone acetate and prednisone group versus 8·3 months (7·4-11·1) in the ADT plus placebos group (HR 0·85 [95% CI 0·74-0·99]; p=0·032). The addition of abiraterone acetate plus prednisone to ADT in patients with newly diagnosed, high-risk metastatic castration-naive prostate cancer improved overall PROs by consistently showing a clinical benefit in the progression of pain, prostate cancer symptoms, fatigue, functional decline, and overall HRQOL. Janssen Research & Development.

A Pilot Study in the Use of Activity Trackers for Assessing Response to Palliative Radiotherapy.

PurposeRadiation therapy (RT) has been a frequently used treatment for painful bone metastasis. The aim of this study was to determine the feasibility of using activity trackers (AT) to assess the patient prognosis and the effects of palliative RT.Methods and materialsTwelve patients planned to receive palliative RT for axial metastases and were prospectively recruited to participate in this pilot clinical trial. The patients were eligible if there was no intent to change the analgesic medications prior to or within seven days of palliative RT. All the patients were lent a Misfit FlashTM activity tracker (Misfit, Burlingame, California, United States of America) and were asked to wear it from the time of baseline assessment prior to RT until seven days after RT. The patients completed the European Organisation for Research and Treatment of Cancer quality of life (QOL) questionnaire (EORTC-QLQ C30) and the Short Form Brief Pain Inventory (SF-BPI) before the treatment and at days seven, 30 and 90 after completion of the RT. The patients' Karnofsky Performance Status (KPS) was assessed at each visit. The patients' overall survival at the end of the RT was recorded. Average daily steps before and after RT were compared using paired Wilcoxon signed-rank test. The patients' overall survival was estimated using the Kaplan-Meier curve and analyzed using the Log-Rank test.ResultsThe median age of the patients was 62 years (range: 40-79 years). Of the 12 patients, there were five prostate, three breasts, three lungs, and one colon cancer-related patients. Six patients received 20 Gray (Gy) in five fractions and six received 8 Gy in one fraction. By day seven, post-RT, there was a 30% (p <0.02) reduction in the patients' daily activity level. There was no correlation between improvements in the QOL or with the level of pain and with the number of daily steps. While baseline KPS was not prognostic of the patient survival, the patients who on average took more than 7800 steps per day prior to RT lived significantly (p=0.034) longer than those who were less active.ConclusionsThe baseline activity level is associated with the patient prognosis. A significant decline in the physical activity was observed at one week after palliative RT. The use of activity trackers was to prognosticate and to monitor the patients' response to the palliative RT and should be evaluated further.

Randomized placebo-controlled pilot trial of omega 3 fatty acids for prevention of aromatase inhibitor-induced musculoskeletal pain.

Aromatase inhibitor (AI)-induced joint symptoms negatively impact drug adherence and quality of life in breast cancer survivors. Mechanisms underlying symptoms may include inflammation. It is hypothesized that n - 3 polyunsaturated fatty acids (PUFAs) have anti-inflammatory properties and may reduce symptoms. We conducted a randomized, double-blind, placebo-controlled study comparing 4.3g/day n - 3 PUFA supplements vs placebo for 24weeks in postmenopausal breast cancer patients starting adjuvant AIs. Primary endpoints were adherence and tolerability; secondary outcomes included inflammatory cytokines and symptoms assessed by the Brief Pain Inventory short form (BPI-SF) and Functional Assessment of Cancer Treatment-Endocrine Symptoms (FACT-ES) at 0, 12, and 24weeks. Forty-four women were randomized, of which 35 completed the study. Adherence was ≥88% based on these 35 patients with pill counts as well as change in red blood cell (RBC) n - 3 PUFAs. Common toxicities included grade 1 flatulence (55% of both groups) and belching (45% of n - 3 group). Mean pain severity scores (BPI-SF) did not change significantly by time or treatment arm. Quality of life, based on FACT-ES scores, significantly decreased within placebo (p=0.04), but not the n - 3 group (p=0.58), with a trend toward between-group differences (p=0.06) at 12weeks, but no significant differences at 24weeks. RBC n - 3 levels were strongly positively correlated with FACT-ES at 12weeks, but attenuated at 24weeks. High-dose n - 3 PUFA supplementation is feasible and well tolerated when administered with AIs. Additional studies are needed to evaluate efficacy in prevention of joint symptoms.