bluuebunny/crossref_metadata_2025_split huggingface dataset:
Aggregated n-of-1 randomized controlled trial of nebulized fentanyl or nebulized furosemide in palliative care patients with refractory breathlessness.
Authors: Pimsa Pongput , Kawamatawong Theerasuk , Nagviroj Kittiphon , Muntham Dittapol , Konmun Jitprapa , Kongsuphon Noppadon , Laorchan Ruamporn , Koomwong Yupawadee , Chansriwong Phichai 
Published: May 2020

e24138 Background: Advance cancer patients frequently have breathlessness and worsening by refractory to conventional therapies, which need adjunctive therapy. Nebulized Fentanyl and nebulized furosemide have been identified as a novel symptoms approach. Individual patients with the same breathlessness conditions may respond differently to similar treatments, thus no standard adjunctive treatments. N-of -1 study is a within-patient randomized, double-blind, and crossover trials in 1 patient. This study aims to comparing the efficacy in relief breathlessness. Methods: N-of-1 study which enrolled patients at Ramathibodi hospital who have breathlessness with mMRC scored ≥ 3 from 1st Jan 2019 to 31st Jan 2020. Study was done as 1 cycle of 3-days of treatment that nebulized fentanyl or furosemide or sterile water (SW). Fentanyl 50 mcg or Furosemide 40 mg or SW that all diluted in SW to be in 6 ml. Jet nebulizer increased delivery of aerosol to lungs that all administered for 4 minutes. Main outcome measured breathlessness intensity Borg scale: 0-10, peripheral capillary O2 saturation, Visual cough score, satisfactions, and adverse events (AEs) that collected at baseline, 15, 30 and 60 minutes post treatment. Type of medication that patients preferred. Results: 19 patients were enrolled; 68.4% were ECOG status 4. All patient previously treated with systemic opioids with dose 29.8±20.9 mg/day. Majority were diagnosed with lung metastatic cancer. Baseline of mean Borg scale were not significant in all groups. All 3 medications significantly reduced Borg scale over time; Fentanyl -2.84 ± 0.17(95% CI -3.19 to -2.49); p = 0.0001, Furosemide -3.05±0.22 (95% CI -3.49 to -2.61); p = 0.0001, and SW -2.52±0.21 (95% CI -2.95 to -2.10); p = 0.0001. No significantly different in reduction of breathlessness, AEs and change in visual cough score in all medications. Most of AEs were mild grade. Majority of patients’ preference was furosemide (42.0%). Conclusions: Adjunctive treatment nebulizer drugs with fentanyl, furosemide and sterile water significantly improve breathlessness symptoms. No significant different in efficacy, adverse events in nebulized fentanyl, furosemide and sterile water. N-of-1 trials may provide a rational and effective method to best choose drugs for individuals with breathlessness.
Pain medication use in patients with HR+, HER2-neg advanced breast cancer treated with endocrine therapy and a CDK 4/6 inhibitor: A U.S. FDA pooled analysis.
Authors: Gao Jennifer J , King-Kallimanis Bellinda , Hodgdon Christine , Cheng Joyce , Fiero Mallorie , Bandaru Pradeep , Girvin Andrew , Osgood Christy , Ison Gwynn , Amiri-Kordestani Laleh , Pazdur Richard , Beaver Julia A. 
Published: May 2020

e24145 Background: Pain medications (PMs) are commonly used to treat pain in patients (pts) with advanced/metastatic breast cancer (MBC). We examined PM usage patterns in pts receiving CDK 4/6 inhibitor (CDKI) based treatment. Methods: We pooled data from seven phase 3 randomized, controlled trials of CDKI + endocrine therapy in pts with hormone receptor positive, human epidermal growth factor receptor-2 negative MBC. PM were categorized as opioid (includes codeine-containing), NSAID, or other (i.e. bone-directed, antiepileptic, topical PMs). All analyzed pts received at least 1 dose of CDKI/placebo and had concomitant PM with a documented start date. Medications prescribed during hospitalizations were not included. We evaluated percent PM by demographic factors and pts with bone mets, and liver/lung mets. Results: 2416 pts met the inclusion criteria, of which 928 pts started a PM before the study and 1488 pts did not start PM before the study. Of the 1488 pts not on a PM before the study, 739 started a PM after study started, and 749 did not receive any PM at any time. Of the 739 pts who started a PM only after study start, overall, 59% were prescribed only an NSAID, 10% were prescribed only opioid, 17% were prescribed both an NSAID and opioid, and 14% were prescribed other PMs. The PM use by percent in demographic subgroups in the 1488 pts who took none or more PMs only after study start are presented in the table. Conclusions: To our knowledge, this is the first analysis of PM usage patterns in pts with MBC receiving CDKI or placebo with hormonal therapy on clinical trials. NSAID use was higher than opiates in all prespecified subgroups. Future analyses will examine the benefit of different classes of pain medications in treating symptoms of pain and whether there are differences between study treatment arms Percent PM Use by Class (Patients Who Took None or More PM Only After Study Start). [Table: see text]
Caregiver and patient distress in young adults with new cancer diagnoses.
Authors: Baum Laura Van Metre , Schremp Emma , Borinstein Scott C. , Friedman Debra L. 
Published: May 2020

e24165 Background: A cancer diagnosis is stressful for both patients and caregivers, and there may be interdependence of mental health. Integration of caregivers into support for AYAO patients may improve outcomes. Methods: We enrolled dyads of AYAO patients (age 15-39) and their caregivers within the first month of treatment. Eligible patients were treated with curative intent or expected remission of at least 5 years. We assessed participants at baseline using validated self-reported survey methods, including the COmprehensive Score for financial Toxicity (COST), Impacts of Events Scale-Revised (IES-R), Adult Self-Report (ASR), NCCN Distress Thermometer and Problem List, and FACT-G and FACT-GP instruments. Results: We enrolled 13 dyads with patient age range 22 to 39 (median 29) years with 60% male patients and 30% male caregivers. Median scores for the NCCN Distress Thermometer were 5.0 for patients (sd 2.9) and caregivers (sd 2.4), with a score of 3 consistent with significant distress. On the Problem List, greater than half of both patients and caregivers reported “yes” to problems with “insurance/financial,” “work/school,” “treatment decisions,” “fears,” “sadness,” “worry,” and “fatigue,” and independently with “family health issues” and “work/school,” respectively. Median patient FACT-G summary score was 78, with median sub-scale scores (27.5 social, 19.5 functional, 17.5 emotional, 15.5 physical). Likewise, median caregiver FACT-GP score was 58 with sub-scale scores (20 physical, 20 functional, 15 social, 10 emotional), with higher scores indicating better quality of life. COST median scores were 12 for patients (sd 9) and caregivers (sd 7), where max score 44 indicates least financial toxicity. IES-R median patient and caregiver scores were 16 (sd 16) and 46 (sd 26), respectively, with scores >24 concerning for PTSS. In contrast, median patient and caregiver ASR depression and anxiety sub-scales were not in the range for concern. Conclusions: Diagnosis is a critical moment of distress for caregivers and patients alike. Effective interventions are needed to alleviate acute suffering and to improve short-term psychological and financial wellbeing for both caregivers and patients. Such outcomes may translate to longer-term benefit. As we continue to accrue dyads, we will follow them over 6 months to assess changes in distress pattern over time and identify the critical time periods for intervention.
An innovative, internet-based assessment of financial toxicity (FT), psychological distress, and quality of life (QOL) in ovarian cancer survivors (OCS).
Authors: Hlubocky Fay J. , Peppercorn Jeffery , Young Karen , Cord Sandra , Wroblewski Kristen , Yamada Seiko Diane , Cella David , Lee Nita Karnik , Daugherty Christopher 
Published: May 2020

e24168 Background: FT is recognized as a significant predictor of stress for OCS on treatment yet little is known about its impact during long-time survivorship. Using an innovative, internet-based design, we assessed the prevalence of FT, psychological distress, and QOL among OCS. Methods: OCS members from the National Ovarian Cancer Coalition (NOCC) completed this web-based assessment using the following measures: COmprehensive Score for Financial Toxicity (COST); Hospital Anxiety/Depression Scale (HADSA/D); and the Functional Assessment of Cancer Therapy-Ovarian (FACIT-O/QOL). Clinical/socio-demographic data were collected. COST-FT severity was categorized into low FT/high FT and the correlation (r) between COST scores and self-reported QOL and distress was conducted. Results: A total of 146/300 (49% ) NOCC subjects were approached for study participation and completed the FT, distress, QOL web-based assessment. Demographics include: median age 59y (range 32-83y); 92.5% Caucasian, 64.4% married/domestic partnership; 59.6% Stage III-IV cancer-diagnosis; median disease duration 6y (range < 1-34y); 50% employed full/part-time; 54.8% college/post-graduate education; and 71.9% completed treatment. Median COST score for the total population was 27 (range: 1–44). The median score in the low FT tertile was 16 (range: 1-22), while the high FT median score was 31 (range: 23-44). High FT respondents rated their HADS-anxiety (8.3 ± 4.9 v. 6.2 ± 3.5, p = 0.002); HADS-depression (5.3 ± 4.2 v. 3.1 ± 3.0, p = 0.004); and overall FACT-O/QOL (99.8 ± 23.6 v. 118.7 ± 19.5; p = 0.001) as significantly worse compared to low FT respondents. Significant moderate correlations between COST and FACT-O/QOL (r = -0.52; p < 0.001), HADS-anxiety (r = 0.4, p < 0.001), and HADS-depression (r = 0.44, p < 0.001) were identified. Older age was associated with less FT (r = -0.30, p < 0.001). Conclusions: Innovative methods of FT evaluation, e.g. using advocacy groups (NOCC) and internet-based assessment, is feasible, and may offer new ways to follow the distress of long term survivor cohorts. Our study data reveal that FT impacts OCS QOL and distress.
Can a brief multimedia intervention facilitate breast cancer patients’ communication about sexual health? Findings from a randomized controlled trial.
Authors: Reese Jennifer B. , Beach Mary Catherine , Sorice Kristen A. , Pollard Whitney , Daly Mary Beryl , Handorf Elizabeth A. , Porter Laura S , Tulsky James A. , Lepore Stephen J 
Published: May 2020

e24179 Background: Many women with breast cancer (BC) lack the confidence to discuss sexual health with their clinicians. We evaluated, in a randomized controlled trial, a brief multimedia intervention designed to facilitate BC patients’ communication about sexual health. Methods: We randomly assigned BC patients to either a multimedia sexual/menopausal health communication skills intervention [ Starting the Conversation (STC), including a video, workbook, and pamphlet with local and web-based resources] or a control [resource guide only]. About 1-2 weeks after patients received materials, we audio recorded a clinic encounter with their BC provider, and subsequently coded the dialogue for patients raising the topic of sexual health or asking > 1 sexual health question. Self-report surveys administered at baseline, post-intervention, and 2-month follow-up assessed patients’ self-efficacy for discussing sexual health with their BC providers, sexual function, anxiety and depression, and quality of life. T-tests or mixed-effects logistic regression compared study arms; analyses of communication outcomes (patient raising the topic or asking a question during clinic encounter) were clustered by providers. Results: Study participants were 144 BC outpatients (82% acceptance rate; mean age = 56; 67% white; 15% metastatic; 31% active treatment). Women in the STC arm versus the control arm were more likely to raise the topic of sexual health [OR = 2.48 (1.11, 5.55), p= .03] and more likely to ask a sexual health question [OR = 2.93 (1.04, 8.26), p= .04]. Specifically, 51% of women in the STC arm raised the topic of sexual health versus 30% in the control arm and 40% of women in the STC arm asked a sexual health question versus 19% in the control arm. At 2-month follow-up, women in the STC arm showed greater improvements in self-efficacy ( p= .03) and anxiety, t(139) = 2.0, p= .04) compared to the control arm. Conclusions: STC, a brief multimedia intervention, was effective in facilitating BC patients’ communication about sexual health during routine clinic encounters and significantly reduced patients’ anxiety, possibly due to greater patient confidence in expressing their medical needs. Future studies should use longer-term follow-up and examine how sexual health communication can translate to improved patient sexual outcomes. Clinical trial information: NCT03624972 .
Longitudinal investigation of Distress Thermometer scores in patients with cancer.
Authors: Ullah Fauzia , Brugioni Emily , Gannon Matthew M , Smith Hayden L , Lukenbill Joshua Cole 
Published: May 2020

e24200 Background: The Distress Thermometer (DT) is a tool used to evaluate distress among cancer patients. The DT can provide information for intervention recommendations such as social work, psychological, and other ancillary services. The National Comprehensive Cancer Network (NCCN) recommends recurrent use of the tool. The DT is widely used as a standard of care for an initial screening of cancer patients, but data on subsequent use is lacking. The aim of this research was to evaluate repeat DT scores in a heterogeneous cancer patient population. Methods: Clinical investigators conducted a longitudinal study of DT ratings for cancer patients receiving outpatient care at a community-based oncology subspecialty practice in a mid-sized city from 2018 to 2019. Study objectives included reviewing referrals and evaluating the relationship between the initial screening and the screening at the 6-month checkup. The Distress Thermometer was used (i.e., 0-10; zero is “no distress” and ten “extreme distress”) with scores of four or greater regarded as a signal of greater risk for patient distress. Results: The study sample included 79 patients with an average score of 4.3 and 4.0 at baseline and the 6-month screening, respectively. Patient referrals included physical and emotional therapy (n=1) or social/psychosocial worker assessment (n=26). Patients with a documented referral had a crude 1.7 (95% CI: 0.6, 3.3) greater point decrease in scores compared to patients not offered a service referral. When adjusting for baseline scores and the time between scores, referral accounted for 1% (95% CI: 0%, 14%) of variability in score changes, while baseline scores accounted for 40% (95% CI: 22%, 52%) and time accounted for 3% (95% CI: 0%, 14%). Conclusions: Study results reveal a possible decrease in higher scores from the initial screening to the 6-month check-up. Patients with a referral did not have their service utilization confirmed and this study failed to show an additional decrease in scores based on referrals when controlling for baseline score and time. Most previous research has focused on one specific cancer type. This study revealed the possible importance in understanding DT scores in a heterogenous cancer patient population. Furthermore, large scale research is needed to confirm preliminary data and further expound on distress at initial and subsequent screenings after interventions. A better understanding of this content area may function to improve future care and patient well-being.
A phase III trial of capivasertib and paclitaxel in first-line treatment of patients with metastatic triple-negative breast cancer (CAPItello290).
Authors: Schmid Peter , Cortes Javier , Robson Mark E. , Iwata Hiroji , Hegg Roberto , Nechaeva Marina , Xu Binghe , Verma Sunil , Haddad Vincent , Rodrigo Imedio Esteban , Schiavon Gaia , Foxley Andrew , Park Yeon Hee 
Published: May 2020

TPS1109 Background: Therapeutic options for patients with metastatic triple-negative breast cancer (TNBC) are limited to sequential chemotherapy, although recent advances with novel agents have been made for specific subgroups (PD-L1 inhibitor atezolizumab in combination with nab-paclitaxel in patients with PD-L1-positive tumors and PARP inhibitors in patients with germline BRCA mutations). The PI3K/AKT/PTEN signaling pathway is often activated in TNBC, mainly through activating mutations in PIK3CA or AKT1 and/or inactivating alterations in PTEN. The phase II PAKT study (NCT02423603) demonstrated that addition of the oral AKT inhibitor capivasertib to first-line paclitaxel resulted in significantly longer progression-free survival (PFS) and overall survival (OS) in patients with advanced TNBC, especially in patients with PIK3CA/AKT1/PTEN-altered tumors (Schmid et al, 2019). This phase III trial (NCT03997123) will further evaluate the efficacy and safety of capivasertib in combination with paclitaxel in first-line treatment of patients with metastatic TNBC in an unselected population and will also explore potential predictive markers of sensitivity to the combination of paclitaxel and capivasertib. Methods: Eligible patients for this double-blind, randomized, placebo-controlled trial must have metastatic TNBC or locally advanced disease not amenable to resection with curative intent. Patients must be candidates for single-agent taxane therapy and have received no prior systemic therapy for locally advanced inoperable or metastatic disease. Prior chemotherapy in the (neo)adjuvant setting must be completed ≥12 months prior to enrollment. Patients will be randomized 1:1 to paclitaxel 80 mg/m2 (days 1, 8 and 15) with either capivasertib 400 mg twice daily or placebo (days 2–5, 9–12 and 16–19) every 28 days, until objective radiologic disease progression as defined by RECIST 1.1, unacceptable toxicity or death. Stratification factors will be prior adjuvant chemotherapy, visceral versus non-visceral disease, and geographic region. Post-randomization central testing of tumor tissue (collected prior to enrollment) will be carried out to identify predictive markers of sensitivity to treatment. The primary endpoints of this study are PFS and OS. Secondary endpoints include safety and tolerability, time to second progression or death, objective response rate, duration of response, and clinical benefit rate. Enrollment for this study started in May 2019. Clinical trial information: NCT03997123 .
Effects of an e-home based symptom management and mindfulness training program on quality of life in breast cancer survivors.
Authors: Cheng Karis Kin-Fong , Siah Rosalind , Zhang Melvyn , Keng Shian-Ling , Wong Wan-Hua , Ho Roger , Lim Hsuen Elaine 
Published: May 2020

TPS12130 Background: The first five years post-treatment for breast cancer are a critical phase, when the survivors may face a multitude of problems, including persistent and/or late-emerging symptoms following the cancer and its treatment, psycho-social distress associated with the risk of cancer recurrence, chronic uncertainty and social disruption. Thus, this trial will answer the research questions of 'Will the combined symptom management and mindfulness-based training programme be a promising approach to assist women with breast cancer in transition from treatment to survivorship?', and 'Since breast cancer survivors have infrequent clinical follow-up, will e-Home based system provide a feasible option for post-treatment care?' Methods: We aim to develop an e-Home based symptom management and mindfulness training programme for breast cancer survivors and to determine its effects on the endpoints including quality of life, symptom distress, psychosocial adjustment, psychological morbidity, and unplanned outpatient attendance or hospitalisation in breast cancer survivors. (ClinicalTrials.gov Identifier: NCT02931864) We employ a randomised clinical trial with four study arms (with 47 subjects, who have completed cancer treatment for stage 0 to 3 breast cancer between 6 months to 5 years previously, in each arm) together with a process evaluation; group 1 (usual care), group 2 (experimental group: five weekly sessions of online symptom management + mindfulness training programme and usual care), group 3 (comparison group 1: online symptom management programme and usual care), and group 4 (comparison group 2: online mindfulness training programme and usual care). Subjects will complete questionnaires measures of 6-item Social Support Questionnaire, Breast Cancer Survivor Self- Efficacy Scale, the Quality of Life-Cancer Survivor Scale, Memorial Symptom Assessment Scale, Psychosocial Adjustment to Illness Scale, short version of the Fear of Recurrence Scale, Hospital and anxiety Depression Scale, and Five Facet Mindfulness Questionnaire at baseline, at 8 weeks from time 1 (time 2), at 12 weeks from time 1 (time 3) and at 24 weeks from time 1 (time 4). Intention-to-treat approach will be used. Repeated measures analysis of variance will be used to examine the differences on outcome measures among the experimental, comparison, and control groups across study time points. Currently, 162 of 188 planned subjects have been enrolled and the trial continues as planned. Clinical trial information: NCT02931864 .
ApricityRx companion digital therapeutic for evidence-based mitigation and phenotype-linked molecular characterization of irAEs in patients receiving immune checkpoint therapy (ICT).
Authors: Campbell Matthew T , Zhang Tian , Chin Lynda , Warner Allison Betof , Mathew Matthen 
Published: May 2020

TPS2089 Background: Presentation of immune-related adverse events (irAEs) is heterogeneous and unpredictable in patients receiving immune checkpoint therapy (ICT). ICT has been approved for cancer patients as single agent, combination of dual ICT, ICT plus chemotherapy, and ICT plus targeted therapy. Given the ever increasing complexity in recognizing and managing irAEs, coupled with the lack of skilled resources and clinical experience in real world practice, there is increasing demand for digital solutions that can detect early toxicity and support evidence-based interventions in real world practice. To this end, we have developed ApricityRx, a companion digital therapeutic for end-to-end irAE management. In addition to (i) teaching patients about immune-related toxicities and (ii) empowering them to monitor key symptoms and vital signs, ApricityRx continuously analyzes the combined patient-reported data and longitudinal EMR data to (iii) detect symptom-triggers and lab test-triggers of irAEs, and (iv) activate the clinical team to triage, evaluate and treat in a timely fashion, while (v) providing access to synthesized longitudinal patient information and expert guidance on evidence-based management and care. In a feasibility trial conducted in a community setting, we demonstrated two-thirds of the study participants completed on average 5 eCheck-ins per calendar week (overall average 4 times per week), with 5% of the check-ins resulting in notifications alerting the clinical team to evaluate for the early signs of an irAE. Methods: To accelerate translational research in irAEs and to develop predictive biomarkers for risk stratification, we are launching a single-arm, open-label study that utilizes ApricityRx in patients receiving ICT alone or in combination. The objectives of the study will include (i) defining the operative characteristics of ApricityRx as an irAE mitigation strategy; (ii) identifying patients and time points for phenotype-triggered biospecimen collection and molecular characterization. The study aims to enroll initially up to 100 participants per site, with a total target of 1,000.