bluuebunny/crossref_metadata_2025_split huggingface dataset:
Safety and effectiveness of medical cannabis as a complementary option for supportive cancer care: Results from the Cannabis Pilot Project.
Authors: Vigano Antonio , Aprikian Saro , Kasvis Popi , Bacis Virginie , Al Harrasi Amna , Aubin Nathalie M , Vigano MariaLuisa , Borod Manuel 
Published: May 2020

12106 Background: Access to medical cannabis (MC) is a common request by patients and caregivers in supportive cancer care (SCC). However, healthcare professionals require more evidence on MC safety and effectiveness. Methods: The Cannabis Pilot Project (CPP) was implemented at the Cedars Cancer Centre of the McGill University Health Centre to evaluate MC as a complementary option for symptom control in SCC. Referral to the CPP was reserved for patients who were receiving SCC but had not obtained adequate symptom relief. An interdisciplinary team (physician, nurse and research coordinator) was established to systematically assess patients, prescribe and monitor MC treatments and record data on their safety and effectiveness. Patients were enrolled in the CPP between February 2018 and December 2019 and reassessed at intervals of one to six months. Results: Ninety-six cancer patients (mean age 60.0y (±13.9); 41 (42.7%) males) had at least one follow-up (FUP) and were included in the study. The main cancer types were breast (19.8%), lung (9.4%) and colorectal (9.4%). Adverse events (top three: drowsiness, low energy and nausea) were reported in 28% of patients, with 9% having to stop MC. Mean Brief Pain Inventory scores significantly improved between baseline, FUP-2 and FUP-3 for worst pain (5.4± SEM 0.3 vs 4.3±0.3 and 3.7±0.4) and average pain severity (4.2±0.2 vs 3.2±0.3 and 3.2±0.4). Anorexia improved (3.4±0.3 vs 2.2±0.4 and 1.7±0.4), as measured via the revised Edmonton Symptom Assessment System (ESAS-r). ESAS-r wellbeing improved significantly between baseline and FUP-1 (4.4±0.2 vs 3.7±0.2). Between baseline and each FUP, approximately a third of patients dropped their use of concurrent medications (including analgesics, antidepressants and anxiolytics), as measured by the Medication Quantification Scale. Conclusions: The CPP data support the safety and effectiveness of MC as a complementary option for improving pain control, appetite and quality of life in SCC.
Questions prompt lists used by palliative care teams help trigger discussions on prognosis and end-of-life issues with advanced cancer patients.
Authors: Bouleuc Carole , Burnod Alexis , Cottu Paul H. , Pierga Jean-Yves , Dolbeault Sylvie 
Published: May 2020

12110 Background: Accuracy of prognosis perception is a key element to allow advanced cancer patients to make informed decisions and to reflect on their end-of-life priorities. This study aims to explore whether a question prompt list can promote discussions on prognosis and end-of-life issues during palliative care consultations for advanced cancer patients. Methods: In this multicentric randomised study, patients assigned in the interventional arm receive a question prompt list during the first palliative care consultation (T1) after referral by oncologists. The primary endpoint is the number of questions asked by patients during the second palliative care consultation (T2) one month later. Secondary objectives are anxiety and depression, quality-of-life, satisfaction with care, coping assessed at baseline (T1) and at two months (T3). Palliative care teams from 3 french comprehensive cancer centers participate in the study. Main inclusion criteria were adult patients with metastatic non-haematological cancer referred to the palliative care team and with an estimated life expectancy less than one year. Results: Patients (n = 71) in the QPL arm asked more questions (mean 21.8 versus 18.2, p-value = 0.03) during the palliative care consultations compared to patients in the control arm (n = 71). These questions addressed palliative care (mean 5.6 versus 3.7, p-value = 0.012) and end-of-life issues (mean 2.2 versus 1, p = 0.018) more frequently than in the control arm. At two months, compared to baseline, there was no change in anxio-depressive symptoms or quality of life. Conclusions: QPL favours discussion on prognosis and end-of-life care during the palliative care consultations for advanced cancer patients. Clinical trial information: NCT02854293 .
A prospective analysis of chemotherapy-induced nausea and vomiting in gastrointestinal cancers: Results from a tertiary cancer center.
Authors: Kapoor Akhil , Ostwal Vikas S. , Ramaswamy Anant , Bhargava Prabhat Ghanshyam , Gupta Sudeep , Prabhash Kumar 
Published: May 2020

12111 Background: Chemotherapy-induced nausea and vomiting (CINV) is a bothersome side-effect associated with cancer chemotherapy which adversely impacts both quality of life and the ability to carry out the activities of daily living. This study was conducted to assess the proportion of patients developing CINV after receiving chemotherapy for gastrointestinal (GI) cancers, in spite of receiving antiemetic prophylaxis as per the standard guidelines. Methods: Consecutive patients with GI malignancy who had not received previous chemotherapy were eligible for enrollment in the study if they were scheduled to receive at least one cycle of chemotherapy. SPSS version 20 was used for all statistical calculations. Results: 701 patients fulfilling the eligibility criteria were included in this study, out of which 55.4% were males, median age was 51 years (range 22-77). Biliary tract cancer (34%) was the most common diagnosis followed by colorectal (30.2%) and gastric cancer (19.6%). As per MASCC guidelines, 22.1% patients received highly emetogenic chemotherapy, 56.0% moderately emetogenic chemotherapy (MEC) while 19.9% received regimen with low emetogenicity. Failure to achieve complete response (CR, absence of acute and delayed CINV) was found in 27.4% patients. On separately analysing MEC group, overall CR was not achieved in 33.8% with failure in acute settings in 17.8% and delayed in 16.0% patients. Only significant factor for not achieving CR was use of oxaliplatin based chemotherapy (p = 0.018 for acute and p = 0.014 for delayed CINV). Conclusions: More than one fourth patients failed to achieve complete response for CINV in gastrointestinal cancers despite using prophylaxis as per standard guidelines. Use of oxaliplatin based therapy is an important factor for MEC causing CINV. There is urgent need to update the guidelines for prophylaxis in this setting. [Table: see text]
Nonconscious nonverbal synchrony and patient and physician affect and rapport in cancer treatment discussions with black and white patients.
Authors: Hamel Lauren M. , Moulder Robert , Penner Louis , Albrecht Terrance Lynn , Boker Steven , Dougherty David W. , Eggly Susan 
Published: May 2020

12116 Background: Clinical communication is poorer with Black patients than with White patients, but most studies are limited to verbal communication. Nonverbal synchrony, the subtle, nonconscious coordination of movement between individuals, has been shown to reflect relationship quality. We investigated nonverbal synchrony’s association with patient and physician affect and rapport in cancer treatment discussions, and if those associations differed by patient race. Methods: We used motion detection software to measure overall synchrony and synchrony based on who is leading in the interaction (similar to leading in dancing) in video recordings of 68 Black patients and 163 White patients discussing treatment with their non-Black physicians. Additionally, naïve observers rated the interaction for six constructs: patient and physician positive and negative affect and patient-physician positive and negative rapport. We examined associations between nonverbal synchrony and the six constructs. Results: In interactions with Black patients, overall synchrony was positively associated with patients’ positive affect and positive patient-physician rapport and negatively associated with patients’ negative affect and negative patient-physician rapport. When the physician was leading, synchrony was positively associated with patients’ positive affect and positive patient-physician rapport and negatively associated with patients’ negative affect and negative patient-physician rapport. When the patient was leading, synchrony was positively associated with patients’ and physicians’ positive affect and positive patient-physician rapport, and negatively associated with patients’ negative affect and negative patient-physician rapport. In interactions with White patients, overall synchrony was positively associated with patient positive affect; when the physician was leading, synchrony was negatively associated with patient negative affect. Conclusions: This is the first study to use an innovative measure of dynamic communication in patient-physician cancer treatment discussions. Nonverbal synchrony was related to patient and physician affect and rapport in interactions with Black patients, but only patient affect in interactions with White patients, suggesting nonverbal synchrony is particularly important in interactions with Black patients. Next steps include investigating associations with patient outcomes (e.g., satisfaction). Findings could contribute to physician training.
Effect of linguistic acculturation on self-efficacy and anxiety in caregivers of Latina breast cancer survivors.
Authors: Schlam Ilana , Campos Claudia , Duron Ysabel , Torres Migdalia , Sampayo Ivis , Graves Kristi D 
Published: May 2020

12121 Background: Latina breast cancer survivors and their caregivers face unique challenges. Acculturation is the acquisition of the cultural elements of a dominant society. Higher acculturation in Latino survivors is positively correlated with self-efficacy in patient-provider communication and improved patient-reported outcomes. There is a paucity of research on how language acculturation affects caregiver and patient outcomes. We examined associations over time between linguistic acculturation among caregivers of Latina survivors and outcomes of caregiver self-efficacy and anxiety. Methods: We partnered with four community-based organizations that serve Latino families facing cancer. We enrolled 136 Latina breast cancer survivors and their caregivers for a randomized trial comparing a dyadic coping intervention to usual care (e.g., support groups). Participants completed surveys including demographic and clinical information, the short acculturation scale for Hispanics, caregiver inventory to assess self-efficacy and PROMIS domains of anxiety at baseline and 6-months after the intervention. Results: In multivariate linear regressions models, we examined the effect of acculturation on caregiver self-efficacy and anxiety, controlling for demographics (patient and caregiver age, caregiver education, employment), patient treatment history (chemotherapy and surgery) patient and caregiver language preference (Spanish or English) and intervention arm (intervention vs. usual care). Greater caregiver self-efficacy at 6-months was associated with younger patient age (t=-2.93, p=.004), older caregiver age (t=2.63, p = .01), female caregiver gender (t=2.79, p = .006) and higher acculturation (t=2.01, p=.04), controlling for baseline self-efficacy, patient language and randomization group. Caregiver anxiety was not related to caregiver acculturation or patient language preferences. Conclusions: Caregivers’ language acculturation was significantly associated with their self-efficacy over time, suggesting that caregivers with lower acculturation experience lower confidence in their provision of care for Latina survivors. These findings are particularly salient because participants for this study were enrolled from organizations with bilingual services. Caregivers of Latina survivors without access to these community resources may face even more striking challenges. Future work can explore how caregivers’ confidence relates to survivors’ adherence to care and patient outcomes over time.
Enhanced coping and self-efficacy in caregivers of hematopoietic stem cell transplant (HCT) recipients: Identifying mechanisms of a multimodal psychosocial intervention.
Authors: Elyze Madeleine , Jacobs Jamie M. , Nelson Ashley , Traeger Lara , Jagielo Annemarie , Greer Joseph A. , Temel Jennifer S. , El-Jawahri Areej 
Published: May 2020

12122 Background: A brief multimodal psychosocial intervention (BMT-CARE) for caregivers of HCT recipients demonstrated promising efficacy for improving caregiver quality of life (QOL), mood, coping skills, and self-efficacy. We examined whether improvements in coping and self-efficacy mediated the intervention effects on QOL and mood. Methods: We conducted a randomized clinical trial of BMT-CARE for caregivers of patients undergoing autologous or allogeneic HCT at a single institution. Caregivers were randomly assigned to BMT-CARE or usual care. BMT-CARE was tailored to the HCT trajectory and integrated treatment-related education and self-care with cognitive-behavioral skills and caregiving-specific strategies to promote coping. Caregivers completed self-report measures of QOL (CareGiver Oncology QOL), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), coping skills (Measure of Current Status), and self-efficacy (Cancer Self-Efficacy Scale-Transplant) at enrollment and 60 days post-HCT. We used causal mediation regression models to examine whether changes in coping and self-efficacy mediated intervention effects on QOL, depression and anxiety symptoms. Results: Caregivers randomized to BMT-CARE reported improved self-efficacy (adjusted means: 156.20 vs. 147.06, P=0.023) and coping skills (adjusted means: 36.54 vs. 25.41, P<0.001). Improved coping and self-efficacy partially mediated the intervention effects on 60-day QOL (indirect effect=6.93, SE=1.85, 95% CI [3.71, 11.05]). Similarly, improved coping and self-efficacy partially mediated reductions in 60-day depression and anxiety symptoms (indirect effect depression=-1.19, SE=0.42, 95% CI [-2.23, -0.53]; indirect effect anxiety=-1.46, SE=0.55, 95% CI [-2.52, -0.43]). Combined improvements in coping and self-efficacy accounted for 67%, 80%, and 39% of the total intervention effect on QOL and depression and anxiety symptoms, respectively. Conclusions: A brief multimodal intervention for caregivers of HCT recipients may improve QOL and mood by enhancing coping skills and self-efficacy. These findings offer important insights into the mechanisms by which caregiver-directed interventions may enhance caregiver QOL and reduce their psychological distress.
Targeted therapy based on germline analysis of tumor-normal sequencing (MSK-IMPACT) in a pan-cancer population.
Authors: Stadler Zsofia Kinga , Maio Anna , Kemel Yelena , Sheehan Margaret , Salo-Mullen Erin E. , Cadoo Karen Anne , Carlo Maria Isabel , Latham Alicia , Walsh Michael Francis , Drilon Alexander E. , Berger Michael F. , Solit David B. , Birsoy Ozge , Mandelker Diana , Diaz Luis A. , Offit Kenneth , Robson Mark E. 
Published: May 2020

1500 Background: Tumor mutational profiling for identification of somatic alterations for targeted treatment is increasingly being performed in advanced cancer patients (pts). We sought to assess the clinical utility of germline mutation profiling for targeted therapeutic interventions in a pan-cancer patient population. Methods: All pts who had germline genetic testing through a prospective protocol via a next-generation sequencing panel (MSK-IMPACT) were identified (N=11,975) from 2015-5/2019. The medical record of pts with likely pathogenic/pathogenic germline (LP/P) alterations in genes with known therapeutic targets were reviewed to identify germline-targeted treatment either in a clinical or research setting. Results: We identified 2,043 (17.1%) pts who harbored LP/P variants in a cancer predisposition genes including 777 (6.5%) in genes with potentially targetable therapeutic implications: 416 BRCA1/2, 149 DNA mismatch repair genes (Lynch syndrome, LS), 122 ATM, 45 PALB2, 26 RAD51C/D, 7 RET, 4 TSC, 3 PTCH1, 2 ALK, 1 EGFR, 1 MET and 1 KIT. Of those with advanced disease (n=554), 45.3% received targeted therapeutic treatment (Table) including 50.9% BRCA1/2, 58.3% LS (67.4% of microsatellite-high LS cases), 41.7% PALB2, 36.8% RAD51C/D and 19.3% ATM carriers. Of patients receiving a poly (ADP-ribose) polymerase inhibitor (PARP-I) in the setting of a BRCA1/2 mutation, 55.1% had breast or ovarian cancer; however, 44.8% had other tumors, including pancreas, prostate, bile duct, gastric, wherein the drug was given in a research setting. Among PALB2 pts receiving PARP-Is, 53.3% (8/15) had breast or pancreas cancer; 46.7% had cancer of the prostate, ovary or unknown primary. Conclusions: In our pan-cancer analysis, 6.5% of pts harbored a targetable germline variant highlighting the importance of germline analysis in advanced cancer pts for selection of both FDA-approved treatments and clinical trial participation with germline-targeted therapeutics. [Table: see text]
Comprehensive breast cancer (BC) risk assessment for CHEK2 carriers incorporating a polygenic risk score (PRS) and the Tyrer-Cuzick (TC) model.
Authors: Gallagher Shannon , Hughes Elisha , Kurian Allison W. , Domchek Susan M. , Garber Judy Ellen , Probst Braden , Morris Brian , Tshiaba Placede , Rosenthal Eric Thomas , Roa Benjamin , Wagner Susanne , Gutin Alexander , Weitzel Jeffrey N. , Lanchbury Jerry , Robson Mark E. 
Published: May 2020

1504 Background: Women with pathogenic variants in the moderate penetrance CHEK2 gene have on average an estimated > 20% lifetime risk for breast cancer, thereby meeting an established threshold for more aggressive screening, including consideration of breast magnetic resonance imaging (MRI). However, we previously showed that CHEK2 penetrance is modified by an 86-SNP PRS. CHEK2 risk is further modified by family history (FH) and other TC model variables. Here, we describe development of a comprehensive risk prediction model for women of European ancestry to more precisely estimate risk by incorporating CHEK2, PRS and TC V7.02. The number of CHEK2 carriers with low ( < 20%), moderate (20%-50%) and high ( > 50%) remaining lifetime risk based on the combined model was examined in an independent study cohort. Methods: This IRB-approved study included de-identified clinical records from 358,471 women of European ancestry who were tested clinically for hereditary cancer risk with a multi-gene panel. Model development was based on analysis of CHEK2 PV carriers ( N= 4,331) and women negative for BC gene PV ( N =353,681) who were tested between September 2013 and July 2019. Risk estimates incorporating CHEK2, PRS and TC were calculated using a fixed-stratified (FS) method that accounts for correlations between risk factors in a manner equivalent to multivariable co-estimation. Risk stratification was assessed in an independent cohort of CHEK2 carriers ( N= 459) who were tested after July 2019 and not included in model development. Results: We detected significant correlation of CHEK2 status with FH ( p= 4.1 × 10−17) and of PRS with FH among CHEK2 carriers ( p= 1.7× 10−5). For these factors, joint effects were co-estimated using the FS method. In an independent cohort, 24.0% of CHEK2 carriers were categorized as low risk ( < 20%), and 62.6% were categorized as moderate risk (20-50%). For 13.4% of CHEK2 carriers, risk estimation incorporating PRS and TC generated BC risks of greater than 50%, consistent with genes recognized as highly penetrant. Conclusions: In CHEK2 PV carriers, comprehensive risk assessment could inform individualized decision-making and may lead to improved targeting of screening and prevention strategies.
Uptake of oophorectomy in women with findings on multigene panel testing: Results from the Prospective Registry of Multiplex Testing (PROMPT).
Authors: Domchek Susan M. , Brower Jamie , Symecko Heather , Marcell Vanessa , Walsh Michael Francis , Hamilton Jada G. , Couch Fergus , Offit Kenneth , Garber Judy Ellen , Robson Mark E. 
Published: May 2020

1508 Background: With the expansion of multigene panel testing for cancer susceptibility, increasing numbers of patients are identified with pathogenic/likely pathogenic variants (P/LP V) in genes which do not have a clearly actionable increased risk of ovarian cancer (OC) (lifetime risk of OC >5%). However, there is concern that patients and/or providers may ascribe OC risk to such genetic findings with the potential for unnecessary oophorectomy (ooph). Methods: The Prospective Registry of Multiplex Testing (PROMPT) is an online registry for individuals with a genetic alteration detected on multiplex panel testing for cancer susceptibility. Participants self-enroll and complete baseline and annual follow-up questionnaires. PROMPT has enrolled 7388 participants (6936; 93.9% women) since September 2014. Results: 1566 women in the PROMPT registry reported ooph, the indications for which were reported as either cancer treatment (n=481, 30.7%) or benign disease (n=432, 27.6%). An additional 186 (12.8%) reported PV in genes associated with lifetime OC risk >5% ( BRCA1, BRCA2, RAD51C, RAD51D, BRIP, or Lynch syndrome genes). The remaining 467 did not have guideline based indications for ooph due to OC risk and are described further here. 92 (19.7%) had a variant of uncertain significance (VUS) in genes associated with OC, 241 (51.6%) had a personal history of breast cancer (BC) and no VUS in OC genes, and 119 (25.5%) had no personal history of BC and no VUS in OC genes. The majority of women had no family history (FH) of OC in first or second degree relatives (Table). Most ooph occurred prior to age 50. Of the 405 women with CHEK2 P/LP, 11.4% reported ooph (59% under age 50 when age known), as did 13.2% (of 228) with CHEK2 VUS, 8.8% (of 261) with ATM P/LP (66.7% under age 50), and 8.3% (of 387) with ATM VUS. In addition, of the 184 women with PALB2 P/LP, 14.1% reported ooph (35.3% under age 50) as did 11.6% (of 198) with PALB2 VUS. Of those who reported provider discussions, 47.2% stated “my provider recommended this” (including >60% in the OC gene VUS group) and an additional 25.2% stated “my provider presented this as an option, but not a requirement”. In those with no FH of OC, 45.8% stated that their provider recommended ooph. Conclusions: 10-15% of women with PV/VUS in genes not associated with a high risk of OC reported ooph without a clear indication. [Table: see text]