bluuebunny/crossref_metadata_2025 huggingface dataset:
Association between tamoxifen and cataract risk in breast cancer patients: Analysis of a national health insurance database.
Authors: Chou Cheng-wei , Lin Ching-Heng , Teng Chieh-Lin , Sher Yuh-Pyng
Published: May 2020

e24072

Background: Tamoxifen is often used for hormone-positive breast cancer. Recent trials suggested that ten years of tamoxifen use improves recurrence rate and death. Ocular side effects and cataracts were reported in previous trials. We revealed the risk of cataracts from real-world data of the Taiwan national health insurance research database. Methods: We retrieved data from the Taiwan National health insurance research database. Female breast cancer patients from 2000-2005 were enrolled in this study. Patients receiving cataract surgery were enrolled and matched with non-cataract surgery patients for comparison in the analysis. Age, cumulative days, chemotherapy, and the time interval between breast cancer and index date were included and as controlled variables. Results: Among 23,957 female breast cancer patients, a total of 1,578 patients receiving cataract surgery were enrolled and matched with patients without cataract surgery until the end of 2013. Age in patients undergoing cataract surgery group was significantly higher than the non-surgery group (59.9 and 58.3, respectively, P < 0.001). Multiple regression analyses showed an adjusted odds ratio of 1.02 (95% CI:1.01-1.03, P< 0.001). However, more prolonged exposure of tamoxifen (≧3 years) also had a higher risk of cataract development requiring surgery (adjusted odds ratio=1.32, 95% CI: 1.03–1.70, P = 0.030). Conclusions: Besides age, there is a significantly higher risk of cataract development requiring surgery among female breast cancer patients with long term tamoxifen use. Information from this study may provide further clinical surveillance efforts in cancer survivors. [Table: see text]
Matrix metalloproteinases 9 and 14 polymorphisms and long-term complications in surgically treated breast cancer patients.
Authors: Besic Nikola , Goricar Katja , Piber Petra , Vavpetic Neza , Dolzan Vita , Strazisar Branka
Published: May 2020

e24074

Background: Matrix metalloproteinases (MMPs) are zinc-containing endopeptidases that are involved in tissue remodeling. They can regulate interactions of cells with extracellular matrix and can play a role in wound healing. High levels of metalloproteinases have been correlated with significantly delayed wound healing in wounds of a variety of etiologies. The aim of our present study was to evaluate the association of MMP9 and MMP14 genetic polymorphisms with long-term complications of surgical treatment in breast cancer patients. Methods: The study included 99 breast cancer patients treated with either 75 or 37.5 mg of tramadol for pain relief after axillary breast cancer surgery as part of a randomized clinical trial KCT 04/2015-DORETAonko/si at Institute of Oncology Ljubljana. All patients were genotyped for MMP9 polymorphisms rs2250889, rs17577, rs17576, and rs20544 as well as MMP14 rs1042703, rs1042704, and rs743257. The association of genetic factors with long-term complications was evaluated using logistic regression. Results: One year after surgery, 24 (24.2%) patients had lymphedema, 25 (25.3%) experienced neuropathic pain and 21 (21.1%) experienced chronic pain. Carriers of polymorphic MMP9 rs2250889 allele experienced significantly more lymphedema compared to carriers of two wild-type alleles (OR = 3.45, 95% CI = 1.10-10.84, P = 0.034), even after adjustment for tramadol dose (OR = 3.76, 95% CI = 1.16-12.18, P = 0.027). Carriers of polymorphic MMP14 rs1042704 allele experienced more neuropathic pain compared to carriers of two wild-type alleles (OR = 3.21, 95% CI = 1.26-8.20, P = 0.015), even after adjustment for tramadol dose (OR = 3.80, 95% CI = 1.42-10.17, P = 0.008). Conclusions: MMP genetic variability was associated with long-term complications after axillary surgery in breast cancer patients, suggesting that MMPs may have an important role as modulators of wound healing.
Clinical application value of prognostic nutritional index for predicting survival in patients with esophageal squamous cell carcinoma undergoing chemoradiotherapy (CRT) or radiotherapy.
Authors: Li Tao
Published: May 2020

e24075

Background: The prognostic nutrition index (PNI) has been shown to have prognostic value in several common cancers. We explore its clinical application value in the prognosis of patients with esophageal squamous cell carcinoma (ESCC) undergoing radical chemoradiotherapy (CRT) or radiotherapy. Methods: Overall, 193 patients with ESCC who received radiotherapy with or without chemotherapy at Sichuan Cancer Hospital from March 20, 2012 to December 25, 2017 were retrospectively analyzed. Based on serum measurements before treatment, PNI at ESCC recurrence was calculated as albumin (g/L) + 5 × total lymphocyte count. Kaplan-Meier method and Cox proportional regression model were used to analyze the relationship between PNI and overall survival (OS). Results: The PNI of 193 ESCC patients was 49.01 ± 4.68. The optimal cutoff value of PNI was calculated to be 47.975. The patients were divided into a low PNI group (<47.975) and a high PNI group (≥47.975). The median OS for the entire group was 22.37 months. The median OS of patients in the high PNI group (PNI ≥ 47.975) and low PNI group (PNI <47.975) were 32.63 months and 15.4 months, respectively. The 3-year overall survival rates were 47.5% and 32.2%, and 5-year overall survival rates were 37.7% and 16.8%, respectively, and the differences were statistically significant (P = 0.001). Multivariate analysis showed that tumor length (P = 0.019), synchronous chemotherapy (P = 0.009), and PNI (P = 0.003) were independent prognostic factors affecting the prognosis of patients in ESCC treated with radical CRT or radiotherapy. Conclusions: The calculation of PNI value is simple, reliable and repeatable, which can improve the accuracy of patients' prognosis. And it needs to be further confirmed by the prospective study of large sample size. Keywords: Esophageal squamous cell carcinoma, chemoradiotherapy, prognostic nutritional index, prognosis.
Effect of weight loss on survival in esophageal cancer patients undergoing neoadjuvant chemoradiotherapy and surgery.
Authors: Li Tao
Published: May 2020

e24076

Background: This study aimed to determine the impact of weight loss during neoadjuvant chemoradiotherapy on the survival of patients with esophageal carcinoma. Methods: We retrospectively examined 102 consecutive patients with esophageal carcinoma who underwent neoadjuvant chemoradiotherapy followed by radical resection at Sichuan Cancer Hospital & Institute between 2003 and 2017. The patients were divided into three groups based on the amount of body weight lost during neoadjuvant chemoradiotherapy: severe weight loss (>10%), high weight loss (5%–10%), and low weight loss (<5%). The correlations of weight loss with toxicity, progression-free survival, and overall survival were investigated. Results: The median overall survival was 49.7 months in the low weight loss group compared with 35.4 and 25.1 months in the high and severe weight loss groups ( P = 0.041). The 1-year overall survival rates in the severe, high, and low weight loss groups were 62.5%, 85.0%, and 90.7%, respectively; the corresponding 3-year overall survival rates were 21.9%, 47.3%, and 68.8%, respectively, and the corresponding 5-year overall survival rates were 21.9%, 31.0%, and 44.4%, respectively. The multivariate analysis indicated that a pathological complete response and severe weight loss were independent prognostic factors for overall survival. Any leukopenia ( P = 0.024), leukopenia of at least grade 3 ( P = 0.021), and anemia ( P = 0.042) occurred more frequently in the severe weight loss group. Conclusions: Weight loss during neoadjuvant CRT is an independent and adverse prognostic factor in esophageal carcinoma patients, whereas a stable weight confers a better prognosis. Keywords: esophageal cancer, prognosis, weight loss, neoadjuvant chemoradiotherapy, toxicity.
Fertility counseling in young patients with colorectal cancer.
Authors: Peng Chengwei , Masri Lena , Sherman Scott , Becker Daniel Jacob
Published: May 2020

e24081

Background: The incidence of colorectal cancer in patients younger than 50 has been increasing over the past two decades. This demographic shift has important implications for survivorship care, in particular regarding issues of future fertility. Although ASCO has a longstanding recommendation for fertility counseling in patients with cancer, the rates of fertility counseling in younger patients with colorectal cancer are unknown. Methods: Records for new patient visits for colorectal cancer in patients younger than age 55 in a large academic cancer center between 2016 and 2019 were retrospectively queried for patient demographics, disease characteristics, and documentation of fertility counseling. Associations between patient demographic/clinical characteristics and receipt of fertility counseling were explored. Univariate analyses and multivariable logistical regression analyses were performed using SAS v9.4. Results: Among the 136 patients who met inclusion criteria, 37.5% of patients were female, 16.2% were African American, 31.6% had rectal cancer, 20.7% of patients had Medicaid insurance. 63.7% were treated with curative intent. Age ranged from 22-55 (median = 46). Among all patients, 21/136 (15.4%) had documented fertility counseling. Of these, 11/51 (21.6%) patients were female and 10/85 (11.8%) were men. In univariate chi-square analysis, age less than or equal to 40 was associated with fertility counseling (p < 0.001) and curative intent therapy was numerically but not statistically associated with fertility counseling (p = 0.07). In multivariable analysis with logistical regression, age less than 40 (OR = 3.90, 95% CI [1.95, 7.81]), female gender (OR = 2.37, 95% CI [1.16, 4.84]), and curative intent therapy (OR = 3.26, 95% CI [1.14, 9.35]) were associated with fertility counseling. Race, stage of cancer, insurance status, prior exposure to chemotherapy, and colon vs rectal cancer were not associated with fertility counseling. Conclusions: The rate of fertility counseling was very low among patients with colorectal cancer, and exceptionally low among men with colorectal cancer. Despite changes in the demographics of colorectal cancer, it does not appear that appropriate changes have been made in fertility counseling. Additional studies to identify barriers and implementation strategies for fertility counseling are urgently needed in a disease that affects more young patients each year.
Patterns of use of medical cannabis in a community oncology clinic.
Authors: Behl Deepti , D'Andre Stacy D. , Parise Carol
Published: May 2020

e24111

Background: Despite the fact that cannabis is still illegal in some states, two-thirds of all patients with cancer may have used cannabis at some point in their life to alleviate anorexia, nausea, chronic pain, and/or insomnia. Cannabis remains a Schedule 1 drug on the federal list with drugs such as heroin and LSD, which limits the ability to conduct quality clinical trials. This purpose of this study was to assess the prevalence, reasons for use, methods of use, and perceived benefits of medical cannabis in an adult community oncology clinic. Methods: Patients completed a questionnaire when they checked in for their appointment at the outpatient oncology clinic at Sutter Medical Center, Sacramento. Patients who used marijuana were asked questions regarding the mode of ingestion, perceived benefits, types of underlying cancer, and estimated monthly cost. Results: Of the 775 patients who completed the study to date, 129 men (29.3%) and 54 women (70.1%) responded that they used medical cannabis. Approximately 72% were white, 29.3% had breast cancer, and 13% had lung cancer. 39% percent had a diagnosis of metastatic cancer and 44% were undergoing chemotherapy. The most often stated reasons for use were pain (45%), sleep (43%), nausea (38%); and anxiety/mood (38%). Over 50% reported use of oils and tinctures and 44% used edibles. A smaller percentage preferred vaping (26%) or smoking (30%). Topical use was preferred by fewer patients (17%). Over 58% of patients stated they used more than one method. Most patients felt that use of cannabis helped alleviate symptoms. Marked improvement was reported by 40% patients; moderate improvement by another 41%. Only 13% users stated that they noted little to no improvement. The majority of patients (66%) spent $100 or less per month on marijuana whereas 22% spent between $100 and$200 per month. Conclusions: Medical cannabis is used by approximately one-fourth of all patients in an urban community cancer center in Northern California and the majority reported that cannabis provided improvements in symptoms associated with cancer and its treatment. Further research regarding mechanism of actions and associated risks is warranted.
Feasibility and effects of home parenteral nutrition (HPN) in cancer patients with or without migrant background.
Authors: Schickhaus Lena Rebekka , Högner Anica , Lorenz Mario , Sturm Prisca , Thuss-Patience Peter C.
Published: May 2020

e24137

Background: Parenteral nutrition is used in cancer patients (pts) requiring intensive nutrition support due to insufficient dietary intake and consuming tumor disease. As there is no data of HPN in pts with migrant background (MB), this observational study examined viability of HPN, influence on QoL and nutrition status of cancer pts with and without MB. Methods: Eligibility included ECOG ≥ 1, life expectancy ≥ 4 weeks, first time HPN for at least 28 days and written informed consent. Migrant background status and patient characteristics were assessed at baseline. At day 1 (baseline), day 14 and day 28 validated questionnaires assessed QoL, nutrition status (EORTC-QLQ-C15-PAL, Subjective global assessment (SGA)), as well as feasibility and complications of HPN. Additionally, bioimpedance analysis, BMI and weight were measured to evaluate response of HPN. Results: Between Mai 2015 and November 2019, 68 pts were included, 17 of them with MB. Tumor entities were gastric (n = 41), esophageal (n = 20) and other (n = 7), treated in a curative (n = 14) or palliative (n = 54) concept. Overall, 40 pts were able to continue HPN until day 14, 26 pts until day 28. 42 pts left study due to death (1 with MB/8 overall), worsening of general condition (3/15), dietary improvement (1/2), change of supplier (1/5), informed consent withdrawal (0/1) and lost to follow up (2/11). Global QoL in all pts was stable from baseline to d14 (n = 36; 36.6 to 40.3), whereas QoL in pts with MB deteriorated (n = 9; 37.0 to 27.8). From baseline to d28, QoL in all pts improved (n = 23; 38.4 to 47.8) and in pts with MB QoL was stable (n = 7; 40.5 to 42.9). Medical problems associated with HPN occurred in 4/11 pts with MB (36%) and 11/37 pts without MB (30%), respectively. The majority of pts reported about HPN-associated organizational complications, whereas there is no significant difference of pts with MB (6/10) and without MB (20/38). SGA improvement was observed in all pts regardless of MB. During the course of HPN, there was no significant change in body weight and BMI in all pts, independent from MB. Conclusions: Overall, 59% of pts received HPN for 14 days, only 38% of pts for 28 days. Discontinuation was mainly due to disease progression. Feasibility and organizational problems did not affect duration of HPN. Assessing HPN prospectively shows, that defining the ideal point to start HPN appears to be essential for response to HPN. In our study, migrant background is not associated with a major difference in incidence of complications, viability, benefit or duration of HPN.
Patterns and prognostic factors of malignant ascites in hospitalized patients with advanced stage cancer.
Authors: Ahmed Shanila , Sajid Mir Ibrahim , Fayyaz Risha , Ilyas Faiza , Nasir Noreen
Published: May 2020

e24141

Background: Ascites is a shared pathological manifestation of numerous diseases, the primary (81%) disease being hepatic cirrhosis. Ascites is termed “malignant” when it is associated with cancers. It can manifest as abdominal swelling, abdominal pain, nausea and vomiting, anorexia and fatigue. Our study aimed at identifying baseline characteristic in patients who present to our hospital with malignant ascites as the first sign of advanced stage cancers and the factors that can affect outcomes in such patients. Methods: This is a retrospective study which includes all the patients who had been diagnosed with malignant ascites at our institute between the years 2012 and 2016.The diagnosis was made either on the basis of cytological examination or medical imaging or both. Patients who were younger than 18 years and who developed ascites due to diseases other than malignancy were excluded from the study. A total of 150 patients were shortlisted using these criteria. Results: The mean age of the sample was 56.52 years with 101 (67%) of the patients being female, 54 (36%) diabetic, 55 (37%) hypertensive, 26 (52%) and 12 (8%) had ischemic heart disease. The most prevalent tumor reported was ovarian cancer 47 (31%) with the highest frequency of metastasis reported in the peritoneal region 34 (23%). Among symptoms, the most prevalent were abdominal distension 127 (85%), abdominal pain 99 (66%), 41 (27%) nausea, 44 (29%) vomiting and 32 (21%) reported weight change. Paracentesis was done in 139 (92%) for palliation of symptoms .Surgery was performed on 11 (7%) of the patients, whereas 70 (47%) of the patients were switched to chemotherapy with Carboplatin-Taxol constituting the major chemotherapeutic regimen. Majority 93 (62%) of the patients were discharged in a stable condition. The median survival following diagnosis of ascites was three months. Ovarian cancer favored longer survival while low serum albumin, low serum protein and liver metastases adversely affected survival. The independent prognostic factors for survival were cancer type, liver metastases and serum albumin. Conclusions: The identified independent prognostic factors should be used to select patients for multimodality therapy for adequate palliation.
Breakthrough cancer pain clinical features and differential opioids response: A machine learning approach in 4,016 cancer patients of IOPS-MS study.
Authors: Pantano Francesco , Manca Paolo , Armento Grazia , Zeppola Tea , Onorato Angelo , Santini Daniele , Vincenzi Bruno , Tonini Giuseppe
Published: May 2020

e24150

Background: A large proportion of patients with cancer suffer from Breakthrough cancer pain (BTcP). Several unmet clinical needs concerning BTcP treatment, like optimal opioids dosage, are being investigated. We explored with an unsupervised learning algorithm whether distinct subtypes of BTcP exist and whether they can provide new insights into clinical practice. Methods: We used partitioning around medoids algorithm on a large dataset of patients with BTcP previously collected by the IOPS group in order to identify possible subgroups of BTcP; the input of the algorithm consisted of different BTcP features, like its duration or its intensity. Silhouette statistics was used to pick an optimal number of clusters. Resulting clusters were analyzed in terms of BTcP therapy satisfaction, clinical features and usage of basal pain and rapid onset opioids. Opioids dosages were converted to a unique scale and BTcP-opioids-to-basal-pain-opioids ratio (OpR) was calculated for each patient. Polynomial logistic regression was used to catch non-linear relationships between therapy satisfaction and opioids usage. Results: The cohort comprised 4016 patients with controlled basal pain and suffering from BTcP. Our algorithm identified 12 distinct BTcP clusters. Optimal OpRs differed across the clusters, ranging from 15% to 50%. In the whole cohort, OpR was more clearly associated with therapy satisfaction compared with BTcP opioids or basal pain opioids alone. The majority of the clusters were linked to peculiar association of certain drugs with therapy satisfaction or dissatisfaction. A free online tool was created for new patients cluster computation ( https://mancapaolo.shinyapps.io/UCBM_BTcPclusters/ ) in order to validate these clusters in future studies and to provide a possible, handy indications for personalized BTcP therapy. Conclusions: This work proposes a classification for BTcP and identifies subgroups of patients with unique efficacy of different pain medications. This work supports the theory that the optimal dose of BTcP opioids depends on the dose of basal opioids and identifies novel values, possibly useful for future trials.
Analysis of the efficacy and safety of naloxegol administered to patients with cancer and opioid-induced constipation with laxative-inadequate response: A real-world 12 months of follow-up study.
Authors: Dols Manuel Cobo , Beato Carmen , Cabezon-Gutierrez Luis , Chicas Sett Rodolfo , Blancas Isabel , García Navalón Francisco Javier , Fírvida Pérez José-Luis , Serrano Bermúdez Gala , Togores Pilar , Delgado Ignacio , Giraldo-Marín Alexandra , Librán-Oriol Anna , Paredes Lario Alfredo , Sánchez Mauriño Pedro , Higuera Oliver , Moreno Diana , Jiménez-López Antonio Javier , Huerta-González Ibone , Sanz-Yagüe Almudena , Soler Begoña
Published: May 2020

e24155

Background: Naloxegol is a peripherally acting, µ-opioid receptor antagonist for treatment of opioid-induced constipation (OIC). The main objective of this study was to analyze the efficacy and safety of naloxegol in patients with cancer in a real-world 12-month follow-up study. Methods: An observational prospective study was conducted in 16 Spanish centers. Patients older than 18 years, with active oncological disease who were under treatment with opioids for pain control and Karnofsky ≥ 50 were selected. OIC with inadequate response to treatment with laxative (s) was the main diagnostic. All the patients received treatment with naloxegol according to clinical criteria. Efficacy was measured by the response rate and symptoms evolution measured by means of PAC-SYM questionnaire. Intensity of pain was measured by a 0-10-point visual analogue scale (VAS). Intent to treat last observation carried forward was applied. Results: A total of 126 patients were included in the study. About 58.7% were men, with a mean age of 61.5 years (34-89). Lung cancer was observed in 35.7%, breast cancer in 16.7%, 10.3% digestive cancer and 8.7% had prostate cancer. About 67.5% had metastases. Naloxegol at doses of 25 mg/day was administered to 88.1% and with concomitant laxatives in 48.4%. At 12 months, 77.8% of the patients were responders to naloxegol treatment: 78.6% at doses of 12.5 mg/day, and 78.4% with 25 mg/day. Furthermore, response was observed in 78.5% of patients without concomitant laxative treatment and 77% of patients with any concomitant laxative. PAC-SYM total score and all the dimensions improved from baseline (p < 0.0001). VAS pain intensity was reduced and controlled from baseline onwards (Baseline-12 months: 4.6 to 3.6, p < 0.001). A total of 28 adverse reactions mainly gastrointestinal were observed in 15.1% of the patients (19/126), 75% (21) mild, 17.9% (5) moderate and 7.1% (2) severe. Most adverse reactions (67.9%) were observed the first 15 days of treatment with naloxegol. Conclusions: The results of this first real-world-data study in patients with cancer confirm the long-term efficacy of naloxegol for the treatment of OIC in this group of patients. Naloxegol is safe and well tolerated in patients with cancer while maintaining pain control.
Radiofrequency ablation versus stereotactic body radiotherapy for painful osseous metastases: A comparative correlation meta-analysis of pain relief.
Authors: Mehta Tej , Heiberger Caleb , Kazi Stephanie , Anton Boggy , Brown Mark , Lommen Matthew , Weissman Simcha , Sandhu Divyajot , Hong Kelvin , Yim Douglas , Mehta Minesh P.
Published: May 2020

e24156

Background: Osseous metastases (OMs), a common cause of cancer pain, are only partially palliated by analgesics. Stereotactic body radiotherapy (SBRT) and radiofrequency ablation (RFA) are increasingly used, but the comparative effectiveness of SBRT vs. RFA for OMs has not been adequately evaluated. Herein we analyzed palliative benefits of SBRT and RFA in terms of pain relief from OMs. Methods: A systematic review was performed for all studies reporting palliative outcomes of SBRT (defined as five or fewer fractions of radiation) or RFA for palliation of OMs. Studies not reporting pain palliation were excluded. Random effects model determined the net Pearson correlation (R2) for post-SBRT and post-RFA pain reduction over time. The pooled correlation coefficient and 95% confidence interval were calculated using Fisher r-to- z transformation. Risk of bias was assessed using sunset plots; heterogeneity was assessed using I2 and meta-regression. Results: Seven full-text articles assessed a total of 1100 SBRT patients and 22 full-text articles assessed a total of 557 RFA patients. No studies directly compared SBRT to RFA. All included studies collected data on pain related to OM disease pre- and post-therapy. The scales used included the visual analog scale (2 SBRT, 15 RFA), brief pain inventory (4 SBRT, 4 RFA), numeric rating scale (0 SBRT, 2 RFA), QLQ-15 (1 SBRT, 0 RFA), or the memorial pain index card (0 SBRT, 1 RFA). Mean SBRT dose and fractions were 17.3 gy and 2.6. Median follow-up was 24 weeks for SBRT and 18 weeks for RFA, with median pain reduction of 59% (R2=0.83, 95%CI:0.80-0.87, I2=58.63%) and 64% (R2=0.52, 95%CI:0.41-0.62, I2=48.16%) respectively. Meta-regression by number of fractions and reporting metric fully accounted for heterogeneity in the SBRT and RFA data respectively. Sunset plots did not indicate significant publication bias. Conclusions: The published literature is predominately non-randomized, limiting the evidence level. Pain reduction and durability post-SBRT or post-RFA are comparable. Pre-SBRT or RFA therapies may obscure the full effect of either treatment modality. SBRT and RFA for painful OMs are associated with pain relief in a majority of patients, but the durability of this relief and the comparative efficacy of SBRT vs. RFA for this purpose has been inadequately reported in the literature. Future, combinatorial therapies as opposed to single-modality approaches may help to increase overall pain relief and durability as well as efficaciously palliating treatment-resistant patients.
Using consistent terms in precision medicine to eliminate patient confusion.
Authors: Martin Nikki A. , Friedman Sue J. , Saxton Claire , Yarden Ronit , Lindsey Stacie , Kuhn Erica , Guglielmino Janine , Garcia Reese , Moravek Cassadie , Zajchowski Deborah A. , Miyahira Andrea K. , Montoya Denisse , Verini Christine , Schrag Janelle , Gonzalez Victor , Hooker Gillian , Bens Cynthia , Davison Beth , Horn Marcia K.
Published: May 2020

e24164

Background: Biomarker testing has advanced precision medicine in cancer. However, not all eligible patients benefit from biomarker-driven therapies due to suboptimal testing rates. A working group of 20 patient advocacy groups representing solid/hematologic malignancies, three professional societies, and 18 pharmaceutical and diagnostics companies identified patient confusion inconsistent testing terms as a possible contributing factor to biomarker testing underutilization. The group aimed to address patients’ confusion by identifying and adopting consistent, plain language terms for biomarker and germline genetic testing that are applicable across cancer types. Methods: Following a stakeholder roundtable discussion on barriers to precision medicine, working group members participated in interviews on their goals for consistent testing terminology for their constituents. We then conducted a framework analysis covering five themes: available testing by cancer type; purpose of test; biospecimen source; terms used in patient education; and preferred plain language term. Working group members were surveyed on preferences for germline testing terminology and also deployed a preliminary patient survey to their constituents to gain insight on preferences for germline testing terms. Results: Interviews, framework analysis, and surveys revealed notable differences across cancer communities. We identified at least 33 different terms related to biomarker, genetic and genomic testing being used in patient education and clinical care among the different cancer communities and stakeholders. Terminology was complicated by the variety of testing modalities and gene mutations tested for across cancers. Following multiple discussions, working group members agreed on two umbrella terms to distinguish between somatic and germline testing with additional context for specific cancer communities. “Biomarker testing” was selected as the somatic testing term. “Genetic testing for an inherited mutation” and “genetic testing for inherited cancer risk” were selected as preferred germline testing terms. Conclusions: Our findings highlight the disparate testing terminology landscape and the need for consistent terms to reduce patient confusion, improve communication, facilitate shared decision-making and assure concordance in policy development.
Understanding the daily needs and challenges of caregivers of patients with lung cancer.
Authors: Zhu Yanyan , Scipione Fatima , Anderson Renee , DiPaolo Robin Y. , Miller Ros , Cherol Kristine , Draft Chris , Lester Georgeta , Bell Jill
Published: May 2020

e24173

Background: Informal caregivers provide critical support in the management of all aspects of care for patients with cancer. Although caring for loved ones with cancer can be rewarding, it can also have a significant impact on caregivers’ quality of life. The aim of this study was to understand how caring for someone with advanced lung cancer affects caregivers’ lives. Methods: A targeted review of the caregiver literature (Medline, Embase, and Psych Info; year limits 2006-19) using a single search strategy, and qualitative focus group discussion among caregivers (N = 6) who have been or are currently caring for a loved one with advanced lung cancer was conducted. Results: The search identified 99 articles; however, few articles met eligibility criteria (N = 12). Impacts focused on: caring for patient, psycho-social well-being, ability to work, hopes for future, and physical well-being. Several gaps describing the caregiver experience remained based on the results from the literature review alone. Qualitative insights from caregivers included: (1) Caregivers must deal with all aspects of the patient’s experience, as well as the broader physical and emotional well-being of themselves and family members. (2) Disease-related symptoms and treatment-related side effects can result in physical and emotional distress for both caregivers and patients. (3) Caregivers feel hopeless, frustrated, and discouraged regarding side effects, particularly when they cannot perceive the benefits of treatment. (4) Caregivers are often compelled to mask or suppress their feelings to maintain a sense of (relative) normalcy. (5) Negative emotional states directly affect family relationships and dynamics, heightening stress and loneliness for caregivers. (6) Caregivers’ contributions to shared treatment decision-making relative to the patient’s role shift throughout the cancer journey based on their loved one’s ability to cope. Conclusions: These results provide valuable insights into the under-studied experience of caregivers of patients with lung cancer. Future quantitative research will improve understanding of the unique challenges associated with cancer caregiving, as well as facilitate development of personalized, evidence-based support programs and interventions for caregivers.
Decision aids for localized prostate cancer: Initial outcomes from NCI Community Oncology Research Program Alliance Research Base Cancer Care Delivery Research (CCDR) Protocol - A191402CD - A Cluster-Randomized Trial.
Authors: Tilburt Jon Charles , Pacyna Joel E , Petereit Daniel G. , Kaur Judith Salmon , Rapkin Bruce D. , Grubb Robert , Chang George J. , Morris Michael J. , Kovac Evan , Sloan Jeff A. , Basch Ethan M. , Storrrick Elizabeth M. , Zahrieh David , Dueck Amylou C. , Paskett Electra D. , Buckner Jan C. , Montori Victor , Frosch Domnick L , Volk Robert Joseph , Kim Simon P.
Published: May 2020

e24176

Background: Decision aids for prostate cancer treatment can improve knowledge, but the relative effect of pre-consultation and within-consultation DAs is not known. Methods: We conducted a parallel design, 2-by-2 factorial, 4-arm, cluster-RCT in urology practices affiliated with the NCI’s Alliance research base. We compared patient knowledge immediately after consultation (%12-item% correct) intervention arms compared to usual care. We used mixed effects regression modeling to assess effect of interventions on knowledge adjusting for site-clustering, race/ethnicity (non-Hispanic White; Other), age (years), clinical stage (T1-3), PSA, and Gleason score. Results: 15 of 21 randomized centers accrued 158 pts from Nov 2017 to June 2019. The arm delivering both DAs (n = 3 sites) recruited 25 pts. The pre-consultation DA arm (n = 4 sites) recruited 39 pts. The within-consultation DA arm (n = 4 sites) recruited 44 pts. The no DA arm (n = 4 sites) accrued 50 pts. Overall, mean age was 64; 54% were AA; 73% had T1 stage; median Gleason = 7; and median PSA = 7. The combined DAs group, followed by pre-consultation reported higher median knowledge (75% and 67%, respectively). The within-consultation and no DA arms both reported median knowledge scores (58%). Within arm, inter-site standard deviations in mean knowledge scores ranged from 0.164 in in the pre-consultation arm to 0.232 in the usual care arm. Neither pre-consultation nor within-consultation DAs had statistically significant effects (p = .15 and p = .99, respectively). Pre-specified adjusted difference [97.5% CIs], comparing the pre-consultation DA and the within-consultation DA with the control was 9.4% [-7.3%, 26.2%] and -0.4% [-16.9%, 16.1%], respectively. Intra-cluster correlation (ICC) coefficient was high (.24). No interaction effects were identified (p = .98). A post-hoc analysis comparing any DA vs usual care found a mean adjusted difference [95% CI] of 5.6% [-8.5%, 19.8%] (p = 0.40), 63.9% for any DA and 58.3% for usual care. Conclusions: Possible knowledge gains associated with some DAs for early prostate cancer were obscured by larger-than-expected intra-cluster correlation effects associated with the primary outcome. How interventions were used was not measured. Support:UG1CA189823; https://acknowledgments.alliancefound.org ; R01 MD008934-06. Clinical trial information: NCT03103321 .
Evaluating sexual function in adolescent and young adult childhood cancer survivors.
Authors: Sopfe Jenna , Marsh Rebekah , Appiah Leslie C. , Klosky James L. , Peterson Pamela N , DorseyHolliman Brooke
Published: May 2020

e24180

Background: Up to half of adolescent and young adult (AYA) childhood cancer survivors (CCS) experience sexual dysfunction (SD) as a result cancer or its treatment. SD in CCS is under-recognized, with low levels of routine screening due to barriers such as discomfort, time, and awareness. This study explores solutions to these barriers by describing AYA CCS preferences for implementation of screening for SD and evaluating the utility of a validated adult screening tool (PROMIS SexFS Brief) in this population. Methods: 16 AYA CCS (aged 15-24 years) completed semi-structured interviews followed by questionnaire completion. Interviews explored patients’ prior experiences with SD screening, along with preferences for screening type (e.g., discussion, screening tool), delivery modality, and timing. Patients then completed the PROMIS SexFS Brief while verbalizing their thoughts and providing open-ended responses to each item. Transcribed interviews were inductively coded and analyzed, guided by content analysis methodology. Results: This analysis represents 2/3 of planned interviews, and all will be completed by April 1, 2020. Interviews were performed with 11 females and 5 males (median age 21). Preliminary analysis demonstrates that participants had minimal experience with SD conversations, but had preferences regarding by whom, how, and when screening/education should occur. Who: Participants felt providers should have preexisting rapport with their patients; preferences existed for provider role and sex/age. How: A combination of written materials and in-person conversations was preferred. Several acknowledged a desire to have a “warning” that the conversation would happen, such as through a questionnaire. Participants did not have a preference regarding delivery modality (paper vs. online). The PROMIS SexFS Brief appeared to demonstrate content validity and acceptability in AYA CCS. When: Participants wanted education and screening to occur regularly throughout cancer therapy and survivorship. SD conversations should be tailored developmentally to the patient. Conclusions: Our results demonstrate a theme throughout interviews of the importance of patient/provider rapport. Further, while AYA CCS prefer in-person conversations about SD, conversations should be preceded by written information or a questionnaire to increase patient preparedness/comfort. Preliminary findings suggest that the PROMIS SexFS Brief is a promising tool for screening SD in this population; further studies evaluating use in clinical settings is warranted.
Patient knowledge and expectations of anti-cancer treatments in the advanced disease setting.
Authors: Cowzer Darren , Hennessy Maeve , Linehan Anna , coyne zac , Creegan Daniel , Glynn Emily , Hennessy Bryan T. , Morris Patrick G. , Grogan William , Breathnach Oscar S.
Published: May 2020

e24187

Background: Systemic treatments can improve symptom burden and prolong life in patients with advanced cancer. However, these therapies come with associated toxicities and in some cases can result in reduced quality of life for patients with no possibility of cure. International data has suggested that this cohort of patients have a poor understanding surrounding the goals of treatment in the advanced disease setting. We aimed to evaluate the expectations for cure and palliation from systemic therapies among patients with advanced, incurable cancer in our institution. Methods: Patients on active treatment attending the Oncology Day Ward completed anonymous questionnaires over a four week period. Personal demographics, decision making for treatment and expectation of benefit and toxicity was assessed. Analysis was carried out on patients assessed to have advanced metastatic disease. Results: 254 patients completed the questionnaire. 217 patients were assessed to have metastatic/incurable disease based on responses. 57% were male, 56% were age 30-64 and 35% had completed university level education. 42% of patients stated that treatment was very likely or somewhat likely to cure their cancer. Among patients who reported that a cure was very likely, there were more men (62%) compared to women (38%), more patients were aged less than 65 (62%) compared to over 65 (38%) and more patients had only completed elementary school level education (71%) compared to university level education (29%). Most patients (84%) felt treatment was either very likely or somewhat likely to help them live longer. 68% of patients felt treatment would help them with problems related to their cancer and 33% of patients felt that treatment was very likely to have side effects or complications. 22% of patients stated that doctors made decisions without their input. Conclusions: Many patients receiving treatment for incurable cancers do not understand that it is unlikely to be curative. Male gender, younger age and a lower level of education appears to be associated with unrealistic expectations. This could compromise their ability to make informed treatment decisions. More effective communication around goals of treatment and end of life care may help to improve patients understanding and expectations around the outcomes of chemotherapy.
Trends in patient misperception and decisional regret during treatment for advanced cancer: A prospective study.
Authors: Miller Eric James , Patell Rushad , Einstein David Johnson , Halleck Jennifer , Dodge Laura , Buss Mary K.
Published: May 2020

e24190

Background: Cancer patients receiving palliative therapy often misperceive the likelihood of benefits and toxicity. Change in misperception during treatment and decisional regret after has not been studied. We assessed shifts in perception of treatment outcomes and decisional regret after treatment in a single-center prospective study. Methods: We enrolled patients with advanced solid cancer starting palliative intent treatment. At baseline, both patients and their treating physicians were asked about their perceived likelihood of treatment response, symptom palliation, survival benefit, and treatment toxicity on scale of 0-100% at start of treatment and at follow-up. The Signed Rank tested whether patient perception changed significantly over time. After treatment, patients alive and not in hospice were asked about their decision to undergo treatment. Results: Of 122 patients with baseline estimates, 65% completed at least one follow-up survey while undergoing treatment. At enrollment, respondents’ mean age was 65 years (range: 32–89); 54% were male. Compared to baseline, there was no change in patients’ perceptions of treatment response, survival benefit, toxicity (all P≥0.52) at follow-up; a trend toward change in perceived curative potential (P = 0.06); an increase (of 7 points) of perceived likelihood of symptom relief (P = 0.04). Perceived likelihood of treatment response and symptom relief increased (both P < 0.03) among patients whose baseline estimates of treatment response were lower than or similar to their physicians’ estimates. Conversely, perceived likelihood of treatment response (P = 0.01) and curative potential (P = 0.02) decreased among patients with more optimistic estimates than their physicians’. Of the surviving 63 patients, 33 (52%) completed the end of treatment survey, 24 were unreachable and 6 declined. Median time of survey response was at 41.2 weeks (IQR: 36.4 – 47.9). Nearly all (95%) agreed that treatment was the right decision. None regretted their choice; 79% agreed they would make the same choice if they had to do it again; 12% agreed that treatment did them a lot of harm. Conclusions: Patients’ perceptions of treatment response converged during therapy as compared to their physicians at baseline. Of surviving patients surveyed, none regretted their decision to receive palliative cancer treatment. Treatment expectations evolve over time, highlighting opportunities for enhanced communication and patient education beyond initial consent procedures.
Drivers and barriers to clinical trials (CTs) participation among oncological and non-oncological patients in Poland: A cross sectional survey.
Authors: Kotowski Artur , Świetlik Dariusz , Kotowska Maja Dominika , Wronowski Michał , Fal Andrzej Mariusz
Published: May 2020

e24191

Background: Understanding patients decision-making process regarding participation in a clinical trial (CT) is crucial for research associates. It enables efficient recruitment and timely completion of a study. The patients perspective is becoming increasingly important worldwide however Polish patients attitudes to CTs have not been studied well enough yet. This study analyses multiple factors influencing oncological (onco) and non-oncological (non-onco) patients decisions to participate in CTs. Methods: Total of 401 hospitalized adults who have never participated in a CT were recruited to take a paper and pencil interview survey. 211 patients (52.6%) were diagnosed or treated for cancer and 190 (47.4%) for non-oncological diseases. The majority of respondents were: (1) women: 256 (63.8%), (2) people with secondary education: 223 (55.6%), (3) at the age of 60-69: 147 (36.7%), (4) living in cities over 100k inhabitants: 179 (44.8%). Results: If proposed, 49.9% of all respondents would agree to be enrolled in a CT (non-onco 52.1% vs onco 47.8%, p = 0.61); 14.9% would refuse (13.3% vs 16.3% respectively) and 35.2% were not certain about the decision (34.6% vs 35.9%). Top two drivers for participation in CTs of non-onco patients were: chance of receiving a new drug (78.6%) and better access to medical care (74.5%), while for oncological respondents: better access to medical care (77.0%) and to additional diagnostic tests (76.0%). Altruism was declared by a total of 54.5% respondents. Main reasons for not participating were: concerns about toxicity – 57.6% (p = 0.14), about lack of efficacy – 44.1% (p = 0.01) and refusal to be a “guinea pig” – 59.3% (p = 0.23). For uncertain respondents, the most convincing factors for enrollment was a terminal phase of the disease: 57.1% in total (onco 69.3% vs non-onco 43.1%, p = 0.01). The results of subanalyses based on demography and type of diagnosis were not of statistical significance. Conclusions: The willingness to participate in CTs is high, which is mainly driven by a chance for a better access to medical care and additional diagnostic tests. Improved access to state-financed care and innovative medicines for chronically ill patients in Poland are needed.
Cancer patients’ perceptions of physicians who use an integrated electronic health record (EHR) approach during clinic visits: A double-blinded randomized clinical trial (RCT).
Authors: Haider Ali , Azhar Ahsan , Tanco Kimberson Cochien , Naqvi Syed Mussadiq Ali Akbar , Epner Margeaux , Reddy Akhila Sunkepally , Williams Janet L. , Wu Jimin , Bruera Eduardo
Published: May 2020

e24201

Background: Our previous RCT found that cancer patients prefer and positively perceive physicians who communicate face-to-face as compared to using the EHR. However, the use of EHR in the examination room remains a practical necessity. Based on the existing literature, our team developed a simple and very short intervention to integrate the EHR into the encounter, which includes optimal positioning of the computer, a proper introduction to the computer, effective time management for data-entry while maintaining patient-physician interaction and use of the EHR as a tool to enhance patient education. Methods: In this double-blind, crossover RCT, 120 patients with advanced cancer were enrolled between April 1, 2019, and September 15, 2019. Our objectives were to compare patients’ perceptions of physicians’ compassion, communication skills, professionalism, and patients’ overall physician preference after watching 2 standardized scripted-video vignettes of physicians: one portraying the use of a standard EHR approach and the other portraying use of an integrated EHR approach. Both actors and patients were blinded to the purpose of the study. Investigators were blinded to the sequence of videos watched by the patients. After viewing each video, patients completed validated questionnaires rating their perception of the physician’s compassion (0 = best, 50 = worst), communication skills (0 = poor, 70 = excellent) and professionalism (0 = poor, 20 = very good). Patients were also asked to rate their overall physician preference. Results: After watching the first video, the integrated EHR, compared to the standard EHR, resulted in better scores for physician compassion (median [interquartile range], (5[0-10] vs 12[4-25]; P = .0009), communication skills (69[63-70] vs 61[50-69]; P = .0026) and professionalism (20[18-20] vs 18[14-20]; P = .0058). The majority of cancer patients preferred an integrated EHR physician as their provider (70[58%] vs 21[18%], P < 0.0001). Patients with college or an advanced degree had a 5 times higher chance of preferring an integrated EHR physician ( P < 0.0171). Conclusions: Cancer patients perceived physicians who used an integrated EHR approach as more compassionate, professional, and with better communication skills. Moreover, they preferred an integrated EHR physician to be their provider. Integrated EHR has the potential to improve communication in oncological settings. Clinical trial information: NCT03856060 .