bluuebunny/crossref_metadata_2025_split huggingface dataset:
The relationships between cancer diagnosis/prognosis awareness and quality of life, anxiety, and depression in Chinese gastroesophageal cancer patients: A cross-correlation analysis.
Authors: Wang Long , Zuo Jing , Wang Yudong , Feng Li , Zhang Xue , Han Jing , Li Dan , Hu Xinyan , Liu Jiayin , Zhou Xinliang , Fan Zhisong 
Published: June 2021

e24111 Background: Many gastroesophageal cancer patients in China are not made aware of their cancer diagnosis/prognosis. Explorations of the differences in depression, anxiety and quality of life between cancer patients with and without such awareness are rare. The aim of this study was to evaluate the correlation between cancer awareness status and quality of life, anxiety and depression in gastroesophageal cancer patients. Methods: Participants were gastroesophageal cancer patients recruited from a medical center in North China. The degree of awareness of their cancer diagnosis/prognosis was evaluated via interviews. Data were collected using the Self-Rating Anxiety/Depression Scale and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and were analyzed using quantitative methods. Results: The study included 157 gastroesophageal cancer patients: 31 were completely unaware of their cancer diagnosis/prognosis (19.75%); 51 were partly aware (32.48%); and 75 were fully aware (47.78%). Thirty patients (19.11%) experienced anxiety and 35 (22.9%) depression. Unawareness of the real disease status was significantly correlated with worse quality of life (cognitive functioning, social functioning and appetite loss) ( Ps < 0.05) and anxiety ( P = 0.003). Conclusions: More than 50% of gastroesophageal cancer patients were unaware their diagnosis/prognosis completely and were more likely to experience worse quality of life and anxiety. Medical staff and family members should take appropriate measures to make patients aware of their cancer diagnosis/prognosis, as awareness is valuable for improving quality of life and negative emotions, contributing to the successful overall management of gastroesophageal cancer.
Developing, implementing, and validating a social toxicity assessment tool of cancer (STAT-C).
Authors: Jazieh Abdul-Rahman , Jradi Hoda , Da'ar Omar B. , Alkaiyat Mohammad , Zafar Yousuf , Alolayan Ashwaq Aman Mohammed 
Published: June 2021

e24115 Background: The social impact of cancer on patients and their family is well known. Yet, unlike with physical and financial toxicities, no validated tools are available to measure this impact. This study aimed at developing, validating, and implementing a novel social toxicity assessment tool for patients with cancer diagnosis (STAT-C). Methods: Questions were generated through multiple steps including focus groups of patients, their families, and oncology care professionals. Content validity, internal consistency, face validity and factor analysis were conducted. The questionnaire (in Arabic language) was administered to 150 patients with cancer served at King Abdulaziz Medical City, Riyadh, Saudi, Arabia. Results: STAT-C contains 14 items covering three domains: Social Relations domain (eight questions) related to relationship with parents, spouse, children, siblings, friends, members of congregation, and caregiver; Social Activities domain (two questions) measures participation in social events and leisure; and Economic Impact domain (four questions) related to standard of living, finances, and loss of job. The total possible score for each patient for the 14 items in the tool varied between -28 and +28 (Range = 56). Dividing the range by three levels of a socioeconomic toxicity yielded the length of each level, which effectively defined the categories as- Severe social toxicity (SST score: -28 to -9.3), mild social toxicity (MST: -9.2 to 9.5) and no social toxicity (NST: 9.6 to 28). Conclusions: Our study revealed that STAT-C is a valid and reliable tool in assessing the social toxicity of cancer in Arabic-speaking patients. Validating the tool in an English-speaking population is planned. The tool should enable oncology professionals to deliver better patient-centered care as a component of a holistic approach.
The SHARE study: Pilot study of a communication intervention designed to elicit advanced-stage cancer patients’ preferences and goals.
Authors: Thompson Embree , Wright Alexi A. , Keating Nancy Lynn 
Published: June 2021

e24120 Background: Helping seriously-ill cancer patients identify and communicate their preferences for care can increase satisfaction, decrease anxiety and depression, and result in less intensive, hospital-based end-of-life medical care. We developed an intervention designed to elicit patients’ preferences and goals for care and share them with their family and care teams. We sought to pilot-test the feasibility and acceptability of this intervention in advanced cancer patients. Methods: We enrolled advanced-stage cancer patients and their clinicians at an academic and community oncology practice. Eligibility criteria included: patients with metastatic solid tumors and ≥2 prior lines of therapy or patients for whom oncologists indicated that they “would not be surprised” if the patient died within 6 months. Participants watched a 2.5 minute video which prompted them to think about how they define “a good day;” completed a 3-page brief questionnaire, which was shared with their care team; and were given a wallet card with question prompts. The primary outcomes were feasibility (i.e., ≥60% approach-to-consent ratio among eligible patients, ≥60% of participants rated the intervention positively) and acceptability (i.e., ≥60% of participants would recommend the intervention to patients like them). Secondary outcomes, measured pre- and post-intervention, included patient anxiety and distress, hope, quality of life, and therapeutic alliance with their care team. Results: Among 59 potentially eligible patients approached, 53 agreed to participate (90% approach-to-consent ratio). Four patients were non-evaluable because they died before study completion. Among the 49 remaining participants (mean age = 63 years, range 40-86 years), all completed the intervention. Overall, 45 of 49 patients (92%) rated their experience as excellent, very good, or good. Most participants agreed or strongly agreed that they would recommend the video (83%), brief questionnaire (88%), and wallet card (63%) to patients with cancers like theirs. However, only 34% of participants reported having an opportunity to review the questionnaire with their oncologist. There were no increases in patient anxiety or distress associated with the intervention or reductions in hope, quality of life, or therapeutic alliances with oncologists (all P > 0.05). Conclusions: A communication intervention that combined a video, questionnaire, and wallet card was both feasible and acceptable for helping advanced cancer patients identify their care preferences and goals. Future studies should examine combining this with an intervention that primes clinicians to engage in goals of care discussions with advanced-stage cancer patients. Clinical trial information: NCT03392090.
Cancer patients’ awareness about clinical research in the era of social media and “fake news”: Preliminary results from ELPIS Study.
Authors: Cagnazzo Celeste , Franchina Veronica , Toscano Giuseppe , Fagioli Franca , Franchina Tindara , Ricciardi Giuseppina Rosaria Rita , Antonuzzo Lorenzo , Di Costanzo Alessandro , Russo Antonio , Cusenza Stefania , Gori Stefania , Marchetti Fabiana , Tambaro Margherita , Piccirillo Patrizia , Nanni Oriana , Cenna Rosita , Delfanti Sara , Di Maio Massimo , Dascanio Fabio , Adamo Vincenzo 
Published: June 2021

e24121 Background: Barriers for low recruitment in clinical trials have been classified based on three main sources: physician, patient, system. A primary role is played by a low patient awareness, which often leads to a lack of confidence in science and a substantial inability to estimate the benefits deriving from trial participation, aggravated by the spread of fake news. A prospective observational study was conducted to investigate the views of cancer patients on aspects of clinical research, their expectations, the level of comprehensibility of informed consent and the impact of the fake news phenomenon. Methods: From January 2018, after Ethics Committees approval, the ELPIS study was initiated in 9 Italian Medical Oncology Units. After signing the informed consent, patients were asked to complete a questionnaire, consisting of a set of multiple choice and Likert-score questions. Results: As of January 2021, 115 patients were enrolled, with a balanced sex distribution and a prevalence of subjects older than 55-years (79.8%). Regarding the previous knowledge about clinical research, the average score was 3.9 (range 1-5). The vast majority of respondents (91.3%) had already started experimental therapy and many of them constantly used internet (65.2%) and social networks (34.8%). More than half (53.9%) stated the interview with the physician was sufficient for a full understanding of informed consent. In case of doubt, the majority seeked support in the clinician (39.1%) while very few (1.7%) relied on the web. The average score attributed to doctor-patient relationship was equal to 8.89 (range 1-10). Respondents were quite confident in their ability to independently search for information on their disease, discriminate fake news and identify reliable sites (average score 3.26, 3.27, 3.09 respectively, over a range of 1-5). The scores related to the presumed ability to understand the results of a clinical study and to actively collaborate to produce research were high (average score 4.72 and 4.39 over a range of 1-5). Conclusions: Preliminary data from our research show a good level of patient awareness and a fine ability to understand information, discerning real from fake news. Continuing and implementing the training initiatives of the population in the health sector will certainly contribute to further improvement, hopefully obtaining an even greater involvement of patients in the early phases of research.
Healthcare professionals’ perspectives on unique communication and care needs for Chinese American cancer patients.
Authors: Schroeder Courtney , Ernst Emma , Vesel Tamara 
Published: June 2021

e24122 Background: Effective clinician-patient discussions of cancer diagnoses and prognoses are essential to enhance health outcomes in diverse oncology populations. To provide guidance on communication preferences and needs among Chinese Americans, one of the fastest growing yet understudied ethnic groups in the United States, we explored considerations and observations from healthcare providers experienced in caring for this oncologic population. Methods: In this inductive, emergent qualitative study, we completed 20 semi-structured virtual interviews with providers from assorted healthcare disciplines with experience caring for Chinese American cancer patients in Boston’s Chinatown. Responses were systematically collected and analyzed using open and focused coding, constant comparative methods, and thematic analysis. Results: Twenty healthcare professionals with experience working with the Chinese American patients were interviewed including medical oncologists, radiation oncologists, primary care physicians, nurses, nurse practitioners, social workers, case managers, patient navigators and dietitians. Fifteen were female, 5 were male, and 11 participants self-identified as Asian. Six key themes were identified: (1) Discussing cancer diagnoses and prognoses is taboo and often avoided by Chinese Americans in family, community, and healthcare settings. (2) A cancer diagnosis may be considered a death sentence by Chinese Americans, regardless of cancer location or stage. This could be related to the meaning implied by direct translation of the word “cancer.” (3) In settings where cancer diagnoses and prognoses are discussed, Chinese American patients often prefer indirect communication approaches including use of expressions such as “tumor,” “mass,” or “illness” to avoid the use of the word “cancer.” (4) The family centered role in medical decision making for Chinese American cancer patients and the preference of some family units to protect the patient from their diagnoses present unique challenges in the context of standard care. (5) Obtaining a detailed psychosocial history is important to guide communication approaches, as patient characteristics like age, generation since immigration, and education play a foundational role in communication preferences. (6) Karma and nutritional beliefs should be considered and addressed in oncologic care, as they play a critical role in health and disease management for Chinese American cancer patients. Conclusions: Further exploration of these insights and confirmation of their accuracy by discussing directly with Chinese American patients is imperative. If these findings are corroborated through further investigation, this knowledge can be used develop educational tools and implement clinical practice changes to enhance care outcomes and communication with Chinese American cancer patients.
Stress as a predictor of tumor growth and development of metastases.
Authors: Peyser Tristen , Geller David A. , Terhorst Lauren , Antoni Michael , Vodovotz Yoram , Hausmann Leslie , Olejniczak Donna , Amin Aarshati , Kiefer Gauri J. , Hecht Carol Lynn , Miceli Jessica , Tong Albert , Johnson Jonas T. , Nilsen Marci Lee , Zandberg Dan Paul , Reyes Vincent Edgar , Steel Jennifer 
Published: June 2021

e24124 Background: The aims of this study were to examine; the predictors of perceived stress; and the associations between perceived stress and tumor growth and development of metastases as well as the mediational role of inflammatory biomarkers. Methods: This study is prospective in design. A battery of questionnaires, including a sociodemographic characteristic and the Perceived Stress Scale, was collected at baseline from patients diagnosed with solid tumors at various stages of treatment. Disease progression was measured over a 12-month period. Poverty threshold was determined using the U.S. Department of Health & Human Services 2020 poverty guidelines. Computerized tomography and Magnetic Resonance Imaging scans were assessed for disease progression between baseline and 12 months using Response Evaluation Criteria in Solid Tumors. Blood was collected and serum levels of IL-2, IL-1a, IL-1b, TNF-a, IL-6, and IL-8 were assessed. The predictors of stress include sociodemographic and disease specific characteristics. Primary outcomes were tumor growth and development of metastases. Descriptive statistics, correlations, and ordinal and linear regression were performed to assess the aims. Results: Of 159 patients diagnosed with cancer, 47.8% were male, mean age was 62.97 (SD = 10.35), 89.3% were Caucasian, and 13.8% met poverty guidelines. Significant predictors of stress were age (b=-.151, p=0.029, 95% C.I.=-2.86-.016) and income below the poverty threshold (b= 5.615, p=0.007, 95% C.I.=1.596-9.635). Gender was the only sociodemographic and disease specific factor significantly associated with disease progression. After adjusting for gender, greater perceived stress was associated with tumor growth and development of metastases (p =0.029), accounting for 33.3% of the variance. Circulating cytokines were significantly related to disease progression [IL-1a, p=0.020; IL-1b, p=0.011; IL-6, p<0.001; and IL-8, p<0.001] but not stress [IL-1a, p=0.369; IL-1b p=0.292; IL-2, p=0.470; IL6 p=0.406; and IL8, p=0.401]. Conclusions: Future research should evaluate inflammation in the tumor microenvironment as well as neutrophils and tumor suppressor genes as potential mediators between stress and disease progression.
Trial in progress: A phase 1b/2 study of the PARP inhibitor niraparib in combination with trastuzumab in patients with metastatic HER2+ breast cancer (TBCRC 050).
Authors: Stringer-Reasor Erica Michelle , Li Yufeng , Witherspoon Felicia , Specht Jennifer M. , Anampa Mesias Jesus Del Santo , Nanda Rita , Dees Elizabeth Claire , Wolff Antonio C. , Krop Ian E. , Lin Nancy U , Rimawi Mothaffar F. , Yang Eddy Shih-Hsin 
Published: June 2021

TPS1098 Background: Approximately 20% of breast cancers (BC) express the human epidermal growth factor receptor 2 (HER2). Although HER2-directed therapies result in improved patient outcome, resistance ultimately occurs. Poly (ADP-Ribose) polymerase (PARP) inhibitors are currently indicated in cancers that express germline mutations in the DNA repair proteins BRCA1/2 due to their synthetic lethality against the homologous recombination repair (HR) pathway. In addition to its role in DNA damage repair, PARP1 has also been implicated in other cellular functions, including co-activation of genes such as NF-κB, which regulate tumor proliferation and HER2 drug resistance. Our group identified that HER2+ BC overexpress the PARP1 and phospho-p65 protein. In HER2+ BC cells and animal models, PARP inhibitors initiated apoptosis independent of a DNA repair deficiency, via inhibition of NF-kB signaling. Key proteins (p65, IKK-α) of the NF-κB-mediated growth pathways were reduced and IκBα was increased in the presence of PARPi, implicating another oncologic pathway in which HER2+ BC cells may be dependent. Methods: The study is a phase 1b/2, multicenter, single arm clinical trial evaluating the safety and efficacy of niraparib 200 mg orally days 1-21 with trastuzumab 6 mg/kg (cycle 1 loading dose of 8 mg/kg) intravenously on day 1 of a 21-day cycle for patients with unresectable or metastatic HER2+ BC. Eligible patients include metastatic HER2+ BC, progression on at least 1 prior HER2-targeted therapy, measurable disease, ECOG PS 0-1, and LVEF ≥ 50%. Stable/treated CNS disease allowed. Prior PARPi and known germline BRCA 1/2 excluded. Forty patients will be enrolled at 7 US sites within the Translational Breast Cancer Research Consortium. The primary objectives are determining the dose-limiting toxicity (DLT) of the combination and assessing the objective response rate. The phase 1b cohort has been completed (N=6). Enrollment in phase 2 began February 2021 with a total accrual goal of 40. Gehan’s two-stage design will be used assuming the response rate is at least 24% and the response rate will be estimated with Clopper-Pearson exact method. Correlative aims include assessing blood and tissue biomarkers (e.g. PARP1, p65, phosphor-p65, let-7a miRNA, NF-kB, ctDNA, etc.) for association with clinical benefit and to predict response to therapy. Clinical trial information: NCT03368729 .
Trial in progress: Phase I/II study of radiation therapy followed by intrathecal trastuzumab/pertuzumab in the management of HER2+ breast leptomeningeal disease.
Authors: Ahmed Kamran A. , Kim Youngchul , DeJesus Michelle , Kumthekar Priya , Williams Nicole Olivia , Palmer Joshua David , Giglio Pierre , Boire Adrienne Ann , Arrington John , Sahebjam Solmaz , Rosa Marilin , Soliman Hatem Hussein , Yu Hsiang-Hsuan Michael , Han Hyo S. , Forsyth Peter A. J. 
Published: June 2021

TPS1099 Background: HER2+ breast cancer patients with leptomeningeal disease (LMD) represent a poor prognosis population with a high unmet clinical need. Although a multitude of treatment options are available for the management of systemic disease, once metastases travel to the leptomeninges, patients have a lack of treatment options aside from traditional local approaches. Data from a phase I/II study reveals intrathecal (IT) trastuzumab to be well tolerated with improved overall survival (OS) compared to historical controls in HER2+ breast LMD. Radiotherapy can improve the flow of IT therapy through the cerebrospinal fluid (CSF) and provide symptomatic relief. The monoclonal antibody pertuzumab is used in conjunction with trastuzumab in the management of metastatic and localized HER2+ breast cancer. Given the role of radiotherapy in the management of LMD along with the role of pertuzumab in the management of HER2+ breast cancer, there is a strong clinical rationale to combine radiotherapy with IT trastuzumab/pertuzumab in the management of HER2+ breast LMD. Methods: The study is designed as a prospective, single-arm, nonrandomized, open-label, phase I/II trial of radiation therapy followed by IT trastuzumab/pertuzumab in the management of HER2+ breast LMD. HER2+ LMD patients identified by magnetic resonance imaging (MRI) and/or CSF cytology, ≥ 18, with a life expectancy > 8 weeks are eligible. Treatment is initiated with radiotherapy, whole brain radiotherapy and/or focal brain/spine radiation followed by IT trastuzumab/pertuzumab. Safety and feasibility will be monitored by a modified toxicity probability interval-2 (mTPI-2) design. Dose reductions of IT trastuzumab will not be allowed. Once the maximum tolerated dose of IT pertuzumab is determined, the phase II portion of the study will commence to determine OS. Secondary objectives involve defining the CSF pharmacokinetics of IT trastuzumab/pertuzumab, evaluating the response rate (leptomeningeal and parenchymal), and progression free survival (leptomeningeal and parenchymal) following IT trastuzumab/pertuzumab. In the phase 2 portion, a single-arm two-stage trial is designed using the Restricted-Kwak-and-Jung’s Method. The primary endpoint is one-year OS. An interim analysis will be performed after 20 patients are enrolled. This study is open with 1 patient enrolled at the time of submission. Clinical trial information: NCT04588545 .