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The usefulness of the Electronic Patient Visit Assessment (ePVA)© as a clinical support tool for real-time interventions in head and neck cancer

Van Cleave, Janet H; Fu, Mei R; Bennett, Antonia V; Concert, Catherine; Riccobene, Ann; Tran, Anh; Most, Allison; Kamberi, Maria; Mojica, Jacqueline; Savitski, Justin; Kusche, Elise; Persky, Mark S; Li, Zujun; Jacobson, Adam S; Hu, Kenneth S; Persky, Michael J; Liang, Eva; Corby, Patricia M; Egleston, Brian L
Background/UNASSIGNED:Patients with head and neck cancer (HNC) experience painful, debilitating symptoms and functional limitations that can interrupt cancer treatment, and decrease their health-related quality of life (HRQoL). The Electronic Patient Visit Assessment (ePVA) for head and neck is a web-based mHealth patient-reported measure that asks questions about 21 categories of symptoms and functional limitations common to HNC. This article presents the development and usefulness of the ePVA as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC. Methods/UNASSIGNED:Between January 2018 and August 2019, 75 participants were enrolled in a clinical usefulness study of the ePVA. Upon signing informed consent, participants completed the ePVA and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) general (C30) questionnaire v3.0 (scores range from 0 to 100 with 100 representing best HRQoL). Clinical usefulness of the ePVA was defined as demonstration of reliability, convergent validity with HRQoL, and acceptability of the ePVA (i.e., >70% of eligible participants complete the ePVA at two or more visits and >70% of ePVA reports are read by providers). Formal focus group discussions with the interdisciplinary team that cared for patients with HNC guided the development of the ePVA as a clinical support tool. Qualitative and quantitative methods were used throughout the study. Descriptive statistics consisting of means and frequencies, Pearson correlation coefficient, and Student's t-tests were calculated using SAS 9.4 and STATA. Results/UNASSIGNED:The participants were primarily male (71%), White (76%), diagnosed with oropharyngeal or oral cavity cancers (53%), and undergoing treatment for HNC (69%). Data analyses supported the reliability (alpha =0.85), convergent validity with HRQoL scores, and acceptability of the ePVA. Participants with the highest number of symptoms and functional limitations reported significantly worse HRQoL (sum of symptoms: r=-0.50, P<0.0001; sum of function limitations: r=-0.56, P<0.0001). Ninety-two percent of participants (59 of 64) who had follow-up visits within the 6-month study period completed the ePVA at two or more visits and providers read 89% (169 of 189) of automated ePVA reports. The use of the ePVA as a clinical support tool for real-time interventions for symptoms and functional limitations reported by patients is described in a clinical exemplar. Conclusions/UNASSIGNED:This research indicates that the ePVA may be a useful mHealth tool as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC. The study findings support future translational research to enhance the usefulness of the ePVA in real world settings for early interventions that decrease symptom burden and improve the QoL of patients with HNC.
PMCID:7882269
PMID: 33634190
ISSN: 2306-9740
CID: 4795022

Improving thyroid function monitoring in head and neck cancer patients: A quality improvement study

Bhatt, Nupur; Taufique, Zahrah; Kamen, Emily; Wang, Binhuan; Concert, Catherine; Li, Zujun; Hu, Kenneth; Givi, Babak
OBJECTIVE:To investigate and improve compliance of thyroid function monitoring in head and neck cancer patients who received radiotherapy to the cervical region before and after instituting quality improvement interventions. METHODS:Using the Plan, Do, Study, Act (PDSA) methodology, patients with head and neck malignancies who received radiotherapy to the cervical region from 2013-2015 were identified at a tertiary medical center. The status of the patients' thyroid monitoring and related characteristics were recorded. A quality improvement project was subsequently implemented by data sharing and providing feedback to practitioners involved in head and neck cancer care and creating a tracking database for all patients who received radiotherapy to the neck. After implementation of these interventions, data was collected on patients meeting the inclusion criteria from 2015-2017. RESULTS:One hundred fifty-six patients met criteria pre-intervention and ninety-eight patients met criteria post-intervention. Compliance of thyroid monitoring went up from 34% to 80% after interventions (P < .0001). There was a significant increase in thyroid testing performed by radiation oncologists after interventions from 2% to 21%, while medical oncologists and otolaryngologists remained consistent in their compliance rates. CONCLUSION/CONCLUSIONS:It is possible to improve compliance with evidence-based recommendations and improve the quality-of-care for head and neck cancer survivors through simple, cost effective interventions. LEVEL OF EVIDENCE/METHODS:2 Laryngoscope, 2019.
PMID: 31778220
ISSN: 1531-4995
CID: 4216182

Prognostic potential of mid-treatment nodal response in oropharyngeal squamous cell carcinoma

Byun, David J; Tam, Moses M; Jacobson, Adam S; Persky, Mark S; Tran, Theresa T; Givi, Babak; DeLacure, Mark D; Li, Zujun; Harrison, Louis B; Hu, Kenneth S
BACKGROUND:We examine the prognostic implications of mid-course nodal response in oropharyngeal cancer (OPX) to radiation therapy. METHODS:In 44 patients with node-positive OPX undergoing concurrent chemoradiation, nodal volumes were measured on cone beam CTs from days 1, 10, 20, and 35. Nodal decrease (ND) was based on percent shrinkage from day 1. RESULTS:At a median follow-up of 17 months, the 2-year disease-free survival (DFS), locoregional control (LRC), distant metastasis-free survival (DMFS), and overall survival (OS) were 87%, 92%, 89%, and 92%, respectively. Patients with ND ≥43% at D20 had improved LRC (100% vs 78.4%, P = .03) compared to D20 ND <43%. On multivariate analysis, D20 ≥43% was independently prognostic for LRC (HR 1.17, P = .05). CONCLUSION/CONCLUSIONS:Patients with low-risk oropharynx cancer with ND of ≥43% by treatment day 20 had significantly improved LRC. The prognostic benefit of ND may assist in identifying candidates for treatment de-escalation.
PMID: 32964574
ISSN: 1097-0347
CID: 4605742

Socioeconomic and Racial Disparities and Survival of Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma

Rotsides, Janine M; Oliver, Jamie R; Moses, Lindsey E; Tam, Moses; Li, Zujun; Schreiber, David; Jacobson, Adam S; Hu, Kenneth S; Givi, Babak
OBJECTIVE:To investigate differences in epidemiology of oropharyngeal squamous cell carcinoma (OPSCC) with regards to human papillomavirus (HPV), race, and socioeconomic status (SES) using the National Cancer Database (NCDB). STUDY DESIGN/METHODS:Population-based cohort study. SETTING/METHODS:Racial and socioeconomic disparities in survival of OPSCC have been previously acknowledged. However, the distribution of HPV-related cancers and its influence on survival in conjunction with race and SES remain unclear. SUBJECTS AND METHODS/METHODS:All patients with OPSCC in the NCDB with known HPV status from 2010 to 2016 were included. Differences in presentation, HPV status, treatment, and outcomes were compared along racial and socioeconomic lines. Univariable and multivariable Cox regression survival analyses were performed. RESULTS:< .001) were associated with worse survival. CONCLUSION/CONCLUSIONS:Significant differences in HPV status exist between socioeconomic and racial groups, with HPV-negative disease more common among blacks and lower SES. When controlling for HPV status, race and SES still influence outcomes in oropharyngeal cancers.
PMID: 32660368
ISSN: 1097-6817
CID: 4527952

Human papillomavirus and survival of patients with sinonasal squamous cell carcinoma

Oliver, Jamie R; Lieberman, Seth M; Tam, Moses M; Liu, Cheng Z; Li, Zujun; Hu, Kenneth S; Morris, Luc G T; Givi, Babak
BACKGROUND:To the authors' knowledge, the question of whether human papillomavirus (HPV) infection is associated with outcomes in patients with sinonasal squamous cell carcinoma (SNSCC) is not well studied at this time. In the current study, the authors investigated patterns of HPV testing and its association with survival in patients with SNSCC using the National Cancer Data Base. METHODS:The authors selected all SNSCC cases diagnosed between 2010 and 2016. HPV testing practices, clinicodemographic factors, treatments, and survival were analyzed. Multivariable Cox regression and propensity score-matched survival analyses were performed. RESULTS:A total of 6458 SNSCC cases were identified. Of these, only 1523 cases (23.6%) were tested for HPV and included in the current study. The median patient age was 64 years and the majority had advanced stage tumors (overall AJCC stage III-IV, 721 patients; 62.1%). HPV-positive SNSCC comprised 31.5% (447 of 1418 cases) of the final study cohort. Among 15 hospitals that routinely tested nonoropharyngeal SCCs for HPV, the percentage of HPV-positive SNSCCs was smaller (24.6%; P = .04). Patients with HPV-positive SNSCC were younger (aged 60 years vs 65 years; P < .001), with tumors that were more likely to be high grade (55.3% vs 41.7%; P < .001), and attributed to the nasal cavity (62.2% vs 44.0%; P < .001). HPV-positive SNSCC was associated with significantly improved overall survival in multivariable regression analysis (hazard ratio, 0.45; 95% CI, 0.28-0.72 [P = .001]) and propensity score-matched (hazard ratio, 0.61; 95% CI, 0.38-0.96 [P = .03]) analyses controlling for clinicodemographic and treatment factors. CONCLUSIONS:Currently, only a minority of patients with SNSCC are tested for HPV. However, a sizable percentage of SNSCC cases may be HPV related; furthermore, HPV-positive SNSCC is associated with improved overall survival. Routine HPV testing may be warranted in patients with SNSCC.
PMID: 31886908
ISSN: 1097-0142
CID: 4251152

Patterns of Care and Survival of Cutaneous Angiosarcoma of the Head and Neck

Chang, Clifford; Wu, S Peter; Hu, Kenneth; Li, Zujun; Schreiber, David; Oliver, Jamie; Givi, Babak
OBJECTIVE:To analyze the patterns of care and survival of cutaneous angiosarcomas of the head and neck. STUDY DESIGN/METHODS:Retrospective cohort study. SETTING/METHODS:National Cancer Database. METHODS:The National Cancer Database was queried to select patients with cutaneous angiosarcoma of the head and neck between 2004 and 2015. For survival analysis, patients were included only if they received definitive treatment and complete data. Prognostic factors were analyzed by univariate and multivariable Cox regression. RESULTS:< .001) predicted worse overall survival. CONCLUSION/CONCLUSIONS:Angiosarcoma of head and neck is a rare malignancy that affects the elderly. Surgical treatment with negative margins is associated with improved survival. Even with curative-intent multimodality treatment, the survival of patients aged ≥75 years is limited.
PMID: 32043919
ISSN: 1097-6817
CID: 4304272

Patterns of Medical Cannabis Use among Cancer Patients from a Medical Cannabis Dispensary in New York State

Kim, Arum; Kaufmann, Christopher N; Ko, Roxanne; Li, Zujun; Han, Benjamin H
BACKGROUND:Research on the patterns of use of medical cannabis among cancer patients is lacking. OBJECTIVE:To describe patterns of medical cannabis use by patients with cancer, and how patterns differ from patients without cancer. DESIGN/MEASUREMENTS/METHODS:We performed secondary data analysis using data from a medical cannabis licensee in New York State, analyzing demographic information, qualifying conditions, and symptoms, and the medical cannabis product used, including tetrahydrocannabinol (THC) to cannabidiol (CBD) ratios. SETTING/SUBJECTS/METHODS:Adults age ≥18 who used New York State medical cannabis licensee products between January 2016 and December 2017. RESULTS:There were a total of 11,590 individuals with 1990 (17.2%) having cancer who used at least one cannabis product. Patients with cancer using cannabis were older and more likely to be female. The most common qualifying symptom for both cancer and noncancer patients was severe or chronic pain. Cancer patients were more likely to use the sublingual tincture form of cannabis (n = 1098, 55.2%), while noncancer patients were more likely to use the vaporization form (n = 4222, 44.0%). Over time, across all patients, there was an increase in the THC daily dose by a factor of 0.20 mg/week, yielding a corresponding increase in the THC:CBD daily ratio. Compared with noncancer patients, these trends were not different in the cancer group for THC daily dose, but there were less pronounced increases in the THC:CBD daily ratio over time among cancer patients. CONCLUSIONS:Our study found some key differences in demographics and medical cannabis product use between patients with cancer and without cancer.
PMID: 30909786
ISSN: 1557-7740
CID: 3778752

A Phase I/II, open-label, two part study of GSK3359609 in combination with tremelimumab in participants with selected, advanced solid tumors [Meeting Abstract]

Hansen, Aaron; Abdul-Karim, Raghad; Rizvi, Naiyer; Rischen, Danny; Hilton, John; Li, Zujun; Ott, Patrick; Karpinich-Fedoriw, Natalie; Yadavilli, Sapna; Wang, Xiaowei; Adams, Laurel; Wyres, Melody; Ferte, Charles; Ballas, Marc; Hoos, Axel; Zandberg, Daniel
ISI:000488129900148
ISSN: 0008-5472
CID: 4135692

The development, usability, and reliability of the Electronic Patient Visit Assessment (ePVA) for head and neck cancer

Van Cleave, Janet H; Fu, Mei R; Bennett, Antonia V; Persky, Mark S; Li, Zujun; Jacobson, Adam; Hu, Kenneth S; Most, Allison; Concert, Catherine; Kamberi, Maria; Mojica, Jacqueline; Peyser, Amanda; Riccobene, Ann; Tran, Anh; Persky, Michael J; Savitski, Justin; Liang, Eva; Egleston, Brian L
Background/UNASSIGNED:Annually, over 65,000 persons are diagnosed with head and neck cancer in the United States. During treatment, up to 50% of patients become severely symptomatic with pain, fatigue, mouth sores, and inability to eat. Long term complications are lymphedema, fibrosis, dysphagia, and musculoskeletal impairment. Patients' ability to perform daily activities and to interact socially may be impaired, resulting in poor quality of life. A pragmatic, clinically useful assessment is needed to ensure early detection and intervention for patients to report symptoms and functional limitations over time. We developed the Electronic Patient Visit Assessment (ePVA) that enables patients to report 42 symptoms related to head and neck cancer and 17 limitations of functional status. This manuscript reports (I) the development of the ePVA, (II) the content validity of the ePVA, and (III) the usability and reliability of the ePVA. Methods/UNASSIGNED:Usability was evaluated using the "Think Aloud" technique to guide the iterative process to refine the ePVA based on participants' evaluations. After signing the informed consent, 30 participants with head and neck cancer completed the ePVA using digital tablet devices while thinking aloud about ease of use. All patient conversations were recorded and professionally transcribed. Reliability of the ePVA symptom and functional limitation measures was estimated using the Kuder-Richardson test. Convergent validity of the ePVA was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 global QoL/health scale. Transcribed qualitative data were analyzed using directed content analysis approach. Quantitative analyses consisted of descriptive statistics and correlation analyses. Results/UNASSIGNED:Among participants, 90% strongly agreed or agreed that the ePVA system was easy to use and 80% were very satisfied. Only minor usability problems were reported due to formatting and software "bugs". Reporting of usability problems decreased in frequency over the study period and no usability problems were reported by the last 3 participants who completed the ePVA. Based on participants' suggestions during the iterative process, refinement of the ePVA included increased touch sensitivity of the touch screen technology and customized error messages to improve ease of use. The ePVA also recorded patient reported symptoms (mouth symptoms: 93%, fibrosis: 60%, fatigue: 60%). The ePVA demonstrated acceptable reliability (alpha =0.82-0.85) and convergent validity (ePVA total number of reported symptoms and function limitations was negatively correlated with EORTC QLQ-C30 global QOL/health scale: r=-0.55038, P<0.01). Conclusions/UNASSIGNED:The ePVA was rigorously developed, accepted by patients with satisfaction, and demonstrated acceptable reliability and convergent validity. Future research will use data generated by the ePVA to determine the impact of symptom trajectories on functional status, treatment interruptions and terminations, and health resource use in head and neck cancer.
PMCID:6691072
PMID: 31463307
ISSN: 2306-9740
CID: 4054542

Phase II study of spartalizumab (PDR001) vs chemotherapy (CT) in patients with recurrent/metastatic nasopharyngeal cancer (NPC) [Meeting Abstract]

Lim, Darren Wan-Teck; Wang, Hung-Ming; Li, Shau-Hsuan; Ngan, Roger; Dechaphunkul, Arunee; Zhang, Li; Yen, Chia Jui; Chan, Po Chung; Chakrabandhu, Somvilai; Ma, Brigette; Tanasanvimon, Suebpong; Lee, Victor; Lou, Pei-Jen; Li, Zujun; Spira, Alexander; Sukari, Ammar; Guigay, Joel; McCune, Steven; Sun, Yongjian; Szpakowski, Sebastian; Yao, Yao; Fan, Xueqiang; Manenti, Luigi; Even, Caroline
ISI:000488129900134
ISSN: 0008-5472
CID: 4135682