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1,355 results on '"Dueck, Amylou C."'

1. Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial

Author

Basch, Ethan, Schrag, Deborah, Jansen, Jennifer, Henson, Sydney, Ginos, Brenda, Stover, Angela M., Carr, Philip, Spears, Patricia A., Jonsson, Mattias, Deal, Allison M., Bennett, Antonia V., Thanarajasingam, Gita, Rogak, Lauren, Reeve, Bryce B., Snyder, Claire, Bruner, Deborah, Cella, David, Kottschade, Lisa A., Perlmutter, Jane, Geoghegan, Cindy, Given, Barbara, Mazza, Gina L., Miller, Robert, Strasser, Jon F., Zylla, Dylan M., Weiss, Anna, Blinder, Victoria S., Wolf, Anna P., and Dueck, Amylou C.

Published
2025
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2. Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®)

Author

Lee, Minji K., Mitchell, Sandra A., Basch, Ethan, Mazza, Gina L., Langlais, Blake T., Thanarajasingam, Gita, Ginos, Brenda F., Rogak, Lauren, Meek, Eric A., Jansen, Jennifer, Deal, Allison M., Carr, Philip, Blinder, Victoria S., Jonsson, Mattias, Mody, Gita N., Mendoza, Tito R., Bennett, Antonia V., Schrag, Deborah, and Dueck, Amylou C.

Published
2025
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5. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable

Author

Yap, Christina, Lee Aiyegbusi, Olalekan, Alger, Emily, Basch, Ethan, Bell, Jill, Bhatnagar, Vishal, Cella, David, Collis, Philip, Dueck, Amylou C., Gilbert, Alexandra, Gnanasakthy, Ari, Greystoke, Alastair, Hansen, Aaron R., Kamudoni, Paul, Kholmanskikh, Olga, King-Kallimanis, Bellinda L., Krumholz, Harlan, Minchom, Anna, O'Connor, Daniel, Petrie, Joan, Piccinin, Claire, Rantell, Khadija Rerhou, Rauz, Saaeha, Retzer, Ameeta, Rizk, Steven, Wagner, Lynne, Sasseville, Maxime, Seymour, Lesley K., Weber, Harald A., Wilson, Roger, Calvert, Melanie, and Peipert, John Devin

Published
2024
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6. Evaluating Treatment Tolerability Using the Toxicity Index With Patient-Reported Outcomes Data

Author

Langlais, Blake, Mazza, Gina L, Thanarajasingam, Gita, Rogak, Lauren J, Ginos, Brenda, Heon, Narre, Scher, Howard I, Schwab, Gisela, Ganz, Patricia A, Basch, Ethan, and Dueck, Amylou C

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Brain Disorders, Patient Safety, Clinical Research, Clinical Trials and Supportive Activities, Prevention, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Clinical Trials as Topic, Humans, Neoplasms, Patient Reported Outcome Measures, PRO-CTCAE, tolerability, toxicity index, patient-reported outcomes, symptomatic adverse event, cancer clinical trials, Medical and Health Sciences, Anesthesiology, Biomedical and clinical sciences, Health sciences
Abstract

ContextSummarizing longitudinal symptomatic adverse events during clinical trials is necessary for understanding treatment tolerability. The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) provides insight for capturing treatment tolerability within trials. Tolerability summary measures, such as the maximum score, are often used to communicate the potential negative symptoms both in the medical literature and directly to patients. Commonly, the proportions of present and severe symptomatic adverse events are used and reported between treatment arms among adverse event types. The toxicity index is also a summary measure previously applied to clinician-reported CTCAE data.ObjectivesApply the toxicity index to PRO-CTCAE data from the COMET-2 trial alongside the maximum score, then present and discuss considerations for using the toxicity index as a summary measure for communicating tolerability to patients and clinicians.MethodsProportions of maximum PRO-CTCAE severity levels and median toxicity index were computed by arm using all trial data and adjusting for baseline symptoms.ResultsGroup-wise statistical differences were similar whether using severity level proportions or the toxicity index. The impact of adjusting for baseline symptoms was equivalently seen when comparing arms using severity rates or the toxicity index.ConclusionThe toxicity index is a useful method when ranking patients from those with the least to most symptomatic adverse event burden. This study showed the toxicity index can be applied to PRO-CTCAE data. Though as a tolerability summary measure, further study is needed to provide a clear clinical or patient-facing interpretation of the toxicity index.

Published
2022

8. SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.

Author

Calvert, Melanie, King, Madeleine, Mercieca-Bebber, Rebecca, Aiyegbusi, Olalekan, Kyte, Derek, Slade, Anita, Chan, An-Wen, Basch, E, Bell, Jill, Bennett, Antonia, Bhatnagar, Vishal, Blazeby, Jane, Bottomley, Andrew, Brown, Julia, Brundage, Michael, Campbell, Lisa, Cappelleri, Joseph C, Draper, Heather, Dueck, Amylou C, Ells, Carolyn, Frank, Lori, Golub, Robert M, Griebsch, Ingolf, Haywood, Kirstie, Hunn, Amanda, King-Kallimanis, Bellinda, Martin, Laura, Mitchell, Sandra, Morel, Thomas, Nelson, Linda, Norquist, Josephine, O'Connor, Daniel, Palmer, Michael, Patrick, Donald, Price, Gary, Regnault, Antoine, Retzer, Ameeta, Revicki, Dennis, Scott, Jane, Stephens, Richard, Turner, Grace, Valakas, Antonia, Velikova, Galina, von Hildebrand, Maria, Walker, Anita, and Wenzel, Lari

Subjects
Humans, Research Design, Quality of Life, Checklist, Research Report, Patient Reported Outcome Measures, clinical trials, education & training, protocols & guidelines, statistics & research methods, Clinical Sciences, Public Health and Health Services, Other Medical and Health Sciences
Abstract

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

Published
2021

11. Expanding Beyond Maximum Grade: Chemotherapy Toxicity over Time by Age and Performance Status in Advanced Non‐Small Cell Lung Cancer in CALGB 9730 (Alliance A151729)

Author

Wong, Melisa L, Gao, Junheng, Thanarajasingam, Gita, Sloan, Jeff A, Dueck, Amylou C, Novotny, Paul J, Jatoi, Aminah, Hurria, Arti, Walter, Louise C, Miaskowski, Christine, Cohen, Harvey J, Wood, William A, Feliciano, Josephine L, Stinchcombe, Thomas E, and Wang, Xiaofei

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Aging, Neurodegenerative, Lung Cancer, Cancer, Patient Safety, Neurosciences, Pain Research, Peripheral Neuropathy, Lung, Aged, Antineoplastic Combined Chemotherapy Protocols, Carboplatin, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Paclitaxel, Geriatric oncology, Chemotherapy, Lung cancer, Fatigue, Neuropathy, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundPrior comparisons of chemotherapy adverse events (AEs) by age and performance status (PS) are limited by the traditional maximum grade approach, which ignores low-grade AEs and longitudinal changes.Materials and methodsTo compare fatigue and neuropathy longitudinally by age (

Published
2021

13. The Impact of Within-Consultation and Preconsultation Decision Aids for Localized Prostate Cancer on Patient Knowledge: Results of a Patient-Level Randomized Trial

Author

Joyce, Daniel D., Tilburt, Jon C., Pacyna, Joel E., Cina, Kristin, Petereit, Daniel G., Koller, Kathryn R., Flanagan, Christie A., Stillwater, Barbara, Miller, Mariam, Kaur, Judith S., Peil, Elizabeth, Zahrieh, David, Dueck, Amylou C., Montori, Victor M., Frosch, Dominick L., Volk, Robert J., and Kim, Simon P.

Published
2023
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15. Landscape of Health-Related Quality of Life in Patients With Early-Stage Pancreatic Cancer Receiving Adjuvant or Neoadjuvant Chemotherapy

Author

Macarulla, Teresa, Hendifar, Andrew E, Li, Chung-Pin, Reni, Michele, Riess, Hanno, Tempero, Margaret A, Dueck, Amylou C, Botteman, Marc F, Deshpande, Chinmay G, Lucas, Eleanor J, and Oh, Do-Youn

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Digestive Diseases, Pancreatic Cancer, Cancer, Clinical Research, Rare Diseases, 7.1 Individual care needs, Management of diseases and conditions, Good Health and Well Being, Aged, Chemotherapy, Adjuvant, Female, Health Status Indicators, Humans, Male, Middle Aged, Minimal Clinically Important Difference, Neoadjuvant Therapy, Neoplasm Staging, Pancreatectomy, Pancreatic Neoplasms, Patient Reported Outcome Measures, Predictive Value of Tests, Quality of Life, Time Factors, Treatment Outcome, health-related quality of life, minimally important difference, pancreatic cancer, pancreatic resection, patient-reported outcome measures, Clinical Sciences, Gastroenterology & Hepatology, Clinical sciences
Abstract

ObjectivesPancreatic resection is associated with postoperative morbidity and reduced quality of life (QoL). A systematic literature review was conducted to understand the patient-reported outcome measure (PROM) landscape in early-stage pancreatic cancer (PC).MethodsDatabases/registries (through January 24, 2019) and conference abstracts (2014-2017) were searched. Study quality was assessed using the Newcastle-Ottawa Scale/Cochrane risk-of-bias tool. Searches were for general (resectable PC, adjuvant/neoadjuvant, QoL) and supplemental studies (resectable PC, European Organisation for Research and Treatment of Cancer QoL Questionnaire [QLQ] - Pancreatic Cancer [PAN26]).ResultsOf 750 studies identified, 39 (general, 22; supplemental, 17) were eligible: 32 used QLQ Core 30 (C30) and/or QLQ-PAN26, and 15 used other PROMs. Baseline QLQ-C30 global health status/QoL scores in early-stage PC were similar to all-stage PC reference values but lower than all-stage-all-cancer values. The QoL declined after surgery, recovered to baseline in 3 to 6 months, and then generally stabilized. A minimally important difference (MID) of 10 was commonly used for QLQ-C30 but was not established for QLQ-PAN26.ConclusionsIn early-stage PC, QLQ-C30 and QLQ-PAN26 are the most commonly used PROMs. Baseline QLQ-C30 global health status/QoL scores suggested a high humanistic burden. Immediately after surgery, QoL declined but seemed stable over the longer term. The QLQ-C30 MID may elucidate the clinical impact of treatment on QoL; MID for QLQ-PAN26 needs to be established.

Published
2020

20. Quality of life outcomes in patients participating in the CALGB 30610 trial (CALGB 70702): Alliance.

Author

Ganti, Apar K., Fruth, Briant, Rimner, Andreas, Waqar, Saiama, Mix, Michael D., Petty, W. Jeffrey, Stinchcombe, Thomas E., Vokes, Everett E., Bogart, Jeffrey A., and Dueck, Amylou C.

Subjects
SMALL cell lung cancer, QUALITY of life, CANCER prognosis, TREATMENT effectiveness, DEGLUTITION
Abstract

Background: CALGB 30610 trial demonstrated that once daily thoracic radiotherapy (TRT) was not superior compared to standard twice daily TRT, in patients with limited stage small cell lung cancer. Quality of life outcomes may help oncologists decide the best treatment approach. Methods: A total of 417 patients on CALGB 30610 participated in the quality‐of‐life substudy (CALGB 70702), which included the FACT Trial Outcome Index‐Lung Cancer (FACT‐L TOI), FACT‐Esophageal Cancer (FACT‐E) Eating and Swallowing Indices, ECOG Acute Esophagitis Scale, Hospital Anxiety and Depression Scale (HADS), difficulty swallowing, EQ‐5D, and treatment convenience assessment at baseline, 3, 5, 7, 12, 26, and 52 weeks after starting TRT. Primary end points included FACT‐L TOI and FACT‐E at 12 weeks. Mean changes from baseline were compared between arms using general linear mixed models. Results: FACT‐L worsening was more in the twice daily arm at week 3 (–1.0 vs. –7.0). FACT‐L TOI worsening was less at week 3 (–2.9 vs. –7.6) and greater at week 12 (–7.6 vs. –2.8) in the once daily arm. The once daily arm had a lower EQ‐5D index worsening at 3 weeks (0.01 vs. –0.02). Increase in acute esophagitis score (1.06 vs. 2.89; p <.001) and difficulty swallowing (0.39 vs. 1.14) were greater in the twice daily arm at week 3. A total of 74.5% of patients on the once daily arm felt that treatment was convenient, compared to 67% of patients in the twice daily arm (p =.03). Conclusions: The once daily arm had better quality‐of‐life scores earlier during treatment and was perceived to be more convenient. Patient‐reported outcomes assessing health‐related quality of life were analyzed for 417 patients with limited stage small cell lung cancer who were enrolled on the CALGB 30610 trial comparing once daily versus twice daily radiation concurrent with platinum‐etoposide chemotherapy. Patients on the once daily radiation arm reported better quality of life scores earlier during treatment and perceived this regimen to be more convenient. [ABSTRACT FROM AUTHOR]

Published
2025
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21. Clinical activity of single-dose systemic oncolytic VSV virotherapy in patients with relapsed refractory T-cell lymphoma

Author

Cook, Joselle, Peng, Kah-Whye, Witzig, Thomas E., Broski, Stephen M., Villasboas, Jose C., Paludo, Jonas, Patnaik, Mrinal, Rajkumar, Vincent, Dispenzieri, Angela, Leung, Nelson, Buadi, Francis, Bennani, Nora, Ansell, Stephen M., Zhang, Lianwen, Packiriswamy, Nandakumar, Balakrishnan, Baskar, Brunton, Bethany, Giers, Marissa, Ginos, Brenda, Dueck, Amylou C., Geyer, Susan, Gertz, Morie A., Warsame, Rahma, Go, Ronald S., Hayman, Suzanne R., Dingli, David, Kumar, Shaji, Bergsagel, Leif, Munoz, Javier L., Gonsalves, Wilson, Kourelis, Taxiarchis, Muchtar, Eli, Kapoor, Prashant, Kyle, Robert A., Lin, Yi, Siddiqui, Mustaqeem, Fonder, Amie, Hobbs, Miriam, Hwa, Lisa, Naik, Shruthi, Russell, Stephen J., and Lacy, Martha Q.

Published
2022
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22. A randomized phase 3 trial of interferon-α vs hydroxyurea in polycythemia vera and essential thrombocythemia

Author

Mascarenhas, John, Kosiorek, Heidi E., Prchal, Josef T., Rambaldi, Alessandro, Berenzon, Dmitriy, Yacoub, Abdulraheem, Harrison, Claire N., McMullin, Mary Frances, Vannucchi, Alessandro M., Ewing, Joanne, O'Connell, Casey L., Kiladjian, Jean-Jacques, Mead, Adam J., Winton, Elliott F., Leibowitz, David S., De Stefano, Valerio, Arcasoy, Murat O., Kessler, Craig M., Catchatourian, Rosalind, Rondelli, Damiano, Silver, Richard T., Bacigalupo, Andrea, Nagler, Arnon, Kremyanskaya, Marina, Levine, Max F., Arango Ossa, Juan E., McGovern, Erin, Sandy, Lonette, Salama, Mohamad E., Najfeld, Vesna, Tripodi, Joseph, Farnoud, Noushin, Penson, Alexander V., Weinberg, Rona Singer, Price, Leah, Goldberg, Judith D., Barbui, Tiziano, Marchioli, Roberto, Tognoni, Gianni, Rampal, Raajit K., Mesa, Ruben A., Dueck, Amylou C., and Hoffman, Ronald

Published
2022
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23. Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies

Author

Thanarajasingam, Gita, Minasian, Lori M, Bhatnagar, Vishal, Cavalli, Franco, De Claro, R Angelo, Dueck, Amylou C, El-Galaly, Tarec C, Everest, Neil, Geissler, Jan, Gisselbrecht, Christian, Gormley, Nicole, Gribben, John, Horowitz, Mary, Ivy, S Percy, Jacobson, Caron A, Keating, Armand, Kluetz, Paul G, Kwong, Yok Lam, Little, Richard F, Matasar, Matthew J, Mateos, Maria-Victoria, McCullough, Kristen, Miller, Robert S, Mohty, Mohamad, Moreau, Philippe, Morton, Lindsay M, Nagai, Sumimasa, Nair, Abhilasha, Nastoupil, Loretta, Robertson, Kaye, Sidana, Surbhi, Smedby, Karin E, Sonneveld, Pieter, Tzogani, Kyriaki, van Leeuwen, Flora E, Velikova, Galina, Villa, Diego, Wingard, John R, Seymour, John F, and Habermann, Thomas M

Published
2022
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28. Adaptive immune signature in HER2-positive breast cancer in NCCTG (Alliance) N9831 and NeoALTTO trials

Author

Chumsri, Saranya, Li, Zhuo, Serie, Daniel J., Norton, Nadine, Mashadi-Hossein, Afshin, Tenner, Kathleen, Brauer, Heather Ann, Warren, Sarah, Danaher, Patrick, Colon-Otero, Gerardo, Partridge, Ann H., Carey, Lisa A., Hilbers, Florentine, Van Dooren, Veerle, Holmes, Eileen, Di Cosimo, Serena, Werner, Olena, Huober, Jens Bodo, Dueck, Amylou C., Sotiriou, Christos, Saura, Cristina, Moreno-Aspitia, Alvaro, Knutson, Keith L., Perez, Edith A., and Thompson, E. Aubrey

Published
2022
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29. Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience

Author

Zahrieh, David, Hillman, Shauna L., Tan, Angelina D., Frank, Jennifer L., Dockter, Travis, Meyers, Bobbi Jo, Cherevko, Cassie L., Peil, Elizabeth S., McCue, Shaylene, Kour, Oudom, Gunn, Heather J., Neuman, Heather B., Chang, George J., Paskett, Electra D., Mandrekar, Sumithra J., and Dueck, Amylou C.

Published
2022
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30. Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials

Author

Basch, Ethan, Dueck, Amylou C, Rogak, Lauren J, Minasian, Lori M, Kelly, William Kevin, O’Mara, Ann M, Denicoff, Andrea M, Seisler, Drew, Atherton, Pamela J, Paskett, Electra, Carey, Lisa, Dickler, Maura, Heist, Rebecca S, Himelstein, Andrew, Rugo, Hope S, Sikov, William M, Socinski, Mark A, Venook, Alan P, Weckstein, Douglas J, Lake, Diana E, Biggs, David D, Freedman, Rachel A, Kuzma, Charles, Kirshner, Jeffrey J, and Schrag, Deborah

Subjects
Cancer, Prevention, Clinical Research, Patient Safety, Management of diseases and conditions, 7.1 Individual care needs, Adult, Adverse Drug Reaction Reporting Systems, Aged, Aged, 80 and over, Antineoplastic Agents, Feasibility Studies, Female, Humans, Male, Middle Aged, Patient Reported Outcome Measures, Self Report, Young Adult, Oncology and Carcinogenesis, Public Health and Health Services
Abstract

ImportanceIn cancer clinical trials, symptomatic adverse events (AEs), such as nausea, are reported by investigators rather than by patients. There is increasing interest to collect symptomatic AE data via patient-reported outcome (PRO) questionnaires, but it is unclear whether it is feasible to implement this approach in multicenter trials.ObjectiveTo examine whether patients are willing and able to report their symptomatic AEs in multicenter trials.Design, setting, and participantsA total of 361 consecutive patients enrolled in any 1 of 9 US multicenter cancer treatment trials were invited to self-report 13 common symptomatic AEs using a PRO adaptation of the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) via tablet computers at 5 successive clinic visits. Patient adherence was tracked with reasons for missed self-reports. Agreement with clinician AE reports was analyzed with weighted κ statistics. Patient and investigator perspectives were elicited by survey. The study was conducted from March 15, 2007, to August 11, 2011. Data analysis was performed from August 9, 2013, to March 21, 2014.ResultsOf the 361 patients invited to participate, 285 individuals enrolled, with a median age of 57 years (range, 24-88), 202 (74.3%) female, 241 (85.5%) white, 73 (26.8%) with a high school education or less, and 176 (64.7%) who reported regular internet use (denominators varied owing to missing data). Across all patients and trials, there were 1280 visits during which patients had an opportunity to self-report (ie, patients were alive and enrolled in a treatment trial at the time of the visit). Self-reports were completed at 1202 visits (93.9% overall adherence). Adherence was highest at baseline and declined over time (visit 1, 100%; visit 2, 96%; visit 3, 95%; visit 4, 91%; and visit 5, 85%). Reasons for missing PROs included institutional errors in 27 of 48 (56.3%) of the cases (eg, staff forgetting to bring computers to patients at visits), patients feeling "too ill" in 8 (16.7%), patient refusal in 8 (16.7%), and internet connectivity problems in 5 (10.4%). Patient-investigator CTCAE agreement was moderate or worse for most symptoms (most κ

Published
2017

33. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study

Author

Mayer, Erica L, Dueck, Amylou C, Martin, Miguel, Rubovszky, Gabor, Burstein, Harold J, Bellet-Ezquerra, Meritxell, Miller, Kathy D, Zdenkowski, Nicholas, Winer, Eric P, Pfeiler, Georg, Goetz, Matthew, Ruiz-Borrego, Manuel, Anderson, Daniel, Nowecki, Zbigniew, Loibl, Sibylle, Moulder, Stacy, Ring, Alistair, Fitzal, Florian, Traina, Tiffany, Chan, Arlene, Rugo, Hope S, Lemieux, Julie, Henao, Fernando, Lyss, Alan, Antolin Novoa, Silvia, Wolff, Antonio C, Vetter, Marcus, Egle, Daniel, Morris, Patrick G, Mamounas, Eleftherios P, Gil-Gil, Miguel J, Prat, Aleix, Fohler, Hannes, Metzger Filho, Otto, Schwarz, Magdalena, DuFrane, Carter, Fumagalli, Debora, Theall, Kathy Puyana, Lu, Dongrui Ray, Bartlett, Cynthia Huang, Koehler, Maria, Fesl, Christian, DeMichele, Angela, and Gnant, Michael

Published
2021
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34. Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 (Cituxumumab) in Patients with HER2-Positive Advanced Breast Cancer Previously Treated with Trastuzumab and Chemotherapy: NCCTG N0733 (Alliance)

Author

Haddad, Tufia C., He, Jun, O’Sullivan, Ciara C., Chen, Beiyun, Northfelt, Donald, Dueck, Amylou C., Ballman, Karla V., Tenner, Kathleen S., Linden, Hannah, Sparano, Joseph A., Hopkins, Judith O., De Silva, Chamath, Perez, Edith A., Haluska, Paul, and Goetz, Matthew P.

Published
2021
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35. Impact of gender representativeness in online symptom survey and clinical trial participation among patients with myeloproliferative neoplasms.

Author

Langlais, Blake, Dueck, Amylou C., Kosiorek, Heidi E., Mead-Harvey, Carolyn, Meek, Eric, Rogak, Lauren, Mascarenhas, John, Mesa, Ruben, Gowin, Krisstina, Palmer, Jean, Scherber, Robyn, Marcellino, Bridget, Hoffman, Ronald, and Mazza, Gina L.

Subjects
*SYMPTOM burden, *MYELOPROLIFERATIVE neoplasms, *INTERNET surveys, *CLINICAL trials, *SYMPTOMS
Abstract

Patients with myeloproliferative neoplasms (MPNs) face chronic symptom burden. Online symptom assessment studies allow for recruitment of large numbers of motivated patients, but patient self-selection can lead to sampling bias. This study evaluated how gender representativeness in MPN symptom surveys and trials impacted symptom score mean estimates, using data from 4825 survey respondents and 291 trial participants with MPNs. The survey data showed that men participated at a rate roughly 50% less than what would be expected based on prevalence, and women reported higher scores than men on average for six of 10 symptoms. Together, this led to potential over estimation in six of 10 symptom score means (ranging from 5.8% to 15.3% overestimated). The trial data showed less gender-based sampling bias compared to the survey data. Studies utilizing online symptom surveys should implement study design features to recruit more men, assess for gender participation imbalances, and provide weighted estimates where appropriate. [ABSTRACT FROM AUTHOR]

Published
2024
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36. Phase 2 study of ruxolitinib and decitabine in patients with myeloproliferative neoplasm in accelerated and blast phase

Author

Mascarenhas, John O., Rampal, Raajit K., Kosiorek, Heidi E., Bhave, Rupali, Hexner, Elizabeth, Wang, Eunice S., Gerds, Aaron, Abboud, Camille N., Kremyanskaya, Marina, Berenzon, Dimitry, Odenike, Olatoyosi, Farnoud, Noushin, Krishnan, Aishwarya, Weinberg, Rona Singer, McGovern, Erin, Salama, Mohamed E., Najfeld, Vesna, Medina-Martinez, Juan S., Arango Ossa, Juan E., Levine, Max F., Zhou, Yangyu, Sandy, Lonette, Heaney, Mark L., Levine, Ross L., Mesa, Ruben A., Dueck, Amylou C., and Hoffman, Ronald

Published
2020
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39. Integrating 4 Methods (In4M) to evaluate physical function in patients with cancer: Results of a comprehensive digital health study.

Author

Thanarajasingam, Gita, primary, Dueck, Amylou C., additional, Bhatnagar, Vishal, additional, Brown, Abbie, additional, Cathcart-Rake, Elizabeth Jane, additional, Diamond, Matthew, additional, Faust, Louis, additional, Fiero, Mallorie, additional, Huntington, Scott F., additional, Jeffery, Molly, additional, Jones, Lee, additional, Paludo, Jonas, additional, Power, Bradford, additional, Ross, Joseph S., additional, Ruddy, Kathryn Jean, additional, Schellhorn, Sarah, additional, Tarver, Michelle, additional, Wood, William Allen, additional, Gross, Cary Philip, additional, and Kluetz, Paul Gustav, additional

Published
2024
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40. Analysis of the sensitivity to endocrine therapy (SET) assay in the PALLAS adjuvant trial of palbociclib in HR+/HER2- breast cancer (ABCSG-42/AFT-05/BIG-14-13).

Author

Metzger, Otto, primary, Ballman, Karla V., additional, Gnant, Michael, additional, Watson, Mark, additional, Chen, Eveline, additional, Tran, Kevin, additional, O'Brien, Patrick, additional, Hlauschek, Dominik, additional, Martin, Miguel, additional, Balko, Justin M, additional, Nowecki, Zbigniew, additional, Hahn, Olwen Mary, additional, Denkert, Carsten, additional, Curtis, Christina, additional, Liu, Yuan, additional, Dueck, Amylou C., additional, Fesl, Christian, additional, Mayer, Erica L., additional, DeMichele, Angela, additional, and Symmans, W. Fraser Fraser, additional

Published
2024
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42. International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium

Author

Coens, Corneel, Pe, Madeline, Dueck, Amylou C, Sloan, Jeff, Basch, Ethan, Calvert, Melanie, Campbell, Alicyn, Cleeland, Charles, Cocks, Kim, Collette, Laurence, Devlin, Nancy, Dorme, Lien, Flechtner, Hans-Henning, Gotay, Carolyn, Griebsch, Ingolf, Groenvold, Mogens, King, Madeleine, Kluetz, Paul G, Koller, Michael, Malone, Daniel C, Martinelli, Francesca, Mitchell, Sandra A, Musoro, Jammbe Z, O'Connor, Daniel, Oliver, Kathy, Piault-Louis, Elisabeth, Piccart, Martine, Quinten, Chantal, Reijneveld, Jaap C, Schürmann, Christoph, Smith, Ashley Wilder, Soltys, Katherine M, Taphoorn, Martin J B, Velikova, Galina, and Bottomley, Andrew

Published
2020
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45. Current state of quality of life and patient-reported outcomes research

Author

Ganz, Patricia A., Ringash, Jolie, O'Connor, Daniel, Kluetz, Paul G., Tafuri, Giovanni, Grønvold, Mogens, Snyder, Claire, Gotay, Carolyn, Fallowfield, Dame Lesley, Apostolidis, Kathi, Wilson, Roger, Stephens, Richard, Schünemann, Holger, Calvert, Melanie, Holzner, Bernhard, Musoro, Jammbe Z., Wheelwright, Sally, Martinelli, Francesca, Dueck, Amylou C., Pe, Madeline, Coens, Corneel, Velikova, Galina, Kuliś, Dagmara, Taphoorn, Martin J.B., Darlington, Anne-Sophie, Lewis, Ian, van de Poll-Franse, Lonneke, Bottomley, Andrew, Reijneveld, Jaap C., Koller, Michael, Flechtner, Henning, Tomaszewski, Krzysztof A., and Greimel, Eva

Published
2019
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46. Pegylated interferon alfa-2a for polycythemia vera or essential thrombocythemia resistant or intolerant to hydroxyurea

Author

Yacoub, Abdulraheem, Mascarenhas, John, Kosiorek, Heidi, Prchal, Josef T., Berenzon, Dmitry, Baer, Maria R., Ritchie, Ellen, Silver, Richard T., Kessler, Craig, Winton, Elliott, Finazzi, Maria Chiara, Rambaldi, Alessandro, Vannucchi, Alessandro M., Leibowitz, David, Rondelli, Damiano, Arcasoy, Murat O., Catchatourian, Rosalind, Vadakara, Joseph, Rosti, Vittorio, Hexner, Elizabeth, Kremyanskaya, Marina, Sandy, Lonette, Tripodi, Joseph, Najfeld, Vesna, Farnoud, Noushin, Papaemmanuil, Elli, Salama, Mohamed, Singer-Weinberg, Rona, Rampal, Raajit, Goldberg, Judith D., Barbui, Tiziano, Mesa, Ruben, Dueck, Amylou C., and Hoffman, Ronald

Published
2019
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48. Impact of High-Molecular-Risk Mutations on Transplantation Outcomes in Patients with Myelofibrosis

Author

Tamari, Roni, Rapaport, Franck, Zhang, Nan, McNamara, Caroline, Kuykendall, Andrew, Sallman, David A., Komrokji, Rami, Arruda, Andrea, Najfeld, Vesna, Sandy, Lonette, Medina, Juan, Litvin, Rivka, Famulare, Christopher A., Patel, Minal A., Maloy, Molly, Castro-Malaspina, Hugo, Giralt, Sergio A., Weinberg, Rona S., Mascarenhas, John O., Mesa, Ruben, Rondelli, Damiano, Dueck, Amylou C., Levine, Ross L., Gupta, Vikas, Hoffman, Ronald, and Rampal, Raajit K.

Published
2019
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49. Cabozantinib Versus Mitoxantrone-prednisone in Symptomatic Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial with a Primary Pain Endpoint

Author

Basch, Ethan M., Scholz, Mark, de Bono, Johann S., Vogelzang, Nicholas, de Souza, Paul, Marx, Gavin, Vaishampayan, Ulka, George, Saby, Schwarz, James K., Antonarakis, Emmanuel S., O'Sullivan, Joseph M., Kalebasty, Arash Rezazadeh, Chi, Kim N., Dreicer, Robert, Hutson, Thomas E., Dueck, Amylou C., Bennett, Antonia V., Dayan, Erica, Mangeshkar, Milan, Holland, Jaymes, Weitzman, Aaron L., and Scher, Howard I.

Published
2019
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50. Quality of life (QOL) for patients with esophageal cancer receiving trimodality therapy with induction chemotherapy, chemoradiation, and surgery: Results from CALGB 80803 (Alliance).

Author

Goodman, Karyn A., primary, Dueck, Amylou C., additional, Fruth, Briant, additional, Noonan, Anne M., additional, Shergill, Ardaman, additional, Bekaii-Saab, Tanios S., additional, O'Reilly, Eileen Mary, additional, Meyerhardt, Jeffrey A., additional, Ilson, David H., additional, and Deshields, Teresa L., additional

Published
2024
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