Clinical Trial Participation as Part of End-of-Life Cancer Care: Associations With Medical Care and Quality of Life Near Death

Nurgat, 2005, Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy, Br J Cancer, 92, 1001, 10.1038/sj.bjc.6602423 National Comprehensive Cancer Network. NCCN guidelines. Available from http://www.nccn.org/clinical.asp. Accessed May 15, 2012. Joffe, 2002, Views of American oncologists about the purposes of clinical trials, J Natl Cancer Inst, 94, 1847, 10.1093/jnci/94.24.1847 Peppercorn, 2004, Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review, Lancet, 363, 263, 10.1016/S0140-6736(03)15383-4 Agrawal, 2003, Ethics of phase 1 oncology studies: reexamining the arguments and data, JAMA, 290, 1075, 10.1001/jama.290.8.1075 Miller, 2006, Evaluating the therapeutic misconception, Kennedy Inst Ethics J, 16, 353, 10.1353/ken.2006.0025 Nickel, 2006, Vulnerable populations in research: the case of the seriously ill, Theor Med Bioeth, 27, 245, 10.1007/s11017-006-9000-2 Sulmasy, 2010, The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials, Cancer, 116, 3702, 10.1002/cncr.25201 Miller, 2008, Benefit in phase 1 oncology trials: therapeutic misconception or reasonable treatment option?, Clin Trials, 5, 617, 10.1177/1740774508097576 Freireich, 2009, The role of investigational therapy in management of patients with advanced metastatic malignancy, J Clin Oncol, 27, 304, 10.1200/JCO.2008.19.6543 Schapira, 2009, Phase I versus palliative care: striking the right balance, J Clin Oncol, 27, 307, 10.1200/JCO.2008.20.7803 Roberts, 2004, Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials, JAMA, 292, 2130, 10.1001/jama.292.17.2130 Horstmann, 2005, Risks and benefits of phase 1 oncology trials, 1991 through 2002, N Engl J Med, 352, 895, 10.1056/NEJMsa042220 Daugherty, 1995, Perceptions of cancer patients and their physicians involved in phase I trials, J Clin Oncol, 13, 1062, 10.1200/JCO.1995.13.5.1062 Meropol, 2003, Perceptions of patients and physicians regarding phase I cancer clinical trials: implications for physician-patient communication, J Clin Oncol, 21, 2589, 10.1200/JCO.2003.10.072 Weinfurt, 2003, The correlation between patient characteristics and expectations of benefit from Phase I clinical trials, Cancer, 98, 166, 10.1002/cncr.11483 Weinfurt, 2008, Expectations of benefit in early-phase clinical trials: implications for assessing the adequacy of informed consent, Med Decis Making, 28, 575, 10.1177/0272989X08315242 Truong, 2011, Altruism among participants in cancer clinical trials, Clin Trials, 8, 616, 10.1177/1740774511414444 Flaherty, 2010, Inhibition of mutated, activated BRAF in metastatic melanoma, N Engl J Med, 363, 809, 10.1056/NEJMoa1002011 Kwak, 2010, Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer, N Engl J Med, 363, 1693, 10.1056/NEJMoa1006448 Topalian, 2012, Safety, activity, and immune correlates of anti-PD-1 antibody in cancer, N Engl J Med, 366, 2443, 10.1056/NEJMoa1200690 Agrawal, 2006, Patients' decision-making process regarding participation in phase I oncology research, J Clin Oncol, 24, 4479, 10.1200/JCO.2006.06.0269 Peppercorn, 2011, American society of clinical oncology statement: toward individualized care for patients with advanced cancer, J Clin Oncol, 29, 755, 10.1200/JCO.2010.33.1744 Temel, 2011, Longitudinal perceptions of prognosis and goals of therapy in patients with metastatic non-small-cell lung cancer: results of a randomized study of early palliative care, J Clin Oncol, 29, 2319, 10.1200/JCO.2010.32.4459 Wright, 2008, Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment, JAMA, 300, 1665, 10.1001/jama.300.14.1665 Steinhauser, 2000, Factors considered important at the end of life by patients, family, physicians, and other care providers, JAMA, 284, 2476, 10.1001/jama.284.19.2476 Pfeiffer, 1975, A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients, J Am Geriatr Soc, 23, 433, 10.1111/j.1532-5415.1975.tb00927.x Charlson, 1987, A new method of classifying prognostic comorbidity in longitudinal studies: development and validation, J Chronic Dis, 40, 373, 10.1016/0021-9681(87)90171-8 Karnofsky, 1968, Determining the extent of the cancer and clinical planning for cure, Cancer, 22, 730, 10.1002/1097-0142(196810)22:4<730::AID-CNCR2820220407>3.0.CO;2-H Loggers, 2009, Racial differences in predictors of intensive end-of-life care in patients with advanced cancer, J Clin Oncol, 27, 5559, 10.1200/JCO.2009.22.4733 Cohen, 1995, The McGill Quality of Life Questionnaire: a measure of quality of life appropriate for people with advanced disease. A preliminary study of validity and acceptability, Palliat Med, 9, 207, 10.1177/026921639500900306 Carver, 1989, Assessing coping strategies: a theoretically based approach, J Pers Soc Psychol, 56, 267, 10.1037/0022-3514.56.2.267 Pargament, 2000, The many methods of religious coping: development and initial validation of the RCOPE, J Clin Psychol, 56, 519, 10.1002/(SICI)1097-4679(200004)56:4<519::AID-JCLP6>3.0.CO;2-1 Weeks, 1998, Relationship between cancer patients' predictions of prognosis and their treatment preferences, JAMA, 279, 1709, 10.1001/jama.279.21.1709 Fried, 2002, Assessment of patient preferences: integrating treatments and outcomes, J Gerontol B Psychol Sci Soc Sci, 57, S348, 10.1093/geronb/57.6.S348 Curtis, 2002, A measure of the quality of dying and death. Initial validation using after-death interviews with family members, J Pain Symptom Manage, 24, 17, 10.1016/S0885-3924(02)00419-0 Zhang, 2012, Factors important to patients' quality of life at the end of life, Arch Intern Med, 172, 1133, 10.1001/archinternmed.2012.2364 Lavori, 1995, A multiple imputation strategy for clinical trials with truncation of patient data, Stat Med, 14, 1913, 10.1002/sim.4780141707 Rosenbaum, 1984, Reducing bias in observational studies using subclassification of the propensity score, J Am Stat Assoc, 79, 516, 10.1080/01621459.1984.10478078 Fu, 2011, Outcome analyses after the first admission to an intensive care unit in patients with advanced cancer referred to a phase I clinical trials program, J Clin Oncol, 29, 3547, 10.1200/JCO.2010.33.3823 Mack, 2012, End-of-life care discussions among patients with advanced cancer: a cohort study, Ann Intern Med, 156, 204, 10.7326/0003-4819-156-3-201202070-00008 The, 2000, Collusion in doctor-patient communication about imminent death: an ethnographic study, BMJ, 321, 1376, 10.1136/bmj.321.7273.1376 Jenkins, 2011, What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions, J Clin Oncol, 29, 61, 10.1200/JCO.2010.30.0814 Aaronson, 1996, Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials, J Clin Oncol, 14, 984, 10.1200/JCO.1996.14.3.984 Cohen, 2001, The association between treatment-specific optimism and depressive symptomatology in patients enrolled in a Phase I cancer clinical trial, Cancer, 91, 1949, 10.1002/1097-0142(20010515)91:10<1949::AID-CNCR1218>3.0.CO;2-A Maciejewski, 2007, An empirical examination of the stage theory of grief, JAMA, 297, 716, 10.1001/jama.297.7.716 Mack, 2010, End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences, J Clin Oncol, 28, 1203, 10.1200/JCO.2009.25.4672 Meropol, 2008, Cancer patient preferences for quality and length of life, Cancer, 113, 3459, 10.1002/cncr.23968 Finlay, 2009, Do phase 1 patients have greater needs for palliative care compared with other cancer patients?, Cancer, 115, 446, 10.1002/cncr.24025 Fu, 2012, Advance care planning in patients with cancer referred to a phase I clinical trials program: the MD Anderson cancer center experience, J Clin Oncol, 30, 2891, 10.1200/JCO.2011.38.0758 Meyers, 2004, Simultaneous care: a model approach to the perceived conflict between investigational therapy and palliative care, J Pain Symptom Manage, 28, 548, 10.1016/j.jpainsymman.2004.03.002 Casarett, 2002, Must patients with advanced cancer choose between a Phase I trial and hospice?, Cancer, 95, 1601, 10.1002/cncr.10820