title: Interest in initiating an early phase clinical trial: results of a longitudinal study of advanced cancer patients.
abstract: OBJECTIVE
  Enhanced recruitment of patients with advanced cancer (ACP) to early phase (EP) trials is needed. However, selective recruitment may affect the kinds of patients who are recruited. To address whether ACP who initiate EP trial enrollment differ from those who do not, we prospectively surveyed ACP well in advance of potential trial recruitment and followed them over time to identify those who initiated the recruitment process.
  
  
  METHODS
  EP trial initiation was defined as a patient being referred for screening to an active EP trial. Depression and anxiety were assessed with the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder Scale (GAD-7), respectively. Demographic and disease characteristics, functional status, and patient preferences regarding decision making were examined as possible predictors of EP trial initiation.
  
  
  RESULTS
  Of the 78 advanced cancer patients in the cohort studied, 21 (27%) initiated EP trial participation, while 57 (73%) did not. Of those who initiated this process, 14 (67%) went on to enroll in an EP study. Level of depression severity was associated with EP trial initiation, with rates of initiation nearly three times higher (35% vs. 12%, p = 0.054) among patients with minimal to mild levels of depression compared to those with moderate or higher levels of depression. EP trial initiation was not associated with demographic or socioeconomic variables, cancer type, functional status, quality of life, or decision-making variables.
  
  
  CONCLUSIONS
  The presence of elevated depressive symptoms may be associated with the EP trial recruitment and enrollment processes. This possible relationship warrants further study. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.
authors.forename: Laura B
authors.initials: LB
authors.lastname: Dunn
authors.affiliation: Department of Family and Community Medicine and Institute for Health Policy Studies, University of California, San Francisco (UCSF), San Francisco, CA, USA.
authors.forename: Jim
authors.initials: J
authors.lastname: Wiley
authors.affiliation: Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco (UCSF), San Francisco, CA, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Garrett
authors.affiliation: Department of Medicine, Section of Hematology/Oncology, Maclean Center for Clinical Medical Ethics, The University of Chicago Medicine, Chicago, IL, USA.
authors.forename: Fay
authors.initials: F
authors.lastname: Hlubocky
authors.affiliation: Department of Medicine, Section of Hematology/Oncology, Maclean Center for Clinical Medical Ethics, The University of Chicago Medicine, Chicago, IL, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Daugherty
authors.affiliation: Department of Medicine, University of California, San Francisco (UCSF), San Francisco, CA, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Trupin
authors.affiliation: Department of Medicine (Hematology/Oncology), and UCSF Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco (UCSF), San Francisco, CA, USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Munster
authors.affiliation: Philip R. Lee Institute for Health Policy Studies and the Department of Anthropology, History, and Social Medicine, University of California, San Francisco (UCSF), CA, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Dohan
mesh_terms: D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic / Q000523:psychology* / Q000706:statistics & numerical data; D003657:Decision Making; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000469:parasitology* / Q000473:pathology / Q000628:therapy; D010358:Patient Participation / Q000523:psychology* / Q000706:statistics & numerical data; D057240:Patient Preference / Q000523:psychology* / Q000706:statistics & numerical data; D010817:Physician-Patient Relations; D011788:Quality of Life
keywords: anxiety; cancer; clinical trials; decision making; depression; oncology