Laura B Dunn1, Jim Wiley2, Sarah Garrett3, Fay Hlubocky4, Christopher Daugherty4, Laura Trupin5, Pamela Munster6, Daniel Dohan7. 1. Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. 2. Department of Family and Community Medicine and Institute for Health Policy Studies, University of California, San Francisco (UCSF), San Francisco, CA, USA. 3. Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco (UCSF), San Francisco, CA, USA. 4. Department of Medicine, Section of Hematology/Oncology, Maclean Center for Clinical Medical Ethics, The University of Chicago Medicine, Chicago, IL, USA. 5. Department of Medicine, University of California, San Francisco (UCSF), San Francisco, CA, USA. 6. Department of Medicine (Hematology/Oncology), and UCSF Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco (UCSF), San Francisco, CA, USA. 7. 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.
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.
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 cancerpatients 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.
Authors: Sarah B Garrett; Christopher J Koenig; Laura Trupin; Fay J Hlubocky; Christopher K Daugherty; Anne Reinert; Pamela Munster; Daniel Dohan Journal: Support Care Cancer Date: 2017-05-09 Impact factor: 3.603
Authors: Sarah B Garrett; Thea M Matthews; Corey M Abramson; Christopher J Koenig; Fay J Hlubocky; Christopher K Daugherty; Pamela N Munster; Daniel Dohan Journal: JCO Oncol Pract Date: 2019-10-11
Authors: Fay J Hlubocky; Tamara G Sher; David Cella; Kristen E Wroblewski; Jeffery Peppercorn; Christopher K Daugherty Journal: JCO Oncol Pract Date: 2021-02