Overcoming barriers to clinical trial enrollment in patients with bone and soft tissue sarcoma: a paradigm for an increasingly heterogeneous cancer population
Ari Rosenberg, MD,a Sheetal Kircher, MD,a,b Elizabeth A. Hahn, MA,b,c,d Karl Bilimoria, MD, MS,b,d,e Jeffrey D. Wayne, MD,b,e,f Alfred Rademaker, PhD,b,c Al Benson III, MD,a,b John Hayes, MD,b,g Terrance Peabody, MD,b,h Samer Attar, MD,b,h Mark Agulnik, MDa,b aDivision of Hematology and Oncology, Department of Medicine, Feinberg School of Medicine of Northwestern University; bRobert H. Lurie Comprehensive Cancer Center, Northwestern University; cDepartment of Preventive Medicine, Feinberg School of Medicine of Northwestern University; dNorthwestern Institute for Comparative Effectiveness Research in Oncology (NICER-Onc), Lurie Comprehensive Cancer Center, Northwestern Medicine, Northwestern University; eDepartment of Surgery, Northwestern University; fDepartment of Dermatology, Northwestern University; gDepartment of Radiation Oncology, Northwestern University; and hDepartment of Orthopedic Surgery, Northwestern University, Chicago, IL 60611
DISCLOSURES: The authors report no conflicts of interest concerning this paper.
ACKNOWLEDGMENT: This work was supported by the Northwestern University Cancer Biostatistics Core and a Cancer Center Support Grant (NCI CA060553), the Jeff Hugo Foundation for Osteosarcoma Research, and the Brett Armin Sarcoma Foundation.
CORRESPONDING AUTHOR: Mark A Agulnik, MD, mark.agulnik@nm.org
Responses were separated from the personal data for complete anonymization. Descriptive statistical analysis was performed for demographics and disease variables and were summarized using frequencies and percentages. Median and range were used for age. Correlations between continuous variables were analyzed using Spearman correlations. Scores were compared between subgroups using the Mann-Whitney test. Descriptive statistics for knowledge, attitude, and ability scores include means and 95% confidence intervals. Correlations were interpreted as small (r=0.10), medium (r=0.30), or large (r=0.50).15 Statistical significance was indicated when P<0.05.
Results
Patients
Seven hundred fifty patients were eligible to participate in the survey and received the initial and two follow-up e-mails. Twenty e-mailed surveys bounced back. Three hundred nine patients opened the initial e-mail and 283 patients (37.7% of total and 91.6% of opened) completed at least a portion of the survey, with 182 patients completing the entire survey (FIGURE 1). Data for analysis were used from patients who completed at least a portion of the survey.
Baseline characteristics of patients who responded can be seen in TABLE 2. Patients had a median age of 56, the majority were female (59.4%), white (88.2%), and most had college or university graduate degrees or higher educational level (69.0%). Patients had various different histological subtypes, with the most common being liposarcoma (16.5%) and leiomyosarcoma (16.0%). Slightly more than a quarter (26.8%) of patients had metastatic disease, and 84.2% had never been enrolled in a clinical trial. Previous treatments included surgery (91.1%), radiation (53.2%), and chemotherapy (51.6%). Prior to completing the survey, 85.4% reported being receptive to a cancer clinical trial, while 60.7% of patients reported willingness to participate in a clinical trial.
