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Identifying and Overcoming Barriers in Clinical Trial Enrollment for Veterans with Blood Cancers

Publication ,  Conference
Friedman, DR; Rodgers, TD; Szumita, L; Weiss, ES
Published in: Blood
November 5, 2021

IntroductionEquitable and diverse clinical trials participation is essential for practice-changing results to be applicable to all patients. However, patients who identify as minorities, who live in rural areas, and who have low income are typically underrepresented in clinical trials. Increasing clinical trial participation in general and among underrepresented patients in particular is a goal of The Leukemia & Lymphoma Society's (LLS) Clinical Trial Support Center (CTSC), a clinical trial nurse navigation service for patients with blood cancers and their oncologists.The Veterans Health Administration (VA) is a national network of health care facilities. Approximately 3% of cancers in the United States are diagnosed in the VA. The prevalence of certain blood cancers is higher in the VA, in part due to military exposures. Veterans who receive care in the VA are more likely to have lower income, live in rural areas, and have comorbidities than patients who receive care in the private sector. Clinical trial participation among Veterans may be hampered by VA-specific factors (e.g. relatively fewer clinical trial options in the VA, lack of awareness that Veterans may be referred to participate in clinical trials outside of the VA) and patient-specific factors (e.g. income, rurality, comorbidities, and minority status). This study aimed to characterize and overcome barriers to Veteran enrollment in blood cancer clinical trials.MethodsThe LLS CTSC performs clinical trial searches using a database with information from clinicaltrials.gov and other proprietary data. To assess the impact of geography and rurality on the availability of clinical trials, we performed simulated searches for clinical trials in proximity of 13 VA facilities (6 rural, 7 urban), six blood cancers (AML, CLL, DLBCL, FL, MDS, MM), and two disease statuses (new diagnosis, relapsed/refractory). To further evaluate barriers to CTSC referral and clinical trial enrollment among Veterans who receive care in the VA, we collected data about referral patterns of VA hematologist-oncologists and Veterans' treatment choices at four VA facilities between September 2020 through May 2021.ResultsWhen evaluating both 100- and 200-mile radii from the VA facilities in simulated searches, there were significantly more clinical trials available for Veterans who receive care in urban compared to rural areas and on the East or West Coast compared to the Midwest, in aggregate (all cancers) and by disease type or status (p unadj < 0.0001).Forty-eight Veterans with blood cancers at the Durham NC, Salem VA, Sioux Falls SD, and Clarksburg WV VA facilities had consideration of clinical trials as a treatment option by oncology providers over a nine-month period. All Veterans were male, with 33 White/15 African-American, 47 non-Hispanic/1 Hispanic, age 41-93 years (median 71), living 0.2-186 miles from their VA facility (median 33.1), with diverse diseases and stages represented.Of the 48 patients, 14 patients were not asked if they wanted clinical trials information; reasons were need for immediate therapy, co-morbidities, or patient circumstances. Of 34 patients who were asked if they wanted clinical trials information, 14 did not agree to a referral to the CTSC; reasons were preference for immediate therapy, wanting care in the VA, wanting standard therapy, and lack of transportation. Of 20 referred Veterans, two enrolled in clinical trials outside the VA (for CLL and PMF), with investigational therapy provided by the study sponsors.ConclusionsUsing data from simulated and actual patient referrals to the LLS CTSC, we identified patient, provider, and location specific barriers for Veteran referral and enrollment in blood cancer clinical trials. When offered information about clinical trials, the majority of patients agreed to an LLS CTSC referral, suggesting that patients are generally willing to receive education and information about trial participation if given the opportunity. The LLS CTSC nurse navigators can overcome barriers to enrollment by providing education and identifying potential clinical trials within a desired geographic area. In addition to resources provided by the LLS CTSC, opening additional clinical trials in rural areas and within the VA system could help increase Veteran participation in clinical trials for blood cancers.

Duke Scholars

Published In

Blood

DOI

EISSN

1528-0020

ISSN

0006-4971

Publication Date

November 5, 2021

Volume

138

Issue

Supplement 1

Start / End Page

1920 / 1920

Publisher

American Society of Hematology

Related Subject Headings

  • Immunology
  • 3213 Paediatrics
  • 3201 Cardiovascular medicine and haematology
  • 3101 Biochemistry and cell biology
  • 1114 Paediatrics and Reproductive Medicine
  • 1103 Clinical Sciences
  • 1102 Cardiorespiratory Medicine and Haematology
 

Citation

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Friedman, D. R., Rodgers, T. D., Szumita, L., & Weiss, E. S. (2021). Identifying and Overcoming Barriers in Clinical Trial Enrollment for Veterans with Blood Cancers. In Blood (Vol. 138, pp. 1920–1920). American Society of Hematology. https://doi.org/10.1182/blood-2021-146736
Friedman, Daphne R., Thomas D. Rodgers, Leah Szumita, and Elisa S. Weiss. “Identifying and Overcoming Barriers in Clinical Trial Enrollment for Veterans with Blood Cancers.” In Blood, 138:1920–1920. American Society of Hematology, 2021. https://doi.org/10.1182/blood-2021-146736.
Friedman DR, Rodgers TD, Szumita L, Weiss ES. Identifying and Overcoming Barriers in Clinical Trial Enrollment for Veterans with Blood Cancers. In: Blood. American Society of Hematology; 2021. p. 1920–1920.
Friedman, Daphne R., et al. “Identifying and Overcoming Barriers in Clinical Trial Enrollment for Veterans with Blood Cancers.” Blood, vol. 138, no. Supplement 1, American Society of Hematology, 2021, pp. 1920–1920. Crossref, doi:10.1182/blood-2021-146736.
Friedman DR, Rodgers TD, Szumita L, Weiss ES. Identifying and Overcoming Barriers in Clinical Trial Enrollment for Veterans with Blood Cancers. Blood. American Society of Hematology; 2021. p. 1920–1920.

Published In

Blood

DOI

EISSN

1528-0020

ISSN

0006-4971

Publication Date

November 5, 2021

Volume

138

Issue

Supplement 1

Start / End Page

1920 / 1920

Publisher

American Society of Hematology

Related Subject Headings

  • Immunology
  • 3213 Paediatrics
  • 3201 Cardiovascular medicine and haematology
  • 3101 Biochemistry and cell biology
  • 1114 Paediatrics and Reproductive Medicine
  • 1103 Clinical Sciences
  • 1102 Cardiorespiratory Medicine and Haematology