Association of Age at Cancer Diagnosis and Clinical Trial Participation | Oncology | JAMA Network Open | JAMA Network
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Table 1.  Sample Characteristics for 5922 Cancer Survivors From the Behavioral Risk Factor Surveillance Systema
Sample Characteristics for 5922 Cancer Survivors From the Behavioral Risk Factor Surveillance Systema
Table 2.  Odds of Participating in Clinical Trial for Treatment Among 5922 Cancer Survivors From the Behavioral Risk Factor Surveillance System
Odds of Participating in Clinical Trial for Treatment Among 5922 Cancer Survivors From the Behavioral Risk Factor Surveillance System
1.
Keegan  THM, Ries  LAG, Barr  RD,  et al; National Cancer Institute Next Steps for Adolescent and Young Adult Oncology Epidemiology Working Group  Comparison of cancer survival trends in the United States of adolescents and young adults with those in children and older adults.   Cancer. 2016;122(7):1009-1016. doi:10.1002/cncr.29869 PubMedGoogle ScholarCrossref
2.
Collins  CL, Malvar  J, Hamilton  AS, Deapen  DM, Freyer  DR.  Case-linked analysis of clinical trial enrollment among adolescents and young adults at a National Cancer Institute-designated comprehensive cancer center.   Cancer. 2015;121(24):4398-4406. doi:10.1002/cncr.29669 PubMedGoogle ScholarCrossref
3.
Chow  CJ, Habermann  EB, Abraham  A,  et al.  Does enrollment in cancer trials improve survival?   J Am Coll Surg. 2013;216(4):774-780. doi:10.1016/j.jamcollsurg.2012.12.036 PubMedGoogle ScholarCrossref
4.
Centers for Disease Control and Prevention. Behavioral Risk Factor Surveillance System. Accessed November 15, 2019. https://www.cdc.gov/brfss/index.html
5.
Sedrak  MS, Freedman  RA, Cohen  HJ,  et al; Cancer and Aging Research Group (CARG).  Older adult participation in cancer clinical trials: a systematic review of barriers and interventions.   CA Cancer J Clin. Published online October 1, 2020. doi:10.3322/caac.21638PubMedGoogle Scholar
6.
Gore  L, Ivy  SP, Balis  FM,  et al.  Modernizing clinical trial eligibility: recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Minimum Age Working Group.   J Clin Oncol. 2017;35(33):3781-3787. doi:10.1200/JCO.2017.74.4144 PubMedGoogle ScholarCrossref
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    Research Letter
    Oncology
    February 18, 2021

    Association of Age at Cancer Diagnosis and Clinical Trial Participation

    Author Affiliations
    • 1Department of Acute and Specialty Care, University of Virginia School of Nursing, Charlottesville
    • 2Department of Pediatrics, University of Virginia School of Medicine, Charlottesville
    • 3Program in Public Health, Department of Family, Population, and Preventive Medicine, Renaissance School of Medicine, Stony Brook University, Stony Brook, New York
    JAMA Netw Open. 2021;4(2):e2037573. doi:10.1001/jamanetworkopen.2020.37573
    Introduction

    Overall survival outcomes for adolescents and young adults with cancer have not kept pace with those of their younger childhood or older adult counterparts. Although the causes for this disparity are multifactorial, 1 prominent reason may be the unequal access to clinical trials.1,2 Numerous studies have shown a survival advantage for children who enrolled in clinical trials for various types of malignant neoplasms,3 yet there is unequal representation in clinical research among older adolescents and young adults.2 It is estimated that only 10% of adolescents aged 15 to 19 years and approximately 1% of young adults aged 20 to 30 years enter clinical trials of pediatric or adult cooperative groups.2 On the opposite end of the age spectrum, older adults represent more than half of all patients with cancer diagnoses, and previous reports suggest that they, too, are underrepresented in cancer clinical trials. Previous studies demonstrate that patients older than 65 years account for less than 10% of all patients enrolled in clinical trials sponsored by the National Cancer Institute.4 Our analysis sought to examine the association of age at diagnosis with cancer-related clinical trial participation among a nationally representative sample of cancer survivors.

    Methods

    The data source for this cross-sectional study was the 2016 Behavioral Risk Factor Surveillance System data set.5 The Behavioral Risk Factor Surveillance System is a nationally representative survey of noninstitutionalized adults whose responses are collected by both landline and cell phone interviews. In 2016, a cancer survivorship module was included in the core outcomes that elicited additional responses among respondents who indicated they had a past or current cancer diagnosis. Age at cancer diagnosis was the primary risk factor. Other independent variables were controlled for in the multivariable model, including race/ethnicity, sex, educational attainment, income, current insurance status, and cancer type. The dichotomous (yes/no) dependent variable was enrollment in a clinical trial that was elicited from the question “Did you participate in a clinical trial as a part of your cancer treatment?” This report followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. Approval for this study was waived by the University of Virginia institutional review board because deidentified publicly available data were used in this analysis.

    Univariate statistics were run for all study variables, and all statistics except sample sizes were weighted. Logistic regression models were then fit to estimate the odds of participating in a clinical trial as part of cancer treatment. A final multivariable model included all confounders simultaneously, along with age. Analyses were conducted from November 15 and December 21, 2020, using Stata version 14.1 software (StataCorp LLC).

    Results

    Only 345 patients (5.98%) of the total number in the study sample (N = 5922) indicated that they ever participated in a clinical trial related to their cancer care. In the full cohort, 2175 (38.79%) were males, 3747 (61.21%) were females, 5510 (91.50%) were White, and 5876 (98.61%) were not Hispanic or Latino. Additional patient characteristics are given in Table 1. Most respondents (3169 [53.31%]) were between the ages of 40 and 64 years at the time of their cancer diagnosis.

    Table 2 shows the bivariate associations between the variables and clinical trial participation along with the results from the final multivariable model. Adolescents and young adults between 18 and 39 years and adults 65 years or older at the time of their cancer diagnosis had significantly lower odds of clinical trial participation (adjusted odds ratio, 0.38; 95% CI, 0.15-0.89 for 18- to 39-year-olds; adjusted odds ratio, 0.14; 95% CI, 0.06-0.35 for adults ≥65 years). Patients with hematologic malignant neoplasms were significantly more likely to participate compared with those with other cancer types (adjusted odds ratio, 3.72; 95% CI, 1.99-6.97).

    Discussion

    This nationally representative analysis highlights the 2 age groups at great risk for unequal participation in cancer clinical trial: (1) adolescents and young adults and (2) older adults. Several limitations of this analysis must be addressed. First, it was not possible to ascertain if the study participants were eligible or invited to participate in clinical trials during their cancer treatment. Second, the sampling strategies used in the Behavioral Risk Factor Surveillance System may limit the generalizability of the study findings. Third, the cancer survivors included are predominantly long-term survivors and may not represent patients with more advanced cancer stages at diagnosis. The current clinical trial infrastructure must expand and modernize eligibility criteria for trials and continue to promote innovation in enrollment and retention among patients that mirror real-world clinical populations.6

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    Article Information

    Accepted for Publication: December 28, 2020.

    Published: February 18, 2021. doi:10.1001/jamanetworkopen.2020.37573

    Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Keim-Malpass J et al. JAMA Network Open.

    Corresponding Author: Jessica Keim-Malpass, RN, PhD, University of Virginia School of Nursing, PO Box 800782, Charlottesville, VA 22908 (Jlk2t@virginia.edu).

    Author Contributions: Both authors had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Both authors.

    Acquisition, analysis, or interpretation of data: Both authors.

    Drafting of the manuscript: Both authors.

    Critical revision of the manuscript for important intellectual content: Both authors.

    Statistical analysis: Alcalá.

    Administrative, technical, or material support: Keim-Malpass.

    Supervision: Keim-Malpass.

    Conflict of Interest Disclosures: Dr Keim-Malpass reported receiving grants from the Translational Health Institute of Virginia during the conduct of the study. No other disclosures were reported.

    Funding/Support: This study was supported by grant GBMF9048 from the Gordon and Betty Moore Foundation (Dr Keim-Malpass).

    Role of the Funder/Sponsor: The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    References
    1.
    Keegan  THM, Ries  LAG, Barr  RD,  et al; National Cancer Institute Next Steps for Adolescent and Young Adult Oncology Epidemiology Working Group  Comparison of cancer survival trends in the United States of adolescents and young adults with those in children and older adults.   Cancer. 2016;122(7):1009-1016. doi:10.1002/cncr.29869 PubMedGoogle ScholarCrossref
    2.
    Collins  CL, Malvar  J, Hamilton  AS, Deapen  DM, Freyer  DR.  Case-linked analysis of clinical trial enrollment among adolescents and young adults at a National Cancer Institute-designated comprehensive cancer center.   Cancer. 2015;121(24):4398-4406. doi:10.1002/cncr.29669 PubMedGoogle ScholarCrossref
    3.
    Chow  CJ, Habermann  EB, Abraham  A,  et al.  Does enrollment in cancer trials improve survival?   J Am Coll Surg. 2013;216(4):774-780. doi:10.1016/j.jamcollsurg.2012.12.036 PubMedGoogle ScholarCrossref
    4.
    Centers for Disease Control and Prevention. Behavioral Risk Factor Surveillance System. Accessed November 15, 2019. https://www.cdc.gov/brfss/index.html
    5.
    Sedrak  MS, Freedman  RA, Cohen  HJ,  et al; Cancer and Aging Research Group (CARG).  Older adult participation in cancer clinical trials: a systematic review of barriers and interventions.   CA Cancer J Clin. Published online October 1, 2020. doi:10.3322/caac.21638PubMedGoogle Scholar
    6.
    Gore  L, Ivy  SP, Balis  FM,  et al.  Modernizing clinical trial eligibility: recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Minimum Age Working Group.   J Clin Oncol. 2017;35(33):3781-3787. doi:10.1200/JCO.2017.74.4144 PubMedGoogle ScholarCrossref
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