Feasibility of oncology clinical trial-embedded evaluation of social determinants of health
Rahela Aziz-Bose
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Search for more papers by this authorDaniel J. Zheng
Divisions of Hematology and Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
Search for more papers by this authorPuja J. Umaretiya
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorLenka Ilcisin
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Department of Pediatric Surgery, Boston Children's Hospital, Boston, Massachusetts, USA
Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA
Search for more papers by this authorKristen Stevenson
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorVictoria Koch
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorAriana Valenzuela
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorPeter D. Cole
Division of Pediatric Hematology/Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA
Search for more papers by this authorLisa M. Gennarini
Division of Pediatric Hematology/Oncology and Blood & Marrow Cell Transplantation, Montefiore Medical Center, Bronx, New York, USA
Search for more papers by this authorJustine M. Kahn
Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Irving Medical Center, New York, New York, USA
Search for more papers by this authorKara M. Kelly
Department of Pediatrics, Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA
Search for more papers by this authorThai-Hoa Tran
Division of Pediatric Hematology-Oncology, Charles-Bruneau Cancer Center, CHU Ste-Justine, University of Montreal, Montreal, QC, Canada
Search for more papers by this authorBruno Michon
Department of Pediatrics, Centre Hospitalier Universitaire de Quebec, Saint-Foy, QC, Canada
Search for more papers by this authorJennifer J. G. Welch
Division of Pediatric Hematology/Oncology, Hasbro Children's Hospital/Brown University, Providence, Rhode Island, USA
Search for more papers by this authorLewis B. Silverman
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Search for more papers by this authorJoanne Wolfe
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorCorresponding Author
Kira Bona
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Division of Population Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Correspondence
Kira Bona, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA.
Email: [email protected]
Search for more papers by this authorRahela Aziz-Bose
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Search for more papers by this authorDaniel J. Zheng
Divisions of Hematology and Oncology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA
Search for more papers by this authorPuja J. Umaretiya
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorLenka Ilcisin
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Department of Pediatric Surgery, Boston Children's Hospital, Boston, Massachusetts, USA
Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA
Search for more papers by this authorKristen Stevenson
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorVictoria Koch
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorAriana Valenzuela
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorPeter D. Cole
Division of Pediatric Hematology/Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA
Search for more papers by this authorLisa M. Gennarini
Division of Pediatric Hematology/Oncology and Blood & Marrow Cell Transplantation, Montefiore Medical Center, Bronx, New York, USA
Search for more papers by this authorJustine M. Kahn
Division of Pediatric Hematology, Oncology and Stem Cell Transplantation, Columbia University Irving Medical Center, New York, New York, USA
Search for more papers by this authorKara M. Kelly
Department of Pediatrics, Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA
Search for more papers by this authorThai-Hoa Tran
Division of Pediatric Hematology-Oncology, Charles-Bruneau Cancer Center, CHU Ste-Justine, University of Montreal, Montreal, QC, Canada
Search for more papers by this authorBruno Michon
Department of Pediatrics, Centre Hospitalier Universitaire de Quebec, Saint-Foy, QC, Canada
Search for more papers by this authorJennifer J. G. Welch
Division of Pediatric Hematology/Oncology, Hasbro Children's Hospital/Brown University, Providence, Rhode Island, USA
Search for more papers by this authorLewis B. Silverman
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Search for more papers by this authorJoanne Wolfe
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Search for more papers by this authorCorresponding Author
Kira Bona
Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Division of Pediatric Hematology/Oncology, Boston Children's Hospital, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA
Division of Population Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Correspondence
Kira Bona, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215, USA.
Email: [email protected]
Search for more papers by this authorPrior Publications: Preliminary feasibility data were presented as an abstract at the 2019 American Society of Pediatric Hematology/Oncology conference in New Orleans, LA.
Abstract
Social determinants of health (SDoH) are associated with stark disparities in cancer outcomes, but systematic SDoH data collection is virtually absent from oncology clinical trials. Trial-based SDoH data are essential to ensure representation of marginalized populations, contextualize outcome disparities, and identify health-equity intervention opportunities. We report the feasibility of a pediatric oncology multicenter therapeutic trial-embedded SDoH investigation. Among 448 trial participants, 392 (87.5%) opted-in to the embedded SDoH study; 375 (95.7%) completed baseline surveys, with high longitudinal response rates (88.9–93.1%) over 24 months. Trial-embedded SDoH data collection is feasible and acceptable and must be consistently included within future oncology trials.
CONFLICT OF INTEREST
The authors declare no conflicts of interest relevant to the subject matter discussed in this manuscript.
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REFERENCES
- 1Aristizabal P, Winestone LE, Umaretiya P, Bona K. Disparities in pediatric oncology: the 21st century opportunity to improve outcomes for children and adolescents with cancer. Am Soc Clin Oncol Educ Book. 2021; 41: e315-e326.
- 2Bona K, Li Y, Winestone L, et al. Poverty and targeted immunotherapy: survival in children's oncology group clinical trials for high-risk neuroblastoma. J Natl Cancer Inst. 2021; 113(3): 282-291.
- 3Singh GK, Jemal A. Socioeconomic and racial/ethnic disparities in cancer mortality, incidence, and survival in the United States, 1950–2014: over six decades of changing patterns and widening inequalities. J Environ Public Health. 2017; 2017: 1.
- 4Wolfson JA, Bhatia S, Ginsberg J, et al. Expenditures among young adults with acute lymphoblastic leukemia by site of care. Cancer. 2021; 127(11): 1901-1911.
- 5Aristizabal P, Singer J, Cooper R, et al. Participation in pediatric oncology research protocols: racial/ethnic, language and age-based disparities. Pediatr Blood Cancer. 2015; 62(8): 1337-1344.
- 6Kahn JM, Kelly KM, Pei Q, et al. Survival by race and ethnicity in pediatric and adolescent patients with hodgkin lymphoma: a children's oncology group study. J Clin Oncol. 2019; 37(32): 3009-3017.
- 7Winestone LE, Getz KD, Miller TP, et al. The role of acuity of illness at presentation in early mortality in black children with acute myeloid leukemia. Am J Hematol. 2017; 92(2): 141-148.
- 8Gupta S, Teachey DT, Devidas M, et al. Racial, Ethnic, and Socioeconomic Factors Result in Disparities in Outcome Among Children with Acute Lymphoblastic Leukemia Not Fully Attenuated By Disease Prognosticators: A Children's Oncology Group (COG) Study. Blood. 2021; 138 (Suppl 1):211.
- 9Fleisch Marcus A, Illescas AH, Hohl BC, Llanos AAM. Relationships between social isolation, neighborhood poverty, and cancer mortality in a population-based study of US adults. PLOS ONE. 2017; 12(3):e0173370.
- 10Loree JM, Anand S, Dasari A, et al. Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncol. 2019; 5(10): e191870-e191870.
- 11Kahn JM, Gray II DM, JM Oliveri, CM Washington, CR DeGraffinreid, ED Paskett. Strategies to improve diversity, equity, and inclusion in clinical trials. Cancer. 2022; 128(2): 216-221.
- 12Zheng DJ, Shyr D, Ma C, Muriel AC, Wolfe J, Bona K. Feasibility of systematic poverty screening in a pediatric oncology referral center. Pediatr Blood Cancer. 2018; 65:e27380.
- 13Bona K, London WB, Guo D, Frank DA, Wolfe J. Trajectory of material hardship and income poverty in families of children undergoing chemotherapy: a prospective cohort study. Pediatr Blood Cancer. 2016; 63(1): 105-111.
- 14Children's defense fund (CDF). The State of America's Children. 2021; https://www.childrensdefense.org/state-of-americas-children/
- 15Ilowite MF, Al-Sayegh H, Ma C, et al. The relationship between household income and patient-reported symptom distress and quality of life in children with advanced cancer: a report from the PediQUEST study. Cancer. 2018; 124(19): 3934-3941.
- 16Umaretiya PJ, Koch VB, Stevenson KE, et al. Household material hardship and parental distress in a multicenter clinical trial for pediatric acute lymphoblastic leukemia. J Clin Oncol. 2021; 39(15): 10025-10025.
- 17Muffly L, Tardif C, de Souza J. Financial toxicity in children, adolescent, and young adult cancer patients and their families: a large national registry analysis from the family reach foundation. J Clin Oncol. 2016; 34: 6615-6615. 15_suppl.
- 18Roser K, Erdmann F, Michel G, Winther JF, Mader L. The impact of childhood cancer on parents' socio-economic situation—a systematic review. Psycho-Oncology. 2019; 28(6): 1207-1226.
- 19Umaretiya PJ, Revette A, Seo A, et al. PediCARE: development of a poverty-targeted intervention for pediatric cancer. Pediatr Blood Cancer. 2021; 68(10):e29195.