Highlights
- •Black women are underrepresented in gynecologic cancer clinical trials despite disproportionately worse cancer outcomes
- •Survey-based ‘return of value’ items show trial design factors that increase desire to participate among Black individuals
- •Gynecologic cancer clinical trials lack facilitators, information, and results Black individuals perceive as most valuable
- •Lack of valuable facilitators, information, and results may contribute to low accrual of Black women in cancer research
- •The results can be used to create person-centered, community-informed clinical trial design for gynecologic cancer research
Abstract
Objective
Underrepresented groups may be dissuaded from clinical trial participation without
perceived value. We therefore comprehensively assessed gynecologic cancer clinical trial protocols
for the inclusion of items of value most important to Black individuals.
Methods
ClinicalTrials.gov was queried for NCI-sponsored gynecologic cancer clinical trials in the US between
Jan.1994 and Nov.2021. Pre-specified return of value (ROV) items were abstracted from
each protocol. Inclusion proportions were calculated for each ROV item and temporal
changes assessed with chi-square tests. Temporality of proportional trends was further
assessed by slope and departure from linearity calculations.
Results
279 gynecologic cancer clinical trials were included. Most commonly trials had first
accrual in 2001–2007 (37%) and involved ovarian cancer (48%), phase II studies (53%),
and chemotherapy (60%) or targeted therapy (34%). Trials often included ROV items
in basic information (99%), medical record information (99%), and imaging (82%). 41%
of trials included ROV items in biomarker testing, 20% genetic testing, and 20% in
patient-reported outcome questionnaires. Over time, there were significant increases
in the proportion of trials that included genetic (3% to 51%; p < 0.001) and biomarker testing (14 to 78%, p < 0.001). Information on lifestyle risk
factors was rare (1%). No trials included ROV items in ancestry, how to connect with
other participants, or remuneration.
Conclusions
Gynecologic cancer clinical trials include few design elements that provide high value
to Black individuals like lifestyle risk factors, ancestry, and remuneration. In any
multi-pronged effort to improve diversity in clinical trial enrollment, inclusion
of items valued by Black individuals should be considered.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Gynecologic OncologyAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- Cancer statistics, 2023.CA Cancer J. Clin. 2023; 73: 17-48https://doi.org/10.3322/caac.21763
- Gynecologic cancer disparities: a report from the health disparities taskforce of the Society of Gynecologic Oncology.Gynecol. Oncol. 2014; 133: 353-361https://doi.org/10.1016/j.ygyno.2013.12.039
- Representation of minorities and women in oncology clinical trials: review of the past 14 years.J Oncol Pract. 2018; 14: e1-e10https://doi.org/10.1200/JOP.2017.025288
- Racial disparities in blacks with gynecologic cancers.Cancer. 2007; 110: 234-243https://doi.org/10.1002/cncr.22797
- Minority participation in gynecologic oncology group (GOG) studies.Gynecol. Oncol. 2015; 138: 441-444https://doi.org/10.1016/j.ygyno.2015.05.014
- Inclusion of minorities and women in cancer clinical trials, a decade later: have we improved?.Cancer. 2013; 119: 2956-2963https://doi.org/10.1002/cncr.28168
- The National Cancer Institute-American Society of Clinical Oncology Cancer trial accrual symposium: summary and recommendations.J Oncol Pract. 2013; 9: 267-276https://doi.org/10.1200/JOP.2013.001119
- Understanding what information is valued by research participants, and why.Health Aff Proj Hope. 2019; 38: 399-407https://doi.org/10.1377/hlthaff.2018.05046
- A scoping review of strategies to increase black enrollment and retention in cancer clinical trials.JCO Oncol Pract. 2022; https://doi.org/10.1200/OP.21.00863
- A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific islanders.Am. J. Public Health. 2014; 104: e16-e31https://doi.org/10.2105/AJPH.2013.301706
- African Americans and clinical research: evidence concerning barriers and facilitators to participation and recruitment recommendations.The Gerontologist. 2017; 57: 348-358https://doi.org/10.1093/geront/gnv118
- Time trends in receipt of germline genetic testing and results for women diagnosed with breast Cancer or ovarian Cancer, 2012-2019.J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol. 2021; 39: 1631-1640https://doi.org/10.1200/JCO.20.02785
- Where is personalized medicine in industry heading?.Nat. Rev. Drug Discov. 2015; 14: 812-813https://doi.org/10.1038/nrd4759
- What Black women know and want to know about counseling and testing for BRCA1/2.J Cancer Educ Off J Am Assoc Cancer Educ. 2015; 30: 344-352https://doi.org/10.1007/s13187-014-0740-9
- Awareness, knowledge, perceptions, and attitudes towards genetic testing for cancer risk among ethnic minority groups: a systematic review.BMC Public Health. 2017; 17: 503https://doi.org/10.1186/s12889-017-4375-8
- Attitudes about genetic testing and genetic testing intentions in African American women at increased risk for hereditary breast cancer.Genet Med. 2005; 7: 230-238https://doi.org/10.1097/01.GIM.0000159901.98315.FE
- Psychosocial factors associated with genetic testing status among African American women with ovarian cancer: results from the African American Cancer epidemiology study.Cancer. 2022; 128: 1252-1259https://doi.org/10.1002/cncr.34053
- African American Women’s limited knowledge and experiences with genetic counseling for hereditary breast Cancer.J. Genet. Couns. 2014; 23: 311-322https://doi.org/10.1007/s10897-013-9663-6
- Racial and ethnic disparities in genetic testing at a hereditary breast and ovarian Cancer center.J. Gen. Intern. Med. 2021; 36: 35-42https://doi.org/10.1007/s11606-020-06064-x
- Genetic testing for all: overcoming disparities in ovarian Cancer genetic testing.Am Soc Clin Oncol Educ Book Am Soc Clin Oncol Annu Meet. 2022; 42: 1-12https://doi.org/10.1200/EDBK_350292
- Disparities in gynecologic cancer genetics evaluation.Gynecol. Oncol. 2019; 153: 184-191https://doi.org/10.1016/j.ygyno.2019.01.024
- Genetic testing and results in a population-based cohort of breast cancer patients and ovarian cancer patients.J. Clin. Oncol. 2019; https://doi.org/10.1200/JCO.18.01854
- Regional differences in awareness and attitudes regarding genetic testing for disease risk and ancestry.Hum. Genet. 2010; 128: 249-260https://doi.org/10.1007/s00439-010-0845-0
- Genetic ancestry testing what is it and why is it important?.JAMA. 2020; 323: 1089-1090https://doi.org/10.1001/jama.2020.0517
- Bio science: genetic genealogy testing and the pursuit of African ancestry.Soc. Stud. Sci. 2008; 38: 759-783https://doi.org/10.1177/0306312708091929
- Participation in Cancer clinical trials: why are patients not participating?.Med. Decis. Mak. 2014; 34: 116-126https://doi.org/10.1177/0272989X13497264
- ‘Who is going to put their life on the line for a dollar? That’s crazy’: community perspectives of financial compensation in clinical research.J. Med. Ethics. 2022; 48: 261-265https://doi.org/10.1136/medethics-2020-106715
- Perceptions of clinical research participation among African American women.J. Women’s Health. 2002; 16: 423-428https://doi.org/10.1089/jwh.2006.0124
- Compensation in clinical research: the debate continues.Perspect Clin Res. 2013; 4: 70-74https://doi.org/10.4103/2229-3485.106394
- A framework for ethical payment to research participants.N. Engl. J. Med. 2018; 378: 766-771https://doi.org/10.1056/NEJMsb1710591
- Paying clinical trial participants: legal risks and mitigation strategies.J. Clin. Oncol. 2020; 38: 532-537https://doi.org/10.1200/JCO.19.00250
- Patient reported outcome assessment must be inclusive and equitable.Nat. Med. 2022; : 1-5https://doi.org/10.1038/s41591-022-01781-8
- Patient experience captured by quality-of-life measurement in oncology clinical trials.JAMA Netw. Open. 2020; 3e200363https://doi.org/10.1001/jamanetworkopen.2020.0363
- Assessing quality of life in research and clinical practice.Oncol Williston Park N. 2002; 16: 133-139
- Reliability and validity of the functional assessment of cancer therapy-ovarian.J. Clin. Oncol. Off. J. Am. Soc. Clin. Oncol. 2001; 19: 1809-1817https://doi.org/10.1200/JCO.2001.19.6.1809
- Evaluating the reliability of the attitudes to randomized trial questionnaire (ARTQ) in a predominantly African American sample.SpringerPlus. 2015; 4: 411https://doi.org/10.1186/s40064-015-1208-z
- Patient navigation as a model to increase participation of African Americans in Cancer clinical trials.J Oncol Pract. 2016; 12: 556-563https://doi.org/10.1200/JOP.2015.008946
- Video intervention increases participation of black breast cancer patients in therapeutic trials.Npj Breast Cancer. 2017; 3: 1-7https://doi.org/10.1038/s41523-017-0039-1
- Financial burden of Cancer clinical trial participation and the impact of a Cancer care equity program.Oncologist. 2016; 21: 467-474https://doi.org/10.1634/theoncologist.2015-0481
- Overcoming barriers to recruitment and retention of African–American women with SLE in behavioural interventions: lessons learnt from the WELL study.Lupus Sci Med. 2020; 7e000391https://doi.org/10.1136/lupus-2020-000391
Article info
Publication history
Published online: March 15, 2023
Accepted:
March 6,
2023
Received in revised form:
March 4,
2023
Received:
December 28,
2022
Footnotes
☆This study was presented at the 15th Annual AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held in Philadelphia, PA, September 16-19, 2022.
Identification
Copyright
© 2023 Elsevier Inc. All rights reserved.
