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Perceptions of Cancer Clinical Research Among African American Men in North Carolina Laurel C. Trantham, Ph.D., William R Carpenter, Ph.D., MHA, Lisa D. DiMartino, M.P.H., Brandolyn White, M.P.H., 0HOLVVD*UHHQ03+5DQGDOO7HDO0$*LVHOOH&RUELH6PLWK0'DQG3DXO$*RGOH\0'3K'
Financial Disclosure: No disclosures. Funding sources are presented in the Acknowledgment. Acknowledgements: The authors are grateful to the men and women who participated in our Focus Groups and shared with us their very personal cancer experience. Their insight is valuable, and will inform and improve cancer care for future generations. The authors thank the Greensboro area Community 5HVHDUFK$GYRFDWHV²HVSHFLDOO\$SULO'XUU(OYLUD0HEDQH0DULH0F$GRR .DWK\1RUFRWWDQG&LQG\7D\ORU²ZKRDVVLVWHGLQWKHFRQGXFWRIWKHVWXG\ including interpretation of results. They also thank Gratia Wright of First Research Group for her expertise in moderating and executing all of the focus groups, DQG/LQGVH\+D\QHV0DVORZIRUKHUDVVLVWDQFHLQUHVSRQGLQJWRUHYLHZHU comments. The study was funded as a part of the Carolina Community Network SURJUDPIXQGHGE\DJUDQWIURPWKH1DWLRQDO&DQFHU,QVWLWXWH 8&$ 7KLVVWXG\ZDVUHYLHZHGDQGDSSURYHGE\WKH,QVWLWXWLRQDO5HYLHZ%RDUG ,5% DW the University of North Carolina at Chapel Hill. Objective: The problem of cancer health disparities is substantial. Clinical trials are widely advocated as a means of reducing disparities and bringing VWDWHRIWKHDUWFDUHWRWKHEURDGHUFRPPXQLW\ZKHUHPRVWFDQFHUFDUH is delivered. This study sought to develop a better understanding of why disproportionately few African American men enroll in clinical trials given their substantial cancer burden. Design:7KLVVWXG\DSSOLHGFRPPXQLW\EDVHGSDUWLFLSDWRU\UHVHDUFK &%35 methods to design and conduct four focus groups of African American male cancer survivors and their caregivers in North Carolina. Results: Among major themes, participants expressed confusion about the relationship between clinical trials, treatment, and research; signifying patient confusion and misinterpretation of common clinical trial terminology. Social norms including gender barriers and generational differences remain problematic; participants often reported that men do not talk about health issues, are unwilling to go to the doctor, and exhibit misapprehension and distrust regarding trials. Participants perceived this misunderstanding as detrimental to community health and expressed the need for more clarity in clinical trials information and a more fundamental social openness and communication about cancer detection and treatment. Conclusion: Findings indicate the importance of clinical trial education in both traditional provider referral to trials and also in general patient navigation. To dispel pervasive misapprehension regarding placebos, clinical trial information should emphasize the role of standard care in modern cancer treatment trials. Many participants described willingness to participate in a trial upon physician recommendation, suggesting merit in LPSURYLQJSDWLHQWSK\VLFLDQFRPPXQLFDWLRQWKURXJKFXOWXUDOO\FRPSHWHQW terminology and trial referral systems. Keywords: Racial disparities Q cancer QFRPPXQLW\EDVHGSDUWLFLSDWRU\ research Q clinical research Q African Americans
Author Affiliations: Lineberger Comprehensive Cancer Center, University of North &DUROLQDDW&KDSHO+LOO&KDSHO+LOO1& 'UV&DUSHQWHU&RUELH6PLWKDQG*RGOH\ 0V DiMartino, White, Green, and Mr Teal); Cecil G. Sheps Center for Health Services Research 8QLYHUVLW\RI1RUWK&DUROLQDDW&KDSHO+LOO&KDSHO+LOO1& 'UV&DUSHQWHU&RUELH6PLWK and Godley; Mr Teal and Ms Green); Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, NC (Dr Carpenter); Blue Cross and Blue Shield of North Carolina (Dr Trantham); Department of Medicine, University of North &DUROLQDDW&KDSHO+LOO&KDSHO+LOO1& 'UV*RGOH\DQG&RUELH6PLWK Correspondence: William R. Carpenter, Ph.D., MHA, University of North Carolina at &KDSHO+LOO$0F*DYUDQ*UHHQEHUJ+DOO&DPSXV%R[&KDSHO+LOO1& 3KRQH )D[ (PDLO ELOOFDUSHQWHU#XQFHGX
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
INTRODUCTION
,
n the United States, compared to Caucasians, African Americans are diagnosed with more advanced cancer, experience a 23% higher cancer mortality rate, and have \HDU VXUYLYDO UDWHV WKDW DUH DV PXFK DV ORZHU DPRQJ the cancers of greatest incidence.1 ,Q 1RUWK &DUROLQD WKH disparity is even more stark: compared to Caucasians, African $PHULFDQV KDYH D JUHDWHU FRORQ FDQFHU PRUWDOLW\ UDWH a 40% greater breast cancer mortality rate, and nearly threefold greater prostate cancer mortality rate.2,3 Given these differences and the fact that African Americans comprise QHDUO\RQHTXDUWHURIWKHVWDWH¶VSRSXODWLRQ1,4 the problem of cancer disparities in North Carolina is particularly acute. A large portion of these acute racial differences are DWWULEXWHG WR UDFLDO EDUULHUV LQ KLJKTXDOLW\ PHGLFDO FDUH and disparities in treatment.± Clinical trials have been ZLGHO\DGYRFDWHGE\WKH,QVWLWXWHRI0HGLFLQHDQGRWKHUVDV a means of reducing such disparities and bringing state-ofthe-art care to individuals living in the broader community. This is where the majority of cancer care is delivered.8–10 +RZHYHU LW LV HVWLPDWHG WKDW RQO\ WR RI WKH DGXOW cancer population receives treatment through a National &DQFHU ,QVWLWXWH 1&, VSRQVRUHG FOLQLFDO WULDO GHVSLWH 80% of adults expressing interest, half of whom indicate a willingness to enroll.11–14 The acute cancer health disparities in North Carolina and elsewhere in the United States further suggest that greater African American participation LQFOLQLFDOWULDOVLVQHHGHGIRUWKLVSRSXODWLRQWREHQH¿WIURP advances in cancer research.9 The North Carolina Comprehensive Cancer Program has recognized the importance of cancer clinical trials and is addressing lack of clinical trial enrollment as a part of the State Cancer Control Plan. ,W LV VXVSHFWHG WKDW SDWWHUQV of trial enrollment follow similar patterns of health care resource availability in the state. The current state of which has been described as fragmented leaving regions and populations substantially underserved, most likely affecting minorities.16 However, despite the promise of clinical trials and the rising interest in facilitating access to them, little is known about the characteristics of individuals enrolling in cancer trials in North Carolina.
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There was lack of agreement on whether physicians should receive incentives for enrolling patients in clinical trials as well as whether disclosure of incentives would affect their relationship with their physician. Roughly half of the participants expressed wariness of their physician’s motives for enrolling them in a trial if they were being compensated by study sponsors. Although one participant felt that physicians’ motives could be so skewed as to encourage them to misdiagnose patients, most participants simply felt that monetary incentives for physicians could result in misplaced priorities. As one participant shared: ´:KHQ WKH GRFWRU EHJLQV JHWWLQJ FRPSHQVDWLRQ , think they may lose your best interests. They may start thinking more about themselves when they’re being FRPSHQVDWHG/LNHWKHPRUHSDWLHQWV,FDQJHWWRGR WKLVWULDOWKHQWKHPRUHPRQH\,·PJRLQJWRJHWVRWKH\ may begin to lose their patients’ best interest.”
Others suggested that such compensation would not be a concern if their doctor was upfront and honest with them. As one participant stated: ´,WZRXOGQ·WERWKHUPHEHFDXVH,KDYHVRPXFKPRUH DSSUHFLDWLRQ IRU GRFWRUV QRZ QXUVHV«WKH UHDVRQ ,·P still here is because of the doctor who operated on me VR,ZRXOGQ·WFDUHLIWKH\JDYHKLPWKHZKROH)RUW.QR[µ
Theme 4: Social norms When asked who participated in clinical trials, participants said “whites,” “Anglos,” “Caucasians,” and “women.” They also agreed that some participants were like themselves, though most were not. They generally acknowledged that Caucasians and African Americans may respond differently to a treatment. For example, when asked why African American men might not want to participate in a trial, one participant said: ´/LNH\RXVDLGLW·VFOHDUWKDWDORWRI$IULFDQ$PHULFDQV don’t participate in clinical trials so even though my doctor is sitting here telling me that you know it has JUHDW SURPLVH IRU WKH W\SH RI FDQFHU , KDYH KRZ PDQ\SHRSOHOLNHPHKDYH\RXDFWXDOO\WHVWHG"+RZ GR\RXNQRZLW·VJRLQJWRZRUNRQVRPHRQHOLNHPH"µ
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
Participants brought up generational differences as a barrier to trial participation. They expressed the idea that men do not want to talk about their medical problems and that older generations of men especially would not be comfortable discussing treatment with family. One participant said that black men will not go to the doctor so they may “miss out” on opportunities for education and preventive care, while another participant felt that discussing cancer with a family member who was receiving cancer treatment was “off limits.” Participants recognized that this silence related to disease and treatment was detrimental to the health of WKHLU FRPPXQLW\ 7KH\ WDONHG IUHHO\ DERXW WKHLU VSHFL¿F treatments and diagnoses and encouraged each other to have these conversations in public to educate others. As one SDUWLFLSDQWUHÀHFWHG ´0RUHRIOLNHP\JUDQGIDWKHU\RXNQRZKHZRXOGQ·W sit around a table like this and talk about it because it was just something they were not taught to do but as we come on now and go and things are FKDQJLQJ ZH·UH PRUH >OLNHO\@ WR RSHQ XS EHFDXVH IURPP\VWDQGSRLQWRIEHLQJFRQFHUQHGWKDWLI,FDQ OHDUQVRPHWKLQJLI,KDYHWRJRWKURXJKVRPHWKLQJ DQGWKHQZKDWHYHU,JRWKURXJKDQGOHDUQ,ZDQWWR help someone else.”
DISCUSSION ,Q WKH IDFH RI VWDUN UDFLDO GLIIHUHQFHV LQ FDQFHU FOLQLFDO WULDO HQUROOPHQW UDWHV WKLV TXDOLWDWLYH VWXG\ VRXJKW WR XQGHUVWDQG reasons for the relatively low enrollment of African American men with substantial cancer burden. Through in-depth focus groups with African American male cancer survivors and their caregivers, several major and consistent themes emerged 7DEOH $PRQJ WKHP WKHUH ZDV FRQIXVLRQ DERXW WKH relationship between clinical trials, treatment, and research, signifying that the common terms researchers and physicians use to describe clinical trials often have a different meaning to patients. Participants expressed confusion about trial protocols and assumed that all cancer treatment trials involve a placebo, WKH IHDU RI ZKLFK ZDV FOHDUO\ LGHQWL¿HG DV FRQWULEXWRU\ WR participants’ unwillingness to participate in trials. Despite this somewhat misapprehended disfavor, participants expressed great trust in their physicians, suggesting that physician recommendation may be a powerful tool in overcoming the historical legacy of discrimination African Americans have experienced in medical research.37,38 Other factors such as generational differences suggest that the barriers to clinical trial participation are multidimensional, which must be considered when developing strategies to improve enrollment. 'H¿QLQJ DQG GLVFXVVLQJ WKH YDULRXV FOLQLFDO UHVHDUFK terms at the beginning of each focus group was intended to
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Perceptions of Cancer Clinical Research Among African American Men in North Carolina Laurel C. Trantham, Ph.D., William R Carpenter, Ph.D., MHA, Lisa D. DiMartino, M.P.H., Brandolyn White, M.P.H., 0HOLVVD*UHHQ03+5DQGDOO7HDO0$*LVHOOH&RUELH6PLWK0'DQG3DXO$*RGOH\0'3K'
Financial Disclosure: No disclosures. Funding sources are presented in the Acknowledgment. Acknowledgements: The authors are grateful to the men and women who participated in our Focus Groups and shared with us their very personal cancer experience. Their insight is valuable, and will inform and improve cancer care for future generations. The authors thank the Greensboro area Community 5HVHDUFK$GYRFDWHV²HVSHFLDOO\$SULO'XUU(OYLUD0HEDQH0DULH0F$GRR .DWK\1RUFRWWDQG&LQG\7D\ORU²ZKRDVVLVWHGLQWKHFRQGXFWRIWKHVWXG\ including interpretation of results. They also thank Gratia Wright of First Research Group for her expertise in moderating and executing all of the focus groups, DQG/LQGVH\+D\QHV0DVORZIRUKHUDVVLVWDQFHLQUHVSRQGLQJWRUHYLHZHU comments. The study was funded as a part of the Carolina Community Network SURJUDPIXQGHGE\DJUDQWIURPWKH1DWLRQDO&DQFHU,QVWLWXWH 8&$ 7KLVVWXG\ZDVUHYLHZHGDQGDSSURYHGE\WKH,QVWLWXWLRQDO5HYLHZ%RDUG ,5% DW the University of North Carolina at Chapel Hill. Objective: The problem of cancer health disparities is substantial. Clinical trials are widely advocated as a means of reducing disparities and bringing VWDWHRIWKHDUWFDUHWRWKHEURDGHUFRPPXQLW\ZKHUHPRVWFDQFHUFDUH is delivered. This study sought to develop a better understanding of why disproportionately few African American men enroll in clinical trials given their substantial cancer burden. Design:7KLVVWXG\DSSOLHGFRPPXQLW\EDVHGSDUWLFLSDWRU\UHVHDUFK &%35 methods to design and conduct four focus groups of African American male cancer survivors and their caregivers in North Carolina. Results: Among major themes, participants expressed confusion about the relationship between clinical trials, treatment, and research; signifying patient confusion and misinterpretation of common clinical trial terminology. Social norms including gender barriers and generational differences remain problematic; participants often reported that men do not talk about health issues, are unwilling to go to the doctor, and exhibit misapprehension and distrust regarding trials. Participants perceived this misunderstanding as detrimental to community health and expressed the need for more clarity in clinical trials information and a more fundamental social openness and communication about cancer detection and treatment. Conclusion: Findings indicate the importance of clinical trial education in both traditional provider referral to trials and also in general patient navigation. To dispel pervasive misapprehension regarding placebos, clinical trial information should emphasize the role of standard care in modern cancer treatment trials. Many participants described willingness to participate in a trial upon physician recommendation, suggesting merit in LPSURYLQJSDWLHQWSK\VLFLDQFRPPXQLFDWLRQWKURXJKFXOWXUDOO\FRPSHWHQW terminology and trial referral systems. Keywords: Racial disparities Q cancer QFRPPXQLW\EDVHGSDUWLFLSDWRU\ research Q clinical research Q African Americans
Author Affiliations: Lineberger Comprehensive Cancer Center, University of North &DUROLQDDW&KDSHO+LOO&KDSHO+LOO1& 'UV&DUSHQWHU&RUELH6PLWKDQG*RGOH\ 0V DiMartino, White, Green, and Mr Teal); Cecil G. Sheps Center for Health Services Research 8QLYHUVLW\RI1RUWK&DUROLQDDW&KDSHO+LOO&KDSHO+LOO1& 'UV&DUSHQWHU&RUELH6PLWK and Godley; Mr Teal and Ms Green); Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, NC (Dr Carpenter); Blue Cross and Blue Shield of North Carolina (Dr Trantham); Department of Medicine, University of North &DUROLQDDW&KDSHO+LOO&KDSHO+LOO1& 'UV*RGOH\DQG&RUELH6PLWK Correspondence: William R. Carpenter, Ph.D., MHA, University of North Carolina at &KDSHO+LOO$0F*DYUDQ*UHHQEHUJ+DOO&DPSXV%R[&KDSHO+LOO1& 3KRQH )D[ (PDLO ELOOFDUSHQWHU#XQFHGX
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
INTRODUCTION
,
n the United States, compared to Caucasians, African Americans are diagnosed with more advanced cancer, experience a 23% higher cancer mortality rate, and have \HDU VXUYLYDO UDWHV WKDW DUH DV PXFK DV ORZHU DPRQJ the cancers of greatest incidence.1 ,Q 1RUWK &DUROLQD WKH disparity is even more stark: compared to Caucasians, African $PHULFDQV KDYH D JUHDWHU FRORQ FDQFHU PRUWDOLW\ UDWH a 40% greater breast cancer mortality rate, and nearly threefold greater prostate cancer mortality rate.2,3 Given these differences and the fact that African Americans comprise QHDUO\RQHTXDUWHURIWKHVWDWH¶VSRSXODWLRQ1,4 the problem of cancer disparities in North Carolina is particularly acute. A large portion of these acute racial differences are DWWULEXWHG WR UDFLDO EDUULHUV LQ KLJKTXDOLW\ PHGLFDO FDUH and disparities in treatment.± Clinical trials have been ZLGHO\DGYRFDWHGE\WKH,QVWLWXWHRI0HGLFLQHDQGRWKHUVDV a means of reducing such disparities and bringing state-ofthe-art care to individuals living in the broader community. This is where the majority of cancer care is delivered.8–10 +RZHYHU LW LV HVWLPDWHG WKDW RQO\ WR RI WKH DGXOW cancer population receives treatment through a National &DQFHU ,QVWLWXWH 1&, VSRQVRUHG FOLQLFDO WULDO GHVSLWH 80% of adults expressing interest, half of whom indicate a willingness to enroll.11–14 The acute cancer health disparities in North Carolina and elsewhere in the United States further suggest that greater African American participation LQFOLQLFDOWULDOVLVQHHGHGIRUWKLVSRSXODWLRQWREHQH¿WIURP advances in cancer research.9 The North Carolina Comprehensive Cancer Program has recognized the importance of cancer clinical trials and is addressing lack of clinical trial enrollment as a part of the State Cancer Control Plan. ,W LV VXVSHFWHG WKDW SDWWHUQV of trial enrollment follow similar patterns of health care resource availability in the state. The current state of which has been described as fragmented leaving regions and populations substantially underserved, most likely affecting minorities.16 However, despite the promise of clinical trials and the rising interest in facilitating access to them, little is known about the characteristics of individuals enrolling in cancer trials in North Carolina.
92/12)(%58$540k (%)
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Have regular source of care (%)
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JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
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There was lack of agreement on whether physicians should receive incentives for enrolling patients in clinical trials as well as whether disclosure of incentives would affect their relationship with their physician. Roughly half of the participants expressed wariness of their physician’s motives for enrolling them in a trial if they were being compensated by study sponsors. Although one participant felt that physicians’ motives could be so skewed as to encourage them to misdiagnose patients, most participants simply felt that monetary incentives for physicians could result in misplaced priorities. As one participant shared: ´:KHQ WKH GRFWRU EHJLQV JHWWLQJ FRPSHQVDWLRQ , think they may lose your best interests. They may start thinking more about themselves when they’re being FRPSHQVDWHG/LNHWKHPRUHSDWLHQWV,FDQJHWWRGR WKLVWULDOWKHQWKHPRUHPRQH\,·PJRLQJWRJHWVRWKH\ may begin to lose their patients’ best interest.”
Others suggested that such compensation would not be a concern if their doctor was upfront and honest with them. As one participant stated: ´,WZRXOGQ·WERWKHUPHEHFDXVH,KDYHVRPXFKPRUH DSSUHFLDWLRQ IRU GRFWRUV QRZ QXUVHV«WKH UHDVRQ ,·P still here is because of the doctor who operated on me VR,ZRXOGQ·WFDUHLIWKH\JDYHKLPWKHZKROH)RUW.QR[µ
Theme 4: Social norms When asked who participated in clinical trials, participants said “whites,” “Anglos,” “Caucasians,” and “women.” They also agreed that some participants were like themselves, though most were not. They generally acknowledged that Caucasians and African Americans may respond differently to a treatment. For example, when asked why African American men might not want to participate in a trial, one participant said: ´/LNH\RXVDLGLW·VFOHDUWKDWDORWRI$IULFDQ$PHULFDQV don’t participate in clinical trials so even though my doctor is sitting here telling me that you know it has JUHDW SURPLVH IRU WKH W\SH RI FDQFHU , KDYH KRZ PDQ\SHRSOHOLNHPHKDYH\RXDFWXDOO\WHVWHG"+RZ GR\RXNQRZLW·VJRLQJWRZRUNRQVRPHRQHOLNHPH"µ
JOURNAL OF THE NATIONAL MEDICAL ASSOCIATION
Participants brought up generational differences as a barrier to trial participation. They expressed the idea that men do not want to talk about their medical problems and that older generations of men especially would not be comfortable discussing treatment with family. One participant said that black men will not go to the doctor so they may “miss out” on opportunities for education and preventive care, while another participant felt that discussing cancer with a family member who was receiving cancer treatment was “off limits.” Participants recognized that this silence related to disease and treatment was detrimental to the health of WKHLU FRPPXQLW\ 7KH\ WDONHG IUHHO\ DERXW WKHLU VSHFL¿F treatments and diagnoses and encouraged each other to have these conversations in public to educate others. As one SDUWLFLSDQWUHÀHFWHG ´0RUHRIOLNHP\JUDQGIDWKHU\RXNQRZKHZRXOGQ·W sit around a table like this and talk about it because it was just something they were not taught to do but as we come on now and go and things are FKDQJLQJ ZH·UH PRUH >OLNHO\@ WR RSHQ XS EHFDXVH IURPP\VWDQGSRLQWRIEHLQJFRQFHUQHGWKDWLI,FDQ OHDUQVRPHWKLQJLI,KDYHWRJRWKURXJKVRPHWKLQJ DQGWKHQZKDWHYHU,JRWKURXJKDQGOHDUQ,ZDQWWR help someone else.”
DISCUSSION ,Q WKH IDFH RI VWDUN UDFLDO GLIIHUHQFHV LQ FDQFHU FOLQLFDO WULDO HQUROOPHQW UDWHV WKLV TXDOLWDWLYH VWXG\ VRXJKW WR XQGHUVWDQG reasons for the relatively low enrollment of African American men with substantial cancer burden. Through in-depth focus groups with African American male cancer survivors and their caregivers, several major and consistent themes emerged 7DEOH $PRQJ WKHP WKHUH ZDV FRQIXVLRQ DERXW WKH relationship between clinical trials, treatment, and research, signifying that the common terms researchers and physicians use to describe clinical trials often have a different meaning to patients. Participants expressed confusion about trial protocols and assumed that all cancer treatment trials involve a placebo, WKH IHDU RI ZKLFK ZDV FOHDUO\ LGHQWL¿HG DV FRQWULEXWRU\ WR participants’ unwillingness to participate in trials. Despite this somewhat misapprehended disfavor, participants expressed great trust in their physicians, suggesting that physician recommendation may be a powerful tool in overcoming the historical legacy of discrimination African Americans have experienced in medical research.37,38 Other factors such as generational differences suggest that the barriers to clinical trial participation are multidimensional, which must be considered when developing strategies to improve enrollment. 'H¿QLQJ DQG GLVFXVVLQJ WKH YDULRXV FOLQLFDO UHVHDUFK terms at the beginning of each focus group was intended to
92/12)(%58$5
