Table 3.
Study enrollment data, overall and by race and ethnicity, and known reasons for not enrolling in a trial
| Lead author, year | Overall data |
Data by race and ethnicity |
Known reasons for not enrolling in trial |
|||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Offered | Enrolled | Not enrolled | Enrolled |
Not enrolled |
No. | Intervention-related reasonsa | Travel | Financial/ insurance |
Fear of experiment or randomization |
Fear of toxicity | Family reasons | Burden | Trust | LTFUb | Supportive care or hospice | Not interested |
Other | |||||||||
| W | B | H | A | O | W | B | H | A | O | |||||||||||||||||
| Studies about treatment trial participation | ||||||||||||||||||||||||||
| Grant et al., 2000 (43) | 130 | 92 | 38 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Siminoff et al., 2000 (57) | 93 | 49 | 44 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Lara et al., 2001 (51)c | 75 | 39 | 36 | — | — | — | — | — | — | — | — | — | — | 32 | 13 | 5 | 3 | 2 | 1 | 1 | 0 | 0 | 2 | 1 | 0 | 4 |
| Kemeny et al., 2003 (48)d | 60 | 32 | 28 | — | — | — | — | — | — | — | — | — | — | 28 | 18 | 0 | 0 | 6 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Adams-Campbell et al., 2004 (34) | 20 | 12 | 8 | 0 | 12 | 0 | 0 | 0 | 0 | 8 | 0 | 0 | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Martel et al., 2004 (53)d | 51 | 35 | 16 | — | — | — | — | — | — | — | — | — | — | 15 | 9 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 1 |
| Moore et al., 2004 (54)e | 347 | 189 | 158 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Simon et al., 2004 (58) | 106 | 36 | 70 | 27 | 6 | 0 | 0 | 3 | 49 | 16 | 0 | 0 | 5 | 56 | 23 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 21 | 0 | 0 | 10 |
| Guarino et al., 2005 (30) | 109 | 40 | 69 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Go et al., 2006 (8)f | 198 | 42 | 156 | — | — | — | — | — | — | — | — | — | — | 156 | 56 | 7 | 7 | 8 | 0 | 0 | 0 | 0 | 0 | 50 | 26 | 2 |
| Umutyan et al., 2008 (60)d,g | 146 | 76 | 70 | — | — | — | — | — | — | — | — | — | — | 24 | 9 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 6 |
| Albrecht et al., 2008 (35)h | 42 | 27 | 15 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Baggstrom et al., 2011 (37) | 82 | 25 | 57 | 19 | 5 | 0 | 0 | 1 | 39 | 10 | 0 | 0 | 8 | 57 | 0 | 13 | 11 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 16 | 14 |
| Biedrzycki, 2011 (39) | 197 | 131 | 66 | 115 | 0 | 0 | 0 | 14 | 62 | 0 | 0 | 0 | 3 | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Zafar et al., 2011 (62) | 216 | 102 | 114 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Javid et al., 2012 (9)d | 364 | 142 | 222 | 125 | 8 | 5 | 4 | 0 | 203 | 11 | 2 | 2 | 4 | 159 | 24 | 16 | 11 | 30 | 24 | 15 | 17 | 1 | 0 | 0 | 0 | 21 |
| Kanarek et al., 2012 (47) | 42 | 11 | 31 | 8 | 3 | 0 | 0 | 0 | 28 | 1 | 1 | 0 | 1 | 31 | 4 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 1 |
| Penberthy et al., 2012 (55)i | 720 | 396 | 324 | 288 | 108 | — | — | — | 200 | 124 | — | — | — | 282 | 77 | 0 | 61 | 26 | 30 | 14 | 14 | 0 | 1 | 0 | 59 | 0 |
| Fu et al., 2013 (42)j,k | 888 | 527 | 361 | 387 | 61 | 56 | 0 | 23 | 286 | 24 | 36 | 0 | 15 | 361 | 0 | 0 | 22 | 0 | 0 | 0 | 0 | 0 | 155 | 47 | 26 | 111 |
| Horn et al., 2013 (45)l | 332 | 141 | 191 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Swain-Cabriales et al., 2013 (59)k,m | 94 | 80 | 14 | 37 | 6 | 25 | 12 | 0 | 7 | 1 | 4 | 2 | 0 | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Unger et al., 2013 (61)d,n | 978 | 496 | 482 | 465 | 15 | 11 | 3 | 2 | 452 | 10 | 9 | 9 | 2 | 482 | 78 | 32 | 32 | 98 | 76 | 36 | 45 | 13 | 0 | 0 | 0 | 72 |
| Brooks et al., 2015 (40) | 252 | 150 | 102 | 107 | 24 | 0 | 11 | 8 | 94 | 2 | 0 | 2 | 4 | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Langford et al., 2014 (50)d,o | 1708 | 816 | 892 | 663 | 94 | 35 | 17 | 7 | 713 | 112 | 32 | 23 | 12 | 892 | 330 | 0 | 25 | 0 | 73 | 0 | 0 | 0 | 27 | 33 | 366 | 38 |
| Krieger et al., 2015 (49) | 46 | 35 | 11 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Greenwade et al., 2017 (44)k,p | 121 | 97 | 24 | 88 | 2 | 3 | 0 | 4 | 22 | 1 | 1 | 0 | 1 | 20 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 5 |
| Logan et al., 2017 (52) | 309 | 160 | 149 | 139 | 0 | 0 | 0 | 21 | 130 | 0 | 0 | 0 | 19 | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Tennapel et al., 2017 (31) | 77 | 63 | 14 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Dayao et al., 2019 (32) | 24 | 16 | 8 | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — | — |
| Jirka et al., 2019 (46) | 88 | 57 | 31 | 52 | 0 | 0 | 0 | 5 | 30 | 0 | 0 | 0 | 1 | 31 | 0 | 12 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 12 | 5 |
| Studies about cancer control study participation | ||||||||||||||||||||||||||
| Sears et al., 2003 (56) | 1314 | 558 | 756 | — | — | — | — | — | — | — | — | — | — | 756 | 0 | 31 | 0 | 49 | 0 | 0 | 65 | 0 | 426 | 16 | 108 | 61 |
| Grubbs et al., 2009 (33) | 148 | 45 | 103 | — | — | — | — | — | — | — | — | — | — | 92 | 0 | 15 | 0 | 72 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Dignan et al., 2011 (41) | 223 | 140 | 83 | 29q | 111 | 0 | 0 | 0 | 7 | 76 | 0 | 0 | 0 | 83 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 43 | 0 | 0 | 40 |
| Bernard-Davila et al., 2015 (38)r | 102 | 70 | 32 | 28 | 18 | 22 | 0 | 2 | 11 | 9 | 8 | 0 | 4 | 13 | 0 | 2 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 6 | 2 |
| Aycinena et al., 2017 (36) | 57 | 42 | 15 | 0 | 9 | 33 | 0 | 0 | 0 | 1 | 14 | 0 | 0 | 15 | 0 | 4 | 0 | 0 | 0 | 0 | 4 | 0 | 5 | 0 | 0 | 2 |
Treatment-related reasons variously framed as desire for other treatment, wish to choose own treatment, desire to avoid protocol treatment, fear of protocol treatment, and preference for standard therapy. “—” indicates data not provided. A = Asian; B = Black; H = Hispanic; LTFU = lost to follow-up; O = other/unknown; W = White.
Also includes “did not return” and “second opinions.”
One patient who was offered a trial did not participate because of death. This patient was excluded from the study denominator.
Reasons for nonenrollment were provided for a subset (n = 159) of patients. Because patients may have indicated >1 reason, category counts were prorated relative to the denominator of number of responses.
801 analyzable patients; 189 enrolled on the Gyncologic Oncology Group study; among remaining 612 patients (Table 4), exclude investigator decision (121), no available GOG protocol (170), and ineligible (163), leaving 158 nonenrolled patients.
Excluded from the denominator of patients offered a trial are those who did not enroll because of physician decision (Figure 1).
Included data from both the premass marketing campaign and the postmass marketing campaign groups. Data on reasons for nonparticipation only available for the postmass marketing group (n = 33).
tConsistent with other studies, we included in the denominator the 7 patients reported as lost to follow-up, as these were considered passive refusers.
Excludes 22 patients who indicated they did not participate because of physician barrier.
Excludes 26 patients who did not enroll because of ineligibility, and 43 patients who did not enroll because of death.
Proportion by race recalculated to be proportional to adjusted rate of patients not enrolled. Cell counts may not sum to the number not enrolled because of rounding.
Reasons for nonenrollment were provided, but category levels were very broad and could not be reconciled with existing category descriptions.
Among the 58 patients who did not enroll, 44 were excluded because their physician did not offer trial participation.
Counts by race obtained by the study team (Unger, JM; personnel communication).
Reasons for nonenrolled derived from St Germaine, 2014.
In total, 47 were not enrolled, but those with trial unavailable (14), ineligible (8), and unable to enroll because of paclitaxel shortage (1) were excluded because these were not patient choice factors, leaving n = 24 not enrolled.
Categorized as “White/other.”
Race reported separately from ethnicity. All patients were Hispanic ethnicity.