Abstract
Background
We assessed attitudes of breast cancer patients regarding molecular testing for personalized therapy and research.
Methods
A questionnaire was given to female breast cancer patients presenting to a cancer center. Associations between demographic, clinical variables and attitudes towards molecular testing were evaluated.
Results
308 patients were approached and 100 completed the questionnaire (32% response rate). Most participants were willing to undergo molecular testing to assist in selection of approved drugs (81%) and experimental therapy (59%) if testing was covered by insurance. Most participants were white (71%). Even if testing was financially covered, non-white participants were less willing to undergo molecular testing for selection of approved drugs (nonwhites vs. whites, 54% vs. 90%, OR=0.13; p=0.0004) or experimental drugs (35% vs. 68%, OR=0.26; p=0.0072). Most participants (75%) were willing to undergo a biopsy to guide therapy, and 46% were willing to undergo research biopsies. Non-white participants were less willing to undergo research biopsies (17% vs. 55%, OR=0.17; p=0.0033). Most participants wanted to be informed when research results had implications for treatment (91%), new cancer risk (90%), and other preventable/treatable diseases (87%).
Conclusions
Most patients are willing to undergo molecular testing and minimally invasive procedures to guide approved or experimental therapy. There are significant differences in attitudes towards molecular testing between racial groups; non-whites are less willing to undergo testing even if the results would guide their own therapy. Novel approaches are needed to prevent disparities in delivery of genomically informed care and to increase minority participation in biomarker-driven trials.
Keywords: Molecular testing, disparities, personalized cancer therapy, biomarkers, questionnaire, survey
INTRODUCTION
Though the concept of individualizing treatment is over a century old,1,2 recent advances in molecular diagnostics have enabled personalized cancer therapybased on molecular characteristics of the patient or tumor and novel molecular-marker-driven clinical trials‥ While we know much about factors that influence general participation in biomedical research, little is known specifically about patient willingness to participate in testing for personalized cancer therapy and their perceptions of participation in biomarker-driven research and targeted therapy trials.3,4 Further, molecular testing brings with it unique problems, such as the potential for discovery of germline variants or mutations health implications for the patient and the patient’s relatives. Little is known about patient wishes for return of these incidental research results. In this study, we assess breast cancer patients’ attitudes towards molecular testing for personalized therapy, and molecular testing for research as well as return of incidental research results.
METHODS
Study Participants and Recruitment
This study was conducted at the University of Texas MD Anderson Cancer Center (MD Anderson), an academic cancer center located within the Texas Medical Center in Houston, Texas. The study was approved by the MD Anderson Institutional Review Board. Patients registering at the breast center between October and December 2012 were invited to participate in a questionnaire study. Eligibility criteria included: 1) being 18 years of age or older, 2) being female, 3) being fluent in English, and 4) having been previous diagnosed with breast cancer. Three hundred and eight consecutive patients were approached and 100 completed the questionnaire (32% response rate).
Study Instrument
Due to the paucity of existing measures from which questions specific to this study could be adapted, new measures were developed informed by the literature and previously validated measures.4–9 to assess attitudes of breast cancer patients regarding molecular testing for personalized therapy and research. The questionnaire was developed and reviewed for content validity by a team of investigators with expertise in genetics, survey research, behavioral science, health communication, and bioinformatics. The questionnaire was pilot-tested on eight subjects prior to the main study. Pilot testing stopped once two consecutive subjects were able to complete the questionnaire without encountering correctable problems. The final questionnaire contained two sections (demographic questions and an assessment of research perceptions) with a total of 20 questions. Items measured socioeconomic status, willingness to be tested for approved or experimental therapies, willingness to provide blood and tissue samples for research, preference to be informed of test results and permitting sample DNA banking for future research. With the exception of demographic information, items were measured on a 1 (strongly disagree) to 5 (strongly agree) scale. The questionnaire, as administered to subjects, is available on request.
Sample Size
This was a descriptive study. The original sample size of 100 was chosen based on acceptable precision of the estimates of means (for continuous variables) and proportions (for categorical variables) related to patients’ attitudes. Specifically, for a continuous variable, when the sample size is 100, a two-sided 95% confidence interval (CI) for a single mean will extend 0.196 from the observed mean, assuming that the standard deviation (SD) is known to be 1 and the CI is based on the large sample z statistic. For a binary variable, when the sample size is 100, a two-sided 95% CI for a single proportion using the large sample normal approximation will extend 0.098 from the observed proportion for an expected proportion of 0.5. Furthermore, a logistic regression of a binary response variable (Y) on a binary independent variable (X) with a sample size of 100 observations achieves 80% power at a 0.05 significance level to detect an odds ratio of 3.2 – 4.2 depending on the baseline probability that Y = 1 and the distribution of X.
Data Collection
Following informed consent, each patient completed the questionnaire. (Supplemental Document 1). Research staff was available to answer questions and provide clarification on questionnaire items. A standard list of definition of terms were provided to participants. The same list was also used by researchers as a means of standardizing responses to questions about specific items in the questionnaire. Participants’ electronic health records also were reviewed to obtain clinical information relevant to the study. Data collected from the electronic health record included: participant age, self-reported race, tumor type and stage, and previous treatment history and participation in the institutional biobanking protocol at MD Anderson.
Data Analysis
Our goal in this descriptive study was to preliminarily assess the association of variables with attitudes towards molecular testing. We performed univariate logistic regression analyses and believe that findings based on these analyses remain informative towards this goal. Descriptive statistics were reported as proportion, mean and standard deviation. Univariate tests of association were conducted using Fisher’s exact test or t-test, depending on the variable’s distribution. Univariate logistic regression using Wald chi-squared test was performed to obtain odds ratios for answering “yes” on the questionnaire. “Yes” was defined as either answering “strongly agree” or “agree.” “No” was defined as answering “neutral,” “disagree,” or “strongly disagree.” A Bonferroni correction for multiple testing was used; statistical significance was defined as p < 0.01. McNemar’s test was used to compare categorical responses within patients/groups. As race was found to be a primary variable associated with our outcomes of interest, we have also conducted further analyses on this relationship controlling for relevant covariants. Data analysis was performed using STATA/SE v12 (College Station, TX).
RESULTS
Patient Characteristics
Demographic, clinical, and pathological characteristics of study participants are reported in Table 1. Most were white (71.4%), married (75%), had at least a college education (55.6%), had children (80%) and were covered by health insurance (98%). Only 37.2% earned less than $50,000 per year, the US median household income in 2011 10. Most had early stage (stage 0-II) breast cancer (60.6%), had a positive family history of cancer (58.8%), and had some form of therapy (55.0%) prior to registration at MD Anderson.
Table 1.
Demographic, Clinical and Pathologic Characteristics of Patients
| Mean age at survey(years, SD) Mean age at diagnosis (years, SD) |
55.3(12.9) 52.1(13.0) |
|
|---|---|---|
| Race | N* | % |
| White, Non-Hispanic | 70 | 71.4 |
| Hispanic or Latino | 16 | 16.3 |
| Black or African American non-Hispanic | 10 | 10.2 |
| Asian | 2 | 2.0 |
| Education | ||
| High School or less | 21 | 21.2 |
| College | 55 | 55.6 |
| Graduate and higher | 23 | 23.2 |
| Marital Status | ||
| Married/Partnered | 75 | 75.0 |
| Single | 18 | 18.0 |
| Widowed | 7 | 7.0 |
| Children | ||
| Yes | 80 | 80.0 |
| No | 20 | 20.0 |
| Income ($) | ||
| 0 – 49,999 | 32 | 37.2 |
| 50,000 – 99,999 | 26 | 30.2 |
| 100,000 and above | 28 | 32.6 |
| Insurance | ||
| Self Pay | 2 | 2.0 |
| Medicare | 24 | 24.0 |
| Medicaid | 8 | 8.0 |
| Other Insurance | 66 | 66.0 |
| Stage | ||
| Stage 0 | 7 | 7.1 |
| Stage I | 26 | 26.3 |
| Stage II | 27 | 27.2 |
| Stage III | 15 | 15.2 |
| Stage IV | 24 | 24.2 |
| Duration of Illness | ||
| 0–1yr | 71 | 71.0 |
| 2–5yr | 13 | 13.0 |
| 6–10yr | 10 | 10.0 |
| >10yr | 6 | 6.0 |
| Therapy to date | ||
| No Therapy | 45 | 45.0 |
| Chemotherapy only | 5 | 5.0 |
| Surgery only | 16 | 16.0 |
| Chemotherapy + Surgery | 14 | 14.0 |
| Surgery + Radiotherapy | 1 | 1.0 |
| Chemotherapy + Radiotherapy + Surgery | 19 | 19.0 |
| Family history of cancer | ||
| Yes | 57 | 58.8 |
| No | 40 | 41.2 |
Not all patients answered all questions; analysis was based on questions answered
Patient Attitudes Towards Molecular Testing and Research Biopsies
Patients were generally willing to undergo molecular testing, biopsies and blood draws to guide therapy as well as research (Fig 1a). Patients were more willing to undergo molecular testing for selection of approved therapy compared to experimental therapy, both if the molecular testing was covered by insurance (81% vs. 59%, p<0.0001) and if the testing cost was not covered (64% vs. 37%, p<0.0001). Patients were more willing to undergo molecular testing if the cost of the testing was covered by insurance, both to guide approved therapy (81% vs. 64%, p=0.0004) and to guide experimental therapy (59% vs. 37% , p<0.0001).
Figure 1. Willingness to participate in molecular testing, blood draws and biopsies.
A. Willingness to participate in molecular testing Overall comparison of agreement between willingness to undergo molecular testing for: approved therapy and experimental therapy if testing is covered by insurance (p=0.0001); approved therapy and experimental therapy if testing is not covered by insurance (p<0.0001); approved therapy if testing is either covered by insurance or not covered by insurance (p=0.0004); experimental therapy if testing is either covered by insurance or not covered by insurance (p<0.0001).
B. Willingness to undergo blood draws and biopsy Overall comparison of agreement between willingness to undergo: blood draws and biopsy to guide treatment (p=0.0027); blood draws and biopsy for research (p=0.0002); blood draws either to guide treatment or for research (p<0.0001); biopsy either to guide treatment or for research (p<0.0001).
Most participants were willing to undergo blood draws to guide treatment (88%) and for research (64%, p<0.0001; Fig 1b). Many also were willing to undergo biopsies for molecular testing for research (46%) but more so to guide treatment (75%, p<0.0001).
Interestingly, 84 participants (88% of those responding to the question) stated on the questionnaire that they were willing to have residual tumor or blood samples stored for future research, versus 91 (93%) actually consenting to the institutional biospecimen banking protocol under a seperate consenting process.
Given the debate over return of incidental research results,11–18 we also asked about patient preferences regarding this issue. Most patients stated they would like to be informed about their research results if these results had implications for therapy (91%), new cancer risk (90%), and other preventable/treatable diseases (87%).
Association of Demographic and Clinicopathological Variables with Patient Attitudes
Next we assessed whether specific demographic or clinicopathologic characteristics were associated with patient attitudes towards molecular testing (Table 2 and Supplemental Table 1) and willingness to have blood draws and research biopsies for testing (Supplemental Table 2 and 3). Overall, race was the only consistent, statistically significant determinant (Table 3). Even if molecular testing was covered by insurance, more white than nonwhite respondents were willing to undergo molecular testing for approved therapy (90% vs. 54%, p=0.0004; Table 3) as well as for experimental therapy (68% vs. 35%, p=0.0072; Tables 2 and 3). A larger majority of white compared to nonwhite respondents were willing to have blood drawn for molecular testing to guide therapy (91% vs. 76%, p = 0.0586) and for research (70% vs. 44%, p = 0.0262), although there differences were not statistically significant (at p=0.01 based on multiple testing). White patients were significantly more willing to undergo tumor biopsies for research (55% white vs. 17% nonwhite, p = 0.0033) and there was a trend towards white patients being more willing to undergo new needle biopsies to guide therapy (81% white vs. 54% nonwhite, p = 0.0116). Since race was found to be a primary variable associated with our outcomes of interest, we conducted further analyses on this relationship controlling for education, stage, and history of chemotherapy.19 The corresponding results are summarized in Table 3. Race was an independent predictor of preferring not to undergo molecular testing (though covered by insurance) for selection of approved and experimental therapy as well as tumor biopsies.
Table 2.
Patient willingness to undergo molecular testing for selection of experimental therapy
| If covered by insurance | If not covered by insurance | |||||||
|---|---|---|---|---|---|---|---|---|
| No N (%) |
Yes N (%) |
OR (95% CI) | p-value | No N (%) |
Yes N (%) |
OR (95% CI) | p-value | |
| Mean age (yrs, SD) | 52.5 (14.6) | 52.2 (11.8) | 1.00 (0.97 – 1.03) | 0.9097 | 52.5 (13.2) | 52.1 (12.7) | 1 (0.97 – 1.03) | 0.8713 |
| Race (n = 91)* | ||||||||
| White | 22 (32.4) | 46 (67.6) | Ref** | 39 (57.4) | 29 (42.6) | ref | ||
| Non-white | 15 (65.2) | 8 (34. 8) | 0.26 (0.09 – 0.69) | 0.0072 | 18 (78.3) | 5 (21.7) | 0.37 (0.12 – 1.12) | 0.0797 |
| Education (n = 92) | 0.1230 | 0.4318 | ||||||
| High school or less | 10 (58.8) | 7 (41.2) | ref | 12 (70.6) | 5 (29.4) | ref | ||
| College | 22 (43.3) | 30 (57.7) | 1.95 (0.64 – 5.92) | 0.2397 | 34 (65.4) | 18 (34.6) | 1.27 (0.39 – 4.17) | 0.6931 |
| Graduate or higher | 6 (26.1) | 17 (73.9) | 4.05 (1.06 – 15.48) | 0.0411 | 12 (52.2) | 11 (47.8) | 2.20 (0.58 – 8.28) | 0.2438 |
| Marital status (n = 93) | ||||||||
| Single/Widowed | 8 (33.3) | 16 (66.7) | ref | 12 (50.0) | 12 (50.0) | ref | ||
| Married + Partner | 30 (43.5) | 39 (56.5) | 0.65 (0.25 – 1.72) | 0.3856 | 47 (68.1) | 22 (31.9) | 0.47 (0.18 – 1.21) | 0.1161 |
| Children (n = 93) | ||||||||
| No | 9 (50.0) | 9 (50.0) | ref | 14 (77.8) | 4 (22.2) | ref | ||
| Yes | 29 (38.7) | 46 (61.3) | 1.59 (0.56 – 4.46) | 0.3820 | 45 (60.0) | 30 (40.0) | 2.33 (0.70 – 7.77) | 0.1676 |
| Income ($) (n = 81) | 0.7199 | 0.2913 | ||||||
| 0 – 49999 | 12 (44.4) | 15 (55.6) | ref | 18 (66.7) | 9 (33.3) | ref | ||
| 50000 – 99999 | 9 (34.6) | 17 (65.4) | 1.51 (0.50 – 4.58) | 0.4655 | 16 (61.5) | 10 (38.5) | 1.25 (0.41 – 3.85) | 0.6973 |
| 100000 and above | 10 (35.7) | 18 (64.3) | 1.44 (0.49 – 4.25) | 0.5095 | 13 (46.4) | 15 (53.6) | 2.31 (0.77 – 6.88) | 0.1333 |
| Insurance (n = 93) | 0.9328 | 0.9286 | ||||||
| Self pay | 1 (50.0) | 1 (50.0) | 0.66 (0.04 – 11.01) | 0.7708 | 1 (50.0) | 1 (50.0) | 1.63 (0.10 – 27.21) | 0.7356 |
| Medicare | 10 (45.5) | 12 (54.5) | 0.79 (0.30 – 2.10) | 0.6361 | 15 (68.2) | 7 (31.8) | 0.76 (0.27 – 2.13) | 0.5990 |
| Medicaid | 2 (33.3) | 4 (66.7) | 1.32 (0.22 – 7.73) | 0.7613 | 4 (66.7) | 2 (33.3) | 0.81 (0.14 – 4.78) | 0.8183 |
| Other Insurance | 25 (39.7) | 38 (60.3) | ref | 39 (61.9) | 24 (38.1) | ref | ||
| Stage (n = 92) | 0.1434 | 0.2289 | ||||||
| Stage 0/I | 14 (43.8) | 18 (56.3) | ref | 17 (53.1) | 15 (46.9) | ref | ||
| Stage II | 13 (56.5) | 10 (43.5) | 0.60 (0.20 – 1.76) | 0.3514 | 18 (78.3) | 5 (21.7) | 0.31 (0.09 – 1.06) | 0.0612 |
| Stage III | 3 (21.4) | 11 (78.6) | 2.85 (0.67 – 12.22) | 0.1581 | 10 (71.4) | 4 (28.6) | 0.45 (0.12 – 1.75) | 0.2513 |
| Stage IV | 7 )30.4) | 16 (69.6) | 1.78 (0.57 – 5.50) | 0.3183 | 13 (56.5) | 10 (43.5) | 0.87 (0.30 – 2.56) | 0.8030 |
| Duration of illness (n = 93) | ||||||||
| 0–1year | 29 (44.6) | 36 (55.4) | ref | 40 (61.5) | 25 (38.5) | ref | ||
| > 1year | 9 (32.1) | 19 (67.9) | 1.70 (0.67 – 4.32) | 0.2640 | 19 (67.9) | 9 (32.1) | 0.76 (0.30 – 1.94) | 0.5622 |
| History of chemotherapy (n = 93) |
||||||||
| No | 29 (51.8) | 27 (48.2) | ref | 39 (69.6) | 17 (30.4) | ref | ||
| Yes | 9 (24.3) | 28 (75.7) | 3.34 (1.34 – 8.35) | 0.0098 | 20 (54.1) | 17 (45.9) | 1.95 (0.82 – 4.62) | 0.1288 |
| Family history of cancer (n = 90) |
||||||||
| No | 13 (34.2) | 25 (65.8) | ref | 19 (50.0) | 19 (50.0) | ref | ||
| Yes | 24 (46.2) | 28 (53.8) | 0.61 (0.26 – 1.44) | 0.2569 | 39 (75.0) | 13 (25.0) | 0.33 (0.14 – 0.81) | 0.0160 |
Not all patients answered all questions; analysis was based on questions answered
ref= Reference for comparison of other groups
Table 3.
Comparison between attitudes of white and nonwhite patients
| Univariate Logisitc Regression | Multivariate Logistic Regression*** | ||||||
|---|---|---|---|---|---|---|---|
| % white patients willing (n=70)* |
% non- white patients willing (n=28) |
p-value | OR | 95% CI** | p-value | HL GoF | |
| Molecular testing for selection of approved therapy |
|||||||
|
If covered by insurance** |
90% | 54% | 0.0004 | 0.10 | 0.02 – 0.39 | 0.001 | 0.6952 |
|
If not covered but affordable** |
71% | 39% | 0.0078 | 0.33 | 0.11 – 1.01 | 0.052 | 0.7859 |
| Molecular testing for selection of experimental therapy |
|||||||
|
If covered by insurance** |
68% | 35% | 0.0072 | 0.17 | 0.04 – 0.69 | 0.013 | 0.9906 |
| If not covered but affordable |
43% | 22% | 0.0797 | 0.48 | 0.14 – 1.68 | 0.251 | 0.127 |
| Blood draw for molecular testing to guide therapy |
91% | 76% | 0.0586 | 0.29 | 0.06 – 1.32 | 0.111 | 0.2824 |
| Blood draw for research | 70% | 44% | 0.0262 | 0.44 | 0.15 – 1.28 | 0.132 | 0.6235 |
| Tumor biopsy for molecular testing to guide therapy |
81% | 54% | 0.0116 | 0.25 | 0.08 – 0.86 | 0.026 | 0.8094 |
|
Tumor biopsy for research** |
55% | 17% | 0.0033 | 0.10 | 0.02 – 0.52 | 0.006 | 0.7642 |
| Tumor/DNA banking for research |
94% | 83% | 0.122 | 0.16 | 0.02 – 1.12 | 0.065 | 0.7749 |
N maximum 98 as two patients declined to state their race. The N differed for different questions as not all patients answered all questions.
Significantly different between the groups.
Regression adjusted for education, staging, and history of chemotherapy.
In addition, patients with a history of chemotherapy where more willing to undergo molecular testing for selection of experimental medication if covered by insurance; 76% of patients who received chemotherapy were willing to undergo testing vs. 48% patients who did not receive chemotherapy (OR = 3.34; p = 0.0098, Table 2).
DISCUSSION
We found that patients with breast cancer are generally willing to participate in molecular testing and clinical research, especially if the results could be used to guide their care. In addition, patients desired the return of individual research results if these results could affect their treatment or predict risk for other diseases. However, nonwhite patients were less willing to undergo molecular testing, minimally invasive procedures, or biospecimen banking compared to white patients; even if the results would guide their own treatment.
Most studies exploring the beliefs, attitudes, and perceptions regarding participation in genetic research have been performed outside of the United States 10. Many of these previous studies focused on perceptions of the general public about biobanking and storage of tissue or a DNA sample for future research and reported that most participants had a positive attitude towards biospecimen banking and were willing to donate tissue or DNA samples to biobanks. A recent survey of the general public by Kerath and colleagues conducted in the north-eastern United States found no association between demographic characteristics – including race and gender – and willingness to participate in genetic research and biobanking.20 Our findings differ from Kerath, et al., in that race was a strong and consistent predictor of willingness to undergo molecular testing as well as minimally invasive procedures for testing. However, these findings are consistent with other studies showing lower participation in clinical trials by racial and ethnic minority groups.21–32
Tumor biopsies and molecular testing are necessary to select patients who will benefit from specific molecularly targeted therapies. Such testing is also required for research to discover and validate putative predictors of response as well as to determine pharmacodynamic effects of drugs. Recent studies have demonstrated that research biopsies can be performed safely with a high rate of successful tissue collection.33–34 With growing interest in biomarker-driven trials, there has also been a growing need to determine patient willingness to undergo biopsies solely for research. In this questionnaire study, most participants stated willing to undergo biopsies to guide treatment (75%), and 46% were willing to undergo research only biopsies. These findings are very similar to the numbers reported from a questionnaire study done in metastatic breast cancer patients, in which 72% of patients expressed willingness to have additional biopsies at the time of a clinically indicated biopsy, and 51% were willing to consider having research only biopsies.35 This suggests that incorporation of optional or mandatory research biopsies is unlikely to be a major barrier for enrollment to biomarker-driven trials.
One striking finding in our study was the difference between white and nonwhite participants with respect to their attitudes toward personalized therapy and research. It has been reported that factors associated with poor education, and lower income, rather than race, are greater barriers to clinical trial participation.36 In our study income and education was not statistically associated with willingness to undergo molecular testing or minimally invasive procedures for testing. In contrast, we found that nonwhite participants were less willing to undergo molecular testing or tumor biopsy, even if the testing was financially covered and was used to guide their own therapy with approved drugs. There was an even greater reluctance to undergo molecular testing or tumor biopsy for research. If widespread, these attitudes are likely to lead to greater disparities in cancer outcomes as nonwhite patients with cancer will not benefit from advances in personalized therapies. Notably, these findings are not likely to be caused by responder bias. Indeed, it seems likely that the nonwhite patients who consented were likely more favorably disposed toward research and molecular testing than patients who did not participate. Further research is needed to identify strategies to increase minority acceptance of molecular testing and to uncover barriers for research participation. In addition, we need to develop methods that will allow us to apply molecular data to genomically dissimilar populations (i.e., learn from white population, apply findings to nonwhite population).
More and more personalized cancer care includes genomically informed therapy. With multiplex somatic tumor testing and high throughput next generation sequencing there is the inherent possibility of unveiling incidental genomic findings, including other somatic alterations or germline variants or mutations that may have therapeutic relevance or that may confer a risk of other cancers or diseases. How to handle such incidental research findings has been a topic of extensive discussion.37–38 However, many believe that findings with clinical relevance should be confirmed and shared, taking into consideration patient preferences about being informed. Indeed, the American College of Medical Genetics and Genomics (ACMG) recently published a policy statement on clinical sequencing, and recommended that laboratories that perform clinical sequencing seek and report mutations of the specified genes.39 In a recent survey of the practices and attitudes of members of the US genetic research community, 12% of the researchers stated they had returned incidental genetic findings, and an additional 28% planned to do so. A large majority of researchers (95%) believed that incidental findings for highly penetrant disorders with immediate medical implications should be offered to research participants.11 Our questionnaire demonstrates that most participants wanted to be informed when research results had implications for treatment (91%), new cancer risk (90%), and other preventable/treatable diseases (87%), confirming the need to genuinely make systematic efforts to identify clinically relevant research findings in a timely fashion and to develop a mechanism for return of these incidental results.
Our study had several limitations. The number of nonwhite participants in our study was not large enough to conduct meaningful studies of racial or ethnic subgroups. By enrolling newly registering patients awaiting their first appointments at the institution we captured patients facing new decisions. This timing may have decreased response rates and we cannot rule out sampling bias. However, the demographic makeup including ethnicity distribution our study population was similar to that of new patients registering at our breast center during the same time period (data not shown). The questionnaire (Supplementary Document 1) was framed with the introductory sentence ”Personalized therapy is often done by testing tumor and normal tissue or blood for specific molecular /genetic abnormalities. However it is possibly that the patients may not have appreciated that the term 'testing' referred to molecular testing including 'genetic testing,'and somatic genomic testing later in the questionnaire. We limited our study to only female patients and there may be differences in attitudes between genders. Indeed in a recent study, Hong et al reported that willingness to undergo study-related biopsy was higher in men.35 Further, we enrolled only breast cancer patients presenting to an academic cancer center. Participants were relatively well-educated and their income was above the national average; reflecting the epidemiology of breast cancer and patterns of referral to an academic cancer center. Thus, our findings may not be generalizable to patients with other diseases or in other care settings (e.g., community practice). However, the focus of our questionnaire was participation in research and molecular testing for personalized cancer therapy. Thus, we chose to enroll patients with cancer who are likely to be candidates for personalized therapy in a setting where molecular testing, biospecimen banking and personalized therapy are likely to be offered.
CONCLUSION
Most patients are willing to undergo molecular testing and minimally invasive procedures to guide approved or experimental therapy. There are significant differences in attitudes towards molecular testing between racial groups. Novel approaches are needed to prevent disparities in delivery of genomically informed care and to increase minority participation in research.
Supplementary Material
ACKNOWLEDGMENTS
This work was supported in part by NCATS grant UL1 TR000371 (EVB and FMB; Center for Clinical and Translational Sciences), 1U01 CA180964 (to EVB and FMB), the Sheikh Khalifa Al Nahyan Ben Zayed Institute for Personalized Cancer Therapy (to FMB), the Nellie B. Connally Breast Cancer Research Chair Funds, and the MD Anderson Cancer Center Support grant (P30 CA016672).
Footnotes
CONFLICT OF INTEREST
The authors declare that they have no conflict of interest with any financial organization that sponsored the material discussed in this manuscript.
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