Factors associated with breast cancer clinical trials participation and enrollment at a large academic medical center.

PURPOSE: The practice patterns of medical oncologists at a large National Cancer Institute Comprehensive Cancer Center in Detroit, MI were evaluated to better understand factors associated with accrual to breast cancer clinical trials. PATIENTS AND METHODS: From 1996 to 1997, physicians completed surveys on 319 of 344 newly evaluated female breast cancer patients. The 19-item survey included clinical data, whether patients were offered clinical trial (CT) participation and enrollment, and when applicable, reasons why they were not. Multivariate analyses using logistic regression were performed to evaluate predictors of an offer and enrollment. RESULTS: The patients were 57% white, 32% black, and 11% other/unknown race. One hundred six (33%) were offered participation and 36 (34%) were enrolled. In multivariate analysis, CTs were less likely offered to older women (mean age, 52 years for those offered v 57 years for those not offered; P =.0005) and black women (21% of blacks offered v 42% of whites; P =.0009). Women with stage 1 disease, poor performance status, and those who were previously diagnosed were also less likely to be offered trials. None of these factors were significant predictors of enrollment. Women were not offered trials because of ineligibility (57%), lack of available trials (41%), and noncompliance (2%). Reasons for failed enrollment included patient refusal (88%) and failed eligibility (12%). CONCLUSION: It is important for cooperative groups to design studies that will accommodate a broader spectrum of patients. Further work is needed to assess ways to improve communication about breast cancer CT participation to all eligible women.     

Physician-reported reasons for non-enrollment of older adults in cancer clinical trials

ObjectivesOlder adults (OA) are under-represented in cancer clinical trials. We sought to identify the proportion of OA(age > 65) vs. younger adults offered clinical trial and identify reasons patients were not offered a trial.MethodsConsecutive patients with cancer (n = 503) seen by medical oncology in consultation were included. Oncologists provided reasons for not offering a study to patients who were offered and accepted systemic therapy. Comparison between older and younger adults was done using the Chi square test or Fisher exact test. Logistic regression was used to determine the association between age and being offered clinical trial participation.ResultsOA had worse performance status (PS) (ECOG 3+ 15.1% vs 5.2%, p < 0.0001) and more comorbidities (Charlson Comorbidity Index ≥2 24.7% vs 10.0%, p < 0.0001) than younger adults. OA were less likely to be offered systemic treatment (68.3% vs 82.1%, p < 0.001), but were as likely as younger adults to accept (86.6% vs 92.2%, p = 0.07). Of patients who accepted systemic treatment, 24.5% were offered trial enrollment. Taking into account patient factors and stage, increased age by decade was associated with a decreased likelihood of being offered a trial [OR 0.74 (95% CI 0.6–0.9), p < 0.001]. Reasons for not offering a trial included no available trial (75.4%), poor PS (7.8%) and ineligibility (6.3%). Poor PS (11.8% vs 3.9%) was more commonly cited for not offering a study to OA.ConclusionsLack of clinical trials is the most common reason patients are not offered a trial. OA remain less likely to be offered a trial than younger adults.     

Barriers to clinical trial participation by older women with breast cancer.

PURPOSE: Although 48% of breast cancer patients are 65 years old or older, these older patients are severely underrepresented in breast cancer clinical trials. This study tested whether older patients were offered trials significantly less often than younger patients and whether older patients who were offered trials were more likely to refuse participation than younger patients. PATIENTS AND METHODS: In 10 Cancer and Leukemia Group B institutions, using a retrospective case-control design, breast cancer patients eligible for an open treatment trial were paired: less than 65 years old and > or = 65 years old. Each of the 77 pairs were matched by disease stage and treating physician. Patients were interviewed as to their reasons for participating or refusing to participate in a trial. The treating physicians were also given questionnaires about their reasons for offering or not offering a trial. RESULTS: Sixty-eight percent of younger stage II patients were offered a trial compared with 34% of the older patients (P =.0004). In multivariate analyses, disease stage and age remained highly significant in predicting trial offering (P =.0008), when controlling for physical functioning and comorbidity. Of those offered a trial, there was no significant difference in participation between younger (56%) and older (50%) patients (P =.67). CONCLUSION: In a multivariate analysis including comorbid conditions, age and stage were the only predictors of whether a patient was offered a trial. The greatest impediment to enrolling older women onto trials in the setting of this study was the physicians' perceptions about age and tolerance of toxicity.     

Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate.

PURPOSE: To explore the association at different time points in the trajectory of breast cancer care, between anxiety, knowledge, and attitudes, on women's willingness to participate in randomized clinical trials. MATERIALS AND METHODS: A cross-sectional survey was undertaken among women attending a breast clinic for screening mammography or diagnostic assessment plus women with newly diagnosed breast cancer to assess attitudes toward and willingness to participate in randomized clinical trials of breast cancer treatment. RESULTS: Five hundred forty-five women completed questionnaires assessing knowledge of and attitudes toward randomized clinical trials. The mean age of respondents was 48.9 years (SD, 11.3 years). Thirty-three percent of women would consider participating in a clinical trial if they had breast cancer. Women with breast cancer (31%) were significantly more likely to decline to participate than women attending for screening mammography (15%) or diagnostic assessment (15%, P =.0002). Women who might consider participating in a randomized clinical trial were more knowledgeable about randomized trials (mean difference, 0.7; 95% confidence interval [CI], 0.2 to 1.2; P =.003). In a multivariate analysis, women who would consider participating in a randomized trial were younger (odds ratio [OR], 0.96; 95% CI, 0.93 to 0.99), more likely to want an active role in decision-making (OR, 3.2; 95% CI, 1.3 to 7.6), and reported a greater impact from the positive aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.8) and less impact from the negative aspects of clinical trials (OR, 2.2; 95% CI, 1.3 to 3.2). CONCLUSION: These findings suggest that women who have a better understanding of issues about clinical trials have more favorable attitudes toward randomized trials and are more willing to consider participation in a clinical trial.     

Informing breast cancer patients about clinical trials: a randomized clinical trial of an educational booklet.

BACKGROUND: To evaluate the impact of an educational booklet on women's knowledge of and willingness to participate in a randomized clinical trial of treatment for breast cancer. MATERIALS AND METHODS: Women undergoing surgery for newly diagnosed early stage breast cancer were randomized to receive, or not, an information booklet explaining the need for and manner in which randomized trials are conducted. RESULTS: Eighty-three women with newly diagnosed early stage breast cancer completed a questionnaire assessing attitudes to random clinical trials (RCTs) and were randomized to receive usual information treatment options provided from their oncologist, or the educational booklet in addition to usual information from their oncologist (42 usual information, 41 booklet). Fewer women who received the clinical trials booklet (40% versus 47%) would consider participating in the hypothetical clinical trial (P = 0.6). Mean knowledge scores increased for both groups; moreover, women who did not receive the booklet showed similar improvements to women who received the booklet [mean difference 0.09, 95% confidence interval (CI) -0.66 to 0.83]. In a multivariate analysis women who would consider participating in the clinical trial were more anxious [odds ratio (OR) 5.9, P = 0.02] had involved lymph nodes (OR 5.8, P = 0.02) and were less influenced by negative aspects of clinical trials (OR 7.7, P = 0.0001). After adjustment for these variables women who received the educational booklet were significantly less likely to consider trial participation (OR 0.22, P = 0.05). CONCLUSIONS: Educating women about clinical trials in this manner appears ineffective in improving recruitment to RCTs. Women appear to be more influenced by their perception of risk than understanding. This finding has ethical implications for communication of information about RCTs.     

A Prospective Analysis of the Influence of Older Age on Physician and Patient Decision-Making When Considering Enrollment in Breast Cancer Clinical Trials (SWOG S0316)

Purpose. Patients older than 65 years are underrepresented in clinical trials. We conducted a prospective study (SWOG S0316) to determine physician- and patient-perceived barriers to breast cancer clinical trial enrollment for older patients. Methods. Eight geographically diverse SWOG institutions participated. The study assessed patients' and physicians' decisions to enroll in or decline clinical treatment trials, including demographics, trial availability, and eligibility. Patient and physician questionnaires elicited concerns related to treatment, medical status, age, family, and financial or transportation concerns. Results. A total of 1,079 patients were registered and eligible and 909 (84%) returned for follow-up. The major reason for nonaccrual was either trial unavailability or ineligibility (60%). Older patients were less likely to be eligible for trials (65% for age ≥65 years vs. 78% for age <65 years). If eligible, trial participation rates did not differ significantly by age (34% for age ≥65 years vs. 40% for age <65 years). Patients ≥65 years more often were concerned about side effects, had friends opposed to participation, or believed that participation would not benefit other generations. When trials were available and patients were eligible, physicians discussed trial participation with 76% of patients <65 years versus 58% of patients ≥65 years of age. For patients ≥65 years, 11% of physicians indicated age as a reason they did not enroll a patient in a clinical trial. Conclusion. Trial unavailability or patient ineligibility were the major reasons for lack of enrollment in breast cancer clinical trials for patients of all ages in this prospective study. Older patients were less likely to be eligible for trials, but if eligible they participated at similar rates to younger patients.     

An educational video to increase clinical trials enrollment among breast cancer patients

Only 3% of women with breast cancer participate in cancer clinical trials nationwide. The lack of awareness about clinical trials is a significant barrier towards clinical trials participation. A study was conducted at a large urban Comprehensive Cancer Center to test (1) the effectiveness of an 18-min educational video on improving attitudes toward clinical trials and trials enrollment among new breast cancer patients seen at the Karmanos Cancer Institute, and (2) to assess racial differences in attitudes regarding clinical trials. Participants were randomized to either the educational intervention prior to their first oncology clinic appointment or to standard care. A baseline and 2-week post-intervention survey to assess attitudes toward clinical trials participation was completed by participants. Of 218 subjects recruited, 196 (55% white vs. 45% African American (AA)) eligible patients were included in the analysis. A small increase in therapeutic clinical trial enrollment was observed in the intervention arm but was not statistically significant (10.4% vs. 6.1%; P = 0.277). The intervention also did not result in a clear improvement in patients’ attitudes toward clinical trials at posttest. However, a lower enrollment rate for the AA women was noted after adjusting for stage (OR = 0.282, P = 0.049). Significantly more negative scores were noted in 3 out of the 5 baseline attitudinal scales for AA women. The educational video did not significantly increase enrollment in breast cancer clinical trials. The findings that AA women had significantly more negative attitudes toward clinical trials than white women may partially explain the racial disparity in enrollment. An educational video remains a simple and cost-effective way to educate patients. Future studies should focus on designing a new educational video to specifically target cultural and attitudinal barriers in the AA population to more effectively change attitudes and increase trial enrollment.     

Recruiting African American women to participate in hereditary breast cancer research.

PURPOSE: This study evaluated the process of recruiting African American women to participate in genetic counseling research for BRCA1 and BRCA2 (BRCA1/2) mutations with respect to referral, study enrollment, and participation in genetic counseling. PATIENTS AND METHODS: African American women (n = 783) were referred for study enrollment. RESULTS: Of 783 referrals, 164 (21%) women were eligible for enrollment. Eligible women were most likely to be referred from oncology clinics (44%) and were least likely to be referred from general medical practices (11%; chi(2) = 96.80; P = .0001). Overall, 62% of eligible women enrolled onto the study and 50% of enrollees completed genetic counseling. Women with a stronger family history of cancer (odds ratio [OR] = 3.18; 95% CI, 1.36 to 7.44; P = .01) and those referred from oncology clinics and community oncology resources (OR = 2.97; 95% CI, 1.34 to 6.58; P = .01) were most likely to enroll onto the study. Referral from oncology clinics was associated significantly with participation in genetic counseling (OR = 5.46; 95% CI, 1.44 to 20.60; P = .01). CONCLUSION: Despite receiving a large number of referrals, only a small subset of women were eligible for enrollment. Oncology settings were the most effective at identifying eligible African American women and general medical practices were the least effective. Factors associated with enrollment included having a stronger family history of cancer and being referred from oncology clinics and community oncology resources. Referral from oncology clinics was the only factor associated significantly with participation in genetic counseling. Education about hereditary breast cancer may be needed among primary care providers to enhance appropriate referral of African American women to genetic counseling for BRCA1/2 mutations.     

Clinical trial discussion, referral, and recruitment: physician, patient, and system factors

Purpose

Patient participation in cancer clinical trials is imperative to the advancement of medical science. Physicians play an important role in recruitment by discussing clinical trials with their cancer patients. Patient–physician discussion is influenced by many factors relating to the physician, the patient, and the healthcare system.

Methods

Physicians selected from the 2008–2009 American Medical Association Physician Masterfile who practiced in California, Florida, Illinois, or New York and specialized in medical oncology, surgery, or radiation oncology were surveyed about their attitudes and practices with respect to breast cancer clinical trials. Practice types were categorized according to the classifications provided by the American College of Surgeons, and clinical trial and practice addresses were geocoded.

Results

Surveys were completed by 706 of 1,534 eligible physicians (46 %). Medical oncologists were more likely than surgical or radiation oncologists to discuss the possibility, benefits, and risks of clinical trial enrollment with their breast cancer patients. Physicians who spent the most time in patient care were least likely to discuss clinical trials with their patients. Distance from a physician’s practice to the nearest clinical trial site was inversely associated with referral and recruitment. Perceived barriers to clinical trial participation were associated with greater referral activity suggesting that physicians who were more involved in trials were also more likely to understand barriers to participation.

Conclusions

Multilevel interventions may be successful at increasing participation of women in clinical trials.     

The impact of socioeconomic status and race on trial participation for older women with breast cancer

BACKGROUND: Older women, and older minorities in particular, are under represented in breast cancer trials. Although socioeconomic status (SES) is associated with both race and age, to the authors' knowledge little is known regarding the impact of SES on trial enrollment among older women with breast cancer. METHODS: The authors performed a case-control study comparing women who were participants in National Cancer Institute cooperative group breast cancer trials (cases) with a population-based sample of breast cancer patients (controls) obtained from the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data base. The sample was restricted to women age >/= 65 years who were living in SEER areas. Proxies for SES included the proportion of the population below poverty level (by zip code) and unemployed (by county) as well those with Medicaid insurance coverage. A multivariable logistic regression model was used to test the association of SES with trial participation after accounting for other patient and county characteristics. RESULTS: In bivariate analysis, trial participants were significantly less likely than community cancer patients to reside in high-poverty zip codes (20.9% vs. 24.9%, respectively; P < 0.001) or to have Medicaid insurance (2.0% vs. 10.0%; P < 0.0001). After adjusting for race, age, and county, trial participation remained inversely related to residing in areas with high poverty (odds ratio [OR] vs. residents of remaining counties, 0.78; 95% confidence interval [95% CI], 0.62-0.98), high unemployment rates (OR vs. residents of residents of counties in the lowest quartile, 0.50; 95% CI, 0.35-0.71), and having Medicaid insurance (OR vs. women without Medicaid, 0.22; 95% CI, 0.13-0.37); black race was not found to be related to trial participation (OR for black vs. white, 1.0; 95% CI, 0.67-1.47). CONCLUSIONS: Low SES was associated inversely with trial enrollment for older women with breast cancer and appeared to account for the enrollment disparities between black patients and white patients. Future efforts to enhance enrollment of elderly women in cancer research should identify specific barriers related to SES that may be amenable to intervention.     

Recruitment and retention challenges in breast cancer survivorship research: results from a multisite, randomized intervention trial in women with early stage breast cancer.

The Moving Beyond Cancer trial is a multisite randomized, controlled trial of an individualized psychoeducational intervention for women with early stage breast cancer. Recruitment early in the cancer trajectory and assessment of retention at multiple points are notable features of the research, offering a unique opportunity to examine recruitment, retention, and predictors of participation. Patients were registered for the study within 6 weeks after definitive surgery and followed until primary medical treatment completion, whereupon they were enrolled, administered baseline measures, and randomized to one of three arms. Of 2,242 women referred, 41% were ineligible. Of eligible women, 42% elected participation through the point of randomization (n = 558). Participants did not differ from nonparticipants on initial self-reported physical functioning and mental health status, employment status, cancer history, cancer treatment plan, or previous cancer-related research participation. Women who were over 65 years of age, of racial minority status, unmarried, or less educated were less likely to participate through the point of randomization. Thus, several patient characteristics predicted trial participation, indicating the need for targeted recruitment attempts.     

Barriers to participation in clinical trials of cancer: a meta-analysis and systematic review of patient-reported factors

BACKGROUND: Enrolling participants onto clinical trials of cancer presents an important challenge. We aimed to identify the concerns of patients with cancer about, and the barriers to, participation in clinical trials. METHODS: We did a systematic review to assess studies of barriers to participation in experimental trials and randomised trials for validity and content. We estimated the frequency with which patients identified particular issues by pooling across studies that presented data for barriers to participation in clinical trials as proportions. FINDINGS: We analysed 12 qualitative studies (n=722) and 21 quantitative studies (n=5452). Two qualitative studies inquired of patients who were currently enrolled onto clinical trials, and ten inquired of patients who were eligible for enrolment onto various clinical trials. Barriers to participation in clinical trials were protocol-related, patient-related, or physician-related. The most common reasons cited as barriers included: concerns with the trial setting; a dislike of randomisation; general discomfort with the research process; complexity and stringency of the protocol; presence of a placebo or no-treatment group; potential side-effects; being unaware of trial opportunities; the idea that clinical trials are not appropriate for serious diseases; fear that trial involvement would have a negative effect on the relationship with their physician; and their physician's attitudes towards the trial. Meta-analysis confirmed the findings of our systematic review. INTERPRETATION: The identification of such barriers to the participation in clinical trials should help trialists to develop strategies that will keep to a maximum participation and cooperation in cancer trials, while informing and protecting prospective participants adequately.     

Predictors of enrollment in lung cancer clinical trials

BACKGROUND: Clinical trials may offer patients innovative therapeutic options with potentially better outcomes, which are particularly relevant for patients afflicted with lung carcinoma, because current therapies provide only modest survival benefits. Only approximately 5% of patients with newly diagnosed cancer participate in clinical trials nationwide, and African-American (AA) patients are particularly under-represented. METHODS: To determine predictors of clinical trials enrollment, the authors reviewed the medical records of 427 patients with lung carcinoma (175 AA patients and 252 non-AA patients) who were eligible for clinical trials between 1994 and 1998 at the Karmanos Cancer Institute in Detroit, Michigan. Logistic regression analysis was used to assess the association of patient demographic characteristics and clinical trial enrollment. RESULTS: Ninety-one patients (21%) were enrolled onto a lung cancer clinical trial during the period of the current study. Enrollment was associated significantly with race (P < 0.001), gender (P = 0.048), age (P = 0.005), and insurance type (P = 0.024). After multivariable adjustment, only race and gender remained significant predictors of enrollment. AA patients were less likely to enroll than non-AA patients (odds ratio [OR], 0.485; 95% confidence interval [95% CI], 0.243-0.966), and men were more likely than women to enroll (OR, 1.812; 95% CI, 1.033-3.178). CONCLUSIONS: The current results suggest disparities by race and gender in the enrollment of patients onto lung cancer clinical trials and support the need to improve educational and outreach endeavors that would make clinical trials available to a wider range of eligible patients.     

Cancer prevention trials and primary care physicians: factors associated with recommending trial enrollment

BACKGROUND: To explore the willingness of primary care providers (PCPs) to encourage enrollment of patients into cancer prevention trials. METHODS: A self-administered survey was mailed to a random sample of PCPs in three geographic regions. Physicians were asked questions about their knowledge and attitudes towards cancer prevention trials. We presented a clinical vignette of a woman at high risk for breast cancer and asked if they would encourage her enrollment into a breast cancer chemoprevention trial (yes/no). Each survey included one of 16 possible clinical vignettes where patient characteristics (age, race socioeconomic status, physical mobility and co-morbidity) varied dichotomously. Bivariate analyses and logistic models were used to examine the independent effects of patient and physician characteristics on physician decisions. RESULTS: Two hundred and sixty-six surveys (50% response) were analyzed. The mean age of respondents was 48; 54% were White, 35% Asian and 5% Black. By design physicians were evenly distributed by gender, specialty and geographic location. Overall, 53% would encourage enrollment into a breast cancer chemoprevention trial. Significant predictors of a recommendation to enroll were: geographic location in California or Georgia, younger vignette patient and anticipating an increase in patient trust after recommending enrollment. CONCLUSION: PCPs are less likely to encourage elderly patients to enroll into cancer chemoprevention trials. Decisions differ based on geographic location and perceived trust in the patient-provider relationship. To achieve successful enrollment, trial investigators must continue to educate PCPs and ensure a strong PCP-patient relationship is maintained.     

The Canadian National Breast Screening Studies are compromised and their results are unreliable. They should not factor into decisions about breast cancer screening

The Canadian National Breast Screening Studies were compromised by an unblinded allocation process and poor quality mammography. Contrary to the requirement that allocation in a randomized controlled trial (RCT) be blinded to avoid any possible intentional or unintentional subversion of a random allocation, all women in the CNBSS trials underwent a clinical breast examination prior to assignment to the study arm or the usual care arm. Women with abnormal clinical breast examinations were identified, and this information was available to the coordinators who then assigned the women on open lists. It was, therefore, possible to assign women to whichever arm the coordinator chose. Although subversion was likely unintended, a significant number of women with four or more positive axillary lymph nodes were assigned to the screening arm of CNBSS1. This explains why there were more breast cancer deaths among the screened women in the first ten years of the trial and why the 5 year survival of the control women was better than 90% when the background survival in Canada at the time was only 75%. The trials were further compromised by the poor quality of the mammography which was confirmed by a review conducted by the trials’ organizers. These fundamental problems compromise the CNBSS and make their results, which are major outliers in the RCT’s of breast cancer screening, unreliable. Consequently, they should not be used to establish guidelines for breast cancer screening.     

Utility of a molecular prescreening program in advanced colorectal cancer for enrollment on biomarker-selected clinical trials

BackgroundIncorporation of multiple enrichment biomarkers into prospective clinical trials is an active area of investigation, but the factors that determine clinical trial enrollment following a molecular prescreening program have not been assessed.Patients and methodsPatients with 5-fluorouracil-refractory metastatic colorectal cancer at the MD Anderson Cancer Center were offered screening in the Assessment of Targeted Therapies Against Colorectal Cancer (ATTACC) program to identify eligibility for companion phase I or II clinical trials with a therapy targeted to an aberration detected in the patient, based on testing by immunohistochemistry, targeted gene sequencing panels, and CpG island methylation phenotype assays.ResultsBetween August 2010 and December 2013, 484 patients were enrolled, 458 (95%) had a biomarker result, and 157 (32%) were enrolled on a clinical trial (92 on biomarker-selected and 65 on nonbiomarker selected). Of the 458 patients with a biomarker result, enrollment on biomarker-selected clinical trials was ninefold higher for predefined ATTACC-companion clinical trials as opposed to nonpredefined biomarker-selected clinical trials, 17.9% versus 2%, P < 0.001. Factors that correlated positively with trial enrollment in multivariate analysis were higher performance status, older age, lack of standard of care therapy, established patient at MD Anderson, and the presence of an eligible biomarker for an ATTACC-companion study. Early molecular screening did result in a higher rate of patients with remaining standard of care therapy enrolling on ATTACC-companion clinical trials, 45.1%, in contrast to nonpredefined clinical trials, 22.7%; odds ratio 3.1, P = 0.002.ConclusionsThough early molecular prescreening for predefined clinical trials resulted in an increase rate of trial enrollment of nonrefractory patients, the majority of patients enrolled on clinical trials were refractory to standard of care therapy. Within molecular prescreening programs, tailoring screening for preidentified and open clinical trials, temporally linking screening to treatment and optimizing both patient and physician engagement are efforts likely to improve enrollment on biomarker-selected clinical trials.Clinical Trials NumberThe study NCT number is NCT01196130.     

Clinical trial accrual among new cancer patients at a community-based cancer center

BACKGROUND: To the authors' knowledge, only limited data are available regarding clinical trial accrual patterns and the barriers encountered among newly diagnosed patients seen at community-based cancer centers. METHODS: In the current study, the authors prospectively collected clinical and sociodemographic data from all adult patients seen at a community-based cancer center who had new cancers diagnosed between 2003-2004. Clinical trial enrollment decisions were noted and factors that prevented accrual were identified. RESULTS: There was a total of 1012 new cancer patients. In 587 patients (58%), clinical trials appropriate for the diagnosis and stage of disease were not available. Among those patients for whom trials were available, 19.8% did not meet eligibility criteria, and only 9.9% of patients were enrolled. Although more trials were found to be available for women compared with men (51% vs. 32%; P < 0.01), the accrual rates were equal (11.2% vs. 7.6%; P = 0.24). Elderly patients comprised approximately 59.4% of those patients with available trials, but they were less likely to be enrolled (5.1% vs. 16.8%; P < 0.01). The major barriers to nonparticipation can be grouped into protocol limitations (68.1%), physician triage (16%), and patient decisions (15.9%). The overall accrual rate when all patients were included was 4% (42 of 1012 patients). CONCLUSIONS: At the study institution, participation in clinical trials is reported to be low. The unavailability of appropriate clinical trials represents the most significant barrier. Continuing efforts to encourage physicians and to educate patients remain necessary. If the current study findings are found to be applicable to other community-based cancer centers, making a larger variety of clinical trials available to the community may help to improve the accrual of patients to national cancer clinical trials.     

How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer

ABSTRACT: BACKGROUND: Germline BRCA1 and BRCA2 mutation testing offered shortly after a breast cancer diagnosis to inform women's treatment choices - treatment-focused genetic testing 'TFGT' - has entered clinical practice in specialist centers and is likely to be soon commonplace in acute breast cancer management, especially for younger women. Yet the optimal way to deliver information about TFGT to younger women newly diagnosed with breast cancer is not known, particularly for those who were not suspected of having a hereditary breast cancer syndrome prior to their cancer diagnosis. Also, little is known about the behavioral and psychosocial impact or cost effectiveness of educating patients about TFGT. This trial aims to examine the impact and efficiency of two models of educating younger women newly diagnosed with breast cancer about genetic testing in order to provide evidence for a safe and effective future clinical pathway for this service. Design/Methods: In this non-inferiority randomized controlled trial, 140 women newly diagnosed with breast cancer (aged less than 50 years) are being recruited from nine cancer centers in Australia. Eligible women with either a significant family history of breast and/or ovarian cancer or with other high risk features suggestive of a mutation detection rate of > 10% are invited by their surgeon prior to mastectomy or radiotherapy. After completing the first questionnaire, participants are randomized to receive either: (a) an educational pamphlet about genetic testing (intervention) or (b) a genetic counseling appointment at a family cancer center (standard care). Each participant is offered genetic testing for germline BRCA mutations. Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome); uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret. A process-oriented retrospective online survey will examine health professionals' attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention. DISCUSSION: This trial will provide crucial information about the impact, efficiency and cost effectiveness of an educational pamphlet designed to inform younger women newly diagnosed with breast cancer about genetic testing. Issues regarding implementation of the trial are discussed.     

Tracking the Nonenrolled: Lung Cancer Screening Patterns Among Individuals not Accrued to a Clinical Trial

IntroductionFor lung cancer screening, the available data are often derived from patients enrolled prospectively in clinical trials. We, therefore, investigated lung cancer screening patterns among individuals eligible for, but not enrolled in, a screening trial.Patients and MethodsFrom February 2017 through February 2019, we enrolled subjects in a trial examining telephone-based navigation during low-dose computed tomography (LDCT) for lung cancer screening. We identified patients for whom LDCT was ordered and who were approached, but not enrolled, in the trial. We categorized nonenrollment as the patient had declined or could not be reached. We compared the characteristics and LDCT completion rates among these groups and the enrolled population using the 2-sample t test and χ² test.ResultsOf 900 individuals approached for participation (mean age, 62 years; 45% women, 53% black), 447 were enrolled in the screening clinical trial. No significant demographic differences were found between the enrolled and nonenrolled cohorts. Of the 453 individuals not enrolled, 251 (55%) had declined participation and 202 (45%) could not be reached, despite up to 6 attempts. LDCT completion was significantly associated with enrollment status: 81% of enrolled individuals, 73% of individuals who declined participation, and 49% of those who could not be reached (P < .001).ConclusionsIn the present single-center study, demographic factors did not predict for participation in a lung cancer screening trial. Lung cancer screening adherence rates were substantially lower for those not enrolled in a screening trial, especially for those who could not be contacted. These findings may inform the broader implementation of screening programs.     

Decision-making about clinical trial options among older patients with metastatic cancer who have exhausted standard therapies

ObjectivesOlder adults under-enroll in early phase cancer clinical trials. There are limited data on their trial experiences, which hampers our ability to understand potential reasons and responses to under-enrollment. We aimed to explore older adults' experiences and deliberations with phase 1 trials.Materials and MethodsWe analyzed 101 in-depth interviews with 39 adults (average 2.6 interviews per participant) about their experiences with phase 1 trials. All respondents were ≥ 65 years and had advanced cancer. Interviews lasted 60–90 min and were audio-recorded, transcribed, and analyzed to identify respondents' understanding of clinical research, perceptions of early phase trials, and experiences with enrollment.ResultsClinical trial participation was an interactive process that unfolded over time. Older adults relied on ongoing guidance and discussion with their oncologist to navigate the process. Respondents were generally interested in life-prolonging therapies, including enrollment in early phase clinical trials, but did not necessarily state this explicitly to their oncologist. While respondents did not mention age as a limitation to trials participation, participants age > 70 were less enthusiastic about participation and more often discussed their quality of life and weighed benefits of trial participation in the context of their remaining months of life.ConclusionEarly phase clinical trial enrollment is complex, and older adults rely on their oncologist to navigate this process. Acknowledging this complexity through shared decision-making may ensure that older adults have appropriate opportunities to enroll in early phase clinical trials and guard against inappropriate under-enrollment.