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BACKGROUND Audio recordings of oncology clinic discussions can help patients retain and understand information about their disease and treatment decisions. Access to this tool relies on acceptance of recordings by oncologists. This is the first study to evaluate experience and attitudes of oncologists toward patients recording clinic visits. METHODS Medical, radiation, and surgical oncologists from 5 US cancer centers and community affiliates were surveyed to evaluate clinicians' experience, beliefs, and practices regarding patient-initiated recordings. RESULTS Among 360 oncologists (69% response rate), virtually all (93%) have experienced patients seeking to record visits. Although 75% are comfortable with recording, 25% are uncomfortable and 56% report concerns ranging from less thorough discussions to legal liability. Most (85%) always agree when patients ask to record, but 15% never or selectively allow recording. Although 51% believe recording is positive for the patient-physician relationship, a sizable minority report that it can lead to less detailed conversations (28%) or avoidance of difficult topics, including prognosis (33%). Views did not vary based on subspecialty, practice setting, or geographic region, but older age and years in practice were associated with more positive views of recording. The majority of clinicians (72%) desire institutional policies to govern guidelines about recordings. CONCLUSIONS Most oncologists are comfortable with patient requests to record visits, but a sizable minority remain uncomfortable, and access to recording varies solely on physician preference. This difference in care delivery may benefit from institutional policies that promote access while addressing legitimate physician concerns over privacy and appropriate use of recordings.

Background The objective of this study was to describe the perspective of patients with early breast cancer toward research biopsies. The authors hypothesized that more patients at academic sites than at community‐based sites would be willing to consider these procedures. Methods In total, 198 patients with early stage breast cancer were recruited from 3 academic centers (n = 102) and from 1 community oncology practice (n = 96). The primary objective was to compare the proportion of patients willing to consider donating excess tissue biospecimens from surgery, from a clinically indicated breast biopsy, or from a research purposes‐only biopsy (RPOB) between practice types. Results Most patients (93% at academic sites, 94% at the community oncology site) said they would consider donating excess tissue from surgery for research. One‐half of patients from academic or community sites would consider donating tissue from a clinically indicated breast biopsy. On univariate analysis, significantly fewer patients from academic sites would consider an RPOB (22% at academic sites, 42% at the community site; P = .003); however, this difference was no longer significant on multivariate analysis (P = .96). Longer transportation times and unfavorable prior experiences were associated with less willingness to consider an RPOB on multivariate analysis. Significantly fewer patients from academic sites (14%) than from the community site (35%) would consider a research biopsy in a clinical trial (P = .04). Contributing to scientific knowledge, return of results, and a personal request by their physician were the strongest factors influencing patients' willingness to undergo research biopsies. Conclusions The current results rejected the hypothesis that more patients with early breast cancer at academic sites would be willing to donate tissue biospecimens for research compared with those at community oncology sites. These findings identify modifiable factors to consider in biobanking studies and clinical trials., In this study of the willingness of patients with early stage breast cancer to consider biospecimen collection procedures for the purposes of research, most patients were willing to provide blood samples for research but were less likely to consider percutaneous breast biopsies. Longer travel time to the clinic and adverse experiences with prior biopsies, but not treatment center type (academic versus community‐based center), were associated with less willingness to consider research biopsies.

Background The investigation of exercise training in metastatic breast cancer has received minimal attention. This study determined the feasibility and safety of aerobic training in metastatic breast cancer. Methods Sixty-five women (age, 21-80 years) with metastatic (stage IV) breast cancer (57% were receiving chemotherapy, and >40% had ≥ 2 lines of prior therapy) were allocated to an aerobic training group (n = 33) or a stretching group (n = 32). Aerobic training consisted of 36 supervised treadmill walking sessions delivered thrice weekly between 55% and 80% of peak oxygen consumption (VO2peak ) for 12 consecutive weeks. Stretching was matched to aerobic training with respect to location, frequency, duration, and intervention length. The primary endpoint was aerobic training feasibility, which was a priori defined as the lost to follow-up (LTF) rate ( Results One of the 33 patients (3%) receiving aerobic training was LTF, whereas the mean attendance rate was 63% ± 30%. The rates of permanent discontinuation and dose modification were 27% and 49%, respectively. Intention-to-treat analyses indicated improvements in PROs, which favored the attention control group (P values > .05). Per protocol analyses indicated that 14 of 33 patients (42%) receiving aerobic training had acceptable tolerability (relative dose intensity ≥ 70%), and this led to improvements in VO2peak and functional capacity (P values Conclusions Aerobic training at the dose and schedule tested is safe but not feasible for a significant proportion of patients with metastatic breast cancer. The acceptable feasibility and promising benefit for select patients warrant further evaluation in a dose-finding phase 1/2 study. Cancer 2018;124:2552-60. © 2018 American Cancer Society.

BACKGROUND Rural US women experience disparities in breast cancer screening and outcomes. In 2006, a national rural health insurance provider, the National Rural Electric Cooperative Association (NRECA), eliminated out-of-pocket costs for screening mammography. METHODS This study evaluated the elimination of cost sharing as a natural experiment: it compared trends in screening before and after the policy change. NRECA insurance claims data were used to identify all women aged 40 to 64 years who were eligible for breast cancer screening, and mammography utilization from 1998 through 2011 was evaluated. Repeated measures regression models were used to evaluate changes in utilization over time and the association between screening and sociodemographic factors. RESULTS The analysis was based on 45,738 women enrolled in the NRECA membership database for an average of 6.1 years and included 279,940 person-years of enrollment. Between 1998 and 2011, the annual screening rate increased from 35% to a peak of 50% among women aged 40 to 49 years and from 49% to 58% among women aged 50 to 64 years. The biennial screening rate increased from 56% to 66% for women aged 40 to 49 years and from 68% to 73% for women aged 50 to 64 years. Screening rates increased significantly (P < .0001) after the elimination of cost sharing and then declined slightly after changes to government screening guidelines in 2009. Younger women experienced greater increases in both annual screening (6.2%) and biennial screening (5.6%) after the elimination of cost sharing in comparison with older women (3.0% and 2.6%, respectively). In a multivariate analysis, rural residence, lower population income, and lower population education were associated with modestly lower screening. CONCLUSIONS In a national sample of predominantly rural working-age women, the elimination of cost sharing correlated with increased breast cancer screening. Cancer 2017. © 2017 American Cancer Society.

BACKGROUND This study evaluated self-reported knowledge, practice, and attitudes toward commercially available cytochrome P450 2D6 (CYP2D6) pharmacogenomic testing for patients on tamoxifen for breast cancer (CYPT) among US oncologists while evidence for the use of the test was evolving. METHODS A self-administered survey of medical oncology breast cancer specialists at National Comprehensive Cancer Network (NCCNO) centers and a random sample of community-based oncologists (CBOs) was undertaken. The survey evaluated knowledge and use of the CYP2D6 test and response to hypothetical test results. RESULTS In total, 201 of 459 (44%) oncologists responded. At a time when CYPT remained experimental, 31% of oncologists reported use of CYPT and 56% reported willingness to order CYPT outside of a clinical trial if requested by a patient. Compared to oncologists specializing in breast cancer, oncologists in community-based practice were more likely to use CYPT routinely (21% versus 11%, P

Rural US women experience disparities in breast cancer screening and outcomes. In 2006, a national rural health insurance provider, the National Rural Electric Cooperative Association (NRECA), eliminated out-of-pocket costs for screening mammography.This study evaluated the elimination of cost sharing as a natural experiment: it compared trends in screening before and after the policy change. NRECA insurance claims data were used to identify all women aged 40 to 64 years who were eligible for breast cancer screening, and mammography utilization from 1998 through 2011 was evaluated. Repeated measures regression models were used to evaluate changes in utilization over time and the association between screening and sociodemographic factors.The analysis was based on 45,738 women enrolled in the NRECA membership database for an average of 6.1 years and included 279,940 person-years of enrollment. Between 1998 and 2011, the annual screening rate increased from 35% to a peak of 50% among women aged 40 to 49 years and from 49% to 58% among women aged 50 to 64 years. The biennial screening rate increased from 56% to 66% for women aged 40 to 49 years and from 68% to 73% for women aged 50 to 64 years. Screening rates increased significantly (P.0001) after the elimination of cost sharing and then declined slightly after changes to government screening guidelines in 2009. Younger women experienced greater increases in both annual screening (6.2%) and biennial screening (5.6%) after the elimination of cost sharing in comparison with older women (3.0% and 2.6%, respectively). In a multivariate analysis, rural residence, lower population income, and lower population education were associated with modestly lower screening.In a national sample of predominantly rural working-age women, the elimination of cost sharing correlated with increased breast cancer screening. Cancer 2017;123:2506-15. © 2017 American Cancer Society.

For early stage breast cancer, treatment decisions frequently center on maximizing treatment effectiveness in terms of survival or cure. However, through advances in early detection and treatment, the risk of recurrence for many patients can be reduced to the point that some treatment options are of only marginal benefit. Patients and clinicians may be faced with complex decisions in which a small reduction in recurrence risk must be weighed against likely short-term toxicities and the potential for rare but serious longterm risks. Database-driven models and genetic predictors of recurrence risk are designed to inform such decision making; however, frequently, difficult choices remain. Because the majority of patients will experience long-term survival after a breast cancer diagnosis, increased attention is focused appropriately on the full spectrum of challenges faced by patients after the initial stages of treatment. In this context, an important area for consideration is the impact of treatment choices on the patient’s ability to continue employment after diagnosis of breast cancer. Although prospective clinical trials frequently include assessment of quality of life, in addition to direct measures of efficacy and toxicity, and most tools take ability to work and degree of difficulty at work into account, to our knowledge few directly address actual changes in employment status. In this issue of Cancer, Hassett et al add to an important literature that examines the association between treatment for breast cancer and employment. On the basis of identifying adult women aged 63 years with incident cases of invasive breast cancer in the Medstat MarketScan Commercial Claims and Encounters Research Database, they evaluated changes in employment status during the 12 months after diagnosis and examined the demographic, disease-related, and treatment-related factors that correlated with employment changes. Specifically, they observed an association between treatment type (chemotherapy) and employment disruption and demonstrated that older women in this cohort, particularly those ages 58 years to 63 years, were more likely to experience an employment change than younger women.

BACKGROUND. Since 1992, pharmaceutical industry support has surpassed National Institutes of Health funding for clinical research in the United States. In this study, the authors sought to evaluate the impact of this shift in funding from public to private sponsors on the nature of published breast cancer clinical research. METHODS. All published breast cancer clinical trials from 2003, 1998, and 1993 were reviewed from 10 select English-language medical journals to evaluate pharmaceutical involvement over time and the association between sponsorship, trial design, and results. Clinical studies that reported disease-specific outcomes from medical therapy for breast cancer were eligible for analysis. Pharmaceutical involvement was defined as reported pharmaceutical industry funding, provision of drug, and/or authorship for each publication. RESULTS. In total, 140 eligible studies were identified, including 45 studies that were published in 1993, 39 studies that were published in 1998, and 56 studies that were published in 2003. Among those, 67 publications (48%) reported pharmaceutical industry involvement, 36 publications (26%) had at least ≥1 pharmaceutical industry author, And 100 publications (71%) were considered positive. Pharmaceutical involvement was identified in 44% of the studies published in 1993, in 38% of the studies published in 1998, and in 58% of the studies published in 2003. Pharmaceutical authorship was reported in 22% of the 1993 studies, in 21% of the 1998 studies, and in 34% of the 2003 studies. For studies that were published in 2003, those that reported pharmaceutical involvement were more likely to be positive (84% vs 54%; P = .02; Fisher exact test), to be single-arm studies (66% vs 33%; P = .03), and to evaluate metastatic disease (72% vs 46%; P = .06). CONCLUSIONS. Pharmaceutical involvement in published clinical breast cancer research may affect study design, focus, and results. Further research is warranted, including analysis of unpublished studies, to evaluate the impact of increasing pharmaceutical industry involvement on clinical research. Cancer 2007;109:. © 2007 American Cancer Society.

BACKGROUND The objective of this study was to compare the quality of life (QOL) after treatment among patients who had breast carcinoma with multiple positive lymph nodes. The patients were randomized to receive either high-dose chemotherapy with autologous stem cell support (HDC) or intermediate-dose chemotherapy (IDC) in the adjuvant setting. METHODS Two hundred forty-six patients with AJCC Stage IIA, IIB, or IIIA breast carcinoma who had ≥ 10 positive lymph nodes and who were participants in Cancer and Leukemia Group B (CALGB) 9082 were enrolled in this companion study, CALGB 9066. Patients were randomized to receive either high-dose cyclophosphamide, carmustine, and cisplatin (CPA/cDDP/BCNU) and autologous bone marrow transplantation (the HDC arm) or intermediate-dose CPA/cDDP/BCNU as consolidation to adjuvant chemotherapy (the IDC arm). QOL was assessed at baseline and at 3 months, 12 months, 24 months, and 36 months using the Functional Living Index-Cancer (FLIC), the Psychosocial Adjustment to Illness Scale (PAIS)-Self Report, and the McCorkle Symptom Distress Scale (SDS). RESULTS At the 3-month assessment, patients in the HDC arm demonstrated significant worsening of QOL compared with the IDC arm in terms of their physical well being (FLIC, P = 0.023), social functioning (FLIC, P = 0.026; PAIS, P < 0.0001), symptom distress (SDS, P = 0.0002), and total QOL scores (FLIC, P = 0.042). At 12 months, the differences in QOL scores between the HDC arm and the IDC arm had resolved. CONCLUSIONS Patients who received more intensive adjuvant therapy experienced transient declines in QOL. By 12 months after therapy, QOL was comparable between the 2 arms, regardless of therapy intensity, and many QOL areas were improved from baseline. Cancer 2005. © 2005 American Cancer Society.

This study evaluated self-reported knowledge, practice, and attitudes toward commercially available cytochrome P450 2D6 (CYP2D6) pharmacogenomic testing for patients on tamoxifen for breast cancer (CYPT) among US oncologists while evidence for the use of the test was evolving.A self-administered survey of medical oncology breast cancer specialists at National Comprehensive Cancer Network (NCCNO) centers and a random sample of community-based oncologists (CBOs) was undertaken. The survey evaluated knowledge and use of the CYP2D6 test and response to hypothetical test results.In total, 201 of 459 (44%) oncologists responded. At a time when CYPT remained experimental, 31% of oncologists reported use of CYPT and 56% reported willingness to order CYPT outside of a clinical trial if requested by a patient. Compared to oncologists specializing in breast cancer, oncologists in community-based practice were more likely to use CYPT routinely (21% versus 11%, P .06), to order CYPT on patient request (66% versus 44%, P .001), and to change management for premenopausal women with intermediate metabolism (34% CBO versus 8% NCCN, P .001). Oncologists cited data from randomized trials and professional guidelines as most influential when considering use of a genetic test.Prior to definitive evidence, a minority of oncologists reported using the CYP2D6 test routinely, and many indicated willingness to change management of patients based on test results. There is a need to educate clinicians and the public regarding the uncertain benefits of commercially available genetic tests in clinical practice when evidence from ongoing trials is still emerging.

BACKGROUND: The rapid pace of genetics research, coupled with evolving standards for informed consent, can create ethical challenges regarding future use of tissue or information from completed clinical trials. The Cancer and Leukemia Group B (CALGB) Oncology Cooperative Group was faced with an ethical dilemma regarding sharing genetic data from a completed genome-wide association study (GWAS) that was conducted as part of a large, multicenter breast cancer clinical trial with a national database: the Database of Genotypes and Phenotypes National Center for Biotechnology Information (dbGaP). METHODS: The CALGB Ethics Committee conducted a series of multidisciplinary meetings and teleconferences involving patient advocates, bioethicists, clinical researchers, and clinical oncologists to evaluate the ethical issues raised by this case and to identify lessons for improving informed consent to future genetics research in oncology trials. RESULTS: The Ethics Committee recommended that GWAS data be provided to dbGaP consistent with documented consent for future use of tissue among trial participants. Ethical issues, including adequacy of informed consent to future research, limitations of privacy in modern genetics research, the potential impact of population-based genetics research on health disparities, and recontact of research participants for clinical care or further research, were identified as major ethical considerations in this area. CONCLUSIONS: Although modern standards for informed consent should not prohibit research or sharing of data consistent with participant's intent and the public interest, there is an urgent need for national consensus on the appropriate use of archived tissue and standardized informed consent for future research among cancer clinical trial participants. Cancer 2012. © 2012 American Cancer Society.

BACKGROUND:Patient advocates are increasingly involved in cooperative group trials, single-institution cancer programs, and peer-review of research applications. The purpose of this study was to evaluate the role and value of patient advocates from the perspective of Cancer and Leukemia Group B (CALGB) advocates and investigators.METHODS:An online survey was sent to current and past (within 5 years) patient advocates and investigators.RESULTS.Response rates were 72.7% (16 of 22) for advocates and 56.4% (102 of 181) for investigators. Patient advocates were more likely than investigators to report the following: the clinical trial process benefited from advocate involvement on committees (100% of advocates vs 72.1% of investigators;P