Comparative Age-Based Prospective Multi-Institutional Observations of 12,367 Patients Enrolled to the American College of Surgeons Oncology Group (ACOSOG) Z901101 Trials (Alliance).

BACKGROUND: The risk of surgery, particularly for older cancer patients with serious, extensive comorbidities, can make this otherwise curative modality precarious. Leveraging data from the American College of Surgeons Oncology Group, this study sought to characterize age-based comparative demographics, adverse event rates, and study completion rates to define how best to conduct research in older cancer patients. METHODS: This study relied on clinical data from 21 completed studies to assess whether older patients experienced more grade 3 or worse adverse events and were more likely to discontinue study participation prematurely than their younger counterparts. RESULTS: The study enrolled 12,367 patients. The median age was 60 years, and 36% of the patients were 65 years of age or older. Among 4008 patients with adverse event data, 1067 (27%) had experienced a grade 3 or worse event. The patients 65 years or older had higher rates of grade 3 or worse adverse events compared to younger patients [32% vs. 24%; odds ratio (OR), 1.5; 95% confidence interval (CI), 1.3-1.7; p < 0.0001]. This association was not observed in multivariate analyses. The study protocol was completed by 97% of the patients. No association was observed between age and trial completion (OR 0.8; 95% CI 0.7-1.1; p = 0.14). Only the older gastrointestinal cancer trial patients were less likely to complete their studies compared to younger patients (OR 0.50; 95% CI 0.30-0.70; p < 0.0001). CONCLUSION: Despite higher rates of adverse events, the older patients typically completed the study protocol, thereby contributing relevant data on how best to render care to older cancer patients and affirming the important role of enrolling these patients to surgical trials.

Developing NaviCanPlan: A Mobile Web Resource Locator for Cancer Providers and Survivors.

As of January, 2012, an estimated 13.7 million persons are living as cancer survivors. This population is expected to grow to nearly 18 million by 2022. While their treatment may be considered successful, many cancer survivors experience long-term physical, emotional, and psychosocial late effects of treatment. Our focus was on community-based cancer care-both rural and urban-as almost 90% of cancer care occurs in community settings, where a full complement of supportive healthcare professionals may not be available. This study describes the results of stakeholder engagement and the feedback processes used to create NaviCanPlan, a mobile web resource locator designed to educate and inform both providers and survivors in finding health-related services, often in noncancer center settings. Individual interviews with survivors and providers regarding resource needs to address a variety of physical and psychosocial late effects were supplemented with site visits, web-based polling, and webinars discussions. Overall, the results indicated a need for a programmatic approach to providing education about community, medical, and nonmedical resources for providers and survivors. Design and content criteria for a web-based mobile resource locator were defined, articulated, and implemented.

Adjuvant chemotherapy for stage III colon cancer in the oldest old: results beyond clinical guidelines.

BACKGROUND: Randomized trials demonstrating the benefits of chemotherapy in patients with American Joint Committee on Cancer stage III colon cancer underrepresent persons aged ≥ 75 years. The generalizability of these studies to a growing elderly population remains unknown. METHODS: Using the California Cancer Registry for 1994 through 2008, the authors conducted a population-based study of postcolectomy patients aged 50 years to 94 years with stage III (N1M0) colon adenocarcinoma. A 2-sided chi-square test and Cochran-Armitage test for trend were used to compare patient and tumor characteristics associated with receipt of chemotherapy across age groups. Multivariate regression was used to assess the association between older age and receipt of chemotherapy. Kaplan-Meier methods and Cox proportional hazards modeling were used to evaluate the association between chemotherapy and mortality, with propensity score adjustment. RESULTS: Approximately 44% (12,382 patients) of the study cohort was aged ≥ 75 years. Persons aged ≥ 75 years were found to be less likely to have received adjuvant chemotherapy than those aged < 75 years (30% vs 68% in patients aged 50 years-74 years; P < .0001). On multivariate analysis, patients aged 75 years to 84 years were 13 times less likely, and those aged 85 years to 94 years were 24 times less likely, to have received chemotherapy as patients aged 50 years to 64 years. Nevertheless, age-stratified multivariate survival analyses indicated that chemotherapy provided comparable mortality reduction across age groups. CONCLUSIONS: The percentage of persons aged ≥ 75 years receiving adjuvant chemotherapy remains low despite demonstrated survival benefits. These findings deserve attention within the context of a patient's life expectancy, underlying comorbidities, and performance status, as well as clinician bias. The results of the current study support the call for phase II/III studies assessing the toxicities and benefits of adjuvant chemotherapy for the treatment of stage III colon cancer in the elderly.

Genetic testing and cancer risk management recommendations by physicians for at-risk relatives.

PURPOSE: Sequence-based cancer susceptibility testing results are described as negative, deleterious mutation or variant of uncertain significance. We studied the impact of different types of test results on clinical decision making. METHODS: Practicing physicians from five specialties in Texas completed an online case-based survey (n = 225). Respondents were asked to make genetic testing and management recommendations for healthy at-risk relatives of patients with cancer. RESULTS: When the patient carried a deleterious BRCA1 mutation or variant of uncertain significance, 98% and 82% of physicians, respectively, recommended testing of at-risk relatives (P < 0.0001). In both situations, comprehensive BRCA1/2 analysis was selected most with a corresponding 9-fold increase in unnecessary genetic testing costs. There was no difference in physicians with (n = 81) or without (n = 144) prior BRCA1/2 testing experience (P = 0.3869). Cancer risk management recommendations were most intense for the relative with a deleterious mutation compared with variant of uncertain significance, negative, or no testing with 63%, 13%, 5%, and 2%, respectively, recommending oophorectomy (P < 0.0001). CONCLUSIONS: Independent of experience, or specialty, physicians chose more comprehensive testing for healthy relatives than current guidelines recommend. In contrast, management decisions demonstrated the uncertainty associated with a variant of uncertain significance. Utilization of genetic professionals and education of physicians on family-centered genetic testing may improve efficacy and substantially reduce costs.

A survey of environmental safety issues at 20 medical clinics.

In the study described in this article, the authors performed safety walk-throughs or inspections for 20 clinics located both inside a major medical center clinic (onsite) and away from the main clinic site (offsite). A checklist was used to evaluate compliance with institutional, local, state, and federal guidelines and regulations. The results obtained at onsite clinics were compared with the results from offsite clinics. Findings suggested no overall difference in the number of yes (desirable) answers. A marginally significant difference, however, was observed between the onsite and offsite clinics with regard to knowledge of infection control and waste/infection control questions. The walk-throughs helped create an improved working relationship between clinic personnel and environmental safety personnel, allowed for correction of safety issues, enabled an informal training opportunity, and increased institutional compliance with guidelines and regulations.

Progress in addressing disparities through comprehensive cancer control.

Cancer-related disparities are the significant differences in cancer incidence, cancer prevalence, cancer death, cancer survivorship, and burden of cancer or related health conditions that exist disproportionately in certain populations compared with the general population with respect to variables like race, ethnicity, and geography. The emergence of comprehensive cancer control efforts provides a framework to address the unequal disease burden felt by these groups. This article illustrates four distinct programs uniquely designed to fit at-risk populations. Specific examples are given that demonstrate a significant impact on the full range of the cancer care continuum. Although measureable progress has been made to improve prevention, detection, and treatment of cancer throughout the United States, many populations remain underserved, impeding our ability to achieve national healthcare goals. Here, we reemphasize the need to sustain this progress through use of partnerships, technology, and policy.

Disparate inclusion of older adults in clinical trials: priorities and opportunities for policy and practice change.

Older adults are vastly underrepresented in clinical trials in spite of shouldering a disproportionate burden of disease and consumption of prescription drugs and therapies, restricting treatments' generalizability, efficacy, and safety. Eliminating Disparities in Clinical Trials, a national initiative comprising a stakeholder network of researchers, community advocates, policymakers, and federal representatives, undertook a critical analysis of older adults' structural barriers to clinical trial participation. We present practice and policy change recommendations emerging from this process and their rationale, which spanned multiple themes: (1) decision making with cognitively impaired patients; (2) pharmacokinetic differences and physiological age; (3) health literacy, communication, and aging; (4) geriatric training; (5) federal monitoring and accountability; (6) clinical trial costs; and (7) cumulative effects of aging and ethnicity.

A descriptive analysis of state legislation and policy addressing clinical trials participation.

OBJECTIVES: This report describes state policy and legislation related to clinical trials participation and Maryland's model to enhance clinical trial availability and participation. METHODS: Descriptive review of state policy and legislation related to coverage for clinical trials costs based on data from the National Cancer Institute (NCI) State Cancer Legislative Database, the American Cancer Society, and NCI; additionally, discussion of Maryland's comprehensive multilevel clinical trial model comprising policy initiatives, community engagement, research, education, and infrastructure support. RESULTS: Twenty-four states have mandated clinical trial coverage through specific legislation or agreements since 1994. Covered benefits varied among the states. CONCLUSIONS: Besides cost and insurance barriers, there is a need to address important patient, physician and researcher, and structural barriers to clinical trial participation. Maryland provides a comprehensive model to address the multi-faceted clinical trial participation determinants as it tracks state and federal policy, documents trial barriers, and conducts community education.

Low-literacy interventions to promote discussion of prostate cancer: a randomized controlled trial.

BACKGROUND: Professional organizations recommend that physicians discuss prostate cancer with patients to make individual screening decisions. However, few studies have tested strategies to encourage such discussions, particularly among high-risk populations. We examined the effects of two low-literacy interventions on the frequency of prostate cancer discussion and screening. DESIGN: Randomized, blinded, controlled trial with concealed allocation. SETTING/PARTICIPANTS: Inner-city primary care clinic, serving a predominately African-American population. Participants were men aged 45-70 with no history of prostate cancer, presenting for a regular appointment. INTERVENTIONS: While waiting to see their physician, patients received a patient education handout on prostate cancer screening (PtEd), a handout simply encouraging patients to talk to their doctor about prostate cancer (Cue), or a control handout. The interventions did not advocate for or against screening. MEASURES: Patient-reported discussion of prostate cancer with the physician and chart reviews determine prostate-specific antigen (PSA) test orders and performance of digital rectal examination (DRE). Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were computed. Data were collected in 2003, and analyses were completed in 2006. RESULTS: Most of the 250 subjects (90.4%) were African American and 78.8% read below the ninth grade level. Overall, 48.4% reported discussing prostate cancer during the appointment. Compared to the control group (37.3%), discussions were significantly more common in the Cue group (58.0%, aOR=2.39 [1.26-4.52]), as well as in the PtEd group (50.0%, aOR=1.92 [1.01-3.65]). When prostate cancer was discussed, patients in the intervention groups more commonly initiated the conversation (47.6% PtEd and 40.0% Cue, vs 9.7% control, p<0.01 for each comparison to control). Compared to the control group (2.4%), PSA test orders increased in the PtEd group (14.1%, aOR=7.62 [1.62-35.83]) and in the Cue group (12.3%, aOR=5.86 [1.24-27.81]). Documentation of DRE did not change significantly (4.7% PtEd, 6.2% Cue, and 6.0% control). CONCLUSIONS: Two simple low-literacy interventions significantly increased discussion of prostate cancer and PSA test orders but not performance of DRE. Both interventions were effective in empowering low-literacy patients to initiate conversations about prostate cancer with their physician.

Environmental health: a survey of Texas primary care physicians.

Although the role of environmental health hazards in cancer and other diseases is increasingly appreciated, most physicians have had little or no training in environmental health or in integrating exposure histories into their clinical practice. As part of the Texas Medical Association Physician Oncology Education Program, we mailed a questionnaire to 350 Texas primary care physicians (PCPs) to evaluate their attitudes, practice, training, and preferred sources for information regarding environmental health issues. Of the respondents, 86.1% reported that they had never received specific training in environmental health history-taking and 91.7% indicated a desire to learn more about environmental health hazards. The data also revealed that patients regularly raise questions about environmental topics that PCPs do not routinely discuss. Our findings identify a need for more environmental health education for Texas PCPs, and we suggest several possible mechanisms by which this might be accomplished.

Attitudes of primary care physicians and specialists about cancer clinical trials: a survey of Texas physicians.

A one-page questionnaire assessing physicians' prior involvement in and attitudes about clinical trials was distributed to primary care physicians (PCPs) and specialists practicing in Texas. The survey form was completed and returned by 57 PCPs and 80 specialists. The two physician groups agreed strongly about the value of what can be learned in clinical trials, and agreed that the greatest barriers to participation were paperwork requirements, time constraints, and concern for patient welfare. Both PCPs and specialists were concerned about enrolling patients if they felt that the patients did not understand what was involved. Because PCPs report only a limited experience with clinical trials, a realistic strategy to increase patient accrual involves developing effective educational outreaches to this group of physicians. In general, PCPs are trusted by their patients and can play an important role in providing information and in encouraging participation in appropriate trials.

Human papillomavirus vaccine recommendations and agreement with mandated human papillomavirus vaccination for 11-to-12-year-old girls: a statewide survey of Texas physicians.

BACKGROUND: The purpose of this study was to examine Texas physicians' recommendations for the quadrivalent human papillomavirus (HPV) vaccine in 11-to-12-year-old girls, intention to recommend HPV vaccines to 11-to-12-year-old boys, and attitudes about mandated HPV vaccination for 11-to-12-year-old girls. MATERIALS AND METHODS: We conducted a cross-sectional, web-based survey of Texas physicians who provide direct patient care in family medicine, pediatrics, obstetrics/gynecology, and internal medicine in September 2008. The three outcome variables were: HPV vaccine recommendations to 11-to-12-year-old girls, likelihood of recommending the vaccine to 11-to-12-year-old boys, and agreement with mandated vaccination of 11-to-12-year-old girls. Univariate and logistic regression analyses were used to determine practice-related and attitudinal factors associated with each outcome. RESULTS: Of the 1,122 respondents, 48.5% stated they always recommended HPV vaccines to girls, 68.4% were likely to recommend the vaccine to boys, and 41.7% agreed with mandated vaccination. In multivariate logistic regression models, variables independently associated with recommendation to 11-to-12-year-old girls included: percentage of patients with Medicaid [odds ratio (OR), 1.02; 95% confidence interval (95% CI), 1.01-1.03], academic versus nonacademic practice (OR, 2.11; 95% CI, 1.05-4.23), office procedures to maximize vaccination (OR, 1.25; 95% CI, 1.01-1.56), HPV knowledge (OR, 1.25; 95% CI, 1.04-1.49), valuing HPV vaccine information from both professional organizations (OR, 1.90; 95% CI, 1.15-3.16) and professional conferences (OR, 1.68; 95% CI, 1.10-2.57), belief in mandated HPV vaccination (OR, 5.38; 95% CI, 3.28-8.83), and barriers to vaccination (OR, 1.08; 95% CI, 1.00-1.16). DISCUSSION: Half of the physicians in this study did not follow current recommendations for universal HPV vaccination of 11-to-12-year-old girls. Factors linked to vaccine recommendations may be targeted in educational or policy interventions.

Increasing mammography screening through inpatient education.

BACKGROUND: The reasons why women do not undergo regular screening mammograms have not been clearly defined. In this study, we addressed an educational intervention based on Health Belief Model constructs for 3 of the most common reasons why women do not participate in mammography screening: cost, fear, and lack of knowledge. The purpose of the project was to study whether an educational intervention addressing these factors could increase mammography screening among age-appropriate women who had not had a recommended mammogram within the previous 12 months. METHODS: The educational intervention consisted of providing a tailored brochure addressing either the barrier of (1) cost, (2) fear, or (3) lack of information. Participants were hospital inpatients admitted for noncancer diagnoses. They were followed up approximately 3 months after hospital discharge to ascertain subsequent mammography utilization either before or after leaving the hospital. RESULTS: Of the 272 women originally interviewed, 147 (54%) were reached for follow-up. Although there were no differences related to which mammography barrier was addressed, 42 (28.6%) reported that they had obtained a mammogram after the intervention. CONCLUSIONS: These data suggest that a fairly simple, low-cost patient education intervention of brochure distribution can produce substantially increased patient awareness and consequent mammography utilization.

Primary care physicians' attitudes and practices regarding cancer genetics: a comparison of 2001 with 1996 survey results.

BACKGROUND: To determine whether Texas primary care physicians' attitudes and practices regarding cancer genetics changed over a five-year period, a follow-up survey was conducted and the results obtained in 1996 were compared with those obtained in 2001. METHODS: A survey was mailed in 2001 to a random sample of 350 primary care physicians in Texas. RESULTS: More primary care physicians in 2001 were discussing the subject of genetic screening with their patients and more physicians were referring their patients for genetic evaluations and testing for cancer risk, compared with 1996. Cost of genetic testing continues to be the most frequently cited barrier to using genetic testing for cancer susceptibility. CONCLUSION: Results suggest a continuing need for more educational programs for physicians regarding genetic testing for cancer susceptibility.

Variation in prostate specific antigen results from 2 different assay platforms: clinical impact on 2304 patients undergoing prostate cancer screening.

PURPOSE: Urologists must contend with fluctuating prostate specific antigen (PSA) results from different assay platforms when deciding whether prostate biopsy is indicated. The contribution of cross-platform variation to these fluctuations is not well understood. To address this question we performed a cross-sectional study comparing 2 popular PSA assays during prostate cancer screening. MATERIALS AND METHODS: The Baylor College of Medicine Prostate Cancer Screening Program is a community outreach program providing free screening to Houston residents. From September 18th to 23, 2000, 2,304 patients underwent digital rectal examination and parallel serum PSA assay by the Hybritech Access (Beckman Coulter, Inc., Chaska, Minnesota) and Centaur (Bayer Diagnostics, Tarrytown, New York) systems. The Wilcoxon signed ranks test was used to compare results. RESULTS: Median PSA was low for the 2 assays (Centaur 0.99 ng/ml and Access 1.09 ng/ml) and Access results were significantly higher (1.23 times) than those obtained with Centaur (p <0.001). Frozen serum from 50 patients with PSA greater than 2.5 were then re-assayed using a third methodology (third Generation Immulite, Diagnostic Products Corp., Los Angeles, California). These data were consistent with Centaur results and significantly lower than Access results (p <0.001). Using a cutoff of PSA greater than 4.0 ng/ml 55 of the 288 patients (19%) with PSA greater than 2.5 ng/ml on the 2 platforms would have been candidates for prostate biopsy based on Access but not on Centaur data. CONCLUSIONS: In a large screening population the Access system measured consistently higher PSA than the Centaur system. These findings provide a basis for interpreting PSA results obtained from 2 commonly used clinical assays.