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1.  Frailty and Adherence to Adjuvant Hormonal Therapy in Older Women With Breast Cancer: CALGB Protocol 369901 
Journal of Clinical Oncology  2014;32(22):2318-2327.
Purpose
Most patients with breast cancer age ≥ 65 years (ie, older patients) are eligible for adjuvant hormonal therapy, but use is not universal. We examined the influence of frailty on hormonal therapy noninitiation and discontinuation.
Patients and Methods
A prospective cohort of 1,288 older women diagnosed with invasive, nonmetastatic breast cancer recruited from 78 sites from 2004 to 2011 were included (1,062 had estrogen receptor–positive tumors). Interviews were conducted at baseline, 6 months, and annually for up to 7 years to collect sociodemographic, health care, and psychosocial data. Hormonal initiation was defined from records and discontinuation from self-report. Baseline frailty was measured using a previously validated 35-item scale and grouped as prefrail or frail versus robust. Logistic regression and proportional hazards models were used to assess factors associated with noninitiation and discontinuation, respectively.
Results
Most women (76.4%) were robust. Noninitiation of hormonal therapy was low (14%), but in prefrail or frail (v robust) women the odds of noninitiation were 1.63 times as high (95% CI, 1.11 to 2.40; P = .013) after covariate adjustment. Nonwhites (v whites) had higher odds of noninitiation (odds ratio, 1.71; 95% CI, 1.04 to 2.80; P = .033) after covariate adjustment. Among initiators, the 5-year continuation probability was 48.5%. After adjustment, the risk of discontinuation was higher with increasing age (P = .005) and lower for stage ≥ IIB (v stage I) disease (P = .003).
Conclusion
Frailty is associated with noninitiation of hormonal therapy, but it does not seem to be a major predictor of early discontinuation in older patients.
doi:10.1200/JCO.2013.51.7367
PMCID: PMC4105485  PMID: 24934786
3.  Cognitive Impairment in Older Patients With Breast Cancer Before Systemic Therapy: Is There an Interaction Between Cancer and Comorbidity? 
Journal of Clinical Oncology  2014;32(18):1909-1918.
Purpose
To determine if older patients with breast cancer have cognitive impairment before systemic therapy.
Patients and Methods
Participants were patients with newly diagnosed nonmetastatic breast cancer and matched friend or community controls age > 60 years without prior systemic treatment, dementia, or neurologic disease. Participants completed surveys and a 55-minute battery of 17 neuropsychological tests. Biospecimens were obtained for APOE genotyping, and clinical data were abstracted. Neuropsychological test scores were standardized using control means and standard deviations (SDs) and grouped into five domain z scores. Cognitive impairment was defined as any domain z score two SDs below or ≥ two z scores 1.5 SDs below the control mean. Multivariable analyses evaluated pretreatment differences considering age, race, education, and site; comparisons between patient cases also controlled for surgery.
Results
The 164 patient cases and 182 controls had similar neuropsychological domain scores. However, among patient cases, those with stage II to III cancers had lower executive function compared with those with stage 0 to I disease, after adjustment (P = .05). The odds of impairment were significantly higher among older, nonwhite, less educated women and those with greater comorbidity, after adjustment. Patient case or control status, anxiety, depression, fatigue, and surgery were not associated with impairment. However, there was an interaction between comorbidity and patient case or control status; comorbidity was strongly associated with impairment among patient cases (adjusted odds ratio, 8.77; 95% CI, 2.06 to 37.4; P = .003) but not among controls (P = .97). Only diabetes and cardiovascular disease were associated with impairment among patient cases.
Conclusion
There were no overall differences between patients with breast cancer and controls before systemic treatment, but there may be pretreatment cognitive impairment within subgroups of patient cases with greater tumor or comorbidity burden.
doi:10.1200/JCO.2013.54.2050
PMCID: PMC4050204  PMID: 24841981
4.  Benefits, Harms, and Costs for Breast Cancer Screening After US Implementation of Digital Mammography 
Background
Compared with film, digital mammography has superior sensitivity but lower specificity for women aged 40 to 49 years and women with dense breasts. Digital has replaced film in virtually all US facilities, but overall population health and cost from use of this technology are unclear.
Methods
Using five independent models, we compared digital screening strategies starting at age 40 or 50 years applied annually, biennially, or based on density with biennial film screening from ages 50 to 74 years and with no screening. Common data elements included cancer incidence and test performance, both modified by breast density. Lifetime outcomes included mortality, quality-adjusted life-years, and screening and treatment costs.
Results
For every 1000 women screened biennially from age 50 to 74 years, switching to digital from film yielded a median within-model improvement of 2 life-years, 0.27 additional deaths averted, 220 additional false-positive results, and $0.35 million more in costs. For an individual woman, this translates to a health gain of 0.73 days. Extending biennial digital screening to women ages 40 to 49 years was cost-effective, although results were sensitive to quality-of-life decrements related to screening and false positives. Targeting annual screening by density yielded similar outcomes to targeting by age. Annual screening approaches could increase costs to $5.26 million per 1000 women, in part because of higher numbers of screens and false positives, and were not efficient or cost-effective.
Conclusions
The transition to digital breast cancer screening in the United States increased total costs for small added health benefits. The value of digital mammography screening among women aged 40 to 49 years depends on women’s preferences regarding false positives.
doi:10.1093/jnci/dju092
PMCID: PMC4067109  PMID: 24872543
5.  Associations among survivorship care plans, experiences of survivorship care, and functioning in older breast cancer survivors: CALGB/Alliance 369901 
Purpose
Survivorship care plans (SCP) are recommended for all cancer patients and could be especially useful to survivors 65 years and over (“older”). This study examined receipt of SCPs among older breast cancer survivors and whether SCPs were associated with improved patient-reported outcomes.
Methods
Three hundred and twenty-eight older women diagnosed with invasive, nonmetastatic breast cancer between 2007–2011 were recruited from 78 cooperative-group sites. Participants completed telephone interviews at baseline and 1-year posttreatment. Regression analyses examined SCP receipt (yes/no) and functioning (EORTC-QLQ-C30), cancer worry, and experiences of survivorship care (care coordination, knowledge).
Results
Only 35 % of women received SCPs. For each 1-year increase in age, there was a 5 % lower odds of receiving an SCP (odds ratio (OR)=0.94, 95 % confidence interval (CI) 0.91–0.98, p=0.007). Besides age, no other factor predicted SCPs. SCP receipt was associated with greater knowledge and understanding of requisite follow-up care (p<0.05); however, functioning was not significantly different among those with vs. without SCPs.
Conclusions
Receipt of care plans was limited. SCPs improved understanding of breast cancer follow-up care among older survivors, but did not impact functioning one year post-treatment.
Implications for Cancer Survivors
To impact functioning and salient needs of the growing cohort of older survivors, survivorship care plans likely should be tailored to geriatric-specific issues. To improve functioning, SCP content should expand to include exercise, nutrition, polypharmacy, social support and management of symptom burden from cancer, and other comorbid conditions. To improve follow-up care for cancer survivors, SCPs should delineate shared care roles between oncology and primary care in managing recurrence surveillance, screening, and cancer sequelae.
doi:10.1007/s11764-014-0371-5
PMCID: PMC4386650  PMID: 24917307
Survivorship care plan; Breast cancer; Cancer survivors; Older adults; Cancer survivorship and aging
6.  Randomized Noninferiority Trial of Telephone Versus In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer 
Journal of Clinical Oncology  2014;32(7):618-626.
Purpose
Although guidelines recommend in-person counseling before BRCA1/BRCA2 gene testing, genetic counseling is increasingly offered by telephone. As genomic testing becomes more common, evaluating alternative delivery approaches becomes increasingly salient. We tested whether telephone delivery of BRCA1/2 genetic counseling was noninferior to in-person delivery.
Patients and Methods
Participants (women age 21 to 85 years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area) were randomly assigned to usual care (UC; n = 334) or telephone counseling (TC; n = 335). UC participants received in-person pre- and post-test counseling; TC participants completed all counseling by telephone. Primary outcomes were knowledge, satisfaction, decision conflict, distress, and quality of life; secondary outcomes were equivalence of BRCA1/2 test uptake and costs of delivering TC versus UC.
Results
TC was noninferior to UC on all primary outcomes. At 2 weeks after pretest counseling, knowledge (d = 0.03; lower bound of 97.5% CI, −0.61), perceived stress (d = −0.12; upper bound of 97.5% CI, 0.21), and satisfaction (d = −0.16; lower bound of 97.5% CI, −0.70) had group differences and confidence intervals that did not cross their 1-point noninferiority limits. Decision conflict (d = 1.1; upper bound of 97.5% CI, 3.3) and cancer distress (d = −1.6; upper bound of 97.5% CI, 0.27) did not cross their 4-point noninferiority limit. Results were comparable at 3 months. TC was not equivalent to UC on BRCA1/2 test uptake (UC, 90.1%; TC, 84.2%). TC yielded cost savings of $114 per patient.
Conclusion
Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs.
doi:10.1200/JCO.2013.51.3226
PMCID: PMC3927731  PMID: 24449235
7.  Costs and Outcomes Evaluation of Patient Navigation Following Abnormal Cancer Screening: Evidence from the Patient Navigation Research Program 
Cancer  2013;120(4):570-578.
Background
Navigators can facilitate timely access to cancer services but there are little data on their economic impact.
Methods
We conduct a cost-consequence analysis of navigation vs. usual care among 10,521 individuals with abnormal breast, cervix, colorectal or prostate cancer screening results who enrolled in the Patient Navigation Research Program study from January 1 2006 to March 31 2010. Navigation costs included diagnostic evaluation, patient and staff time, materials, and overhead. Consequences or outcomes were time to diagnostic resolution and probability of resolution. Differences in costs and outcomes were evaluated using multi-level, mixed-effects regression adjusting for age, race/ethnicity, language, marital status, insurance, cancer, and site clustering.
Results
Most individuals were minority (70.7%) and un- or publically-insured (72.7%). Diagnostic resolution was higher for navigation vs. usual care at 180 (56.2% vs. 53.8%, p=0.008) and 270 days: 70.0% vs. 68.2%, p<0.001). While there were no differences in average days to resolution (110 vs. 109 days, p=.63), the probability of ever having diagnostic resolution was higher for navigation vs. usual care (84.5% vs. 79.6%, p <0.001). The added cost of navigation vs. usual care was $275 per patient (95% CI $260 – $290, p <0.001). There was no significant difference in stage distribution among the 12.4% of navigated vs. 11% of usual care patients diagnosed with cancer.
Conclusions
Navigation adds costs and modestly increases the probability of diagnostic resolution among patients with abnormal screening tests. Navigation is only likely to be cost-effective if improved resolution translates into earlier cancer stage at diagnosis.
doi:10.1002/cncr.28438
PMCID: PMC3946403  PMID: 24166217
cancer; navigation; cost; outcomes; abnormal cancer screening
8.  Perceived Risk of Breast Cancer among Latinas Attending Community Clinics: Risk Comprehension and Relationship with Mammography Adherence 
Cancer causes & control : CCC  2008;19(10):1373-1382.
Objective
To describe breast cancer risk perceptions, determine risk comprehension, and evaluate mammography adherence among Latinas.
Methods
Latina women age ≥ 35, primarily from Central and South America, were recruited from community-based clinics to complete in-person interviews (n=450). Risk comprehension was calculated as the difference between numeric perceived risk and Gail risk score. Based on recommended guidelines from the year data were collected (2002), mammography adherence was defined as having a mammogram every one to two years for women ≥ 40 years of age.
Results
Breast cancer risk comprehension was low, as 81% of women overestimated their risk and only 6.9% of women were high risk based on Gail risk scores. Greater cancer worry and younger age were significantly associated with greater perceived risk and risk overestimation. Of women age eligible for mammography (n = 328), 29.0% were non-adherent to screening guidelines. Adherence was associated with older age, (OR = 2.99, 95% CI = 1.76 – 5.09), having insurance (OR = 1.81, 95% CI = 1.03 – 3.17), greater acculturation (OR = 1.18, 95% CI = 1.02 – 1.36), and higher breast cancer knowledge (OR = 2.03, 95% CI = 1.21 – 3.40).
Conclusions
While most Latinas over-estimated their breast cancer risk, older age, having insurance, being more acculturated, and having greater knowledge were associated with greater screening adherence in this Latino population. Perceived risk, risk comprehension, and cancer worry were not associated with adherence. In Latinas, screening interventions should emphasize knowledge and target education efforts at younger, uninsured, and less acculturated mammography-eligible women.
doi:10.1007/s10552-008-9209-7
PMCID: PMC4309545  PMID: 18704716
Latina; breast cancer; risk perception; risk comprehension; mammography adherence; acculturation
9.  Personalizing Age of Cancer Screening Cessation Based on Comorbidity: Model estimates of harms and benefits 
Annals of internal medicine  2014;161(2):104-112.
Background
Harms and benefits of cancer screening depend on age and comorbidity, yet reliable estimates are lacking.
Objective
To estimate the harms and benefits of cancer screening by age and comorbidity to inform decisions about screening cessation.
Design
Collaborative modeling with seven well-established cancer simulation models and common data on average and comorbidity level-specific life expectancy from SEER-Medicare.
Setting
US population.
Patients
US cohorts aged 66–90 years in 2010 with average health or one of four comorbidity levels (linked to specific conditions): none, mild, moderate, or severe.
Intervention
Mammography, prostate-specific antigen testing, or fecal immunochemical testing.
Measurements
Lifetime cancer deaths prevented and life-years gained (benefits); false-positive tests and overdiagnosed cancers (harms). For each comorbidity level: the age at which harms and benefits of screening were similar to that for individuals with average health undergoing screening at age 74.
Results
Screening 1000 women with average life expectancy at age 74 for breast cancer resulted in 79–96 (range across models) false-positives, 0.5–0.8 overdiagnosed cancers, and 0.7–0.9 breast cancer deaths prevented. While absolute numbers of harms and benefits differed across cancer sites, the ages at which to cease screening were highly consistent across models and cancer sites when based on harm-benefit ratios comparable to screening average-health individuals at age 74. For individuals with no, mild, moderate, and severe comorbidities, screening until ages of 76, 74, 72, and 66, respectively, resulted in similar harms and benefits as for average-health individuals.
Limitations
Comorbidity only influenced life expectancy.
Conclusion
Comorbidity is an important determinant of harms and benefits of screening. Estimates of screening benefits and harms by comorbidity can inform discussions between providers and their older patients about personalizing decisions about when to stop cancer screening.
Primary Funding Source
National Cancer Institute at the National Institutes of Health
doi:10.7326/M13-2867
PMCID: PMC4160041  PMID: 25023249
11.  Cognitive Effects of Cancer and its Treatments at the Intersection of Aging: What do we Know; What do we Need to Know? 
Seminars in oncology  2013;40(6):10.1053/j.seminoncol.2013.09.006.
There is a fairly consistent, albeit non-universal body of research documenting cognitive declines after cancer and its treatments. While few of these studies have included those 65 and older, it is logical to expect that older patients are at risk of cognitive decline. In this paper, we use breast cancer as an exemplar disease for inquiry into the intersection of aging and cognitive effects of cancer and its therapies. There are a striking number of common underlying potential biological risks and pathways for the development of cancer, cancer-related cognitive declines, and aging processes, including the development of a frail phenotype. Candidate shared pathways include changes in hormonal milieu, inflammation, oxidative stress, DNA damage and compromised DNA repair, genetic susceptibility, decreased brain blood flow or disruption of the blood-brain barrier, direct neurotoxicity, decreased telomere length, and cell senescence. There are also similar structure and functional changes seen in brain imaging studies of cancer patients and those seen with “normal” aging and Alzheimer’s disease. Disentangling the role of these overlapping processes is difficult since they require aged animal models and large samples of older human subjects. From what we do know, frailty and its low cognitive reserve seem to be a clinically useful marker of risk for cognitive decline after cancer and its treatments. This and other results from this review suggest the value of geriatric assessments to identify older patients at the highest risk of cognitive decline. Further research is needed to understand the interactions between aging, genetic predisposition, lifestyle factors and frailty phenotypes to best identify the sub-groups of older patients at greatest risk for decline and to develop behavioral and pharmacological interventions targeting this group. We recommend that basic science and population trials be developed specifically for older hosts with intermediate endpoints of relevance to this group, including cognitive function and trajectories of frailty. Clinicians and their older patients can advance the field by active encouragement of and participation in research designed to improve the care and outcomes of the growing population of older cancer patients.
doi:10.1053/j.seminoncol.2013.09.006
PMCID: PMC3880205  PMID: 24331192
12.  Cost-effectiveness of internet and telephone treatment for smoking cessation: an economic evaluation of The iQUITT Study 
Tobacco control  2012;22(6):e11.
Background
Internet and telephone treatments for smoking cessation can reach large numbers of smokers. There is little research on their costs and the impact of adherence on costs and effects.
Objective
To conduct an economic evaluation of The iQUITT Study, a randomised trial comparing Basic Internet, Enhanced Internet and Enhanced Internet plus telephone counselling (‘Phone’) at 3, 6, 12 and 18 months.
Methods
We used a payer perspective to evaluate the average and incremental cost per quitter of the three interventions using intention-to-treat analysis of 30-day single-point prevalence and multiple-point prevalence (MPP) abstinence rates. We also examined results based on adherence. Costs included commercial charges for each intervention. Discounting was not included given the short time horizon.
Results
Basic Internet had the lowest cost per quitter at all time points. In the analysis of incremental costs per additional quitter, Enhanced Internet+Phone was the most cost-effective using both single and MPP abstinence metrics. As adherence increased, the cost per quitter dropped across all arms. Costs per quitter were lowest among participants who used the ‘optimal’ level of each intervention, with an average cost per quitter at 3 months of US$7 for Basic Internet, US$164 for Enhanced Internet and US$346 for Enhanced Internet +Phone.
Conclusions
‘Optimal’ adherence to internet and combined internet and telephone interventions yields the highest number of quitters at the lowest cost. Cost-effective means of ensuring adherence to such evidence-based programmes could maximise their population-level impact on smoking prevalence.
doi:10.1136/tobaccocontrol-2012-050465
PMCID: PMC3626730  PMID: 23010696
13.  Non-initiation and early discontinuation of adjuvant trastuzumab in women with localized HER2-positive breast cancer 
Breast cancer (Tokyo, Japan)  2014;21(6):780-785.
One year of trastuzumab therapy is recommended for women with HER2-positive breast cancer ≥1.0 cm in size to increase survival and is considered for women with tumors 0.5–0.9 cm in size. We analyzed compliance with trastuzumab among women with HER2-positive breast cancer in a prospective cohort study. Of 1145 recruited patients with breast cancer, 152 were HER2-positive (13.2 %), of whom 126 had tumors ≥1.0 cm; 110/126 (87.3 %) of these initiated trastuzumab. Non-receipt was associated with older age, better prognosis tumors, and with non-receipt of adjuvant chemotherapy. Of the 110 who initiated treatment, 18 (15 %) did not complete treatment, 15 (83 %) of them because of cardiotoxicity. Of 20 women with tumors 0.5–0.9 cm, 5 (25 %) initiated trastuzumab. Compliance with trastuzumab was very high among those with HER2-positive breast cancer, as was the completion of the recommended therapy.
doi:10.1007/s12282-014-0543-1
PMCID: PMC4213210  PMID: 24902664
Trastuzumab; Breast cancer; Adjuvant therapy; Adherence; Early discontinuation; Non-initiation
14.  Disparities in knowledge and willingness to donate research biospecimens: a mixed-methods study in an underserved urban community 
Journal of Community Genetics  2014;5(4):329-336.
Although research involving biospecimens is essential in advancing cancer research, minorities, especially African-Americans, are underrepresented in such research. We conducted a mixed-method (qualitative focus groups among African-Americans and quantitative cross-sectional surveys) study on factors associated with biospecimen knowledge and donation intent in the medically underserved urban communities in Southeast and Southwest Washington, DC. Focus groups were conducted among 41 African-Americans and survey data was available from 302 community residents of different races/ethnicities using convenience sampling. We used logistic regression to model the association between biospecimen knowledge and donation intent with selected sociodemographic variables using survey data. Only 47 % of the participants had knowledge of the different types of biospecimens. In multivariate logistic regression models, male gender, African-American race, and low education levels were significantly associated with lower knowledge about biospecimens. Compared to Whites (79 %), fewer African-Americans (39 %) and Hispanics (57 %) had knowledge of biospecimens but the difference was significant for African-Americans only. Positive intent to donate biospecimens for research was observed among 36 % of the survey respondents. After multivariate adjustment, only biospecimen knowledge was associated with donation intent (odds ratio = 1.91, 95 % confidence interval 1.12, 3.27). Contrary to popular opinion, “mistrust of the medical community” was not the most commonly reported barrier for biospecimen donation among African-Americans. “Not knowing how biospecimens will be used” and “lack of knowledge of biospecimens” were the most common barriers. Our study highlights the importance of education on biospecimens among community residents to increase minority participation in biospecimen research.
Electronic supplementary material
The online version of this article (doi:10.1007/s12687-014-0187-z) contains supplementary material, which is available to authorized users.
doi:10.1007/s12687-014-0187-z
PMCID: PMC4159473  PMID: 24771039
Biospecimen; Knowledge; African-American; Disparities
15.  Knowledge and Willingness to Provide Research Biospecimens Among Foreign-born Latinos Using Safety-net Clinics 
Journal of community health  2013;38(4):652-659.
Background
Latinos tend to be under-represented in cancer research and in bio-repositories.
Methods
We conducted a Spanish-language, interviewer-administered cross-sectional survey of 331 foreign-born Latinos from Central and South America attending safety-net clinics in order to describe factors associated with knowledge about and intention to provide bio-specimens for research purposes. We used logistic regression and multiple imputation methods to evaluate associations between socio-cultural measures, medical trust, demographics, as well as knowledge about and intentions to provide bio-specimens.
Results
Almost half (47%) of respondents knew what bio-specimens were, and 67% said that they would provide a specimen after being given information about what this involved; this increased to 72% among those with prior knowledge. Controlling for covariates, Latinos with a high school education and above were more likely to know what a bio-specimen was and to say they would provide bio-specimens than were those with lower levels of education (adjusted OR [aOR] 2.85, 95% CI 1.37-5.96; and 3.49, 95% CI 1.41-8.63, p <.01, respectively). Those with greater social integration were more likely to know about bio-specimens than those with less integration (aOR 2.54, 95% CI 1.45-4.46, p=0.001). Higher endorsement of family values was independently associated with intent to give bio-specimens (aOR 1.11, 95% CI 1.02-1.20, p=0.017 per five-point increase in “familism” score). Medical mistrust was not related to intentions to provide specimens.
Conclusions
Our results suggest that interventions to increase willingness to provide bio-specimens could leverage trusted clinics or social networks and should consider individuals’ education and socio-cultural perspectives.
doi:10.1007/s10900-013-9660-6
PMCID: PMC3706511  PMID: 23543371
Biospecimens; Latinos; Culture; Research
16.  WHICH STRATEGIES REDUCE BREAST CANCER MORTALITY MOST? COLLABORATIVE MODELING OF OPTIMAL SCREENING, TREATMENT, AND OBESITY PREVENTION 
Cancer  2013;119(14):2541-2548.
Background
US breast cancer mortality is declining but thousands of women still die each year.
Methods
Two established simulation models examine 6 strategies that include increased screening and/or treatment or elimination of obesity vs. continuation of current patterns. The models use common national data on incidence and obesity prevalence, competing causes of death, mammography characteristics, treatment effects and survival/cure. Parameters are modified based on obesity (defined as BMI ≥ 30kg/m2). Outcomes are presented for the year 2025 among women age 25+ and include numbers of cases, deaths, mammograms and false positives; age-adjusted incidence and mortality; breast cancer mortality reduction and deaths averted; and probability of dying of breast cancer.
Results
If current patterns continue, the models project that there would be about 50,100–57,400 (range across models) annual breast cancer deaths in 2025. If 90% of women were screened annually from ages 40–54 and biennially from ages 55–99 (or death) then 5,100–6,100 fewer deaths would occur vs. current patterns, but incidence, mammograms and false-positives increase. If all women receive indicated systemic treatment (with no screening change) then 11,400–14,500 more deaths would be averted vs. current patterns, but increased toxicity could occur. If 100% receive screening plus indicated therapy, there would be 18,100–20,400 fewer deaths. Eliminating obesity yields 3,300–5,700 fewer breast cancer deaths vs. continuation of current obesity levels.
Conclusions
Maximal reductions in breast cancer deaths could be achieved through optimizing treatment use, followed by increasing screening use and obesity prevention.
doi:10.1002/cncr.28087
PMCID: PMC3700651  PMID: 23625540
Simulation; Modeling; Breast Cancer; Treatment; Mammography; Obesity
17.  Costs, Evidence, and Value in the Medicare Program 
JAMA internal medicine  2013;173(3):227-228.
doi:10.1001/jamainternmed.2013.2127
PMCID: PMC4071606  PMID: 23303388
18.  Narrowing Racial Gaps in Breast Cancer Chemotherapy Initiation: The Role of the Patient-Provider Relationship 
Purpose
Chemotherapy improves breast cancer survival but is underused more often in black than in white women. We examined associations between patient-physician relationships and chemotherapy initiation and timeliness of initiation among black and white patients.
Methods
Women with primary invasive, non-metastatic breast cancer were recruited via hospitals (in Washington, DC and Detroit) and community outreach between July 2006 and April 2011. Data were collected via telephone interviews and medical records. Logistic regression models evaluated associations between chemotherapy initiation and independent variables. Since there were race interactions, analyses were race-stratified. Factors associated with time from surgery to chemotherapy initiation and delay of ≥ 90 days were evaluated with linear and logistic regressions, respectively.
Results
Among eligible women, 82.8% were interviewed and 359 (90.9%)of those had complete data. The odds of initiating chemotherapy were 3.26 times (95% CI: 1.51, 7.06) higher among black women reporting greater communication with physicians (vs. lesser), after considering covariates. In contrast, the odds of starting chemotherapy were lower for white women reporting greater communication (vs. lesser) (adjusted OR .22, 95% CI: .07, .73). The opposing direction of associations was also seen among the sub-set of black and white women with definitive clinical indications for chemotherapy. Among those initiating treatment, black women had longer mean time to the start of chemotherapy than whites (71.8 days vs. 55.0 days, p= .005), but race was not significant after considering trust in oncologists, where initiation time decreased as trust increased, controlling for covariates. Black women were also more likely to delay ≥ 90 days than whites (27% vs. 8.3%; p=.024), but this was not significant after considering religiosity.
Conclusion
The patient-physician dyad and sociocultural factors may represent leverage points to improve chemotherapy patterns in black women.
doi:10.1007/s10549-013-2520-3
PMCID: PMC3662254  PMID: 23588954
chemotherapy initiation; disparities; patient-provider communication
19.  Racial Disparities in Posttraumatic Stress After Diagnosis of Localized Breast Cancer: The BQUAL Study 
Background
Little is known about the development of posttraumatic stress disorder (PTSD) over time among women diagnosed with breast cancer. This study examines changes in PTSD symptoms in the first 6 months after diagnosis and assesses racial/ethnic differences in PTSD symptomatology over time.
Methods
We recruited women with newly diagnosed breast cancer, stages I to III, from three sites in the United States. Three telephone interviews were conducted: baseline at about 2 to 3 months after diagnosis, first follow-up at 4 months after diagnosis, and second follow-up at 6 months after diagnosis. We measured traumatic stress in each interview using the Impact of Events Scale; recorded sociodemographic, tumor, and treatment factors; and used generalized estimating equations and polytomous logistic regression modeling to examine the associations between variables of interest and PTSD.
Results
Of 1139 participants, 23% reported symptoms consistent with a diagnosis of PTSD at baseline, 16.5% at first follow-up, and 12.6% at the second follow-up. Persistent PTSD was observed among 12.1% participants, as defined by having PTSD at two consecutive interviews. Among participants without PTSD at baseline, 6.6% developed PTSD at the first follow-up interview. Younger age at diagnosis, being black (odds ratio [OR] = 1.48 vs white, 95% confidence interval [CI] =1.04 to 2.10), and being Asian (OR = 1.69 vs white, 95% CI = 1.10 to 2.59) were associated with PTSD.
Conclusions
Nearly one-quarter of women newly diagnosed with breast cancer reported symptoms consistent with PTSD shortly after diagnosis, with increased risk among black and Asian women. Early identification of PTSD may present an opportunity to provide interventions to manage symptoms.
doi:10.1093/jnci/djt024
PMCID: PMC3627645  PMID: 23434900
20.  Screening Outcomes in Older US Women Undergoing Multiple Mammograms in Community Practice: Does Interval, Age, or Comorbidity Score Affect Tumor Characteristics or False Positive Rates? 
Background
Uncertainty exists about the appropriate use of screening mammography among older women because comorbid illnesses may diminish the benefit of screening. We examined the risk of adverse tumor characteristics and false positive rates according to screening interval, age, and comorbidity.
Methods
From January 1999 to December 2006, data were collected prospectively on 2993 older women with breast cancer and 137 949 older women without breast cancer who underwent mammography at facilities that participated in a data linkage between the Breast Cancer Surveillance Consortium and Medicare claims. Women were aged 66 to 89 years at study entry to allow for measurement of 1 year of preexisting illnesses. We used logistic regression analyses to calculate the odds of advanced (IIb, III, IV) stage, large (>20 millimeters) tumors, and 10-year cumulative probability of false-positive mammography by screening frequency (1 vs 2 years), age, and comorbidity score. The comorbidity score was derived using the Klabunde approximation of the Charlson score. All statistical tests were two-sided.
Results
Adverse tumor characteristics did not differ statistically significantly by comorbidity, age, or interval. Cumulative probability of a false-positive mammography result was higher among annual screeners than biennial screeners irrespective of comorbidity: 48.0% (95% confidence interval [CI] = 46.1% to 49.9%) of annual screeners aged 66 to 74 years had a false-positive result compared with 29.0% (95% CI = 28.1% to 29.9%) of biennial screeners.
Conclusion
Women aged 66 to 89 years who undergo biennial screening mammography have similar risk of advanced-stage disease and lower cumulative risk of a false-positive recommendation than annual screeners, regardless of comorbidity.
doi:10.1093/jnci/djs645
PMCID: PMC3589257  PMID: 23385442
21.  Cognitive function in older women with breast cancer treated with standard chemotherapy and capecitabine on Cancer and Leukemia Group B 49907 
Cognitive changes in older women receiving chemotherapy are poorly understood. We examined self-reported cognitive function for older women who received adjuvant chemotherapy on Cancer and Leukemia Group B (CALGB) 49907. CALGB 49907 randomized 633 women aged ≥65 with stage I–III breast cancer to standard adjuvant chemotherapy (cyclophosphamide–methotrexate–5-fluoro-uracil or doxorubicin–cyclophosphamide) versus capecitabine. We examined self-reported cognitive function in 297 women (CALGB 361002) who enrolled on the quality of life substudy and had no gross impairment on cognitive screening. Women were evaluated using an 18-item instrument at six time points (baseline through 24 months). At each time point for each patient, we calculated a cognitive function score (CFS) defined as the mean response of items 1–18 and defined impairment as a score >1.5 standard deviations above the overall average baseline score. Differences in scores by patient characteristics were evaluated using a Kruskal–Wallis test. A linear mixed-effects model was used to assess CFSs by treatment over time. Among 297 women, the median age was 71.5 (range 65–85) and 73 % had performance status of 0. Baseline depression and fatigue were reported in 6 and 14 % of patients, respectively. The average CFS at baseline was 2.08 (corresponding to “normal ability”), and baseline cognitive function did not differ by treatment regimen (p = 0.350). Over 24 months, women reported minimal changes at each time point and insignificant differences by treatment arm were observed. In a healthy group of older women, chemotherapy was not associated with longitudinal changes in self-reported cognitive function.
doi:10.1007/s10549-013-2562-6
PMCID: PMC3920483  PMID: 23681403
Cognitive function; Older women; Breast cancer; Age
22.  A planned, prospective comparison of short-term quality of life outcomes among older breast cancer patients treated with standard chemotherapy in a randomized clinical trial vs. an observational study: CALGB #49907 and #369901✰ 
Journal of geriatric oncology  2013;4(4):353-361.
Objectives
Patients ≥65 years old (“older”) are often not included in randomized clinical trials (RCT), but when they are, care in an RCT might improve quality of life (QoL). We conducted a prospective comparison of QoL among older women receiving standard chemotherapy from the same cooperative group physicians in an RCT vs. an observational study (“off-trial”).
Methods
Older women with invasive, non-metastatic breast cancer (n = 150 RCT; 530 off-trial) were included. Linear mixed-effects models tested associations between chemotherapy on- vs. off-trial and changes in EORTC (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) QoL scores over 24 months, controlling for pre-treatment QoL, age, education, tumor factors, comorbidity, and other covariates.
Results
Anthracycline regimens were used by 58% of women treated on-trial vs. 54% of those treated off-trial. Women in the RCT reported an adjusted mean increase of 13.7 points (95% CI 10.2, 17.1) in global QoL at 24 months (vs. mid-treatment), while women treated off-trial had only an adjusted improvement of 7.0 points (95% CI 3.5, 10.4; p = .007 for difference in mean changes). Women in the RCT had significantly greater improvement in emotional function than those treated off-trial, controlling for baseline; they also had greater reductions in therapy side effects and fatigue at 24 months than women off-trial, controlling for covariates.
Conclusion
There may be different QoL trajectories for older women undergoing breast cancer chemotherapy on- vs. off-trial. If confirmed, the results suggest that the extra monitoring and communication within an RCT could provide the infrastructure for interventions to address symptoms and improve QoL for the growing older cancer population.
doi:10.1016/j.jgo.2013.05.004
PMCID: PMC3910230  PMID: 24472479
Older patients; Breast cancer; Chemotherapy; Quality of Life; Randomized clinical trials; Observational studies
23.  Interpersonal Influences and Attitudes about Adjuvant Therapy Treatment Decisions among Early Stage Breast Cancer Patients: An Examination of Differences by Age and Race/Ethnicity in the BQUAL Study 
Patients are increasingly involved in cancer treatment decisions and yet little research has explored factors that may affect patient attitudes and beliefs about their therapeutic choices. This paper examines psychosocial factors (e.g., attitudes, social support), provider-related factors (e.g., communication, trust), and treatment considerations in a prospective study of a sample of early stage breast cancer patients eligible for chemotherapy and/or hormonal therapy (BQUAL cohort). The data comes from a multi-site cohort study of white, black, Hispanic, and Asian non-metastatic breast cancer patients recruited in New York City, Northern California, and Detroit Michigan. Baseline surveys were conducted over the telephone between 2006 and 2010 among a total of 1145 women. Most participants were white (68%), had more than a high school education (76%), and were diagnosed with stage I disease (51%). The majority of women reported discussing chemotherapy and hormonal therapy with their doctor (90% and 83% respectively); these discussions primarily took place with medical oncologists. Nearly a quarter of women reported that the treatment decision was difficult and the majority were accompanied to the doctor (76%) and involved a friend or family member in the decision (54%). Positive considerations (e.g., beliefs about treatment reducing risk of recurrence) were important in making treatment decisions. Participants preferred a shared decision-making style, but results suggested that there is room for improvement in terms of actual patient involvement in the decision and provider communication, particularly among black patients. Patients 65 years and older reported fewer provider discussions of chemotherapy, poorer patient-provider communication, higher rates of being assisted by family members in making the decision, and more negative attitudes and beliefs towards treatment.
doi:10.1007/s10549-012-2370-4
PMCID: PMC3563273  PMID: 23263696
adjuvant therapy; breast cancer; treatment decisions; quality of care; racial disparities
24.  Influence of Study Features and Methods on Overdiagnosis Estimates in Breast and Prostate Cancer Screening 
Annals of internal medicine  2013;158(11):831-838.
Knowledge of the likelihood that a screen-detected cancer case has been overdiagnosed is vitally important for treatment decision making and screening policy development. An overdiagnosed case is an excess case detected because of cancer screening. Estimates of the frequency of overdiagnosis in breast and prostate cancer screening are highly variable across studies. In this article we identify features of overdiagnosis studies that influence results and illustrate their impact using published studies. We first consider different ways to define and measure overdiagnosis. We then examine contextual features and how they affect overdiagnosis estimates. Finally, we discuss the effect of estimation approach. Many studies use excess incidence under screening as a proxy for overdiagnosis. Others use statistical models to make inferences about lead time or natural history and then derive the corresponding fraction of cases that are overdiagnosed. We conclude with a list of questions that readers of overdiagnosis studies can use to evaluate the validity and relevance of published estimates and recommend that authors of publications quantifying overdiagnosis provide information about these features of their studies.
doi:10.7326/0003-4819-158-11-201306040-00008
PMCID: PMC3733533  PMID: 23732716
25.  Patient and Provider Factors Associated with Colorectal Cancer Screening in Safety Net Clinics Serving Low-income, Urban Immigrant Latinos 
Journal of health care for the poor and underserved  2012;23(3):10.1353/hpu.2012.0109.
Background
Latinos have lower colorectal cancer screening rates than Whites.
Methods
We reviewed a random sample of charts between July 2009 and February 2010 of safety-net clinic of 840 immigrants (50 years and older) from Central and South America receiving care. Logistic regression evaluated associations of ever vs. never screening, patient and physician factors.
Results
Ever screening rates were 24.5%, and only 17% of charts noted a physician screening recommendation. However, the odds of screening were 9.89 times higher (95% CI: 6.25–15.64, p<.001) among patients with a physician recommendation vs. those without, considering covariates. The odds of screening were 0.61 times lower (95% CI: 0.40–0.92, p=.02) in patients with a body mass index ≥ 30 vs. <30.
Conclusions
While rates were low, determinants of screening were similar in this Latino subgroup to those reported in other Latino and non-Latino populations. Low rates of documented physician screening recommendations may indicate a potential missed opportunity for cancer control in safety-net clinics.
doi:10.1353/hpu.2012.0109
PMCID: PMC3824152  PMID: 24212154
Latinos; colorectal cancer; screening; immigrants; obesity

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