Breast cancer treatment receipt and the role of financial stress, health literacy, and numeracy among diverse breast cancer survivors.

PURPOSE: Disparities in breast cancer treatment for low-income and minority women are well documented. We examined economic hardship, health literacy, and numeracy and whether these factors were associated with differences in receipt of recommended treatment among breast cancer survivors. METHODS: During 2018-2020, we surveyed adult women diagnosed with stage I-III breast cancer between 2013 and 2017 and received care at three centers in Boston and New York. We inquired about treatment receipt and treatment decision-making. We used Chi-squared and Fisher's exact tests to examine associations between financial strain, health literacy, numeracy (using validated measures), and treatment receipt by race and ethnicity. RESULTS: The 296 participants studied were 60.1% Non-Hispanic (NH) White, 25.0% NH Black, and 14.9% Hispanic; NH Black and Hispanic women had lower health literacy and numeracy and reported more financial concerns. Overall, 21 (7.1%) women declined at least one component of recommended therapy, without differences by race and ethnicity. Those not initiating recommended treatment(s) reported more worry about paying large medical bills (52.4% vs. 27.1%), worse household finances since diagnosis (42.9% vs. 22.2%), and more uninsurance before diagnosis (9.5% vs. 1.5%); all P < .05. No differences in treatment receipt by health literacy or numeracy were observed. CONCLUSION: In this diverse population of breast cancer survivors, rates of treatment initiation were high. Worry about paying medical bills and financial strain were frequent, especially among non-White participants. Although we observed associations of financial strain with treatment initiation, because few women declined treatments, understanding the scope of impact is limited. Our results highlight the importance of assessments of resource needs and allocation of support for breast cancer survivors. Novelty of this work includes the granular measures of financial strain and inclusion of health literacy and numeracy.

Clonal hematopoiesis in older patients with breast cancer receiving chemotherapy.

BACKGROUND: The expansion of hematopoietic stem cells carrying recurrent somatic mutations, termed clonal hematopoiesis (CH), is common in elderly individuals and is associated with increased risk of myeloid malignancy and all-cause mortality. Though chemotherapy is a known risk factor for developing CH, how myelosuppressive therapies affect the short-term dynamics of CH remains incompletely understood. Most studies have been limited by retrospective design, heterogeneous patient populations, varied techniques to identifying CH, and analysis of single timepoints. METHODS: We examined serial samples from 40 older women with triple-negative or hormone receptor-positive breast cancer treated on the prospective ADjuVANt Chemotherapy in the Elderly trial to evaluate the prevalence and dynamics of CH at baseline and throughout chemotherapy (6 and 12 weeks). RESULTS: CH was detected in 44% of patients at baseline and in 53% at any timepoint. Baseline patient characteristics were not associated with CH. Over the course of treatment, mutations exhibited a variety of dynamics, including emergence, expansion, contraction, and disappearance. All mutations in TP53 (n = 3) and PPM1D (n = 4), genes that regulate the DNA damage response, either became detectable or expanded over the course of treatment. Neutropenia was more common in patients with CH, particularly when the mutations became detectable during treatment, and CH was significantly associated with cyclophosphamide dose reductions and holds (P = .02). CONCLUSIONS: Our study shows that CH is common, dynamic, and of potential clinical significance in this population. Our results should stimulate larger efforts to understand the biological and clinical importance of CH in solid tumor malignancies. TRIAL REGISTRATION: ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT03858322). Clinical trial registration number: NCT03858322.

'ADVANCE' (a pilot trial) ADjuVANt chemotherapy in the elderly: Developing and evaluating lower-toxicity chemotherapy options for older patients with breast cancer.

INTRODUCTION: Older adults with breast cancer receiving neo/adjuvant chemotherapy are at high risk for poor outcomes and are underrepresented in clinical trials. The ADVANCE (ADjuVANt Chemotherapy in the Elderly) trial evaluated the feasibility of two neo/adjuvant chemotherapy regimens in parallel-enrolling cohorts of older patients with human epidermal growth factor receptor 2-negative breast cancer: cohort 1-triple-negative; cohort 2-hormone receptor-positive. MATERIALS AND METHODS: Adults age ≥ 70 years with stage I-III breast cancer warranting neo/adjuvant chemotherapy were enrolled. Cohort 1 received weekly carboplatin (area under the curve 2) and weekly paclitaxel 80 mg/m2 for twelve weeks; cohort 2 received weekly paclitaxel 80 mg/m2 plus every-three-weekly cyclophosphamide 600 mg/m2 over twelve weeks. The primary study endpoint was feasibility, defined as ≥80% of patients receiving ≥80% of intended weeks/doses of therapy. All dose modifications were applied per clinician discretion. RESULTS: Forty women (n = 20 per cohort) were enrolled from March 25, 2019 through August 3, 2020 from three centers; 45% and 35% of patients in cohorts 1 and 2 were age > 75, respectively. Neither cohort achieved targeted thresholds for feasibility. In cohort 1, eight (40.0%) met feasibility (95% confidence interval [CI] = 19.1-63.9%), while ten (50.0%) met feasibility in cohort 2 (95% CI = 27.2-72.8). Neutropenia was the most common grade 3-4 toxicity (cohort 1-65%, cohort 2-55%). In cohort 1, 80% and 85% required ≥1 dose holds of carboplatin and/or paclitaxel, respectively. In cohort 2, 10% required dose hold(s) for cyclophosphamide and/or 65% for paclitaxel. DISCUSSION: In this pragmatic pilot examining chemotherapy regimens in older adults with breast cancer, neither regimen met target goals for feasibility. Developing efficacious and tolerable regimens for older patients with breast cancer who need chemotherapy remains an important goal. CLINICALTRIALS: gov Identifier: NCT03858322.

Breast cancer knowledge and understanding treatment rationales among diverse breast cancer survivors.

PURPOSE: The degree to which breast cancer survivors know about their tumors and understand treatment rationales is not well understood. We sought to identify information gaps within a diverse sample and explore whether knowledge about breast cancer and treatment may impact care. METHODS: We conducted a one-time, interviewer-administered survey of women who were diagnosed with breast cancer during 2013-2017 and received care at one of three centers in Boston, MA, and New York, NY. We examined knowledge of breast cancer and treatment rationales, information preferences, and treatment receipt. RESULTS: During 2018-2020, we interviewed 313 women (American Association for Public Opinion Research Cooperation Rates 58.4-76.5% across centers) who were 56.9% White, 23.6% Black, 14.1% Hispanic, and 5.4% other. Among the 296 included in analyses, we observed high variability in knowledge of breast cancer and treatment rationales, with a substantial number demonstrating limited knowledge despite feeling highly informed; > 25% actively avoided information. Black and Hispanic (vs. White) women consistently knew less about their cancers. Lack of understanding of treatment rationales for chemotherapy, radiation, and hormonal therapy was common but not consistently different by race and ethnicity. Understanding treatment rationale (but not cancer knowledge) was associated with treatment initiation, but small sample sizes limited in-depth examination. CONCLUSIONS: Our study highlights the need for enhanced informational support for breast cancer survivors, who are challenged with complex information during the decision-making process and beyond. More research is needed to understand how to further educate and empower diverse populations of patients with breast cancer.

Perceptions of patients and medical oncologists toward biospecimen donation in the setting of abnormal breast imaging findings.

PURPOSE: We sought to understand the attitudes of individuals with abnormal breast imaging findings prompting a diagnostic breast biopsy toward donation of blood, excised tissue, or percutaneous biospecimens for research, and to understand medical oncologists' attitudes toward research biospecimen collection in this population. METHODS: We included individuals who presented to a single academic medical center for a clinically indicated, image-guided, percutaneous breast biopsy. We administered a survey prior to knowledge of biopsy results to assess willingness to consider, entirely for research purposes, donating blood or excess excised breast tissue, or having additional biospecimens (AB) obtained during a clinically indicated percutaneous biopsy. We also surveyed breast medical oncologists from National Cancer Institute-designated cancer centers to assess attitudes toward approaching patients for biospecimen research. RESULTS: Overall, 53/63 patients responded to the survey; 70% would consider donating blood, 85% would consider donating excess excised breast tissue, and 32% would consider having AB obtained during a clinically indicated biopsy. Main motivating factors for considering AB included contributing to scientific knowledge and return of study or biopsy results, whereas anxiety and the potential discomfort were the main dissuading factors. Among 191 medical oncologists, most were very comfortable (59.2%), or somewhat comfortable (32.5%) asking patients to have AB obtained during a clinically indicated breast biopsy. Medical oncologists reported hesitancy to refer a patient for AB due to potential pain/discomfort, and other procedure risks. CONCLUSIONS: Only one-third of individuals with breast imaging findings would consider consenting to AB during a diagnostic biopsy, whereas most were open to donating blood or excess excised breast tissue. Most medical oncologists would be comfortable asking patients to have AB obtained during the biopsy. Understanding patients' and oncologists' baseline attitudes may inform the design and approach to breast biospecimen-based research.

Perceptions of patients with early stage breast cancer toward research biopsies.

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.

Perceptions of Oncologists About Sharing Clinic Notes with Patients.

In a large survey (n = 809) conducted to understand how oncologists differ from nononcologists regarding routinely sharing visit notes with patients, oncologists were less likely to agree patient safety would improve (p = .03) or that patients would be offended after reading notes (p = .01); however, they agreed with nononcologists that sharing notes would lead to less candid documentation (69% vs. 73%; p = .39). Oncologists share a high level of worry about the impact of sharing notes on documentation practices, a concern that will need to be addressed as the practice of sharing visit notes expands to cancer care.

The Grief of Mothers After the Sudden Unexpected Death of Their Infants.

: media-1vid110.1542/5741323271001PEDS-VA_2017-3651Video Abstract BACKGROUND: The loss of a child is associated with elevated grief severity, and sudden infant death syndrome (SIDS) is the leading cause of postneonatal mortality in the United States. The diagnosis of prolonged grief disorder (PGD) has gained broader acceptance and use. Little is known about PGD in mothers after SIDS. METHODS: Between May 2013 and July 2016, we assessed 49 SIDS-bereaved mothers living in informal settlements near Cape Town, South Africa, and on the Pine Ridge Indian Reservation and 359 SIDS-bereaved mothers affiliated with SIDS parent-support organizations in the United States, United Kingdom, Australia, New Zealand, and the Netherlands. We examined PGD symptom severity and diagnostic prevalence rates between the samples and other significant grief indicators during the period 2 to 48 months after the deaths of their infants. RESULTS: Extremely high, persistent, and similar rates of PGD were found in both samples at every time interval. The prevalence of PGD was 50.0% in either sample (mean months from loss: 20.5 vs 24.9). Daily, intrusive emotional pain or yearning was found in 68.1% of subjects; yearning was significantly associated with emotional pain (P < .0001). Role confusion and anger were the most prevalent symptoms, reported by the majority at every time interval. Rates of role confusion, anger, and diminished trust in others remained constant. Acceptance was less prevalent than other grief indicators at every interval. CONCLUSIONS: Severe symptoms and heightened risk for PGD was seen in mothers after their infants died of SIDS, with discernible symptom profiles. Given their involvement with families after SIDS, pediatricians may have a unique role in identifying this problem and helping address its consequences.

Delayed Workup of Rectal Bleeding in Adult Primary Care: Examining Process-of-Care Failures.

BACKGROUND: Although delayed colorectal cancer diagnoses figure prominently in medical malpractice claims, little is known about the quality of primary care clinicians' workup of rectal bleeding. METHODS: In this study, 438 patients were identified using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for rectal bleeding, hemorrhoids, and blood in the stool at 10 Boston adult primary care practices. Following nurse chart abstraction, physician reviewers assessed the overall quality of care and key care processes. Subjects' characteristics and physician reviewers' processes-of-care assessments were tabulated, and logistic regression models were used to examine the association of process failures with overall quality and guideline concordance. RESULTS: Although reviewers judged the overall quality of care to be good or excellent in 337 (77%) of 438 cases, 312 (71%) patients experienced at least one process-of-care failure in the workup of rectal bleeding. Clinicians failed to obtain an adequate family history in 38% of cases, complete a pertinent physical exam in 23%, and order laboratory tests in 16%. Failure to order or perform tests, or to make follow-up plans were associated with increased odds of poor or fair care. Guideline concordance bore little relationship with quality judgments. Reviewers judged that 128 delays could have been reduced or prevented. CONCLUSION: Process-of-care failures among adult primary care patients with rectal bleeding were frequent and associated with fair or poor quality. Educating practitioners and creating systems to ensure adequate history taking, physical examination, and processes for ordering, performing, and interpreting diagnostic tests may improve performance.

Working up rectal bleeding in adult primary care practices.

RATIONALE, AIMS AND OBJECTIVES: Variation in the workup of rectal bleeding may result in guideline-discordant care and delayed diagnosis of colorectal cancer. Accordingly, we undertook this study to characterize primary care clinicians' initial rectal bleeding evaluation. METHODS: We studied 438 patients at 10 adult primary care practices affiliated with three Boston, Massachusetts, academic medical centres and a multispecialty group practice, performing medical record reviews of subjects with visit codes for rectal bleeding, haemorrhoids or bloody stool. Nurse reviewers abstracted patients' sociodemographic characteristics, rectal bleeding-related symptoms and components of the rectal bleeding workup. Bivariate and multivariable logistic regression models examined factors associated with guideline-discordant workups. RESULTS: Clinicians documented a family history of colorectal cancer or polyps at the index visit in 27% of cases and failed to document an abdominal or rectal examination in 21% and 29%. Failure to order imaging or a diagnostic procedure occurred in 32% of cases and was the only component of the workup associated with guideline-discordant care, which occurred in 27% of cases. Compared with patients at hospital-based teaching sites, patients at urban clinics or community health centres had 2.9 (95% confidence interval 1.3-6.3) times the odds of having had an incomplete workup. Network affiliation was also associated with guideline concordance. CONCLUSION: Workup of rectal bleeding was inconsistent, incomplete and discordant with guidelines in one-quarter of cases. Research and improvements strategies are needed to understand and manage practice and provider variation.

Elements of external validity of tools for health: an intervention for construction laborers.

PURPOSE: To examine the external validity of an efficacious tailored smoking cessation and nutrition improvement telephone intervention. DESIGN: Comparison of characteristics of participants and nonparticipants (representativeness); examination of the extent of intervention implementation. SETTING: Cancer center collaboration with a labor union. SUBJECTS: Unionized construction laborers. INTERVENTION: Tailored feedback report, telephone counseling, and supplementary educational materials focused on smoking cessation and improved nutrition. MEASURES: Background survey identifying socio-demographic and behavioral characteristics; process evaluation data; and final efficacy survey to determine participant satisfaction. ANALYSIS: Cross-classification and the chi(2) test of homogeneity were used with categorically measured variables comparing participants and nonparticipants. We compared the means in the two groups for continuously scaled measures using the Student t-test and investigated the multivariable association of the characteristics of participation with a multiple logistic regression. For process data we present frequencies, percentages, and means. RESULTS: Characteristics associated with participation included self-efficacy to change fruit and vegetable consumption (p = .0009) and self-identification with union's problems (p = 0.05). Eighty-six percent of non-smokers and 61% of smokers completed between 1 and 4 counseling sessions. Over one-half of non-smokers (61%) and smokers (53%) completed 4 or more calls and more smokers (34%) than non-smokers (11%) completed the 5+ sessions. CONCLUSIONS: These results provide a snapshot of characteristics of construction laborers to whom this intervention can be generalized and indicators of feasibility necessary for translating research into practice.