ABSTRACT
Background Guidelines recommend annual surveillance imaging after diagnosis of ductal carcinoma in situ (DCIS). Guideline adherence has not been characterized in a contemporary cohort. Purpose To identify uptake and determinants of surveillance imaging in women who underwent treatment for DCIS. Materials and Methods A stratified random sample of women who underwent breast-conserving surgery for primary DCIS between 2008 and 2014 was retrospectively selected from 1330 facilities in the United States. Imaging examinations were recorded from date of diagnosis until first distant recurrence, death, loss to follow-up, or end of study (November 2018). Imaging after treatment was categorized into 10 12-month periods starting 6 months after diagnosis. Primary outcome was per-period receipt of asymptomatic surveillance imaging (mammography, MRI, or US). Secondary outcome was diagnosis of ipsilateral invasive breast cancer. Multivariable logistic regression with repeated measures and generalized estimating equations was used to model receipt of imaging. Rates of diagnosis with ipsilateral invasive breast cancer were compared between women who did and those who did not undergo imaging in the 6-18-month period after diagnosis using inverse probability-weighted Kaplan-Meier estimators. Results A total of 12 559 women (median age, 60 years; IQR, 52-69 years) were evaluated. Uptake of surveillance imaging was 75% in the first period and decreased over time (P < .001). Across the first 5 years after treatment, 52% of women participated in consistent annual surveillance. Surveillance was lower in Black (adjusted odds ratio [OR], 0.80; 95% CI: 0.74, 0.88; P < .001) and Hispanic (OR, 0.82; 95% CI: 0.72, 0.94; P = .004) women than in White women. Women who underwent surveillance in the first period had a higher 6-year rate of diagnosis of invasive cancer (1.6%; 95% CI: 1.3, 1.9) than those who did not (1.1%; 95% CI: 0.7, 1.4; difference: 0.5%; 95% CI: 0.1, 1.0; P = .03). Conclusion Half of women did not consistently adhere to imaging surveillance guidelines across the first 5 years after treatment, with racial disparities in adherence rates. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Rahbar and Dontchos in this issue.
Subject(s)
Breast Neoplasms , Carcinoma, Ductal, Breast , Carcinoma, Intraductal, Noninfiltrating , Female , Humans , United States , Middle Aged , Carcinoma, Intraductal, Noninfiltrating/pathology , Retrospective Studies , Breast Neoplasms/pathology , Mammography/methods , Mastectomy, Segmental , Carcinoma, Ductal, Breast/surgeryABSTRACT
OBJECTIVE: The purpose of this secondary analysis was to describe the prevalence of anxiety, depression, and perceived stress among women newly diagnosed with breast cancer and the impact of baseline and changes in anxiety on cognitive functioning following exercise and mind-body prehabilitation interventions. METHODS: The sample consisted of 49 women with newly diagnosed breast cancer (stages I-III) who planned to undergo breast cancer surgery at two academic cancer centers. Participants were randomized to receive an exercise or mind-body prehabilitation intervention between the time of diagnosis and breast cancer surgery. Participants completed self-report measures of anxiety, depression (HADS), perceived stress, and cognitive functioning (EORTC-QLQ-C30) at study enrollment and prior to surgery (post-intervention). The relationships between change in cognitive functioning and change in anxiety among all participants were estimated using linear regression modeling. RESULTS: A significant proportion of women with newly diagnosed breast cancer had clinically significant anxiety (34.0%). Greater anxiety was moderately associated with worse cognitive functioning (r = -0.33) at baseline. Linear modeling found that changes in cognitive functioning and anxiety were inversely related: Each one-unit decrease in anxiety was associated with a two-unit improvement in cognitive function (p = .06). CONCLUSIONS: Anxiety was common in women with newly diagnosed breast cancer and was related to worse cognitive functioning. Assessment of anxiety at the time of diagnosis may allow for earlier anxiety management and subsequent improvement in cognitive functioning.
ABSTRACT
BACKGROUND: Of the nearly 50,000 women in the United States who undergo treatment for ductal carcinoma in situ (DCIS) annually, many may not benefit from treatment. To better understand the impact of a DCIS diagnosis, patients self-identified as having had DCIS were engaged regarding their experience. METHODS: In July 2014, a web-based survey was administered through the Susan Love Army of Women breast cancer listserv. The survey included open-ended questions designed to assess patients' perspectives about DCIS diagnosis and treatment. Deductive and inductive codes were applied to the responses; common themes were summarized. RESULTS: Among the 1832 women included in the analytic sample, the median age at diagnosis was 60 years. Four primary themes were identified: 1) uncertainty surrounding a DCIS diagnosis, 2) uncertainty about DCIS treatment, 3) concern about treatment side effects, and 4) concern about recurrence and/or developing invasive breast cancer. When diagnosed, participants were often uncertain about whether they had cancer or not and whether they should be considered a "survivor." Uncertainty about treatment manifested as questioning the appropriateness of the amount of treatment received. Participants expressed concern about the "cancer spreading" or becoming invasive and that they were not necessarily "doing enough" to prevent recurrence. CONCLUSIONS: In a large, national sample, participants with a history of DCIS reported confusion and concern about the diagnosis and treatment, which caused worry and significant uncertainty. Developing strategies to improve patient and provider communications regarding the nature of DCIS and acknowledging gaps in the current knowledge of management options should be a priority.
Subject(s)
Breast Neoplasms , Carcinoma, Ductal, Breast , Carcinoma, Intraductal, Noninfiltrating , Breast Neoplasms/diagnosis , Breast Neoplasms/pathology , Breast Neoplasms/therapy , Carcinoma, Intraductal, Noninfiltrating/diagnosis , Carcinoma, Intraductal, Noninfiltrating/pathology , Carcinoma, Intraductal, Noninfiltrating/therapy , Communication , Female , Humans , Survivors , Uncertainty , United StatesABSTRACT
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.
Subject(s)
Breast Neoplasms , Oncologists , Biopsy , Breast , Breast Neoplasms/diagnostic imaging , Female , Humans , Surveys and QuestionnairesSubject(s)
Carcinoma in Situ/therapy , Carcinoma, Ductal, Breast/therapy , Triple Negative Breast Neoplasms/therapy , Antineoplastic Agents/therapeutic use , Carcinoma in Situ/diagnostic imaging , Carcinoma in Situ/pathology , Carcinoma, Ductal, Breast/diagnostic imaging , Carcinoma, Ductal, Breast/pathology , Chemotherapy, Adjuvant , Combined Modality Therapy , Decision Making , Female , Humans , Lymph Node Excision , Lymph Nodes/diagnostic imaging , Lymph Nodes/pathology , Magnetic Resonance Imaging , Mastectomy , Middle Aged , Neoadjuvant Therapy , Neoplasm Staging , Patient Advocacy , Radiotherapy, Adjuvant , Triple Negative Breast Neoplasms/diagnostic imaging , Triple Negative Breast Neoplasms/pathologyABSTRACT
PURPOSE: To compare the impact of exercise and mind-body prehabilitation interventions on changes in quality of life and cancer treatment-related symptoms in women with newly diagnosed breast cancer. METHODS: The following describes a secondary analysis of a randomized window of opportunity trial (The Pre-Operative Health and Body Study). Forty-nine women were randomized to participate in either an exercise prehabilitation intervention or a mind-body prehabilitation intervention from the time of enrollment to surgery. Participants (N = 47) completed measures of quality of life, anxiety, depression, and stress at the time of enrollment (T1), post-intervention/surgery (T2), and one-month post-surgery (T3). Changes in outcome measures between groups were compared over time using longitudinal models. RESULTS: Mind-body group participants experienced significant improvements in cognitive functioning in comparison to exercise group participants between T1 and T3 (difference in average change: -9.61, p = 0.04, d = 0.31), otherwise, there were no significant differences between groups. Within group comparisons demonstrated that both groups experienced improvements in anxiety (exercise: average change = -1.18, p = 0.03, d = 0.34; mind-body: average change = -1.69, p = 0.006, d = 0.43) and stress (exercise: average change = -2.33, p = 0.04, d = 0.30; mind-body: average change = -2.59, p = 0.05, d = 0.29), while mind-body group participants experienced improvements in insomnia (average change = -10.03, p = 0.04, d = 0.30) and cognitive functioning (average change = 13.16, p = 0.0003, d = 0.67). CONCLUSIONS: Both prehabilitation interventions impacted cancer treatment-related symptoms. Further work in larger groups of patients is needed to evaluate the efficacy of prehabilitation interventions on quality of life in women with breast cancer. Pre-operative exercise and mind-body interventions may impact physical and/or psychological effects of cancer diagnosis and treatment in women with breast cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01516190. Registered January 24, 2012.
Subject(s)
Breast Neoplasms , Preoperative Exercise , Breast Neoplasms/surgery , Exercise , Female , Humans , Mind-Body Therapies , Quality of LifeABSTRACT
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.
Subject(s)
Attitude , Biomedical Research , Breast Neoplasms/pathology , Breast/pathology , Tissue Donors/psychology , Academies and Institutes/statistics & numerical data , Adult , Aged , Aged, 80 and over , Analysis of Variance , Biopsy/psychology , Blood Donors/statistics & numerical data , Breast Neoplasms/psychology , Cancer Care Facilities/statistics & numerical data , Female , Health Services Accessibility , Humans , Middle Aged , Neoplasm Staging , Socioeconomic Factors , Surveys and Questionnaires , Tissue and Organ ProcurementABSTRACT
BACKGROUND: We assessed health-related quality of life (symptoms of therapy/patient functioning/global health status), in APHINITY (pertuzumab/placebo, trastuzumab, and chemotherapy as adjuvant HER2-positive early breast cancer therapy). METHODS: Patients received 1 year/18 cycles of pertuzumab/placebo with trastuzumab and chemotherapy and completed EORTC QLQ-C30 and BR23 questionnaires until 36 months post-randomisation/disease recurrence. Changes ≥10 points from baseline were considered clinically meaningful. RESULTS: 87-97% of patients completed questionnaires. In the pertuzumab versus placebo arms, mean decrease in physical function scores (baseline â end of taxane) was -10.7 (95% CI -11.4, -10.0) versus -10.6 (-11.4, -9.9), mean decrease in global health status was -11.2 (-12.2, -10.2) versus -10.2 (-11.1, -9.2), and mean increase in diarrhoea scores (baseline â end of taxane) was +22.3 (21.0, 23.6) versus +9.2 (8.2, 10.2). Diarrhoea scores remained elevated versus baseline in the pertuzumab arm throughout HER2-targeted treatment (week 25: +13.2; end of treatment: +12.2). Role functioning was maintained in both arms. CONCLUSIONS: Improved invasive disease-free survival achieved by adding pertuzumab to trastuzumab and chemotherapy did not adversely affect the ability to conduct activities of daily living versus trastuzumab and chemotherapy alone. Patient-reported diarrhoea worsened during taxane therapy in both arms, persisting during HER2-targeted treatment in the pertuzumab arm. CLINICALTRIALS.GOV: NCT01358877.
Subject(s)
Antibodies, Monoclonal, Humanized/administration & dosage , Breast Neoplasms/drug therapy , Trastuzumab/administration & dosage , Activities of Daily Living , Antibodies, Monoclonal, Humanized/adverse effects , Drug Therapy , Female , Humans , Intention to Treat Analysis , Patient Reported Outcome Measures , Quality of Life , Survival Analysis , Trastuzumab/adverse effects , Treatment OutcomeABSTRACT
Members of the Translational Breast Cancer Research Consortium conducted an expert-driven literature review to identify a list of domains and to evaluate potential measures of these domains for inclusion in a list of preferred measures. Measures were included if they were easily available, free of charge, and had acceptable psychometrics based on published peer-reviewed analyses. A total of 22 domains and 52 measures were identified during the selection process. Taken together, these measures form a reliable and validated list of measurement tools that are easily available and used in multiple cancer trials to assess patient-reported outcomes in relevant patients.
Subject(s)
Breast Neoplasms/therapy , Clinical Trials as Topic/statistics & numerical data , Patient Reported Outcome Measures , Quality of Life , Surveys and Questionnaires/standards , Female , HumansABSTRACT
PURPOSE: As local therapies improve, contralateral breast cancer (CBC) risk for women with ductal carcinoma in situ (DCIS) may exceed the risk of a second ipsilateral breast cancer. We sought to determine whether estrogen-receptor (ER) status influenced CBC risk. METHODS: We identified women aged 40-79 with DCIS diagnosed between 1990 and 2002 using the Surveillance, Epidemiology, and End Results database. We used multivariable competing risk regression to examine predictors of time from index DCIS to CBC (invasive or in situ). RESULTS: Multivariable competing risk regression found ER status to be a highly significant predictor of CBC. The 10-year cumulative incidence was estimated to be 5.3% (95% CI 4.8-5.8%) among ER positive (ER+) cases and 3.3% (95% CI 2.6-4.0%) among ER negative (ER-). CONCLUSIONS: This finding suggests that ER+ DCIS may represent a field effect that confers increased propensity for developing cancer across breast tissue, regardless of laterality. In contrast, ER- DCIS may represent an isolated local event. Given that the majority of DCIS is ER+, and only a minority of DCIS patients receive hormonal therapy, consideration of ER status may influence treatment and surveillance approaches.
Subject(s)
Breast Neoplasms/epidemiology , Carcinoma, Intraductal, Noninfiltrating/epidemiology , Neoplasm Recurrence, Local/epidemiology , Receptors, Estrogen/genetics , Adult , Aged , Breast Neoplasms/genetics , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma, Intraductal, Noninfiltrating/genetics , Carcinoma, Intraductal, Noninfiltrating/pathology , Carcinoma, Intraductal, Noninfiltrating/surgery , Female , Humans , Mastectomy, Segmental , Middle Aged , Neoplasm Recurrence, Local/genetics , Neoplasm Recurrence, Local/pathology , Receptors, Progesterone/genetics , Risk FactorsABSTRACT
INTRODUCTION: Parathyroid hormone-related peptide (PTHrP) is involved in activating pathways, allowing tumor cells to form bone metastases. Measurement of PTHrP is used for the diagnosis and clinical management of patients suspected of hypercalcemia of malignancy. We developed an LC-MS/MS method for measuring PTHrP, established sex-specific reference intervals, and assessed the method's performance. METHODS: PTHrP was enriched from plasma samples with rabbit polyclonal anti-PTHrP antibody conjugated to magnetic beads. Enriched PTHrP was digested with trypsin, and PTHrP-specific tryptic peptide was analyzed with 2-dimensional LC-MS/MS in multiple reaction monitoring mode. RESULTS: The lower limit of quantification was 0.6 pmol/L, and the upper limit of linearity was 600 pmol/L. Total imprecision was <10%. Very poor agreement was observed with the RIA (n = 207; Deming regression RIA = 0.059 × LC-MS/MS - 1.8, r = 0.483; Sy|x = 3.9). Evaluation of the clinical performance of the assay using samples from patients with and without hypercalcemia (n = 199) resulted in an area under the ROC curve of 0.874. In sets of consecutively analyzed routine samples of patients assessed for hypercalcemia, the PTHrP positivity rate by RIA (n = 1376) was 1.9%, and 26.6% by LC-MS/MS (n = 1705). Concentrations were below the lower limit of quantification in 95.6% of the samples by RIA and 2.0% by LC-MS/MS. CONCLUSIONS: PTHrP is a normal constituent in circulating blood and its concentrations are substantially underestimated by commercial RIAs, causing false-negative results in samples from patients suspected of hypercalcemia. Our observations suggest a link between increased concentrations of PTHrP in postmenopausal women with low body mass index and increased incidence of osteoporosis.
Subject(s)
Parathyroid Hormone-Related Protein/blood , Tandem Mass Spectrometry , Adult , Aged , Chromatography, High Pressure Liquid , Female , Healthy Volunteers , Humans , Male , Middle Aged , Young AdultABSTRACT
BACKGROUND: Tissue from research biopsies provides access to insights into tumor biology. We aimed to determine medical oncologists' (MOs') attitudes toward research biopsies in patients with metastatic breast cancer (MBC). MATERIALS AND METHODS: A total of 309 breast MOs from National Cancer Institute (NCI)-designated cancer centers were invited to complete a self-administered survey about their attitudes toward approaching patients for research purpose-only biopsies (RPOBs), performed as a standalone procedure, or additional biopsies, performed with a clinically indicated biopsy. The MOs were asked to predict what proportion of their MBC patients would consider undergoing research biopsies. RESULTS: Of the 309 MOs, 221 (72%) responded. Of these 221 MOs, 30 were ineligible, leaving 191 eligible responders. Nearly all the MOs reported they were comfortable approaching patients regarding research biopsies of blood or skin. One fifth of MOs were uncomfortable approaching patients for RPOBs of the breast. One half of MOs were uncomfortable approaching patients for RPOBs of the liver. A significant variation was found in the perceptions by MOs of their patients' willingness to undergo research biopsies. The factors associated with increased comfort in approaching patients for research biopsies included fewer years in practice, caring for patients who had undergone recent research biopsies, and the predicted willingness of patients to consent to biopsies. The risk of a biopsy and biopsy-related pain were the most common reasons for reluctance to refer patients for research biopsies. CONCLUSION: Significant variation exists, even at NCI centers, in the comfort level of MOs in approaching MBC patients for research biopsies. MOs' attitudes toward research biopsies might be a modifiable factor in increasing tissue collection for research. IMPLICATIONS FOR PRACTICE: Tissue-based research is critical in advancing our understanding of cancer biology, and obtaining tissue from a research biopsy provides an essential resource. This study demonstrates the variability of oncologists' attitudes toward research biopsies and elicits factors associated with increased comfort levels with approaching patients for research biopsies. Biopsy risk and biopsy-related pain were commonly cited reasons not to refer patients for research biopsies. If the risk of a research biopsy is deemed sufficiently low enough to be acceptable, oncologists' attitudes might be a potential target for education and change, which may assist in increasing the availability of tissue for cancer research.
Subject(s)
Attitude of Health Personnel , Biopsy/methods , Breast Neoplasms/pathology , Medical Oncology/methods , Adult , Aged , Aged, 80 and over , Breast Neoplasms/therapy , Female , Humans , Middle Aged , Neoplasm Metastasis , Physicians , Surveys and QuestionnairesSubject(s)
Breast Neoplasms/surgery , Mastectomy , Patient Preference , Patient Reported Outcome Measures , Quality of Life , Radiotherapy, Adjuvant , Adult , Breast Implantation , Breast Neoplasms/physiopathology , Breast Neoplasms/psychology , Female , Humans , Mammaplasty , Middle Aged , Patient Satisfaction , Psychosocial FunctioningABSTRACT
OBJECTIVES: To compare blood thiamine concentrations, echocardiography findings, and plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in infants with clinically diagnosed beriberi and healthy matched controls, and to evaluate changes after thiamine treatment. STUDY DESIGN: Sixty-two Cambodian infants (20 cases and 42 controls), aged 2-47 weeks, were enrolled in this prospective study. Echocardiography and phlebotomy were performed at baseline and after thiamine treatment. RESULTS: Both cases and controls were thiamine-deficient, with median blood thiamine diphosphate (TDP) concentrations of 47.6 and 55.1 nmol/L, respectively (P = .23). All subjects had normal left ventricular ejection fraction. The median NT-proBNP concentration in cases (340 pg/mL [40.1 pmol/L]) was higher than previously reported normal ranges, but not statistically significantly different from that in controls (175 pg/mL [20.7 pmol/L]) (P = .10), and was not correlated with TDP concentration (P = .13). Two cases with the lowest baseline TDP concentrations (24 and 21 nmol/L) had right ventricular enlargement and elevated NT-proBNP levels that improved dramatically by 48 hours after thiamine administration. CONCLUSION: Only a minority of thiamine-deficient Cambodian infants demonstrate abnormal echocardiography findings. Thiamine deficiency produces echocardiographic evidence of right ventricular dysfunction, but this evidence is not apparent until deficiency is severe. NT-proBNP concentrations are mildly elevated in sick infants with normal echocardiography findings, indicating possible physiological changes not yet associated with echocardiographic abnormalities.
Subject(s)
Natriuretic Peptide, Brain/blood , Peptide Fragments/blood , Thiamine Deficiency/complications , Thiamine Pyrophosphate/therapeutic use , Ventricular Dysfunction, Left/etiology , Asian People/statistics & numerical data , Beriberi/blood , Beriberi/complications , Beriberi/ethnology , Biomarkers/metabolism , Case-Control Studies , Echocardiography, Doppler/methods , Female , Follow-Up Studies , Heart Function Tests , Humans , Infant , Infant, Newborn , Male , Reference Values , Risk Assessment , Severity of Illness Index , Thiamine Deficiency/blood , Thiamine Deficiency/drug therapy , Thiamine Deficiency/ethnology , Thiamine Pyrophosphate/blood , Treatment Outcome , Ventricular Dysfunction, Left/diagnosis , Ventricular Dysfunction, Left/ethnologyABSTRACT
BACKGROUND: Breast cancer patients experienced heightened anxiety during the pandemic. Also, modifications to clinical trial activities allowing for virtual platforms, local assessments, and greater flexibility were introduced to facilitate participation. We sought to evaluate the association between pandemic-related anxiety and willingness to participate in trials and how pandemic-era modifications to trial activities affect the decision to participate. METHODS: We conducted an online survey from August to September, 2021 of patients with breast cancer assessing pandemic-related anxiety; clinical trials knowledge and attitudes; willingness to participate during and before the pandemic; and how each modification affects the decision to participate. Fisher's exact tests evaluated differences in proportions and two-sample t-tests evaluated differences in means. The association of pandemic-related anxiety with a decline in willingness to participate during compared to prior to the pandemic was modeled using logistic regression. RESULTS: Among 385 respondents who completed the survey, 81% reported moderate-severe pandemic-related anxiety. Mean willingness to participate in a trial was lower during the pandemic than prior [2.97 (SD 1.17) vs. 3.10 (SD 1.09), (p < 0.001)]. Severe anxiety was associated with higher odds of diminished willingness to participate during the pandemic compared to prior (OR 5.07). Each of the modifications, with the exception of opting out of research-only blood tests, were endorsed by >50% of respondents as strategies that would increase their likelihood of deciding to participate. CONCLUSIONS: While pandemic-related anxiety was associated with diminished willingness to participate in trials, the leading reasons for reluctance to consider trial participation were unrelated to the pandemic but included worries about not getting the best treatment, side effects, and delaying care. Patients view trial modifications favorably, supporting continuation of these modifications, as endorsed by the National Cancer Institute and others.
Subject(s)
Breast Neoplasms , Clinical Trials as Topic , Pandemics , Patient Participation , Female , Humans , Anxiety/etiology , Breast Neoplasms/therapy , Surveys and QuestionnairesABSTRACT
There are ethical concerns regarding the performance of biopsies in patients for research purposes. We examined our single-institution experience regarding acceptance, safety, and success rate with research biopsies in patients with breast cancer. Among patients with data from paired samples, receptor status agreement between primary and metastatic samples was examined, either on first recurrence or after progression on one or more lines of therapy. An IRB-approved prospective study at the Dana-Farber Cancer Institute collects research biopsies as additional passes at the time of a clinical biopsy (AB, additional biopsy) or as a separate procedure for banking purposes (RPOB, research purposes only biopsy). Biopsies are not linked to a specific therapeutic or correlative trial. Grade 2-5 adverse events are prospectively collected. 151 patients were included in the analytic cohort (total procedures = 161); 80.8 % underwent AB, 17.2 % underwent RPOB, and 2.0 % underwent both AB and RPOB. Most patients were white (88.7 %) with a performance status of 0-1 (94.0 %). 96.0 % of patients underwent a biopsy in the setting of known or suspected metastatic disease. Receptor status between primary cancer and recurrent research biopsies differed in 43.2 % of patients with available data (18.8 % among patients who underwent the research biopsy before any systemic treatment, 48.1 % after treatment). Tissue was successfully collected in 92.3 % of patients undergoing AB and 100 % patients undergoing RPOB. Only three (2.0 %) patients had adverse events ≥ grade-2: one grade-2 pain; one grade-2 pneumothorax; and one grade-3 pain. Our experience suggests research biopsies can be performed safely with a high rate of successful tissue collection. Consistent with previous reports we found a high rate of discordance between primary and metastatic samples, which was even higher among treated patients. This supports continued efforts to study tissue samples at multiple points in a patient's disease course.
Subject(s)
Biopsy , Breast Neoplasms/pathology , Research , Adult , Aged , Aged, 80 and over , Biopsy/adverse effects , Breast/pathology , Female , Humans , Middle Aged , Prospective Studies , Risk Factors , Young AdultABSTRACT
Drug-induced nephrolithiasis is an important consideration in recurrent stone formers with polypharmacy. While felbamate nephrolithiasis has previously been published in the paediatric population, we present the oldest published case of a felbamate stone in an adult, a man in his 30s with Lennox-Gastaut syndrome. Even with moderate dosing, high drug serum levels can occur. Performing at least one stone analysis remains a critical component to care in these patients. Urologists should have a high index of suspicion for drug stone when stone analysis returns indeterminate characterisation in the absence of infection. Close communication with neurology is key to preventing recurrent stone disease.
Subject(s)
Epilepsy , Felbamate , Nephrolithiasis , Urolithiasis , Adult , Humans , Male , Anticonvulsants/therapeutic use , Epilepsy/drug therapy , Felbamate/adverse effects , Phenylcarbamates/therapeutic use , Propylene Glycols , Urolithiasis/chemically induced , Urolithiasis/drug therapyABSTRACT
CONTEXT: Family caregivers of patients with advanced cancer are integrally involved in communications regarding prognosis and end-of-life (EOL) planning and care. Yet little research has examined caregivers' communication experiences or the impact of these experiences on patients and caregivers at EOL. OBJECTIVES: Investigate cancer caregivers' communication experiences and potential impact on patient and caregiver outcomes. METHODS: Semistructured interviews with bereaved family cancer caregivers (N=19) about their communication needs and experiences as their loved one approached EOL and died. Audiotaped interviews were transcribed and thematically analyzed for communication-related themes. RESULTS: Caregivers described fulfilling many important communication roles including information gathering and sharing, advocating, and facilitating-often coordinating communication with multiple partners (e.g., patient, family, oncology team, hospital team). Caregivers reported that, among the many topics they communicated about, prognosis and EOL were the most consequential and challenging. These challenges arose for several reasons including caregivers' and patients' discordant communication needs, limited opportunity for caregivers to satisfy their personal communication needs, uncertainty regarding their communication needs and responsibilities, and feeling unacknowledged by the care team. These challenges negatively impacted caregivers' abilities to satisfy their patient-related communication responsibilities, which shaped many outcomes including end-of-life decisions, care satisfaction, and bereavement. CONCLUSION: Caregivers often facilitate essential communication for patients with advanced cancers yet face challenges successfully fulfilling their own and patients' communication needs, particularly surrounding prognostic and end-of-life conversations. Future research and interventions should explore strategies to help caregivers navigate uncertainty, create space to ask sensitive questions, and facilitate patient-caregiver discussions about differing informational needs.
Subject(s)
Bereavement , Neoplasms , Terminal Care , Humans , Caregivers , Prognosis , Qualitative Research , Neoplasms/therapy , Death , CommunicationABSTRACT
PURPOSE: The incidence of urolithiasis in children is increasing. However, stone composition studies in this population are limited. We sought to determine the effects of age, gender and geographical location on urinary stone composition in the United States pediatric population. MATERIALS AND METHODS: We obtained composition analyses for all urinary stones submitted to a reference laboratory between 2000 and 2009. Stones were excluded if the patient was younger than 1 year or older than 18 years. Stone composition was determined by Fourier transform infrared spectroscopy. Logistic regression analysis was performed to determine associations between stone composition frequency and age, gender and geographical region. RESULTS: A total of 5,245 stones were included in our analysis. Calcium was found in 89.2% of stones. The percentage of stones containing calcium oxalate increased, while magnesium ammonium phosphate and ammonium acid urate containing stones decreased with age. Calcium oxalate and magnesium ammonium phosphate containing stones were more common in females, while uric acid stones were more common in males. Additionally, significant differences in stone composition frequency were noted between males and females in specific age groups and between age groups within the same gender. Geographical distribution was not significantly associated with stone composition. CONCLUSIONS: This series is the largest analysis to date of urinary stone composition in the pediatric population in the United States. Age and gender were significantly associated with stone composition, while geographical region was not significantly associated with stone composition.