UNASSIGNED: Adjuvant endocrine therapy (AET) use among women with early-stage, hormone receptor-positive breast cancer reduces the risk of cancer recurrence, but its adverse symptoms contribute to lower adherence.
UNASSIGNED: To test whether remote monitoring of symptoms and treatment adherence with or without tailored text messages improves outcomes among women with breast cancer who are prescribed AET.
UNASSIGNED: This nonblinded, randomized clinical trial (RCT) following intention-to-treat principles included English-speaking women with early-stage breast cancer prescribed AET at a large cancer center with 14 clinics across 3 states from November 15, 2018, to June 11, 2021. All participants had a mobile device with a data plan and an email address and were asked to use an electronic pillbox to monitor AET adherence and to complete surveys at enrollment and 1 year.
UNASSIGNED: Participants were randomized into 3 groups: (1) an app group, in which participants received instructions for and access to the study adherence and symptom monitoring app for 6 months; (2) an app plus feedback group, in which participants received additional weekly text messages about managing symptoms, adherence, and communication; or (3) an enhanced usual care (EUC) group. App-reported missed doses, increases in symptoms, and occurrence of severe symptoms triggered follow-ups from the oncology team.
UNASSIGNED: The primary outcome was 1-year, electronic pillbox-captured AET adherence. Secondary outcomes included symptom management abstracted from the medical record, as well as patient-reported health care utilization, symptom burden, quality of life, physician communication, and self-efficacy for managing symptoms.
UNASSIGNED: Among 304 female participants randomized (app group, 98; app plus feedback group, 102; EUC group, 104), the mean (SD) age was 58.6 (10.8) years (median, 60 years; range, 31-83 years), and 60 (19.7%) had an educational level of high school diploma or less. The study completion rate was 87.5% (266 participants). There were no statistically significant differences by treatment group in AET adherence (primary outcome): 76.6% for EUC, 73.4% for the app group (difference vs EUC, -3.3%; 95% CI, -11.4% to 4.9%; P = .43), and 70.9% for the app plus feedback group (difference vs EUC, -5.7%; 95% CI, -13.8% to 2.4%; P = .17). At the 1-year follow-up, app plus feedback participants had fewer total health care encounters (adjusted difference, -1.23; 95% CI, -2.03 to -0.43; P = .003), including high-cost encounters (adjusted difference, -0.40; 95% CI, -0.67 to -0.14; P = .003), and office visits (adjusted difference, -0.82; 95% CI, -1.54 to -0.09; P = .03) over the previous 6 months compared with EUC participants.
UNASSIGNED: This RCT found that a remote monitoring app with alerts to the patient\'s care team and tailored text messages to patients did not improve AET adherence among women with early-stage breast cancer; however, it reduced overall and high-cost health care encounters and office visits without affecting quality of life.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT03592771.

BACKGROUND: In JCOG0306 trial, a phase II study to examine the efficacy of neoadjuvant chemotherapy followed by radiation therapy (NAC-RT) to primary breast cancer, pathological complete response (pCR) was evaluated from specimens of the representative cross-section including the tumor center that had been accurately marked [representative specimen (RS) method]. In this ancillary study, we examined if the RS method was comparable to the conventional total specimen (TS) method, which is widely employed in Japan, to identify the pCR group showing excellent prognosis.
METHODS: We obtained long-term follow-up data of 103 patients enrolled in JCOG0306 trial. As histological therapeutic effect, pCR (ypT0 and ypT0/is) and quasi-pCR [QpCR, ypT0/is plus Grade 2b (only a few remaining invasive cancer cells)] were evaluated with RS and TS methods. Concordance of pCR between these two methods and associations of the pCR with prognosis were examined.
RESULTS: ypT0, ypT0/is, and QpCR were observed in 28 (27.2%), 39 (37.9%), and 45 (43.7%) patients with RS method, whereas these were 20 (19.4%), 25 (24.3%) and 40 (38.9%) with TS method, respectively. Between RS and TS methods, concordance proportions of ypT0 and ypTis were 92.2% and 86.4%, respectively. Risk of recurrence of ypT0/is group was lower than that of non-ypT0/is group (HR 0.408, 95% CI [0.175-0.946], P = 0.037) and risk of death of ypT0/is group was lower than that of non-ypT0/is group (HR 0.251, 95% CI [0.073-0.857], P = 0.027). The ypT0 and ypT0/is groups with RS method showed excellent prognosis similarly with those with TS method, and RS method was able to differentiate the OS and RFS between pCR and non-pCR than TS method significantly even if pCR was classified ypT0 or ypT0/is. With TS method, QpCR criteria stratified patients into the better and worse prognosis groupsmore clearly than pCR criteria of ypT0 or ypT0/is.
CONCLUSIONS: RS method was comparable to TS method for the evaluation of pCR in the patients who received NAC-RT to primary breast cancer provided the tumor center was accurately marked. As pCR criteria with RS method, ypT0/is appeared more appropriate than ypT0.

Early breast cancer (EBC) is cancer that has not spread beyond the breast or the axillary lymph nodes. The present retrospective cohort study investigated the efficacy and safety of the Pingxiao capsule (PXC), which contains a formula of traditional Chinese herbs, as adjuvant therapy in patients with EBC in a single Chinese academic medical center. Patients with EBC who had received surgery and chemotherapy were analyzed and divided into the PXC and non-PXC groups. Disease-free survival (DFS) time, overall survival (OS) time, demographic characteristics and adverse events were examined. Kaplan-Meier survival curves were used to compare the differences in DFS and OS. A total of 371 participants with a median age of 54 years were included in this study. The median DFS time of all patients was 101 months. The overall DFS rate was 72.1% in the PXC group compared with 63.6% in the non-PXC group. For women with hormone receptor-negative tumors, the DFS rate in the PXC group was significantly higher than that in the non-PXC group, irrespective of node status. Adjuvant treatment with PXC for ≥3 months was associated with significantly longer median DFS time compared with that in the non-PXC group. In addition, the incidence of neutropenia rated to be grade 2 or higher was significantly lower in the PXC group compared with that in the control group, and a markedly, but non-significantly, lower prevalence of nausea was observed in PXC group (0 vs. 4.1%). In conclusion, PXC as an adjuvant therapy along with chemotherapy is associated with prolonged DFS times in patients with EBC when compared with chemotherapy alone. The therapeutic value of combined PXC and systemic chemotherapy should be further elucidated by rigorous prospective clinical trials.

UNASSIGNED: Breast cancer incidence has overtaken that of cervical cancer among women in India according to the Globacon 2020 reports. Cancer management is also being streamlined at the Center and district levels, such that comprehensive integrated management is offered to cases to optimize the best results. In breast cancer, there are two modes of surgery namely Breast Conservation Surgery(BCS) and Modified Radical Mastectomy (MRM) now over 2 decades, with recommended Chemo radiation depending on the extent of the disease. HRQOL (Health-related Quality of Life) studies have been done in these groups of patients, due to their added relevance in terms of the loss of a vital organ like the breast. EORTC 30 and BR23 are standardized and detailed tools that have been seen to estimate QOL, keeping in mind a whole array of domains that are affected by the disease.
UNASSIGNED: To evaluate the \"Body Image\" and \"Quality of life\" (QOL) in operated breast cancer patients using BR -23 and EORTC - QLQ- questionnaire at 1month (after surgery) and then 3 to 4 months after surgery.
UNASSIGNED: This article attempts to draw a comparison among of EORTC30 and BR 23 scores calculated for 46 breast cancer patients operated during the pandemic time in one center and consenting to repeat the measures at pre-decided three time periods during the course of management.
UNASSIGNED: No significant differences are noted in the mean scores for EORTC 30 and BR23 for the two types of surgeries. Visit 1 scores for both modes of surgery are over 75 and by Visit 3 become less than 55 for EORTC. BR 23 (which measures the symptoms core to Breast cancer) at all 3 visits are between 45 to 55. Friedman\'s test shows that the scores are not significant for age groups, the number of living children, or lifestyle factors like alcohol or tobacco chewing, though quadratic graphs depict the distinct variations in the scores at the 3 times reinforcing the need for follow-up of mental health in these subjects at intervals. The study largely brings out a strong need for repeated follow-up and counseling at regular and short intervals, post-surgery in breast cancer patients. EORTC 30 and BR 23 tools are excellent to use to essay information on the mental health of patients with breast cancer.

UNASSIGNED: Evidence on variation in the information provided to mothers during antenatal and postnatal periods, its influence on breastfeeding awareness, and practice in urban and rural settings of India is scarce. The aim of the study was to assess the variation in mothers experience during pregnancy, delivery, and maternity period across settings and its influence on breastfeeding practices in the first six months of infants\' life.
UNASSIGNED: A community-based analytical cross-sectional study was carried out in urban and rural settings of Coimbatore, Tamil Nadu, among 800 mothers who had delivered between one year and six months before the date of the survey using simple random sampling.
UNASSIGNED: The proportion of mothers with less than four antenatal visits were significantly higher in urban areas (urban vs rural, 11.4% vs 6.2%). The mean scores for positive experiences during pregnancy (MD -0.99, 95% CI -1.31 to -0.69), experiences during birth and maternity period (MD -0.59, 95% CI -0.83 to -0.35) were significantly lower in the urban areas compared to rural areas. The prevalence of exclusive breastfeeding was 75.8% and 85.0% in urban and rural areas, respectively. Mothers not satisfied with experiences during delivery and maternity period (OR 1.69, 95% CI 1.18 to 2.42) and from urban areas (OR 1.81, 95% CI 1.27 to 2.59) were at significantly increased risk of nonexclusive breastfeeding.
UNASSIGNED: The present study showed that mothers from urban areas were not provided with appropriate, adequate, and timely information by the healthcare providers. It is the need of the hour to train and motivate healthcare providers regarding maternal awareness of antenatal, intranatal, and postnatal care practices including breastfeeding and infant care.

The effects of preterm birth, neonatal morbidities and environmental influences on infant sleep development is an important yet under-researched topic, with little known about normative sleep for infants born sick or preterm. The aim of this prospective, observational longitudinal study was to evaluate maternal perceptions and degree of bother with infant sleep behaviours and feeding outcomes across the first 9 months after discharge for sick/preterm infants cared for in the neonatal intensive care unit (NICU) and for healthy term-born infants. This paper reports outcomes for the sick/preterm cohort (I = 94) that were recruited from two NICUs in Perth, Western Australia. Total bother scores were on average 20.2% higher at 9 months than at two weeks post-discharge (p < 0.001). Increased night waking frequency, evening settling duration and crying duration were all positively associated with total bother scores. Maternal confidence scores were negatively associated with maternal bother scores; with each unit increase in confidence, maternal bother decreased by 8.5% (p < 0.001). Covariates such as birth gestation, breastfeeding status and multiple births were not associated with maternal bother. Families may benefit from additional support when experiencing increased night waking frequency and crying and settling durations in the first 9 months after discharge from NICU.

BACKGROUND: This prospective cohort study, conducted from pregnancy to six months postpartum and grounded in STROBE methodology, quantitatively explores the relationship between antenatal breastfeeding intentions and subsequent breastfeeding outcomes among high-risk pregnant women, compared to a low-risk pregnancy group.
METHODS: The study was conducted in one of the largest public hospitals in Attica that provides care to pregnant women, enrolling 380 participants divided into high-risk (n = 200) and low-risk (n = 180) cohorts. Data were collected over 20 months (starting from the end of May 2020 until January 2022), spanning from pregnancy to six months postpartum, via comprehensive questionnaires.
RESULTS: Statistical analysis revealed a pronounced correlation between prenatal breastfeeding intentions and actual breastfeeding behaviors across both groups. Specifically, 81.1% of women in the high-risk group and 82.5% in the low-risk group expressed intentions of exclusively breastfeeding during pregnancy. By six months postpartum, 54.9% of the high-risk and 64.3% of the low-risk pregnancy group managed to sustain breastfeeding. Extended antenatal hospitalization emerged as a statistically significant factor (p = 0.045) negatively impacting exclusive breastfeeding intentions among high-risk pregnancies.
CONCLUSIONS: The findings illuminate the critical influence of antenatal intentions on breastfeeding outcomes, particularly among high-risk pregnancies. Moreover, the study identifies the detrimental effect of prolonged hospital stays on breastfeeding aspirations. These insights underscore the necessity for nuanced, supportive interventions aimed at bolstering breastfeeding rates, thereby advancing maternal and neonatal health objectives aligned with World Health Organization recommendations.

BACKGROUND: Serum bone turnover markers might play a role in the prediction of the development of bone metastases in breast cancer (BC) patients. We conducted a retrospective cohort study to address the association of serum bone turnover markers with oncologic outcomes.
METHODS: We included 80 women with BC, who were operated on at the Department of Gynecology, Obstetrics and Reproductive Medicine, Homburg/Saar, Germany. Serum samples were obtained prior to surgery and were used for estimation of the concentration of tumor and bone turnover markers using enzyme-linked immunosorbent assay (ELISA) and radioimmunoassay (RIA).
RESULTS: At baseline, pyridinoline cross-linked carboxy-terminal telopeptide of type-1 collagen (ICTP) concentrations were higher in nodal positive vs. negative tumors (Mann-Whitney test p = 0.04). After a median follow-up of 79.4 months, 17 patients developed metastases, with 9 demonstrating, among other organs, osseous metastases. ICTP demonstrated the best area under the curve in the predection of osseous metastases in our cohort (AUC = 0.740, DeLong Test p = 0.005). Univariable Cox proportional hazard models failed to demonstrate significant associations between serum bone turnover markers and oncologic outcomes (progression-free survival, overall survival).
CONCLUSIONS: Serum bone turnover markers (e.g., ICTP) were able to predict the development of osseous metastases but were not associated with oncologic outcomes. Further investigation and validation are required for the use of such markers in clinical practice.

Nitric oxide (NO) in human milk may have important functions in lactation and infant health. This longitudinal pilot cohort study investigated the total nitrite and nitrate (NOx) concentration in human milk and maternal saliva during the first 60 days postpartum. Additionally, we explored the association between selected breastfeeding variables and milk and saliva NOx concentration. Human milk and maternal saliva samples were collected on days 2, 5, 14, 30, and 60 postpartum and analyzed for NOx concentration. Breastfeeding data were collected through self-assessed questions. Data analyses were performed using mixed models. The concentration of NOx in milk was significantly higher during the first 30 days compared to day 60, and there was a positive association between milk and saliva NOx concentrations throughout the entire study period. In absolute numbers, partially breastfeeding mothers had a lower concentration of NOx in milk on day 2 compared to exclusively breastfeeding mothers (8 vs. 15.1 μM, respectively). Partially breastfeeding mothers reported a later start of secretory activation and fewer mothers in this group started breastfeeding within the first hour after birth. Due to the small numbers, these differences could not be statistically evaluated. Further research is warranted to elucidate the role of NO in lactation success and breastfeeding outcomes.

OBJECTIVE: Breast cancer treatment may interfere with work ability. Previous return-to-work studies have often focused on participants who were invited to participate after treatment completion. Participation varied, resulting in potential selection bias. This is a health-record-based study evaluating data completeness, both at baseline and one year after diagnosis. Correlations between baseline variables and return to work were also analyzed.
METHODS: This is a retrospective review of 150 relapse-free survivors treated in Nordland county between 2019 and 2022 (all-comers managed with different types of systemic treatment and surgery). Work status was assessed in the regional electronic patient record (EPR). A 65-years age cut-off was employed to define two subgroups.
RESULTS: At diagnosis, occupational status was assessable in all 150 patients. Almost all patients older than 65 years of age were retired (79%) or on disability pension for previously diagnosed conditions (19%). Data completeness one year after diagnosis was imperfect, because the EPR did not contain required information in 19 survivors. The majority of those ≤65 years of age at diagnosis returned to work. Only 14 of 88 patients (16%) did not return to work. Postoperative nodal stage was the only significant predictive factor. Those with pN1-3 had a lower return rate (68%) than their counterparts with lower nodal stage.
CONCLUSIONS: This pilot study highlights the utility and limitations of EPR-based research in a rural Norwegian setting, emphasizing the need for comprehensive, individualized interventions to support breast cancer survivors in returning to work. The findings underscore the importance of considering diverse sociodemographic and clinical factors, as well as the potential benefits of long-term, population-based studies to address these complex challenges.