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Results
PMC10349515
Patient baseline characteristics
breast cancer
MPBC, BREAST CANCER
A total of 1412 older women with MpBC were included in this study. Patients were randomly divided into a training set (Clinicopathological characteristics of older women with metaplastic breast cancer
PMC10349515
Prognostic factors of survival
tumor, T stage, breast cancer
MPBC, TUMOR, BREAST CANCER
In the training set, the proportional sub-distribution hazard model was used to analyze the risk factors of CSM and OCM. The results showed that age, T stage, N stage, M stage, tumor size, surgery and radiotherapy were risk factors for CSM. In addition, age is a risk factor for OCM in older women with MpBC (Table The p...
PMC10349515
Development of the competitive risk model
MPBC
Based on the proportional sub-distribution hazard model analysis results, we incorporated risk factors affecting CSM in patients. We established a competitive risk model to predict 1-, 3-, and 5-year cancer-specific survival in older women with MpBC. As shown in Fig. Competitive risk model nomogram for predicting the 1...
PMC10349515
Validation of the competitive risk model
MPBC
We used a series of validation methods to validate the accuracy and discrimination of the model. The C-index of the model was 0.792 ( 95% CI: 0.763–0.821) in the training set and 0.744 ( 95% CI: 0.691–0.797) in the validation set. The calibration curves in the training and validation sets showed that the model’s predic...
PMC10349515
Clinical application
MPBC
We used DCA to validate the practical clinical value of the model. The results showed that the prediction model showed good practical value in predicting 1-, 3-, and 5-year survival. And the predictive ability of the prediction model is better than the traditional TNM staging system (Fig. DCA of competitive risk model ...
PMC10349515
Discussion
tumor, T stage, comorbidity, breast cancer
MPBC, TUMOR, LYMPH NODE METASTASIS, BREAST CANCER
MpBC is mainly composed of mesenchymal histological components and epithelial cells, a rare breast cancer type [Older breast cancer patients are a particular group. Compared with young women, they have different physiology, tumor biological behaviour and social dynamics [In this study, we reported the clinicopathologic...
PMC10349515
Conclusion
death, tumor
MPBC, TUMOR
This study explored the competitive risk factors for cancer-specific death in older women with MpBC. Age, T stage, N stage, M stage, tumor size, surgery and radiotherapy were risk factors for cancer-specific death in older patients with MpBC. Based on these risk factors, we developed a competitive risk model to predict...
PMC10349515
Acknowledgements
Not applicable.
PMC10349515
Authors’ contributions
JT, DZ, and XP contributed to the conception and design. DZ and JT collected and analyzed the data. DZ and JT drew the figures and tables. JT and DZ wrote the draft. XP and JT contributed to manuscript writing and revision. All authors approved the final manuscript.
PMC10349515
Funding
Not applicable.
PMC10349515
Availability of data and materials
The data analyzed in this study is available at
PMC10349515
Declarations
PMC10349515
Ethics approval and consent to participate
The data of this study is obtained from the SEER database. The patients’ data is public and anonymous, so this study does not require ethical approval and informed consent.
PMC10349515
Consent for publication
Not applicable.
PMC10349515
Competing interests
The authors declare no competing interests.
PMC10349515
References
PMC10349515
PURPOSE:
toxicity
ADVANCED CANCER
The time spent in pursuing treatments for advanced cancer can be substantial. We have previously proposed a pragmatic and patient-centered metric of these time costs—which we term time toxicity—as any day with physical health care system contact. This includes outpatient visits (eg, bloodwork, scans, etc), emergency de...
PMC10337749
METHODS:
Cancer
SECONDARY, COLORECTAL CANCER, CANCER
We conducted a secondary analysis of the Canadian Cancer Trials Group CO.17 RCT that evaluated weekly cetuximab infusions versus supportive care alone in 572 patients with advanced colorectal cancer. Initial results reported a 6-week improvement in median overall survival (OS) with cetuximab (6.1
PMC10337749
RESULTS:
In the overall population, median time toxic days were higher in the cetuximab arm (28
PMC10337749
CONCLUSION:
toxicity
SECONDARY
This proof-of-concept feasibility study demonstrates that measures of time toxicity can be extracted through secondary analyses of RCTs. In CO.17, despite an overall OS benefit with cetuximab, home days were statistically similar across arms. Such data can supplement traditional survival end points in RCTs. Further wor...
PMC10337749
INTRODUCTION
toxicity
ONCOLOGY, ADVANCED CANCER
Despite progress over the past few decades, most individual treatments for advanced cancer are associated with modest survival benefits (often < 2 months as median).We have previously extracted and compared the time toxicity in clinical trials using trial publications and protocols.Clinical trials, the gold standard to...
PMC10337749
METHODS
PMC10337749
Study Background, Procedures, and Efficacy/Safety Data
Cancer
SECONDARY, CANCER
We conducted a secondary analysis of the Canadian Cancer Trials Group CO.17 open-label RCT (ClinicalTrials.gov identifier: A total of 572 patients were randomly assigned. Initial results published in 2007 reported a 6-week improvement in median OS with cetuximab (6.1 months
PMC10337749
Measure of Time Toxicity
toxicity, toxicities
EVENTS, INFUSION REACTION
As previously described, we considered any day with physical health care system contact as a time toxic day.We calculated patient-level time toxicity (days with physical health care system contact) by analyzing treatment and follow-up forms and resource utilization assessment forms. The treatment and follow-up forms li...
PMC10337749
Statistical Analysis
We compared medians of time measures (time toxic days, home days, and proportion of home days alive) across arms by a Wilcoxon test and stratified results by
PMC10337749
RESULTS
toxicity, Tumor, Toxicity
ONCOLOGY, TUMOR
All trial participants (n = 572) had data on time toxicity available and were included in the current analyses. The median age was 63 years, 64% of participants were men, and 77% had an Eastern Cooperative Oncology Group performance status of 0-1. Baseline characteristics were balanced between arms, and detailed data a...
PMC10337749
DISCUSSION
toxicity
DISEASE, SECONDARY
In this secondary analysis of the CO.17 trial, we demonstrate that a measure of patient-level time toxicity can be successfully extracted. In CO.17, despite a statistically significant OS benefit with cetuximab in the overall study population, the number of home days was similar across arms and patients receiving cetux...
PMC10337749
ACKNOWLEDGMENT
We thank the participants in the study for volunteering.
PMC10337749
PRIOR PRESENTATION
We presented this work in abstract form at the 2022 ASCO Quality Care Symposium held in Chicago, IL (and virtually), September 30-October 1, 2022.
PMC10337749
SUPPORT
Colorectal Cancer, Cancer
COLORECTAL CANCER, CANCER
Supported by the Canadian Cancer Society (Grant No. 707213). Arjun Gupta is supported by a grant from the Minnesota Colorectal Cancer Research Foundation.
PMC10337749
AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
PMC10337749
APPENDIX
Toxicity
Details of Unplanned Time Toxicity in CO.17
PMC10337749
REFERENCES
PMC10337749
Abstract
PMC10278496
Background
primary breast cancer
There has been steadily increasing use of bilateral mastectomy (BMX) in the treatment of primary breast cancer (BC). In this study, we utilized functional magnetic resonance imaging (fMRI) to examine the influence of emotion regulation on the decision of newly diagnosed BC patients to choose BMX rather than non‐BMX tre...
PMC10278496
Methods
We recruited 123 women with unilateral BC, 61 of whom received BMX and 62 of whom received non‐BMX treatments, and 39 healthy controls. While participants were in the fMRI scanner, we showed them BC‐related and non‐BC‐negative images. In one condition, they were instructed to watch the images naturally. In another, the...
PMC10278496
Results
With non‐BC‐negative images as the baseline, BC patients showed greater self‐reported reactivity and neural reactivity to BC‐related images in brain regions associated with self‐reflection than did controls. Among the BC patients, the BMX group showed weaker activation in prefrontal emotion regulation brain regions dur...
PMC10278496
Conclusions
anxiety
BC patients are understandably emotionally hyper‐reactive to BC‐related stimuli and those who ultimately received BMX experience more difficulty in regulating BC‐related negative emotion than non‐BMX BC patients. These findings offer neuropsychological evidence that difficulty in managing anxiety related to the possibi...
PMC10278496
Trial Registration
NCT03050463.
PMC10278496
INTRODUCTION
primary breast cancer, anxiety
SURGICAL COMPLICATIONS, TREATMENT SIDE EFFECTS
While the use of unilateral mastectomies in the treatment of primary breast cancer (BC) has decreased, there has been steadily increasing use of bilateral mastectomy (BMX)BMX is an elective procedure for a unilateral BC, because it involves more surgery than is required for treatment. Given that BMX may have detrimenta...
PMC10278496
METHODS
PMC10278496
Participants
cancers, Stanford Cancer, cancer, substance/alcohol, psychosis, neurologic disease, bipolar disorder
OVARIAN CANCER, CANCERS, BREAST CANCER, CANCER, RECRUITMENT, HEARING IMPAIRMENT
We recruited a patient sample of 123 women diagnosed with BC within the preceding 12 months (mean 4.9 months; SD 3.5) with stage 0‐III unilateral breast cancer. We identified 33% of potential participants from Stanford Cancer Center records, 26% from the Army of Women website, 26% from social media, and the remaining 1...
PMC10278496
Emotion regulation task
During the task, participants viewed a series of pictures and were instructed to either respond naturally (“WATCH” condition) or to regulate their emotional response (“RETHINK” condition). Specifically, following the “WATCH” cue, they were instructed to look at and respond naturally to the picture without attempting to...
PMC10278496
Data analysis
The study is preregistered on the Open Science Framework, and its detail can be found in the wiki pages of each of the components (
PMC10278496
In the first‐level analysis, individual functional runs were modeled by a GLM with regressors representing the conditions including neutral‐watch, IAPS‐watch, BC‐watch, IAPS‐rethink picture, and BC‐rethink pictures (convolved with a double‐gamma function), and nuisance regressors (Data 
PMC10278496
Self‐report data
The self‐report negativity rating data of each participant were averaged across trials for each trial type. Following the preregistered analysis above (more details in Data 
PMC10278496
RESULTS
PMC10278496
Sample characteristics
SD, breast cancer
POSITIVE, BREAST CANCER
The sample characteristics, including demographics, are presented in Table Sample characteristics. Data are presented in a format of Mean ± SD or number (percentage).Tumor status of breast cancer participants.Positive for a pathogenic variant.
PMC10278496
Mastectomies
Forty‐six (75.4%) of participants with BMX had their BMXs before their fMRI assessments (median of 173 days, interquartile range (IQR) 119.25, 252.5); and nine (14.5%) of non‐BMX participants had their unilateral mastectomies before their fMRI assessments (median of 84 days, IQR 34, 177) (Table 
PMC10278496
Chemotherapy
Fifteen (24.6%) of participants with BMX finished chemotherapy before their fMRI assessments (median of 128 days before the fMRI, IQR 69.5, 173.5). Seven (11.3%) of non‐BMX participants finished chemotherapy before their fMRI assessments (median of 121 days before the fMRI, IQR 1126.5). Six (9.8%) of participants with ...
PMC10278496
Emotion regulation
PMC10278496
A BMX versus non‐BMX group comparison revealed that, for the BC‐IAPS differential regulation, the non‐BMX recipients showed greater activation in dmPFC (clusterwise Group comparison between BMX and non‐BMX BC patients in the neural BC‐IAPS differential regulation. (A) Group comparison map of non‐BMX > BMX. The yellow r...
PMC10278496
Self‐report data
We compared emotion regulation between controls and BC patients and between BMX recipients and non‐BMX recipients (Figure 
PMC10278496
Emotional reactivity
PMC10278496
A patient‐control group comparison revealed that, for the BC‐IAPS differential reactivity (Figure Group comparison between BC patients and controls in the neural BC‐IAPS differential reactivity. (A) Group comparison map of BC patients > controls. Yellow regions indicate where BC patients had greater activation for the ...
PMC10278496
Self‐report data
As expected and consistent with the fMRI result, BC patients reported more similar emotional reactivity to BC‐related and general emotionally negative images (IAPS) than did controls,
PMC10278496
DISCUSSION
The women who ultimately received BMX showed less activation in prefrontal brain regions that are associated with emotion regulation than those who received non‐BMX surgeries. Particularly, the non‐BMX group showed greater activation than the BMX group in the dmPFC and dlPFC during the application of reappraisal to reg...
PMC10278496
Limitations & future directions
anxiety
SECONDARY, BREAST CANCER
There are several limitations to the study. First, some of our BC participants underwent the fMRI assessment after undergoing their surgical treatment. Although our secondary analysis showed that including surgery timing as a covariate did not change the main finding, future studies would benefit from assessing emotion...
PMC10278496
CONCLUSIONS
cancer, anxiety, breast cancer
CANCER, BREAST CANCER
Employing an fMRI experiment, we found that BC patients experienced greater negative emotion in response to BC‐related stimuli than their healthy counterparts. More importantly, those who chose BMX had less activation in prefrontal regions while regulating BC‐related negative emotion than did those who chose more conse...
PMC10278496
AUTHOR CONTRIBUTIONS
PMC10278496
CONFLICT OF INTEREST STATEMENT
The authors declare no potential conflicts of interest.
PMC10278496
Supporting information
Data S1. Click here for additional data file.
PMC10278496
ACKNOWLEDGMENTS
Cancer
RECRUITMENT, CANCER
This work was supported by the National Cancer Institute (U01CA197282) and the National Center for Advancing Translational Science (NIH‐NCATS‐CTSA grant # 5UL1TR003142), National Institutes of Health. We thank our research participants for their time, wisdom, and willingness to participate, and the Dr. Susan Love Resea...
PMC10278496
DATA AVAILABILITY STATEMENT
We share the neural and self‐report data on the Open Science Framework (
PMC10278496
REFERENCES
PMC10278496
Background
cancer, disability, anxiety
CANCER
The use of graphic novels is a trending topic in health communication as a new form of visual storytelling which explores narratives of health care, cancer, healing, and disability. The objective of the present study was to evaluate - for the first time in the literature - the effect of graphic novels in reducing the ...
PMC10635625
Material and Methods
Depression
DISORDERS
This open-label randomized clinical trial comprised 50 patients with a clinical suspicion of oral potentially malignant disorders. Twenty-five patients were randomly allocated to the test group, and a colourful graphic novel was provided. Subsequently, the Beck Depression Inventory and the Depression Anxiety Stress Sc...
PMC10635625
Results
No statistically significant difference was observed between the test and control groups for the variables regarding the demographic data (
PMC10635625
Introduction
orofacial disorders, anxiety
DISEASE
Oral medicine is the main speciality, together with maxillofacial surgery, dealing with severe and on occasions life-threatening orofacial disorders or outcomes; it, therefore, elicits states of fear and anxiety in patients (Patients with a specific phobia often experience intense and immediate fear and/or anxiety prio...
PMC10635625
Material and Methods
Anxiety, anxiety, anhedonia, depression, subjects3, hyperactivity, P., OPMD, depressive, agitation, Post-biopsy, cognitive deficits, cognitive and motivational psychomotor, Depression, irritability
DISORDER, MAY, CAVITY
- Study designThis open-label randomized clinical trial (RCT) was approved by the local Institutional Ethics Committee of the P. Giaccone University Hospital of Palermo, Italy (approval #1/2022). The study was conducted according to the principles of the Declaration of Helsinki regarding experimentation involving human...
PMC10635625
Results
The descriptive statistics relating to the patients’ socio-demographic and physical characteristics are displayed in
PMC10635625
Descriptive statistics relating to patient socio-demographic and physical characteristics.
PMC10635625
Summary statistics of the BDI and DASS-21 scores.
Boxplot describing the distribution and summary statistics of BDI and DASS-21 scores for the control and test groups.The results are shown in Each question of the BDI and DASS-21 questionnaires was also tested for differences between treatment groups. Thus far, a significant difference in BDI and DASS-21 scores has be...
PMC10635625
Mean and standard deviation, and Mann-Whitney U Test for each BDI question and total score.
PMC10635625
Mean and standard deviation, and Mann-Whitney U Test for each DASS-21 question and total score.
PMC10635625
Discussion
anger, anxiety, cancer, panic, OPMD, psychological distress, mental disorders, depression
CANCER, EVENT, SAID, BLIND, EVENTS
This study has proposed for the first time in the field of dentistry the use of a graphic novel, which is aimed at adults, that is, patients who are waiting for an incisional biopsy to ascertain the presence of OPMD. A further component of the study is to assesses its efficacy in reducing patient anxiety, as measured b...
PMC10635625
Conclusions
P., anxiety
SAID, DISEASES
Comics can be said to communicate concepts by telling stories with relevant characters, settings, and situations; they are also accessible, even for patients with different educational levels. Graphic novels are a recently-created, original and creative way of informing patients about diseases or medical procedures. In...
PMC10635625
Background
cancer
CANCER, DYSFUNCTION, COMPLICATIONS
Patients undergoing hematopoietic cell transplantation (HCT) are at high risk of chronic health complications, including frailty and physical dysfunction. Conventional exercise programs have been shown to improve frailty in other cancer populations, but these have largely been based out of rehabilitation facilities tha...
PMC10150529
Methods
We conducted a pilot randomized trial to assess the feasibility of an 8-week telehealth exercise intervention in 20 pre-frail or frail HCT survivors. Participants were randomized to either a telehealth exercise (N = 10) or delayed control (N = 10). We administered a remote physical function assessment at baseline, foll...
PMC10150529
Results
fatigue
The mean [standard deviation] age at study enrollment was 64.7 [9.1] years old. Twelve had undergone allogenic and 8 had undergone autologous HCT at an average of 17 years from study enrollment. Both feasibility criteria were achieved. Nineteen patients (95%) completed all remote study outcome assessments at baseline a...
PMC10150529
Conclusion
cancer
CANCER
Implementing an 8-week telehealth exercise intervention for long-term HCT survivors was feasible. Our findings set the stage for innovative delivery of supervised exercise intervention that reduces the burden of frailty in HCT survivors as well as other at-risk cancer survivors.
PMC10150529
Trial registration
The protocol and informed consent were approved by the institutional IRB (IRB#20731) and registered (ClinicalTrials.gov NCT04968119; date of registration: 20/07/2021).
PMC10150529
Keywords
PMC10150529
Background
cancer
CANCER, HEMATOLOGICAL MALIGNANCIES
Advances in hematopoietic cell transplantation (HCT) have led to marked improvements in the survival of patients with hematological malignancies [Exercise is an established strategy to decrease the risk of frailty in conventionally-treated cancer patients [In the general population, there is increased recognition about...
PMC10150529
Methods and analysis
hematologic malignant diseases
BLOOD, APLASTIC ANEMIA
Study participants were identified from the Blood or Marrow Transplant Survivor Study (BMTSS), which is a retrospective cohort study of patients who received HCT at City of Hope (COH), University of Minnesota, or University of Alabama at Birmingham (UAB) for hematologic malignant diseases, or severe aplastic anemia, an...
PMC10150529
Study procedures
CVD, BLOOD, CARDIOVASCULAR DISEASE
Information on frailty status was obtained from questionnaires completed by BMTSS participants [ Study schemaAbbreviations: BMTSS: Blood or Marrow Transplant Survivor Study; COH: City of Hope; CVD: Cardiovascular disease, UAB: University of Alabama Birmingham
PMC10150529
Remote assessments of frailty and physical function
hand dynamometer, fatigue
SECONDARY, CHRONIC ILLNESS
The primary endpoint was feasibility as determined by 1) > 70% of participants completing all remote physical functional assessments, and 2) > 70% of participants in the exercise group completing > 70% (17/24) of the prescribed telehealth exercise sessions. Study participants were mailed a set of 3 gait sensors (for hi...
PMC10150529
Exercise intervention
The 8-week telehealth exercise intervention (> 30 min per session; 3 sessions/week for 8 weeks) began within 3 weeks of baseline study assessments. Exercise programs were individualized and prescribed based on participants’ baseline assessment, physical limitations, and exercise preferences. Exercise intensity progress...
PMC10150529
Sample size and statistical analysis
The sample size was evaluated using the statistical recommendation for the standardized effect size of 0.8 in 10 participants each arm [
PMC10150529
Results
MM, CML, AML, MDS, SD, HL, Hodgkin’s lymphoma, Non-Hodgkin’s lymphoma, ALL, NHL
ACUTE LYMPHOCYTIC LEUKEMIA, CLL, ACUTE MYELOID LEUKEMIA, AML, CHRONIC MYELOID LEUKEMIA, MULTIPLE MYELOMA, CML, MYELODYSPLASTIC SYNDROMES, CHRONIC LYMPHOCYTIC LEUKEMIA, NHL, BLOOD
There were 137 self-reported prefrail/frail HCT survivors identified in the BMTSS cohort. Of the 75 self-reported prefrail/frail survivors who were successfully contacted, 17 refused the referral, and 16 were deemed ineligible; Fig.  CONSORT diagram of telehealth exercise interventionAbbreviations: BMTSS: Blood or Marr...
PMC10150529
Study assessments and adherence to prescribed exercise sessions
ADVERSE EVENTS
Nineteen patients (95%) successfully completed all remote physical function assessments at pre- and post-intervention, and nine participants (90%) in the exercise group completed > 70% prescribed exercise sessions. The mean adherence to the 24 prescribed sessions for 10 patients in the exercise group was 94.2% (226/240...
PMC10150529
Physical function outcomes
Frailty
Table  Frailty Characteristics Telehealth ExerciseDelayed Control10.0 (2.0)8.2 (2.4)10.4 (2.2)7.8 (3.8)0.630.69 Telehealth ExerciseDelayed Control0.86 (0.22)0.78 (0.27)0.98 (0.25)0.75 (0.23) 0.11 Telehealth ExerciseDelayed Control0.63 (0.30)0.68 (0.24)0.79 (0.24)0.64 (0.27) 0.13 Telehealth ExerciseDelayed Control28.7 (...
PMC10150529
Gait speed
Four-meter gait speed was significantly improved (0.86 ± 0.22 to 0.98 ± 0.25 m/s; P = 0.004) in the exercise group, while there was no significant change in the delayed control group (0.78 ± 0.27 to 0.75 ± 0.23 m/s, P = 0.11). However, there was no group x time interaction between the two groups before and after 8 week...
PMC10150529
Handgrip strength
There was no group x time interaction between the two groups before and after 8 weeks. Overall, there was a slight improvement in dominant arm handgrip strength in the exercise group, but it did not reach statistical significance (28.7 ± 11.7 to 30.3 ± 14.0 kg; P = 0.15). However, 5 out of 10 participants increased > 1...
PMC10150529
SPPB
At baseline, mean SPPB score was 10.0 ± 2.0 for the exercise group and 8.2 ± 2.4 for the delayed control group. There was no significant mean difference between the two groups before and after 8 weeks. Of note, among 4 participants who had an SPPB score < 10 at baseline in the exercise group, 3 participants increased S...
PMC10150529
Fatigue
There was no significant mean difference between the two groups before and after 8 weeks in the exercise (39.3 ± 6.6 to 40.7 ± 5.6) and control (31.7 ± 11.3 to 31.3 ± 9.9) groups; P > 0.05.
PMC10150529
Acknowledgements
Not applicable.
PMC10150529
Author Contribution
Conceptualization (All authors); Methodology (KL, JS, LL, ER, LH, MSS, RN, SJF, FLW, SB, SA); Writing Original Draft (all authors); Writing Review & Editing (All authors); Resources (KL, SB, SA); Supervision (KL). All authors read and approved the final manuscript.
PMC10150529
Funding
Leukemia Lymphoma, Cancer
CANCER
This study was supported by the Conrad N. Hilton Foundation Pilot Award; the National Cancer Institute (R01 CA078938, U01 CA213140); the Leukemia Lymphoma Society (R6502-16).
PMC10150529