BACKGROUND:Women with metastatic breast cancer (mBC) are living longer than in prior decades due to advances in treatment. However, risk of cardiovascular disease (CVD) remains understudied in this patient population. METHODS:We identified 33,239 women diagnosed with de novo mBC between 2000 and 2020 (aged 20-84, survived ≥1 year) from 17 Surveillance, Epidemiology, and End Results Program registries. We estimated standardized mortality ratios (SMRs) and cumulative incidence, accounting for competing risks, for CVD mortality overall and by key characteristics. RESULTS:Over 3.1 median years of follow-up, 724 women with mBC died of CVD (554 heart disease; 127 cerebrovascular disease; 43 other CVD). Overall, women with mBC had an elevated risk of CVD mortality compared to women in the general population after accounting for age, year, and race/ethnicity (SMR=1.45, 95 % CI=1.34-1.55). SMRs for women with mBC were further elevated among those aged < 50 years at diagnosis (3.48, 95 % CI=2.67-4.46), non-Hispanic Asian American and Pacific Islander and Black women (2.18, 95 % CI=1.60-2.90; 2.14, 95 % CI=1.79-2.52, respectively), more recently diagnosed women (1.57, 95 % CI=1.32-1.86), and those with triple negative tumors (2.51, 95 % CI=1.71-3.57). Among women aged < 50 years, SMRs were further elevated among those recently diagnosed (5.44, 95 % CI=2.90-9.31) and within the first five years after diagnosis (5.02, 95 % CI=3.63-6.76). Approximately 1 in 60 women died from CVD within five years following their mBC diagnosis (cumulative incidence: 1.73 %, 95 % CI=1.58-1.88 %) with the highest cumulative incidence among those aged 50 years or older (2.13 %, 95 % CI=1.95-2.33 %). CONCLUSIONS:Women with mBC have significantly elevated CVD mortality and further research is warranted to address this heightened risk.

Data from wearable devices have the potential to transform personal health, clinical care and biomedical research. The purpose of this study was to quantify early adoption and short-term engagement with consumer-based wearable devices connected to an EHR outside of a study setting. We analyzed device data from 843 patients (mean age 48 years, 41% female) who connected their devices to the electronic health record (EHR) of a large academic medical center in the US between 2023 and 2025. The most popular connected consumer devices were the Apple Watch (56%), followed by the Oura ring (7.7%), and the Fitbit activity tracker (4.6%). Using survival analysis, we found that 692 (82%) patients remained engaged at three months, with actively connected devices. Cox regression models identified statistically significant differences in time to disengagement based on gender and step count. Regular and updated analyses of device adoption and engagement patterns are therefore warranted to increase the value of these devices and their data for the purpose of health monitoring and improvement.

Breast cancer is the most diagnosed cancer among women in the United States. While rates of advanced-stage breast cancer have declined overall, incidence is rising among Korean American women. Advanced-stage breast cancer is more frequent among Korean women compared to other Asian ethnic groups, largely attributed to low adherence to breast cancer screening. Church settings offer important opportunities for education as most Korean American women over age 50 regularly attend church services. The objective of this trial is to evaluate the efficacy of a culturally tailored intervention Faith in Action! on breast cancer screening adherence rates among Korean American women. A parallel cluster randomized trial with staggered roll-out was designed to evaluate the efficacy of the Faith in Action! intervention, a church-based small group education and lay health navigator program, delivered by trained church members, on breast cancer screening among Korean American women (NCT05298605). The study was designed and will be conducted in partnership with our center’s Community Outreach and Engagement (COE), which formed a Community Advisory Board. Twenty-four total Korean churches in Los Angeles will be randomized within blocks of 8 churches to either intervention or waitlist control conditions in a 1:1 ratio. Using a train-the-trainer approach, lay navigators from the Korean Church community nominated by church leadership will be trained by COE and certified to deliver the Faith in Action! intervention to study participants over a 6-month program period. Participants at churches randomized to the waitlist control group receive an educational presentation on physical activity and nutrition and, after 6-month follow-up, are invited to receive the Faith in Action! intervention. Eligible participants include women, ages 45–75 years, who attend a participating church in Los Angeles County, do not have a breast cancer diagnosis, and did not receive a mammogram in the last 2 years. The primary outcome is adherence to breast cancer screening guidelines within 6 months from the end of the intervention. Secondary outcomes include adherence to breast cancer screening within 1 year and knowledge on breast cancer screening. This study addresses a current need for developing and testing culturally tailored interventions to increase breast cancer screening adherence among Korean American women. Leveraging faith-based organizations and delivering the intervention through trained lay health navigators, if found to be effective, has the potential to provide a scalable and sustainable strategy for increasing screening rates and ultimately improve health and well-being as well as reduce cancer-related disparities in this population. ClinicalTrials.gov NCT05298605. Registered on March 17, 2022.

5084 Background: Among patients with prostate cancer (PC), treatment with androgen deprivation therapy (ADT) is associated with reduced physical function, which can result in diminished quality of life and the occurrence of adverse medical events. The use of wearable activity monitors allows for remote monitoring of daily activity to potentially detect early functional decline and predict significant medical events such as hospitalization, serious adverse events, and premature death. This study evaluated whether wearable activity monitoring could serve as an early indicator of functional decline and impending adverse events in patients with PC undergoing ADT. Methods: PC patients receiving ADT at Cedars-Sinai and Durham VA who enrolled in the DigiPRO trial (NCT04575402) wore a Fitbit Charge over 12 weeks to track quantitative physical activity and sleep data for prediction of the occurrence of unexpected medical events (composite of hospitalization, premature death, or fall) and significant patient-reported physical function decline (> 5 NIH PROMIS T score points) within 6-months follow-up. Results: 40 patients were included in the analysis (median age 70, range 51-87, 37% Black and 63% White; 10% identified as Hispanic). On average, PC patients walked 5,189 steps/day, were sedentary 16 hours/day, and slept 5.8 hours/night. A clinically meaningful decline in daily steps (> 500 steps) within the first 3 months of initiating ADT was associated with higher odds of experiencing an unexpected medical event (hospitalization, death, fall) (OR = 3.03; 95% CI 1.6-5.9, p = 0.001 ) and clinically meaningful decline in patient-reported physical function (> 5 PROMIS T score points) occurring within 6 months from study completion (OR = 5.2, 95% CI; 1.3-11.7, p = 0.02 ). Conclusions: These findings suggest remote activity monitoring may serve as a novel early warning system to identify patients who are at increased risk of unexpected medical events and clinically meaningful physical function decline in PC patients undergoing ADT. Use of this early warning system could lead to targeted interventions in high-risk patients to reduce morbidity and perhaps even prolong survival in patients undergoing ADT. Clinical trial information: NCT04575402 .

Abstract Background: Breast cancer remains a leading cause of cancer mortality in the United States, yet screening rates are suboptimal among certain populations, particularly Korean Americans. Access-related barriers, language, and trust contribute to delayed diagnosis and persistent disparities in cancer outcomes. Faith-based organizations represent trusted, accessible settings for delivering health interventions. Through Community Outreach and Engagement (COE) partnerships, and guided by a community advisory sub-committee, we developed and adapted a culturally tailored intervention, Faith in Action!, which uses a train-the-trainer approach to prepare lay navigators and trusted church members to deliver the intervention and provide cancer education and screening navigation in faith-based settings. The objective of this study was to evaluate the efficacy of “Faith in Action!” on cancer screening adherence. Methods: A cluster randomized trial with staggered roll-out (NCT05298605) was conducted in 24 faith-based organizations randomized to either a faith-based breast cancer screening intervention or a wait-list control group. The intervention incorporated health education, community health advisor engagement, and facilitated access to cancer screening. Eligible participants were aged 45-75 years, attending participating Los Angeles County Korean churches, without a breast cancer diagnosis and not up to date with breast cancer screening at baseline. The primary outcome was guideline-concordant breast cancer screening within 6 months post-intervention. Secondary outcomes included intention to screen at 6 months and one yer, 1-year breast cancer screening adherence, and knowledge, assessed through standardized questionnaires. Results: A total of 235 women (median age 58 years) were enrolled across 3 cohorts of 8 churches (total 24 churches). Forty-five lay navigators were trained through the intervention. At 6-month follow-up, screening completion was higher in the intervention group compared with wait-list control (60.8% vs. 22.4%, p<0.0001). After adjustment for baseline characteristics and clustering, intervention group participants had statistically significant higher odds of receiving breast cancer screening compared to wait-list control (OR: 9.27, 95% CI 3.3-26.3). Significant improvements were also observed in intention to screen among intervention participants at 6 months (OR: 9.8, 95% CI 3.4-28.7). Retention was high, with 97% follow-up achieved at the primary 6-month time point among intervention participants. Conclusions: These findings suggest that Faith in Action! can increase breast cancer screening uptake among women who are not up to date on screening. Faith-based settings may offer a scalable, culturally acceptable cancer screening promotion strategy to reduce screening disparities among Korean women. Future research will evaluate the program’s long-term scalability, sustainability, and screening uptake in diverse faith settings and denominations and across other cancer types. Citation Format: Gillian Gresham, Zulfikarali Surani, Dong Hee Kim, Min Jung Sung, Marcio A. Diniz, Galen Cook-Wiens, Laurel Barosh, Michael Fine, Jane Fiegueiredo, Jeong Yup Lee, Alison K. Herrmann, Robert W. Haile. Evaluating a church-based navigation model to increase breast cancer screening uptake: Results from a cluster randomized trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2026; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2026 Apr 17-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2026;86(8_Suppl):Abstract nr LB214.

e17091 Background: Exercise is critical for the prevention of functional decline and maintaining overall health, especially among patients with prostate cancer (PC) undergoing androgen deprivation therapy (ADT). Despite the well-established benefits of exercise intervention, the most acceptable exercise programs for PC patients receiving ADT remain unclear. Thus, this qualitative study sought to understand patient perspectives regarding exercise preferences and barriers to inform tailoring of exercise interventions for this population. Methods: Patients undergoing ADT were recruited from two sites: a large academic medical center and a Veterans Affairs (VA) medical center and were enrolled in the DigiPRO trial (NCT04575402) which integrates 12 weeks of wearable activity monitors with patient-reported outcomes to model functional decline. As an optional sub-study, virtual semi-structured qualitative interviews were conducted with enrolled patients, exploring patient preferences for exercise interventions, perceptions of functional changes, and views on wearables using a semi-structured interview guide. Interview transcripts were analyzed using content analysis. Results: Among the 30 interviewed participants in the sub-study (Median age: 68 years, SD; 8.8), resistance and aerobic training guided by an instructor were favored, with preferences for small groups, one-on-one, or solo workouts in gym or outdoor settings. As participants reported ADT-related fatigue, muscle loss, and fluctuating energy levels, they emphasized the need for flexible pacing and recovery days, expressing the need for adaptable and personalized programming that accommodates treatment side effects. Patients reported that wearables enhanced their motivation to be active, noting that the self-monitoring encouraged exercise goal completion (such as meeting daily step count targets) and helped them counteract treatment-related lethargy. Reported additional benefits of the wearables included activity reminders, sleep and heart rate tracking, and guided breathing, which patients found useful for managing the side-effects of ADT. Conclusions: These findings support the integration of wearable activity monitors as a motivational tool to enhance adherence to future prescribed exercise regimens, improving physical function and survivorship among PC survivors on ADT. Given ADT-associated fluctuations in physical function, patient input also highlighted the benefits of instructor-guided exercise interventions, such as aerobic and resistance training, tailored to individual needs and energy levels. Clinical trial information: NCT04575402 .

Fasting combined with anti-cancer therapies improves tumor regression and survival in animals. Fasting sensitizes cancer cells to cytotoxic therapies while promoting stress resistance in healthy cells, a phenomenon known as differential stress resistance. Since prolonged water-only fasting is challenging, intermittent fasting has emerged as an attractive alternative. Here, we describe the protocol of a single-blind, randomized controlled trial testing whether time-restricted eating (TRE) can improve clinical, molecular, and behavioral outcomes in cancer patients. We will enroll 175 adults with newly diagnosed stage I-III human epidermal growth factor receptor 2-positive or triple-negative breast cancer or stage II-IV rectal cancer who are receiving neoadjuvant therapy. Patients will be randomized to early TRE (eTRE; ≤8-hour eating window early in the day) or to eat over a ≥12-hour window (control group) from around the start of treatment until surgery (typically 4-8 months). The primary outcomes are the pathologic complete response, the organ preservation rate, and patient-reported adverse events. Secondary outcomes include clinical response, tumor response, quality of life, and provider-reported adverse events. To test the differential stress resistance theory, we will measure the expression of proteins involved in cell growth, cell death, and stress resistance in tumor and adjacent normal tissue. Finally, we will determine the effects of eTRE on emotional, psychosocial, and lifestyle factors and how these factors influence adherence and clinical responsiveness. This trial will provide critical insight into whether intermittent fasting can potentially improve cancer outcomes, reduce toxicities from anti-cancer therapies, and enhance quality of life in cancer patients. The study is registered on ClinicalTrials.gov (NCT04722341).

Objective: Spiritual distress is common in those with metastatic cancer. We evaluated the sustained effects of an empirically anchored 6-week psychoeducation program, Growing Resilience And CouragE (GRACE), on spiritual well-being, quality of life, and psychosocial symptoms. Methods: Primary and secondary outcomes were assessed at baseline (T0), immediately after GRACE (T1), 1 month after GRACE (T2), and 6 months later (T3). Intervention and waitlist control groups (from the randomized clinical trial) were combined for this analysis. A generalized additive model for location, scale, and shape was used. Results: Data from 54 women with metastatic breast cancer who received GRACE were analyzed. All outcomes (spiritual well-being, quality of life, and psychosocial symptoms) significantly improved at T1, T2, and T3 compared to baseline (p < 0.001). Conclusion: GRACE is beneficial for the spiritual well-being, quality of life, and psychosocial well-being of women with metastatic breast cancer, and these benefits appear to be sustained at 6 months post-intervention.

In the original publication [...].

Supplementary Methods S1 provides a comprehensive statistical description of the two applied predictive survival models (PC Cox model and PC Cox BLUP model).

Supplementary Figure S6 (a) shows the actual eight PROs of patient 1 at two time points, baseline, and 6 months (shown by the black dotted line). This patient is also overweight at baseline (25 < BMI < 30). In the clinical data set, this patient discontinued treatment at 14 months, but this information was not used in the model. Supplementary Figure S6 (b) shows the estimated probability of treatment discontinuation for patient 1 anytime after 6 months but before 18 months. Supplementary Figure S6 (c) shows similar information for patient 2 who is also overweight. However, patient 2 completed treatment by 60 months. Supplementary Figure S6 (d) shows the estimated probability of treatment discontinuation for patient 2 anytime after 6 months but before 18 months.

Supplementary Figure S7 presents a screenshot of the web tool; the supplementary data provides instructions for utilizing the web-based treatment discontinuation predictive tool developed based on the predictive survival models.

e17090 Background: ADT, a standard treatment for prostate cancer (PC), is associated with significant side effects such as fatigue, muscle loss, weight gain, and mood changes, which can lead to physical function decline and poor quality of life. Wearable technology for continuous activity monitoring combined with routine patient-reported outcome (PRO) collection may provide a more complete and accurate picture of a patient’s treatment experience, offering valuable information for guiding symptom management. This study aimed to evaluate the feasibility and acceptability of remote patient monitoring with wearable technology and PROs in men diagnosed with PC undergoing ADT. Methods: Men diagnosed with PC undergoing ADT, recruited from two healthcare facilities as part of the DigiPRO trial (NCT04575402), wore an activity monitor (Fitbit Charge HR) continuously to monitor daily activity and sleep and completed monthly electronic PROs (NIH PROMIS and PRO-CTCAE) over a 12-week study period. Feasibility was defined as >60% of patients adhering to wearing the device and completing PROs at the 12-week primary study endpoint. Acceptability was also assessed through qualitative interviews among a subset of patients, gathering feedback on the usability and impact of the wearable devices. Additionally, a survey was conducted among clinicians with experience treating PC patients to assess their interest in accessing and using the wearable and PRO data. The proportion of patients adhering to wearing the devices and completing PROs at 12 weeks was calculated. Descriptive statistics were computed to summarize clinician survey responses, and inductive thematic analysis was applied to patient interview data. Results: All 40 PC participants (100%) (Median age: 70 years, range 51-87, 60% White/37% Black) consistently used the monitoring devices and 38 participants (95%) completed monthly PROs over the 12-week period. From the interviews, patients reported that the devices were easy to use and enjoyed wearing them to monitor their PA and sleep. Clinicians expressed overall support for accessing the device data, where 7/10 clinicians responded that they would access patient wearable activity data in the medical chart and believe EMR-integrated wearable activity data would help them better take care of patients. Conclusions: Our findings suggest that remote activity and PRO monitoring are feasible and acceptable for PC patients, with high device adherence, PRO completion, and perceived benefits of use observed by clinicians and patients. Clinicians and researchers should consider incorporating remote activity and PRO monitoring into future research studies. Clinical trial information: NCT04575402 .

Supplementary Table S3 provides information about the number of patients with missing adverse events at each timepoint for tamoxifen treatment.

Supplementary Figure S5 illustrates the estimated time-dependent ROC curves using the PCCox and PCCox BLUP models in the validation cohort for tamoxifen treatment. The area under the ROC curve (AUC) and its corresponding 95% confidence interval for the four sets of s and tau are embedded within the plots.

BACKGROUND:The PRO-CTCAE Measurement System was designed to enhance the quality of the standard toxicity evaluation in clinical trials. We developed a substudy within NRG-BR004, a phase III clinical trial in patients with newly documented HER2-positive metastatic breast cancer (MBC), to examine the added value and feasibility of frequent PRO-CTCAE data collection. METHODS:Patients were asked to complete 23 PRO-CTCAE items assessing 12 symptoms. Electronic PRO (ePRO) reporting was preferred; however, paper administration was allowed. The data on items assessed before treatment initiation, then weekly during Cycles 1-2 (12 weeks), are presented herein. Feasibility of frequent assessment with ePRO reporting was assessed using these data and was predefined as ≥25% of patients being compliant (submitted ≥75% of scheduled assessments). We also examined PRO-CTCAE and clinician-reported CTCAE data for key symptoms using maximum toxicity grade and the toxicity index (TI). RESULTS:Overall, 80% of patients (82 of 103) were compliant with expected weekly assessments (90% CI = 0.72 to 0.86). For all symptoms, the median maximum grade (TI value) of clinician-reported CTCAE was lower than the median maximum score (TI value) of patient-reported PRO-CTCAE. The differences in the data trend for weekly vs less frequent assessment were more apparent when data were evaluated using the TI vs the maximum score. CONCLUSIONS:Weekly assessments within the first two chemotherapy cycles were feasible in this trial of MBC patients. As expected, patients reported greater severity of symptoms than clinicians. Demonstrating the feasibility of frequent assessment could have implications for future research and clinical practice. CLINICALTRIALS.GOV:NCT03199885 (https://clinicaltrials.gov/study/NCT03199885).

Pancreatic and gastrointestinal cancers are associated with debility, frailty, and chemotherapy regiments with significant toxicity. Practical exercise guidelines to combat these ailments and optimize functional status are lacking. We present a model for exercise for these cancers based on the Dietz framework for rehabilitation in cancer. The Dietz framework for rehabilitation describes four phases of rehabilitation including preventative (prehabilitation), restorative, supportive, and palliative. We present practical guidelines for exercise at each phase. Prehabilitation seeks to optimize functional performance typically prior to surgical resection and may occur concurrently with neoadjuvant therapy. Restorative rehabilitation occurs following the development of a physical deficit such as after surgery and may utilize skilled therapies in the inpatient, subacute, outpatient, and home settings to address functional impairments. Supportive rehabilitation occurs during stable disease or remission and depends on the frequent monitoring of functional status and particularly the development of chemotherapy-induced neuropathy to ensure timely exercise interventions. Palliative rehabilitation occurs at the end stage of life and shifts to a focus on patient comfort and safety. Exercise is a critical component of treatment in cancer demonstrating numerous quality-of-life benefits. The customization of exercise recommendations to individual patients based on their functional status and phase in treatment is essential for safety and adherence.