Context. Patients with breast cancer taking adjuvant endocrine therapy (AET) experience significant symptoms impacting mood, quality of life (QOL), and AET adherence and satisfaction. Objectives. The aim of this study was to examine the extent to which coping ability and self-efficacy for symptom management moderate the relationships between patients' symptom distress and their mood, QOL, and AET adherence and satisfaction. Methods. As part of a randomized controlled trial, participants completed baseline measures including: sociodemographics, symptom distress (breast cancer prevention trial symptom checklist), coping skills (measure of current status), self-efficacy (self-efficacy for managing symptoms), anxiety and depression (hospital anxiety and depression scale), QOL (functional assessment of cancer therapy - general), AET adherence (medication adherence report scale), and AET satisfaction (cancer therapy satisfaction questionnaire). We conducted moderated regression analyses to examine whether coping and self-efficacy moderated the associations of symptom distress with baseline measures. Results. Coping skills moderated the associations of symptom distress with depression and QOL. Among those with lower coping, higher symptom distress was associated with worse depression symptoms (p=.04) and worse QOL (p < 0.001). Self-efficacy moderated the associations of symptom distress with depression symptoms and AET adherence and satisfaction. Among those with higher self-efficacy, higher symptom distress was associated with worse depression symptoms (p < 0.001), worse AET adherence (p < 0.001), and less AET satisfaction (p = 0.01). Conclusion. Coping skills may buffer the effect of AET symptom distress. Findings indicate the relationship between symptom distress and self-efficacy is more nuanced and requires further research to better understand. (c) 2023 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

PURPOSEIn patients with lung cancer, dyspnea is one of the most prevalent and disabling symptoms, for which effective treatments are lacking. We examined the efficacy of a nurse-led brief behavioral intervention to improve dyspnea in patients with advanced lung cancer.METHODSPatients with advanced lung cancer reporting at least moderate breathlessness (n = 247) were enrolled in a randomized trial of a nurse-led two-session intervention (focused on breathing techniques, postural positions, and fan therapy) versus usual care. At baseline and weeks 8 (primary end point), 16, and 24, participants completed measures of dyspnea (Modified Medical Research Council Dyspnea Scale [mMRCDS]; Cancer Dyspnoea Scale [CDS]), quality of life (Functional Assessment of Cancer Therapy-Lung [FACT-L]), psychological symptoms (Hospital Anxiety and Depression Scale), and activity level (Godin-Shephard Leisure Time Physical Activity Questionnaire). To examine intervention effects, we conducted analysis of covariance and longitudinal mixed effects models.RESULTSThe sample (Agemean = 66.15 years; 55.9% female) primarily included patients with advanced non-small cell lung cancer (85.4%). Compared with usual care, the intervention improved the primary outcome of patient-reported dyspnea on the mMRCDS (difference = -0.33 [95% CI, -0.61 to -0.05]) but not the CDS total score at 8 weeks. Intervention patients also reported less dyspnea on the CDS sense of discomfort subscale (difference = -0.59 [95% CI, -1.16 to -0.01]) and better functional well-being per the FACT-L (difference = 1.39 [95% CI, 0.18 to 2.59]) versus the control group. Study groups did not differ in overall quality of life, psychological symptoms, or activity level at 8 weeks or longitudinally over 24 weeks.CONCLUSIONFor patients with advanced lung cancer, a scalable behavioral intervention alleviated the intractable symptom of dyspnea. Further research is needed on ways to enhance intervention effects over the long-term and across additional outcomes.

The evidence base demonstrating the benefits of an early focus on palliative care for patients with serious cancers, including advanced lung cancer, is substantial. Early involvement of specialty-trained palliative care clinicians in the care of patients with advanced lung cancer improves patient-reported outcomes, such as quality of life, and health care delivery, including hospice utilization. Since the time that many of these palliative care trials were conducted, the paradigm of cancer care for many cancers, including lung cancer, has changed dramatically. The majority of patients with advanced lung cancer are now treated with immune checkpoint inhibitors or targeted therapies, both of which have had a significant impact on patient's experience and outcomes. With this changing landscape of lung cancer therapeutics, patients are facing new and different challenges, including dealing with novel side effect profiles and coping with greater uncertainty regarding their prognosis. Patients who are living longer with their advanced cancer also struggle with how to address survivorship issues, such as sexual health and exercise, and decision making about end-of-life care. Although palliative care clinicians remain well-suited to address these care needs, they may need to learn new skills to support patients treated with novel therapies. Additionally, as the experience of patients with advanced lung cancer is becoming more varied and individualized, palliative care research interventions and clinical programs should also be delivered in a patient-centered manner to best meet patient's needs and improve their outcomes. Tailored and technology-based palliative care interventions are promising strategies for delivering patient-centered palliative care.

Adjuvant endocrine therapy (AET) reduces breast cancer morbidity and mortality; however, adherence is suboptimal. Interventions exist, yet few have improved adherence. Patient characteristics may alter uptake of an intervention to boost adherence. We examined moderators of the effect of a virtual intervention (STRIDE; #NCT03837496) on AET adherence after breast cancer. At a large academic medical center, patients taking AET (N = 100; Mage = 56.1, 91

Patients with triple-negative breast cancer (TNBC) are at high risk for breast cancer recurrence and metastatic disease, yet the scholarly literature on the distress and uncertainty of this vulnerable population is limited. This study aimed to characterize the experiences of patients with TNBC and obtain feedback about the development of a supportive care intervention targeted to this population’s psychosocial needs. From 9/2021 to 2/2023, we purposefully recruited 23 patients with stage I–III TNBC who recently completed curative therapy and conducted a parallel mixed qualitative and quantitative study. We conducted in-depth semi-structured interviews regarding the transition from curative therapy to surveillance. Patients also completed self-report measures of fear of cancer recurrence (FCR) (Fear of Cancer Recurrence Inventory Severity) and psychological distress (Hospital Anxiety and Depression Scale; PROMIS Anxiety). Patients were, on average, 51 years old (SD = 13.56). Most patients (87.0

PURPOSE Adjuvant endocrine therapy (AET) is a life-saving medication for patients with hormone-sensitive breast cancer, yet many struggle with adherence, warranting behavioral intervention. In our recent trial, participation in a group cognitive behavioral intervention (STRIDE) for symptom management and adherence was associated with improvements in symptom distress, coping, quality of life, and mood. We now explore whether baseline patient- and medication-specific factors—which may be modifiable by clinician-led discussions—moderated the effect of STRIDE on adherence rates. METHODS From October 2019 to June 2021, 100 patients with early-stage breast cancer reporting AET-related distress were enrolled and randomly assigned to STRIDE or a medication monitoring (MM) control group. All patients stored their AET in electronic pill bottles to track objective adherence. Patients also self-reported their adherence on the Medication Adherence Report Scale-5 and their perceptions of AET on the Cancer Therapy Satisfaction Questionnaire at baseline. We conducted hierarchical linear modeling to test moderators of intervention effects on objective adherence rates. We report the time × group × moderator effects. RESULTS Among patients reporting greater perceived difficulties with AET adherence at baseline, STRIDE participants had higher adherence rates over time compared with MM ( b = –13.80; SE = 4.56; P < .01). Patients with greater expectations of therapeutic benefit from AET also had improved adherence rates if they were assigned to STRIDE, versus MM ( b = 0.25; SE = 0.10; P = .01). Patients who perceived taking AET as convenient and had been taking their AET for less time had higher adherence rates in STRIDE, versus MM. CONCLUSION The current study identified patient- and medication-specific factors that may augment AET adherence interventions and may be modifiable through clinician-led discussions, such as perceptions of adherence problems, therapeutic efficacy, and convenience of AET.

12000 Background: Studies show that early PC (EPC) integrated with oncology care from the time of diagnosis of advanced cancer improves patient and caregiver outcomes. However, this care model has not been widely implemented given the shortage of PC clinicians and challenges in providing PC visits throughout the course of cancer treatment, especially as novel therapeutics prolong survival in this population. Therefore, to deliver more patient-centered and less resource-intensive PC, we evaluated a stepped PC (SPC) model in patients with advanced lung cancer. Methods: Between 2/12/18 and 12/15/22, we enrolled patients with advanced lung cancer, diagnosed in the past 12 weeks and an ECOG PS = 0-2 to a multi-site randomized trial of SPC versus EPC. All patients assigned to SPC started on Step 1, with an initial PC visit within four weeks of enrollment and subsequent PC visits scheduled only at the time of a change in cancer treatment or after a hospitalization. Patients on Step 1 also completed a measure of quality of life (QOL; Functional Assessment of Cancer Therapy-Lung [FACT-L]) every six weeks for up to 18 months from enrollment, and those with a greater than or equal to a 10-point decrease in their score from baseline were stepped up to meet with the PC clinician every four weeks (Step 2). Patients assigned to EPC had PC visits every four weeks from enrollment. The primary aim was to evaluate the non-inferiority of the effect of SPC versus EPC on QOL as measured by the FACT-L at week 24, using regression modeling. For the secondary outcomes, we conducted a superiority analysis of the number of PC visits between groups and non-inferiority analyses of patient-reported end-of-life (EOL) communication with clinicians and days enrolled in hospice, controlling for multiple comparisons with a False Discovery Rate of 0.15. Results: The sample (N = 507) included mostly patients with NSCLC (78.3%; mean age = 66.48 years; 51.4% female; 84.2% White). QOL scores at week 24 for patients assigned to SPC were non-inferior to those receiving EPC (adjusted means: 100.62 versus 97.75, p < 0.0001 for non-inferiority). Sixty-six patients (26.4%) assigned to SPC transitioned to Step 2 by 24 weeks. The mean number of PC visits by week 24 was lower for SPC versus EPC patients (adjusted means 2.44 v. 4.70, p < 0.0001). While the rate of EOL communication was non-inferior for SPC versus EPC (adjusted proportions: 0.30 v. 0.33, p = 0.09), non-inferiority was not demonstrated for days in hospice (adjusted means SPC = 19.72 v. EPC = 34.64, p = 0.9). Conclusions: A stepped care model, with PC visits scheduled only at key points in patients’ cancer trajectories and using a decrement in QOL to trigger more intensive PC exposure, results in significantly fewer PC visits without sacrificing the benefits for patients’ QOL. While SPC was associated with fewer days in hospice, this novel model holds promise as a more scalable way to deliver early PC to enhance patient-reported outcomes. Clinical trial information: NCT03337399 .

CONTEXT:Dyspnea is a complex, multidimensional symptom comprising sensory-perceptual, affective, and functional domains that commonly persists in patients with lung cancer and impairs mental health and quality of life (QOL). However, data are lacking on how dyspnea's dimensions or self-efficacy to manage dyspnea are associated with patient outcomes. OBJECTIVES:To assess the associations of dyspnea dimensions (dyspnea-related sensory-perceptual experience, affective distress, and functional impact) and dyspnea self-efficacy with depression, anxiety, and QOL in patients with advanced lung cancer reporting dyspnea. METHODS:We conducted a secondary analysis of baseline clinical trial data testing a supportive care intervention for dyspnea. Patients with advanced lung cancer reporting at least moderate dyspnea (≥2 on the Modified Medical Research Council Dyspnea Scale) self-reported dyspnea and patient outcome measures. Hierarchical regressions tested the associations of the dyspnea dimensions with depressive and anxiety symptoms (Hospital Anxiety and Depression Scale) and QOL (Functional Assessment of Cancer Therapy-Lung) while adjusting for variables known to affect these outcomes. RESULTS:The sensory-perceptual experience of dyspnea (effort) was associated with worse depressive symptoms (b = 0.21, P < 0.01) and QOL (b = -0.53, P = 0.01). Dyspnea self-efficacy was associated with improved depressive (b = -1.26, P < 0.01) and anxiety symptoms (b = -1.72, P < 0.01) and QOL (b = 3.66, P < 0.01). The affective and functional dimensions of dyspnea were not associated with the patient outcomes in the final models. CONCLUSIONS:Dyspnea-related sensory-perceptual experience and self-efficacy were associated with mental health and QOL outcomes in patients with lung cancer. Examining the individual contributions of dyspnea's multiple dimensions provides a nuanced understanding of its patient impact.

The absence of effective therapeutic targets and aggressive nature of triple-negative breast cancer (TNBC) renders this disease subset difficult to treat. Although estrogen receptor beta (ERβ) is expressed in TNBC, studies on its functional role have yielded inconsistent results. However, recently, our preclinical studies, along with other observations, have shown the potential therapeutic utility of ERβ in the context of mutant p53 expression. The current case study examines the efficacy of the selective estrogen receptor modulator tamoxifen in p53-mutant TNBC with brain metastases. Significant increase in ERβ protein expression and anti-proliferative interaction between mutant p53 and ERβ were observed after cessation of tamoxifen therapy, with significant regression of brain metastases. This case study provides supporting evidence for the use of tamoxifen in p53-mutant, ERβ+TNBC, especially in the setting of brain metastasis.

12131 Background: Adjuvant endocrine therapy (AET) reduces risk of breast cancer (BC) recurrence; however, adherence is suboptimal and interventions are needed. We conducted a randomized controlled trial of a novel telehealth intervention (STRIDE), which led to improvements in symptom distress, coping, quality of life, and mood. Here we examine which patients had improved adherence following STRIDE by exploring characteristics that may moderate intervention effects. Methods: Women (n = 100) with nonmetastatic BC who reported AET-related distress were randomized to receive STRIDE or a medication monitoring control (MM) between 10/2019-6/2021. STRIDE consisted of six weekly, small-group cognitive behavioral telehealth sessions to enhance symptom management and adherence. All patients stored their AET in electronic MEMS Caps bottles to measure objective adherence. We collected patient characteristics (i.e., months on AET, education) and self-report measures at baseline. Patients completed the Medication Adherence Report Scale (MARS-5) and Cancer Therapy Satisfaction Questionnaire to report adherence behaviors (e.g., “I alter the dose”) and AET perceptions (e.g., convenience, expectations, satisfaction), respectively. We conducted hierarchical linear modeling to test moderators of intervention effects on adherence rates (MEMS Caps) across months 1-3, controlling for ovarian suppression receipt and baseline distress due to group differences/stratification. We report the ‘time X group X moderator’ effects here. Results: Among participants reporting greater difficulty (lower MARS-5) with their AET regimen at baseline, STRIDE participants had greater improvement in adherence over time compared to MM participants ( b= -13.80, SE = 4.56, p < .01). Greater expectations of therapeutic benefit predicted improvements in adherence for STRIDE versus MM participants ( b= 0.25 SE = 0.10, p = .01). Additionally, among participants who reported greater convenience of taking AET ( b= 0.33 SE = 0.17, p = .06), had lower education levels ( b= -4.02, SE = 2.12, p = .06), and had been taking AET for fewer months ( b= -0.43 SE = 0.25, p = .09), STRIDE participants showed adherence increases that approached significance. Other moderators were not significant. Conclusions: STRIDE demonstrated effects of a behavioral intervention on AET adherence. Participants reporting greater difficulty adhering to their AET regimen and who expected more benefit showed improved adherence following STRIDE. Gains in adherence from STRIDE were also more pronounced among those who reported that AET was convenient, started the medication more recently, and had lower levels of education. Patient-level and socioeconomic factors influence response to AET adherence interventions. Clinicians may play a key role in addressing modifiable targets at AET initiation (e.g., logistical barriers, perceived benefit) to enhance adherence. Clinical trial information: NCT03837496 .

247 Background: Despite the importance of having a clear understanding of the likely outcome of cancer to inform medical decision-making, about one third of patients with advanced lung cancer report inaccurate perceptions of their prognosis. To identify factors associated with lower and higher prognostic understanding, we examined the relationships among patients’ perceptions of prognosis and their demographic characteristics, quality of life (QOL), and mood symptoms. Methods: We conducted a cross-sectional analysis of baseline data from patients enrolled in two multisite palliative care trials. Eligible participants included adults with advanced non-small cell lung cancer, small cell lung cancer, or mesothelioma diagnosed in the past 12 weeks and an ECOG Performance Status <3 across 23 cancer centers in the US. At baseline, patients self-reported their current health status and understanding of whether their cancer is curable. Patients’ prognostic understanding was categorized into three levels: “high” if patients reported that their illness was terminal and incurable, “medium” if patients reported that their illness was either terminal or incurable, and “low” if patients reported that their illness was neither terminal nor incurable. To assess QOL and depression symptoms, patients completed the Functional Assessment of Cancer Therapy-Lung (FACT-L) and the Patient Health Questionnaire-9 (PHQ-9), respectively. Linear regression models adjusting for patient demographic factors were used to examine the associations among prognostic understanding, QOL, and depression symptoms. Results: The sample included 1430 patients with advanced lung cancer (Mean age = 65.50 years; 52.5% female; 4.0% Asian, 10.6% Black, 81.8% White; 65.9% married). Patient-reported prognostic understanding varied as follows: high (45.1%), medium (32.7%), and low (22.2%). Patients who were older (p =.015), male (p <.001), Black or Asian (p =.015), or married (p =.012) had lower prognostic understanding. Adjusting for demographic factors, patients with higher prognostic understanding reported worse QOL (FACT-L: B = -5.392, SE = 0.71, p <.001) and depression symptoms (PHQ-9: B = 0.99, SE = 0.19, p < 0.001) versus those with lower prognostic understanding. Conclusions: A substantial proportion of patients with newly diagnosed advanced lung cancer have low prognostic understanding. Those with high prognostic understanding report worse QOL and depression symptoms, which may be due to patients relating their poor health status to their prognosis. Furthermore, patient age, gender, race, and relationship status are salient correlates of prognostic understanding. Tailored interventions are needed to improve illness understanding and address the related supportive care needs of patients with advanced lung cancer, especially those at risk for low prognostic understanding.

IntroductionIntegrating palliative care (PC) early in the illness course for patients with serious cancers improves their outcomes and is recommended by national organisations such as the American Society of Clinical Oncology. However, monthly visits with PC clinicians from the time of diagnosis can be challenging to implement due to the lack of specialty-trained PC clinicians and resources. Therefore, we developed a stepped care model to triage PC service based on patients’ needs.Methods and analysisWe are conducting a non-blinded, randomised trial to evaluate the non-inferiority of a stepped PC model compared with an early integrated PC model for improving patients’ quality of life (QOL) at 24 weeks (primary outcome). Patients assigned to early integrated PC meet with PC every 4 weeks throughout their illness. Patients assigned to stepped PC have PC visits only at clinically significant points in their illness (eg, cancer progression) unless their QOL decreases, at which time they are ‘stepped up’ and meet with PC every 4 weeks throughout the remainder of their illness. Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation. Patients are recruited from the Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Duke Cancer Center, Durham, North Carolina and University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania. The target sample size is 510 patients.Ethics and disseminationThe study is funded by the National Cancer Institute, approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and will be reported in accordance with the Consolidated Standards of Reporting Trials statement. We will disseminate results through professional society meetings, peer-reviewed publications and presentations to patient organisations.Trial registration numberNCT03337399.

Background Patients taking adjuvant endocrine therapy (AET) after breast cancer face adherence challenges and symptom-related distress. We conducted a randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth intervention (Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy [STRIDE]) for patients taking AET. Methods From October 2019 to June 2021, 100 patients reporting difficulty with AET were randomly assigned to either STRIDE or a medication monitoring (MedMon) control group. STRIDE included six weekly small-group videoconferencing sessions and two individual calls. We defined feasibility as having >50% of eligible patients enroll, >70% complete the 12-week assessment, and > 70% of STRIDE patients complete >= 4/6 sessions. We monitored adherence with the Medication Event Monitoring System Caps (MEMS Caps). At baseline and 12- and 24-weeks after baseline, patients self-reported adherence (Medication Adherence Report Scale), AET satisfaction (Cancer Therapy Satisfaction Questionnaire), symptom distress (Breast Cancer Prevention Trial-Symptom Checklist), self-management of symptoms (Self-efficacy for Symptom Management-AET), coping (Measure of Current Status), quality of life (QOL; Functional Assessment of Cancer Therapy-Breast), and mood (Hospital Anxiety and Depression Scale). We used linear mixed effects models to assess the effect of STRIDE on longitudinal outcomes. Results We enrolled 70.9% (100/141) of eligible patients; 92% completed the 12-week assessment, and 86% completed >= 4/6 STRIDE sessions. Compared with MedMon, STRIDE patients reported less symptom distress (B[difference] = -1.91; 95% CI, -3.29 to -0.52; p = .007) and better self-management of AET symptoms, coping, QOL, and mood. We did not observe significant differences in AET satisfaction or adherence. Conclusions STRIDE is feasible and acceptable, showing promise for improving outcomes in patients taking AET after breast cancer. Lay summary Patients taking adjuvant endocrine therapy (AET) after breast cancer may face challenges while following their treatment regimen. In this randomized controlled trial of 100 patients taking AET, a brief, small-group virtual intervention (STRIDE) was well-received by patients and led to improvements in how upset patients were due to symptoms, how confident they were in managing symptoms, and how well they could cope with stress. Thus, STRIDE is a promising intervention and should be tested in future multi-site trials.