Physical health-related quality of life trajectories over two years following breast cancer diagnosis in older women: a secondary analysis.

PURPOSE: To identify distinct trajectories of physical health-related quality of life (HRQoL) in older women over the first two years following breast cancer diagnosis, and to examine characteristics associated with trajectory group membership. METHODS: A secondary analysis of a longitudinal study of women diagnosed with stage I-III breast cancer who completed surveys within eight months of diagnosis and six, twelve, and eighteen months later that focuses on a subset of women aged ≥ 65 years (N = 145).Physical HRQoL was assessed using the Physical Component Score (PCS) of the SF-36 Health Survey. Finite mixture modeling identified distinct PCS trajectories. Multivariable logistic regression identified variables predictive of low PCS group membership. RESULTS: Two distinct patterns of PCS trajectories were identified. The majority (58%) of women had PCS above the age-based SF-36 population norms and improved slightly over time. However, 42% of women had low PCS that remained low over time. In multivariable analyses, older age, difficulty paying for basics, greater number of medical comorbidities, and higher body mass index were associated with low PCS group membership. Cancer treatment and psychosocial variables were not significantly associated. CONCLUSION: A large subgroup of older women reported very low PCS that did not improve over time. Older age, obesity, multiple comorbidities, and lower socioeconomic status may be risk factors for poorer PCS in women with breast cancer. Incorporating routine comprehensive geriatric assessments that screen for these factors may help providers identify older women at risk for poorer physical HRQoL post breast cancer treatment.

The impact of non- and anthracycline-based chemotherapy on fatigue in breast cancer survivors: results from WF-97415.

PURPOSE: To examine the differential effect of non- and anthracycline-based chemotherapy on fatigue over 12 months post-diagnosis among breast cancer survivors. METHODS: This study is based on a prospective Wake Forest NCI Community Oncology Research Program (NCORP) multicenter cohort study (WF-97415) of women with stage I to III breast cancer and non-cancer controls. Analyses compared those: 1) receiving, or 2) not receiving anthracycline chemotherapy, 3) receiving aromatase inhibitors (AIs) without chemotherapy, with 4) a comparator group without a history of cancer. In-person clinic assessments were conducted at: baseline (prior to chemotherapy or start of AI therapy), and 3 and 12 months after baseline. The Functional Assessment of Chronic Illness Therapy-Fatigue scale was the primary outcome. Estimated least squares means by group using mixed models with a random subject effect, fixed effects of time and group, and the interaction between time and group was used to compare groups across time, controlling for age, comorbidities, and treatment variables. RESULTS: Among 284 women (mean age = 53.4 years, sd 11.9 years), there was a significant (p < 0.0001) group by time interaction, with a sharp increase in fatigue at 3 months in the two chemotherapy groups in comparison to the non-chemotherapy and non-cancer controls. The two chemotherapy groups did not significantly differ in fatigue at any time point. CONCLUSION: Women with breast cancer who receive non- or anthracycline-based chemotherapy experience similar trends in and levels of fatigue within the first year of treatment and greater fatigue than women receiving AIs alone or women without breast cancer.

Qualitative results from a randomized pilot study of eHealth Mindful Movement and Breathing to improve gynecologic cancer surgery outcomes.

PURPOSE: Improved management of pain and co-morbid symptoms (sleep disturbances, psychological distress) among women undergoing surgery for suspected gynecologic malignancies may reach a population vulnerable to chronic pain. PARTICIPANTS: Women undergoing surgery for a suspected gynecologic malignancy. METHOD: We conducted a pilot randomized controlled trial of eHealth Mindful Movement and Breathing (eMMB) compared to an empathic attention control (AC). Semi-structured interviews were conducted by telephone (n = 23), recorded, transcribed, coded, and analyzed using thematic analysis. FINDINGS: Participants reported overall high acceptability such that all would recommend the study to others. Positive impacts of practicing eMMB included that it relieved tension, facilitated falling asleep, and decreased pain. Participants also reported high adherence to self-directed eMMB and AC writing practices and described facilitators and barriers to practicing. CONCLUSIONS: This qualitative feedback will inform future research to assess the efficacy of eMMB for reducing pain and use of remotely-delivered interventions more broadly. CLINICAL TRIAL REGISTRATION NUMBER: NCT03681405.

Keratin-based topical cream for radiation dermatitis during head and neck radiotherapy: a randomised, open-label pilot study.

Introduction: Radiation dermatitis (RD) is a frequent toxicity during radiotherapy (RT) for head and neck cancer (HNC). We report the first use of KeraStat® Cream (KC), a topical, keratin-based wound dressing, in patients with HNC receiving RT. Methods: This pilot study randomized HNC patients treated with definitive or postoperative RT (≥60 Gy) to KC or standard of care (SOC), applied at least twice daily during and for 1-month after RT. Outcomes of interest included adherence to the assigned regimen (at least 10 applications per week of treatment), clinician- and patient-reported RD, and skin-related quality of life. Results: 24 patients were randomized and completed the study. Most patients had stage III-IV disease and oropharynx cancer. Median RT dose was 68 Gy; the bilateral neck was treated in 19 patients, and 18 patients received concurrent chemotherapy. Complete adherence was observed in 7/12 (SOC) vs. 10/12 (KC, p = 0.65). Adherence by patient-week was 61/68 versus 64/67, respectively (p = 0.20). No differences in RD were observed between groups. Conclusion: A randomized trial of KC versus SOC in HNC patients treated with RT is feasible with good adherence to study agent. An adequately powered randomized study is warranted to test the efficacy of KC in reducing RD.

Survival and Swallowing Function after Primary Radiotherapy versus Transoral Robotic Surgery for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma.

INTRODUCTION: The aim of this study was to investigate the impact of primary transoral robotic surgery (TORS) versus radiotherapy (RT) on progression-free survival (PFS), overall survival (OS), and 1-year swallowing function for patients with early-stage HPV-associated oropharyngeal squamous cell carcinoma (OPSCC). METHODS: Patients with stage I-II (AJCC 8th Ed.) HPV-associated OPSCC treated with TORS followed by risk-adapted adjuvant therapy or (chemo)radiotherapy between 2014 and 2019 were identified. PFS, OS, and swallowing outcomes including gastrostomy tube (GT) use/dependence, and Functional Oral Intake Scale (FOIS) change over 1 year were compared. RESULTS: One hundred sixty-seven patients were analyzed: 116 treated with TORS with or without adjuvant RT and 51 treated with RT (50 chemoRT). The RT group had more advanced tumor/nodal stage, higher comorbidity, and higher rates of concurrent chemotherapy. There were no differences in 3-year PFS (88% TORS vs. 75% RT) or OS (90% vs. 81%) between groups, which persisted after adjusting for stage, age, and comorbidity. GT use/dependence rates were higher in the RT group. Mean (SD) FOIS scores in the TORS group were 6.9 (0.4) at baseline and 6.4 (1.0) at 1 year, compared with 6.7 (0.6) and 5.6 (1.7) for the RT group. Only clinical nodal stage was found to be significantly associated with FOIS change from baseline to 1 year. CONCLUSION: There were no differences in PFS or OS between patients treated with primary TORS or RT for early-stage HPV-associated OPSCC. Clinical N2 status is associated with FOIS change at 1 year and may be the major factor affecting long-term swallowing function, irrespective of primary treatment modality.

A randomized pilot of eHealth mindful movement and breathing to improve gynecologic surgery outcomes.

OBJECTIVE: To conduct a pilot randomized controlled trial of eHealth Mindful Movement and Breathing (eMMB) compared to an empathic attention control (AC). PARTICIPANTS: Women undergoing surgery for a suspected gynecologic malignancy. METHODS: eMMB is a brief yoga intervention delivered remotely during the perioperative timeframe. We assessed feasibility and participants completed assessments (baseline, weeks 2 and 4 postoperatively). We summarized feasibility, participant characteristics, and outcomes by intervention group and time. FINDINGS: Forty-three percent of eligible patients approached participated (n = 31). Adherence to the interventions was 77%. Percent of participants to complete outcomes was 81% at Week 2 and 84% at Week 4 (>70%; retention was the primary feasibility indicator). Average reductions in the primary outcome of pain intensity were larger in the eMMB group than AC group (Week 2 d = -0.38; Week 4 d = -0.46). IMPLICATIONS: This pilot study of eMMB supported feasibility and improvements in pain intensity that warrant a future efficacy study.

A spotlight on avoidance coping to manage fear of recurrence among breast cancer survivors in an eHealth intervention.

BACKGROUND: Fear of recurrence (FoR) is prevalent among breast cancer survivors (BCS) and may be exacerbated by avoidance coping. This study examined BCS with avoidance coping and their engagement in a FoR eHealth intervention (FoRtitude). METHODS: BCS (N = 196) with elevated FoR participated in FoRtitude. Patient-reported measures assessed avoidance coping with FoR and baseline emotional and behavioral health. Intervention engagement was measured quantitatively (e.g., website logins, telecoaching attendance) and qualitatively (i.e., telecoaching notes). RESULTS: 38 BCS (19%) endorsed avoidance coping, which was associated with more severe post-traumatic anxiety-related symptoms and worse global mental health (ps < .05), but not anxiety (p = .19), depression (p = .11), physical health (p = .12), alcohol consumption (p = .85), or physical activity (p = .39). Avoidance coping was not associated with engagement levels (ps > .05) but did characterize engagement-related motivators and barriers. CONCLUSIONS: Avoidance coping was not a barrier to FoRtitude engagement. eHealth delivery is a promising modality for engaging survivors with avoidance coping in FoR interventions.

A non-compensatory analysis of quality of life in breast cancer survivors using multivariate hidden Markov modeling.

PURPOSE: Health-related quality of life (HRQoL) is a multidimensional concept comprising multiple domains such as physical, emotional, and social well-being. Many analyses use a sum score to represent the construct. However, this approach implies that gain in one domain can compensate for a deficit in another, and thus such analyses may not capture HRQoL profiles. Additionally, within-individual change over time, such as improvement in one domain but deterioration in another, may not be detected. The objectives of this research are to demonstrate the utility of a non-compensatory approach by (1) evaluating this approach applied to HRQoL data, and (2) comparing the approach to a compensatory method. METHODS: Data from a sample of 653 breast cancer survivors (BCS) provided five measurement time points over 18 months. We analyzed the scores from five domains on the FACT-B questionnaire (physical, functional, social, and emotional well-being and breast cancer-related concerns) using the multivariate hidden Markov model (MHMM), a non-compensatory approach that identifies different HRQoL states and associated BCS subgroups and their trajectories. RESULTS: The MHMM delineated six states. States 1 and 2 had low well-being scores across all domains, with state 2 slightly better than state 1. States 3 and 4 had similar overall HRQoL scores, but different profiles with compensation occurring across the domains of both physical and social well-being. States 5 and 6 had almost identical overall scores with compensation occurring between the domains of both social and emotional well-being. Over time, states 3-6 mostly "communicated" with each other (with moderate probabilities of transitioning between states). Compensation across domains could mask subtle changes occurring in BCS. We found that a trend analysis using both compensatory and non-compensatory approaches showed improvement in the HRQoL in BCS over time. CONCLUSION: The non-compensatory analysis of FACT-B shows differential profiles and trajectories in the HRQoL of BCS not captured by the sum score or one-domain-at-a-time approach.

Trajectories of quality of life following breast cancer diagnosis.

PURPOSE: Although quality of life (QoL) improves over time for most breast cancer survivors (BCS), BCS may show different patterns of QoL. This study sought to identify distinct QoL trajectories among BCS and to examine characteristics associated with trajectory group membership. METHODS: BCS (N = 653) completed baseline assessments within 8 months of diagnosis. QoL was assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) at baseline and 6, 12, and 18 months later. Finite mixture modeling was used to determine QoL trajectories of the trial outcome index (TOI; a composite of physical well-being, functional well-being, and breast cancer-specific subscales) and emotional and social/family well-being subscales. Chi-square tests and F tests were used to examine group differences in demographic, cancer-related, and psychosocial variables. RESULTS: Unique trajectories were identified for all three subscales. Within each subscale, the majority of BCS had consistently medium or high QoL. The TOI analysis revealed only stable or improving groups, but the emotional and social/family subscales had groups that were stable, improved, or declined. Across all subscales, women in "consistently high" groups had the most favorable psychosocial characteristics. For the TOI and emotional subscales, psychosocial variables also differed significantly between women who started similarly but had differing trajectories. CONCLUSIONS: The majority of BCS report good QoL as they transition from treatment to survivorship. However, some women have persistently low QoL in each domain and some experience declines in emotional and/or social/family well-being. Psychosocial variables are consistently associated with improving and/or declining trajectories of physical/functional and emotional well-being.

Sexual functioning among early post-treatment breast cancer survivors.

PURPOSE: This study aims (1) to estimate percentages of partnered women who are sexually active over the first 2 years post-breast cancer diagnosis; (2) to identify factors related to sexual inactivity; and (3) to evaluate separately, among both sexually active and inactive survivors, the relation between sexual problems and treatment-related variables, symptoms, and psychosocial factors. METHODS: Longitudinal observational study of breast cancer survivors recruited within 8 months of cancer diagnosis and followed for 18 months. The main outcome measures were (1) being sexually active/inactive in the past month and (2) sexual problems assessed with the four-item sexual problem domain of the Quality of Life in Adult Cancer Survivors (QLACS) scale. RESULTS: At baseline, 52.4% of women reported being sexually active in the past month. This percentage increased to 60.7% 18 months later. In multivariable repeated-measures analyses, age, past chemotherapy, depressive symptoms, and lower perceived attractiveness were related to inactivity. Sexually inactive women reported more problems on the QLACS than sexually active women. In stratified multivariable analyses, depressive symptoms were related to greater sexual problems for both sexually active and inactive women, as was vaginal dryness. Among the sexually active women, younger age at diagnosis, less illness intrusiveness, and lower perceived attractiveness were related to more problems. CONCLUSIONS: Research has shown that sexual functioning/sexual health are key aspects of quality of life for many cancer survivors, and are often not addressed by health care providers. Future studies should examine how such topics are handled by clinicians in their interactions with survivors.

Posttreatment trajectories of physical activity in breast cancer survivors.

BACKGROUND: Breast cancer survivors face a risk of disease recurrence and a higher risk of developing comorbidities such as cardiovascular disease when compared with the general population. Physical activity (PA) has been shown to reduce such risks. The current analyses sought to identify: 1) unique patterns of PA among breast cancer survivors; and 2) characteristics associated with the level of PA. METHODS: A total of 548 women reported PA and sociodemographic, health-related, and psychosocial factors at 3 time points, 6 months apart, after primary treatment of breast cancer. Cancer-related factors were obtained from chart reviews. Finite mixture modeling was used to examine trajectory groups of moderate-intensity to vigorous-intensity PA (MVPA) in the early posttreatment period. The authors then examined the characteristics associated with trajectory group membership. RESULTS: Three groups with distinct, stable patterns of PA were identified: the low MVPA (42.5% of patients), medium MVPA (45.5% of patients), and high MVPA (12.0% of patients) groups. In a multivariable setting, compared with more active breast cancer survivors, the least active group was found to have a higher body mass index, were less likely to report alcohol consumption, were more likely to smoke cigarettes, and had worse physical functioning and vitality scores. Cancer treatment-related factors did not significantly predict group membership. CONCLUSIONS: A large percentage of breast cancer survivors remain physically inactive after treatment, suggesting the need for interventions to reduce morbidity and mortality in this population. Cancer 2017;123:2773-80. © 2017 American Cancer Society.

Met and Unmet Expectations for Breast Reconstruction in Early Posttreatment Breast Cancer Survivors.

The purpose of this study was to evaluate the prevalence of met and unmet expectations after breast reconstruction among breast cancer survivors following mastectomy. A secondary objective was to examine reasons women report their experiences of reconstructive surgery were better or worse than expected. As part of a larger study of breast cancer survivors, participants completed self-administered questionnaires within 8 months of diagnosis and at 6, 12, and 18 months later. At the 18-month follow-up, women who had breast reconstruction were asked whether their reconstruction was better, the same, or worse than expected. The sample consisted of 130 survivors (mean age = 48.5 years) who had breast reconstruction following mastectomy and completed the 18-month follow-up, 42% of whom reported their reconstruction was worse than expected and only 25% reported it was better. Most frequently reported reasons for reconstruction being worse than expected were related to appearance of the reconstructed breast and pain. A high percentage of patients with breast cancer undergoing breast reconstruction following mastectomy reported the results as worse than expected, with the primary reasons for dissatisfaction related to the feel and appearance of the reconstructed breast. Patients with breast cancer considering breast reconstruction need better preoperative education or understanding about what to expect from reconstruction.

The Association Between an Electronic Health Record (EHR)-Embedded Frailty Index and Patient-Reported Outcomes Among Patients with Metastatic Non-Small-Cell Lung Cancer on Immunotherapy: A Brief Report.

Background: While frailty is a well-established predictor of overall mortality among patients with metastatic non-small cell lung cancer (mNSCLC), its association with patient-reported outcomes is not well-characterized. The goal of this study was to examine the association between an electronic frailty index (eFI) score and patient-reported outcome measures along with prognostic awareness among patients with mNSCLC receiving immunotherapy. Methods: In a cross-sectional study, patients with mNSCLC who were on immunotherapy completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) and the National Cancer Institute Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). We utilized bivariate analyses to compare quality of life, symptoms, supportive services, and prognostic awareness among 3 groups defined by e-frailty status. Results: Sixty patients (mean age 62.5 years, 75% Caucasian, 60% women) participated. Most patients were pre-frail (68%), with 13% being frail and 18% non-frail. Pre-frail and frail patients had significantly lower physical function scores (mean 83.9 fit vs 74.8 pre-frail vs 60.0 frail, P = .04) and higher rates of self-reported pain (75% frail vs 41.5% pre-frail vs 18.2% fit; P = .04) compared to non-frail patients. We found no differences in palliative referral rates. Conclusion: Pre-frail and frail mNSCLC patients identified by the eFI have higher rates of pain and physical functional impairments than non-frail patients. These findings highlight the importance of emphasizing preventive interventions targeting social needs, functional limitations, and pain management, especially among pre-frail patients to reduce further decline.

Sepsis Prediction Model for Determining Sepsis vs SIRS, qSOFA, and SOFA.

Importance: The Sepsis Prediction Model (SPM) is a proprietary decision support tool created by Epic Systems; it generates a predicting sepsis score (PSS). The model has not undergone validation against existing sepsis prediction tools, such as Systemic Inflammatory Response Syndrome (SIRS), Sequential Organ Failure Assessment (SOFA), or quick Sepsis-Related Organ Failure Asessement (qSOFA). Objective: To assess the validity and timeliness of the SPM compared with SIRS, qSOFA, and SOFA. Design, Setting, and Participants: This retrospective cohort study included all adults admitted to 5 acute care hospitals in a single US health system between June 5, 2019, and December 31, 2020. Data analysis was conducted from March 2021 to February 2023. Main Outcomes and Measures: A sepsis event was defined as receipt of 4 or more days of antimicrobials, blood cultures collected within ±48 hours of initial antimicrobial, and at least 1 organ dysfunction as defined by the organ dysfunction criteria optimized for the electronic health record (eSOFA). Time zero was defined as 15 minutes prior to qualifying antimicrobial or blood culture order. Results: Of 60 507 total admissions, 1663 (2.7%) met sepsis criteria, with 1324 electronic health record-confirmed sepsis (699 [52.8%] male patients; 298 [22.5%] Black patients; 46 [3.5%] Hispanic/Latinx patients; 945 [71.4%] White patients), 339 COVID-19 sepsis (183 [54.0%] male patients; 98 [28.9%] Black patients; 36 [10.6%] Hispanic/Latinx patients; and 189 [55.8%] White patients), and 58 844 (97.3%; 26 632 [45.2%] male patients; 12 698 [21.6%] Black patients; 3367 [5.7%] Hispanic/Latinx patients; 40 491 White patients) did not meet sepsis criteria. The median (IQR) age was 63 (51 to 73) years for electronic health record-confirmed sepsis, 69 (60 to 77) years for COVID-19 sepsis, and 60 (42 to 72) years for nonsepsis admissions. Within the vendor recommended threshold PSS range of 5 to 8, PSS of 8 or greater had the highest balanced accuracy for classifying a sepsis admission at 0.79 (95% CI, 0.78 to 0.80). Change in SOFA score of 2 or more had the highest sensitivity, at 0.97 (95% CI, 0.97 to 0.98). At a PSS of 8 or greater, median (IQR) time to score positivity from time zero was 68.00 (6.75 to 605.75) minutes. For SIRS, qSOFA, and SOFA, median (IQR) time to score positivity was 7.00 (-105.00 to 08.00) minutes, 74.00 (-22.25 to 599.25) minutes, and 28.00 (-108.50 to 134.00) minutes, respectively. Conclusions and Relevance: In this cohort study of hospital admissions, balanced accuracy of the SPM outperformed other models at higher threshold PSS; however, application of the SPM in a clinical setting was limited by poor timeliness as a sepsis screening tool as compared to SIRS and SOFA.

Prognostic Awareness, Palliative Care Use, and Barriers to Palliative Care in Patients Undergoing Immunotherapy or Chemo-Immunotherapy for Metastatic Lung Cancer.

Background and Objectives: This study describes patients' prognostic awareness and palliative care use in the setting of immunotherapy for metastatic non-small cell lung cancer (mNSCLC). Design: We surveyed 60 mNSCLC patients receiving immunotherapy at a large academic medical center; conducted follow-up interviews with 12 survey participants; and abstracted palliative care use, advance directive completion, and death within a year of survey completion from the medical record. Results: Forty seven percent of patients surveyed thought they would be cured; 83% were not interested in palliative care. Interviews suggested oncologists emphasized therapeutic options when discussing prognosis and that commonly used descriptions of palliative care may exacerbate misperceptions. Only 7% had received outpatient palliative care and 8% had an advance directive a year after the survey; only 16% of the 19 patients who died had received outpatient palliative care. Conclusions: Interventions are needed to facilitate prognostic discussions and outpatient palliative care during immunotherapy. Clinical Trial Registration Number NCT03741868.

Bridging the Communication Gaps: A Prospective Single-Arm Pilot Study Testing the Feasibility of Interdisciplinary Radiotherapy Planning in Locally Advanced Lung Cancer.

RATIONALE AND OBJECTIVES: The treatment of locally advanced lung cancer (LALC) with radiotherapy (RT) can be challenging. Multidisciplinary collaboration between radiologists and radiation oncologists (ROs) may optimize RT planning, reduce uncertainty in follow-up imaging interpretation, and improve outcomes. MATERIALS AND METHODS: In this prospective clinical treatment trial (clinicaltrials.gov NCT04844736), 37 patients receiving definitive RT for LALC, six attending ROs, and three thoracic radiologists were consented and enrolled across four treatment centers. Prior to RT plan finalization, representative computed tomography (CT) slices with overlaid outlines of preliminary irradiation targets were shared with the team of radiologists. The primary endpoint was to assess feasibility of receiving feedback no later than 4 business days of RT simulation on at least 50% of plans. RESULTS: Thirty-seven patients with lung cancer were enrolled, and 35 of 37 RT plans were reviewed. Of the 35 patients reviewed, mean age was 69 years. For 27 of 37 plans (73%), feedback was received within 4 or fewer days (interquartile range 3-4 days). Thirteen of 35 cases (37%) received feedback that the delineated target potentially did not include all sites suspicious for tumor involvement. In total, changes to the RT plan were recommended for over- or undercoverage in 16 of 35 cases (46%) and implemented in all cases. Radiology review resulted in no treatment delays and substantial changes to irradiated volumes: gross tumor volume, -1.9 to +96.1%; planning target volume, -37.5 to +116.5%. CONCLUSION: Interdisciplinary collaborative RT planning using a simplified workflow was feasible, produced no treatment delays, and prompted substantial changes in RT targets.

Results of a pilot study of a cooling mattress pad to reduce vasomotor symptoms and improve sleep.

OBJECTIVE: This single-arm pilot study was designed to generate pilot data on the use of a cooling mattress pad system on vasomotor symptoms (VMS; hot flashes and/or night sweats), self-assessed sleep, and daily hot flash interference among perimenopausal and postmenopausal women. METHODS: A total of 15 perimenopausal and postmenopausal women aged 45 to 59 years experiencing four or more VMS per day were recruited from the community. After completion of baseline questionnaires and a 2-week daily diary to confirm VMS eligibility, all women received a cooling mattress pad system to use at night for 8 weeks, during which time they continued to complete their daily diaries to record VMS frequency and severity. The primary study outcome was change from baseline in VMS frequency. Secondary outcomes were sleep quality, measured by the Pittsburgh Sleep Quality Index, and hot flash interference with daily life, assessed by the Hot Flash Related Daily Interference Scale, where higher sores indicate worse sleep quality and higher interference, respectively. We used repeated-measures methods (analysis of covariance, paired t tests, and McNemar test) to evaluate outcomes. RESULTS: VMS frequency significantly declined by 52% at 8 weeks ( P < 0.0001). Mean total Pittsburgh Sleep Quality Index score significantly declined 3.27 points from 11.14 at baseline to 7.87 at follow-up ( P = 0.011). The total Hot Flash Related Daily Interference Scale score significantly declined from 4.16 at baseline to 1.92 at follow-up ( P = 0.011). CONCLUSIONS: Women who used a cooling mattress pad system experienced significant and clinically meaningful reductions in VMS frequency, sleep disturbance, and hot flash interference with daily activities over an 8-week period. These results provide preliminary evidence suggesting that a cooling mattress pad used while sleeping can provide a nonpharmacological option to reduce VMS and sleep disturbance for women experiencing menopausal hot flashes.

Sleep disturbance among breast cancer survivors and controls from midlife to early older adulthood: Pink SWAN.

PURPOSE: To compare sleep disturbance from 5 years pre- to 5 years post-diagnosis between breast cancer survivors (BCS) and women without cancer over the same period and to identify BCS subgroups exhibiting different sleep trajectories. METHODS: Analyses included data from 152 BCS and 2163 controls from 20 years of follow-up in the longitudinal Study of Women's Health Across the Nation (SWAN), a multi-racial/ethnic cohort study. SWAN participants were assessed approximately annually from 1995 to 2015 using a standardized protocol. Pink SWAN focused on women who reported no cancer at SWAN enrollment and developed incident breast cancer after enrollment or did not develop breast cancer. Nonparametric locally weighted scatterplot smoothing plots and linear mixed models were used to compare the prevalence of the most frequently reported sleep problem, frequently waking several times a night (a sleep maintenance problem) during the previous 2 weeks, between BCS and controls in the 5 years pre- to 5 years post-diagnosis. We characterized heterogeneity among BCS on this sleep problem using group-based trajectories and examined pre-diagnosis variables as predictors of group membership. RESULTS: No differences were found between BCS and controls in prevalence of frequent nighttime awakenings either before or after diagnosis. Among BCS, three trajectory groups were identified. Thirty-seven percent of BCS had consistently low prevalence of waking several times per night, 30% had high prevalence, and 33% had increasing prevalence which started 2 years pre-diagnosis. Prevalence of pre-diagnosis vasomotor symptoms, anxiety, depressive symptoms, and smoking differed among these groups. CONCLUSION: Among mid-aged women diagnosed with breast cancer, this diagnosis did not trigger/amplify a sleep maintenance problem. The majority of BCS had similar levels of this sleep problem from pre- to post-diagnosis. IMPLICATIONS FOR CANCER SURVIVORS: Although sleep maintenance problems were not amplified by a cancer diagnosis, a subset of BCS may have sleep issues that should be monitored and treated, as indicated.

Chemoradiotherapy with high-dose cisplatin compared with weekly cisplatin for locally advanced head and neck squamous cell carcinoma.

INTRODUCTION: Concurrent chemoradiotherapy (CRT) using high-dose cisplatin (HDC) is standard for patients with locally advanced head and neck squamous cell carcinoma (HNSCC); weekly cisplatin (WC) is an alternative. We aim to compare retrospectively the survival and disease control outcomes between these regimens in our institutional experience. METHODS: Patients with stage III-IV HNSCC treated with definitive or postoperative CRT between 2012 and 2018 were identified. Patients were stratified by intent-to-treat CRT. Overall survival (OS) and disease-free survival (DFS) were generated and multivariable Cox models were performed. RESULTS: 193 patients were treated with concurrent HDC (n = 69), WC at 40 mg/m2 (WC40, n = 88) or WC at <40 mg/m2 (WC<40, n = 36). Treatment intent was definitive in 74% and adjuvant in 26%. Baseline differences included age, performance status and HPV status. Cumulative cisplatin dose ≥200 mg/m2 was achieved in 89% (HDC), 86% (WC40) and 25% (WC<40, P < 0.0001). For HDC, WC40 and WC<40, 2-year OS rates were 87%, 77%, 60% and 2-year DFS rates were 75%, 68% and 52%, respectively. Multivariable analysis revealed gender, performance status, primary site, T/N stage and chemotherapy as predictive of OS. Primary site, T/N stage and chemotherapy regimen were associated with DFS. Compared with HDC, no differences in locoregional control (LRC) or distant metastasis were observed between groups. CONCLUSION: Concurrent HDC is associated with increased total cisplatin intensity, OS and DFS compared with weekly cisplatin regimens. LRC was not associated with chemotherapy regimen. HDC remains the standard of care; WC40 is a reasonable alternative that does not appear to sacrifice LRC.