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.

Impact of Anti-Estrogen Therapy on Early Cardiovascular Referrals, Tests and Medications in Premenopausal Women with Operable Breast Cancer.

INTRODUCTION: Premenopausal women with high-risk hormone receptor (HR)-positive breast cancer often receive ovarian function suppression (OFS) and anti-estrogen therapy which induces near complete estrogen deprivation (NCED). This treatment improves recurrence-free survival but may increase cardiovascular risk. We sought to identify patterns of cardiovascular care and outcomes in premenopausal women with operable breast cancer. METHODS: Premenopausal women ≤ 50 years of age with stage I-III HR-positive or triple negative breast cancer (TNBC) were identified by retrospective review. We categorized women into 3 groups based on anti-estrogen therapy approach: NCED (HR + OFS), anti-estrogen therapy without OFS (HRnoOFS), and no anti-estrogen therapy (TNBC). Baseline characteristics, post-diagnosis cardiovascular events and cardiovascular actions (tests, referrals and medications) were recorded. Categorical variables were compared among the groups using chi-square and Fisher's exact tests; continuous outcomes were compared using ANOVA. RESULTS: 82, 83, and 52 women were identified in the HR + OFS, HRnoOFS, and TNBC groups respectively; mean follow-up was 5.0 years. Mean number of cardiovascular actions per year were highest in the HR + OFS group compared with HRnoOFS and TNBC groups (0.35 vs. 0.20 and 0.27, respectively; P = .036). The HR + OFS group had significantly more referrals and tests per year than the other groups. Cardiovascular medication initiation did not differ among groups. CONCLUSIONS: In this early follow-up period, there were meaningful numbers of cardiovascular actions, with women on NCED experiencing the most per year. Future work should seek to further understand the impact of anti-estrogen therapy on the cardiovascular health of premenopausal women and test strategies to mitigate cardiotoxicity.

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.

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.

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.

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.

Validation of the Lee-Jones theoretical model of fear of cancer recurrence among breast cancer survivors using a structural equation modeling approach.

OBJECTIVE: The Lee-Jones model posits that antecedent individual and interpersonal factors predicate the development of fear of cancer recurrence (FCR) through cognitive and emotional processing, which further to behavioral, emotional, and/or physiological responses. We analyzed data from FoRtitude, a FCR intervention grounded in the Lee-Jones FCR model, to evaluate associations between FCR antecedents, resources (e.g., breast cancer self-efficacy, BCSE) and psychological and behavioral consequences. METHODS: Women with breast cancer who completed treatment and reported clinically elevated levels of FCR were randomized into a 4-week online psychosocial intervention or contact control group. We assessed BCSE, FCR, and physical activity, anxiety and depression, or symptoms at baseline, 4 and 8 weeks. Separate structural equation models were constructed with both baseline data and change scores (baseline-8 weeks) to examine the pathways linking BCSE, FCR and: (1) physical activity; (2) anxiety and depression; and (3) symptoms (fatigue, sleep disturbance, cognitive concerns). RESULTS: At baseline, higher levels of BCSE were associated with lower levels of FCR. Higher FCR was associated with worse psychological effects and symptoms but not behavioral response. Change models revealed that an increase in BCSE was associated with a decrease in FCR at 8-week assessment, which was associated with reductions in psychological effects. A change in BCSE was also directly associated with reductions in psychological effects. CONCLUSIONS: Results support the Lee-Jones model as a foundation for FCR interventions among breast cancer survivors. Replicability among varied populations is needed to examine effects on behavioral outcomes of FCR such as health care utilization. CLINICAL TRIALS REGISTRATION: NCT03384992.

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.

Feasibility of Systems Support Mapping to guide patient-driven health self-management in colorectal cancer survivors.

OBJECTIVE: To evaluate feasibility of System Support Mapping (MAP), a systems thinking activity that involves creating a diagram of existing self-management activities (e.g. symptom management, health behaviors) to facilitate autonomous engagement in optimal self-management. DESIGN: One-arm pilot study of MAP in colorectal cancer survivors (NCT03520283). MAIN OUTCOME MEASURES: Feasibility of recruitment and retention (primary outcome), acceptability, and outcome variability over time. RESULTS: We enrolled 24 of 66 cancer survivors approached (36%) and 20 completed follow-up (83%). Key reasons for declining participation included: not interested (n = 18), did not perceive a need (n = 9), and emotional distress/overwhelmed (n = 7). Most participants reported that MAP was acceptable (e.g. 80% liked MAP quite a bit/very much). Exploratory analyses revealed a -4.68 point reduction in fatigue from before to 2 weeks after MAP exceeding a minimally important difference (d = -0.68). There were also improvements in patient autonomy (d = 0.63), self-efficacy (for managing symptoms: d = 0.56, for managing chronic disease: d = 0.44), psychological stress (d = -0.45), anxiety (d = -0.34), sleep disturbance (d = -0.29) and pain (d = -0.32). Qualitative feedback enhanced interpretation of results. CONCLUSIONS: MAP feasibility in colorectal cancer survivors was mixed, predominantly because many patients did not perceive a need for this approach. MAP was acceptable among participants and showed promise for improving health outcomes.

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.

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.

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.

Feasibility and Acceptability of a Multi-Modality Self-Management Intervention for Head and Neck Cancer Caregivers: A Pilot Randomized Trial.

BACKGROUND: Head and neck cancer (HNC) patients undergoing radiation therapy (RT) experience significant side effects, presenting challenging care tasks for their informal (unpaid) caregivers. HNC caregivers report low caregiving self-efficacy, high distress, and interest in supportive care interventions. OBJECTIVE: This randomized pilot trial assessed the feasibility and acceptability of a 6 to 7 week supported self-management intervention (Prepare to Care) offering psychoeducation and stress management skills building for caregivers of patients receiving RT for HNC. METHODS: Caregivers were randomized to Prepare to Care or standard of care. Primary feasibility measures included participation and retention percentages. Assessments were completed before the intervention, at intervention completion, and 6-weeks later after intervention completion. RESULTS: Caregivers (N = 38) were predominantly female (88.6%), an average age of 56 years old, and a spouse/partner to the patient (71.4%). Participation percent was 42.2%; retention at intervention conclusion was 80% and 77% at the 6-week follow-up. Quantitative and qualitative results support acceptability, with 64% to 88% reporting each intervention module was helpful (quite a bit or very). Intervention caregivers reported a significantly greater improvement in self-efficacy for progressive muscle relaxation (PMR). CONCLUSIONS: Prepare to Care and the randomized pilot trial methods are feasible and acceptable for HNC caregivers of patients receiving RT. A significant treatment effect was observed for self-efficacy for PMR, and findings were in the expected direction regarding improved caregiving self-efficacy. Further research is necessary to determine the efficacy of this intervention with a focus on increased engagement strategies and longer-term outcomes. TRIAL REGISTRATION: NCT03032250.

Pilot study to assess sexual function, quality of life (QOL) and change in vaginal dimensions following vaginal brachytherapy (VBT).

METHODS: 63 patients with early stage endometrial carcinoma treated with VBT 30 Gy in three fractions to the vaginal surface were invited to participate. 18 patients enrolled. Vaginal length and diameter were measured using original VBT cylinders to assess change. Patients completed sexual function, QOL, and toxicity questionnaires. The assessment of patients' sexual function relative to national mean was calculated and reported by the Health Measures Scoring Service, a third party. RESULTS: Median length of time from VBT start until research visit was 3.6 years. Mean original vaginal length of the 18 women was 13.7 cm (Range: 11-18 cm); mean original diameter was 3.0 cm (Range: 2.5-3.5 cm). There was a significant decrease in vaginal length of 1.2 cm (p = 0.0005). There was a mean vaginal diameter decrease of 0.03 cm that was not significant. Toxicities were grade 1-2 and infrequent. There were no grade two acute toxicities, and 1 patient (5.6%) who had a chronic toxicity, diarrhea. 7 patients had evaluable sexual function responses. Reported sexual function was above the national mean in global satisfaction, interest, and lubrication (52.9, 50.2, and 56.2 percentile). Patients performed beneath national mean in the categories of orgasm and discomfort (3.1, 46.7 percentile) which was not correlated with the decrease in vaginal length. DISCUSSION/CONCLUSION: VBT resulted in significant vaginal shortening. Patients underperformed in the categories of orgasm and vaginal discomfort relative to national mean. This report adds to the scarce literature of objective data on sexual satisfaction and vaginal sequelae of VBT for endometrial carcinoma.

A Pilot Study of a Comprehensive School Physical Activity Program in Elementary Schools: Be a Champion!

OBJECTIVE: In the present study, we sought to determine if a comprehensive school physical activity program (CSPAP) delivered using the Be a Champion! (BAC) framework was effective in increasing moderate-to-vigorous physical activity (MVPA) and decreasing sedentary time in elementary school youth. METHODS: We implemented a CSPAP in 3 elementary schools to determine its effectiveness to youth behaviors compared to 2 control schools. Youth physical activity was assessed via accelerometry in spring 2015 and spring 2016 during school hours on school days. Implementation of the BAC components and youth behavior was assessed through direct observation from fall 2015 through winter 2016. RESULTS: In a multilevel, mixed model examining the effects of intervention, we found no statistically significant effect of the intervention on overall MVPA. However, a significant increase in MVPA was observed among girls (but not boys) in the intervention schools relative to controls. No differences in sedentary behaviors were observed by group. CONCLUSION: CSPAP implementation may be effective in reducing sedentary time and increasing MVPA in girls, but not boys. Research is necessary to increase implementation dose and fidelity to best practices in physical activity promotion.

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.

Targeted eHealth Intervention to Reduce Breast Cancer Survivors' Fear of Recurrence: Results From the FoRtitude Randomized Trial.

BACKGROUND: Fear of recurrence (FoR) is a prevalent concern among breast cancer survivors (BCS), yet few accessible interventions exist. This study evaluated a targeted eHealth intervention, "FoRtitude," to reduce FoR using cognitive behavioral skills training and telecoaching. METHODS: BCS (N = 196) were recruited from an academic medical center and 3 National Cancer Institute Community Oncology Research Program community sites, had stage 0-III breast cancer, were 1-10 years postprimary treatment, with moderate to high FoR and familiarity with the internet. Using the Multiphase Optimization Strategy, participants were independently randomly assigned to 3 cognitive behavioral skills (relaxation, cognitive restructuring, worry practice) vs an attention control condition (health management content [HMC]) and to telecoaching (motivational interviewing) vs no telecoaching. Website content was released across 4 weeks and included didactic lessons, interactive tools, and a text-messaging feature. BCS completed the Fear of Cancer Recurrence Inventory at baseline and at 4 and 8 weeks. Fear of Cancer Recurrence Inventory scores over time were compared using mixed-effects models. All statistical tests were 2-sided. RESULTS: FCRI scores [SD] decreased statistically significantly from baseline to postintervention (T0 = 53.1 [17.4], T2 = 41.9 [16.2], P < .001). The magnitude of reduction in FCRI scores was comparable across cognitive behavior therapy (CBT) and attention control HMC conditions and was predicted by increased self-efficacy. Telecoaching was associated with lower attrition and greater website use (mean adherence score [SD] = 26.6 [7.2] vs 21.0 [10.5], P < .001). CONCLUSIONS: BCS experienced statistically significant reductions in FoR postintervention, but improvements were comparable between CBT and attention controls. Telecoaching improved adherence and retention. Future research is needed on optimal integration of CBT and HMC, dose, and features of eHealth delivery that contributed to reducing FoR. In the COVID-19 era, remote delivery has become even more essential for reaching survivors struggling with FoR.