Patient-reported Outcome Surveys Research Articles

The use of actigraphy to objectively define motion and function before and after shoulder arthroplasty

IntroductionActigraphy is a quantitative means of measuring activity data that has proven viable in post-surgery recovery analysis for arthroplasties in lower extremities, but scant literature has been published on the utilization actigraphy to evaluate shoulder motion and function before and after shoulder arthroplasty. The purpose of this prospective cohort study is to identify if actigraphy can serve as a valid means for objective evaluation of shoulder function and motion before and after shoulder arthroplasty. Secondarily, the data collected by the actigraphy can be analyzed with standard patient-reported outcomes to report correlations between the subjective and objective methods used in this study. Materials and methodsSixty-four subjects wore an actigraphy device for one day at pre-op, six, twelve and twenty-four weeks. In addition, subjects completed three patient-reported outcome surveys at each time-point. Student t-tests were used to compare percent activity preoperatively with 24-weeks and to compare PROs preoperatively with 24-week results; categorical variables were compared with one-way ANOVAs. ResultsAll Patient reported outcome scores significantly improved following arthroplasty (p-value<0.001). The percent of physical activity was highly correlated with vector magnitude (p-value<0.001), but neither percent activity or the vector magnitude were correlated with any of the PROs: UCLA Pain p-value = 0.656, SANE p-value = 0.328, UCLA Function p-value = 0.532. ConclusionsActigraphy results from this study mirror findings in previous literature utilizing the technology in similar manners and demonstrate its potential for motion and function analysis before and after total shoulder arthroplasties. Despite both being suitable methods independently for the evaluation of shoulder function, there was no significant correlation between standard actigraphy measurements and PROs at 24-weeks. Future research to determine clinical utility and an overall broader scope for actigraphy monitoring could benefit from improved technology, such as increased battery life for prolonged durations of data collection during observation periods.

Clubfoot Correction with Ponseti Technique: Three-Dimensional Alignment Analysis and Residual Adult Deformity Effects on Patient-Reported Outcomes

Introduction/Purpose: Few studies have assessed the long-term outcomes of the Ponseti technique and none have utilized 3- dimensional weightbearing analysis. The goal of this study was to understand how potential residual 3D deformities and abnormalities influence patient reported outcomes (PROs). This was accomplished by assessing anatomical foot and ankle alignment in adult clubfoot patients treated with the Ponseti method using 3D weightbearing CT (WBCT) imaging and then correlating residual foot and ankle malalignment with PROs. Methods: There were 37 consecutive patients (57 feet) included and 14 volunteers healthy controls (28 feet) included in this study. Every participant was evaluated using a WBCT (HiRise©) in a bipedal standing position. From these scans Cavus, Adductus, and Varus components were evaluated using multiple 3D measurements calculated using the semi-automatic segmentation software Bonelogic®. Specific Cavus related measurements included sagittal talus-first metatarsal angle and the calcaneal inclination angle. Varus related measurements included talocalcaneal angle in both the sagittal and axial planes as well as the hindfoot moment arm and the hindfoot alignment angle. Adductus deformity was evaluated using talonavicular coverage angle. These measurements were then correlated with patient reported outcome surveys, which included Visual Acuity Scale for pain, PROMIS general health, PROMIS physical function, PROMIS pain interference, pain catastrophic scale, and European foot and ankle society score. Results: There was no significant overall residual 3D-deformity observed in clubfoot patients when compared to controls, with similar FAO measurements observed between the groups, clubfoot=2.63% (95%CI=1.41%-3.85%) and control=3.2% (CI=1.6%- 4.8%,P=0.58). The sagittal talus-first-metatarsal in the clubfoot-patients had a mean-value of -0.12° compared to the controls, −5.2°. Clubfoot patients also had a decreased calcaneal-inclination-angle relative to the controls, 13.01° and 21.5° respectively. Talocalcaneal-angle for clubfoot patients in both the sagittal-plane,44.28°, and axial-plane, 17.74°, were reduced compared to the controls, 57.51° and 25.78°. Talonavicular-coverage-angle in the clubfoot-group (18.63°) was less than the controls (29.19°). Talus- first-metatarsal-angle in the sagittal-plane was significantly correlated with VAS-scores (RSquare=0.19,P=0.0118) and the EFAS- Score (RSquare=0.27,P=0.0025). Talocalcaneal-angle in the sagittal plane was also significantly correlated with the PROMIS-Pain- Interference-score (P=0.038) and PROMIS-Physical-Function-score (RSquare=0.32,P=0.0007). Conclusion: The Ponseti technique is an effective nonsurgical treatment for the overall three-dimensional foot and ankle alignment of Clubfoot. While mild, but statistically significant residual Varus and Adductus deformities were observed in adult clubfoot patients, the overall 3D alignment (FAO) was found to be similar between clubfoot patients and controls. These findings highlight the efficacy of the Ponseti technique and potentially explain the overall good PROs. The results of this study could potentially provide insight into treatment targets that may be applied to help optimize patient outcomes when treating children with Clubfoot in the future. The Ponseti technique is an effective nonsurgical treatment for Clubfoot's overall three-dimensional foot and ankle alignment. While mild, but statistically significant residual Varus and Adductus deformities were observed in adult clubfoot patients, the overall 3D alignment (FAO) was found to be similar between clubfoot patients and controls. These findings highlight the efficacy of the Ponseti technique and potentially explain the overall good PROs. The results of this study could potentially provide insight into treatment targets that may be applied to help optimize patient outcomes when treating children with Clubfoot in the future.

Prospective Trial of Functional Lung Avoidance Radiation Therapy for Lung Cancer: Quality of Life Report

PurposeA novel form of lung function imaging has been developed that uses 4DCT data to generate lung ventilation images (4DCT-ventilation). Functional avoidance uses 4DCT-ventilation to reduce doses to functional lung with the aim of reducing pulmonary side-effects. A 4DCT-ventilation functional avoidance, phase II, multi-center clinical trial was completed. The purpose of this work is to quantify patient reported outcomes (PRO) changes for patients treated with functional avoidance and to determine which metrics are predictive of PRO changes. Materials and MethodsPatients with locally advanced lung cancer receiving curative intent radiotherapy were accrued. Each patient had a 4DCT-ventilation image generated using 4DCT data and image processing. PRO instruments included the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, administered pre-treatment, 3, 6, and 12 months post-treatment. FACT-TOI (Trial Outcome Index) and the FACT-LCS (Lung Cancer Subscale) percentage of clinically meaningful declines (CMD) were determined. A linear mixed-effects model was used to determine which patient, clinical, dose, and dose-function metrics were predictive of PRO decline. Results59 patients completed baseline PRO surveys. 83% of patients had non-small-cell lung cancer, with 75% having stage III disease. The median dose was 60 Gy in 30 fractions. CMD FACT-TOI decline was 46.3%, 38.5%, and 26.8%, at 3, 6, and 12 months, respectively. CMD FACT-LCS decline was 33.3%, 33.3%, and 29.3%, at 3, 6, and 12 months, respectively. While an increase in most dose and dose-function parameters was associated with a modest decline in PROs, none of the results were significant (all p>0.053). ConclusionThe current work provides an innovative combination of functional avoidance and PROs and is the first report of PROs for patients treated with prospective 4DCT-ventilation functional avoidance. Approximately 30% of patients had clinically significant decline in PROs at 12 months. The study provides additional data on outcomes with 4DCT-ventilation functional avoidance.

Cryoballoon pulmonary vein isolation versus radiofrequency ablation of the pulmonary veins and left atrial posterior wall: Patient-reported outcomes.

Data are lacking on patient-reported outcomes (PRO) following cryoballoon ablation (CBA) versus radiofrequency ablation (RFA). We sought to evaluate QoL and clinical outcomes of cryoballoon pulmonary vein isolation only (CRYO-PVI-ONLY) versus RFA with PVI and posterior wall isolation (RF-PVI+PWI) in a large prospective PRO registry. Patients who underwent AF ablation (2013-2016) at our institution were enrolled in an automated, prospectively maintained PRO registry. CRYO-PVI-ONLY patients were matched (1:1) with RF-PVI+PWI patients based on age, gender, and type of AF (paroxysmal vs. persistent). QoL and clinical outcomes were assessed using PRO surveys at baseline and at 1-year. The atrial fibrillation symptom severity scale (AFSSS) was the measure for QoL. Additionally, we assessed patient-reported clinical improvement, arrhythmia recurrence, and AF burden (as indicated by AF frequency and duration scores). A total of 296 patients were included (148 in each group, 72% paroxysmal). By PRO, a significant improvement in QoL was observed in the overall study population and was comparable between CRYO-PVI-ONLY and RF-PVI+PWI (baseline median AFSSS of 11.5 and 11; reduced to 2 and 4 at 1 year, respectively; p=0.44). Similarly, the proportion of patients who reported improvement in their overall QoL and AF related symptoms was high and similar between the study groups [92% (CRYO-PVI-ONLY) vs. 92.8% (RF-PVI+PWI); p=0.88]. Arrhythmia recurrence was significantly more common in the CRYO-PVI-ONLY group (39.7%) compared to RF-PVI+PWI (27.7 %); p=0.03. Comparable results were observed in paroxysmal and persistent AF. CRYO-PVI-ONLY and RF-PVI+PWI resulted in comparable improvements in patient reported outcomes including QoL and AF burden; with RF-PVI+PWI being more effective at reducing recurrences.

Association of Social Determinants with Patient-Reported Outcomes in Patients with Cancer.

Patient-reported outcome (PRO) scores have been utilized more frequently, but the relationship of PRO scores to determinants of health and social inequities has not been widely studied. Our goal was to determine the association of PRO scores with social determinants. All patients with a new cancer diagnosis who completed a PRO survey from 2020 to 2022 were included. The PRO survey recorded scores for depression, fatigue, pain interference and physical function. Higher depression, fatigue and pain scores indicated more distress. Higher physical condition scores indicated improved functionality. A total of 1090 patients were included. Married patients had significantly better individual PRO scores for each domain. Patients who were able to use the online portal to complete their survey also had better individual scores. Male patients and non-White patients had worse pain scores than female and White patients, respectively. Patients with prostate cancer had the best scores while patients with head and neck and lung cancer had the worst scores. PRO scores varied by cancer disease site and stage. Social support may act in combination with specific patient/tumor factors to influence PRO scores. These findings present opportunities to address patient support at institutional levels.

Can RESPiratory hospital Admissions in children with cerebral palsy be reduced? A feasibility randomised Controlled Trial pilot study protocol (RESP-ACT)

IntroductionThe most common cause of morbidity and mortality in children with severe cerebral palsy (CP) is respiratory disease. BREATHE-CP (Better REspiratory and Airway Treatment and HEalth in Cerebral Palsy) is...

EMBARK post hoc analysis of sexual activity (SA) patient-reported outcome (PRO) measures.

313 Background: In the phase 3 EMBARK trial (NCT02319837), enzalutamide (ENZ) + leuprolide (L) and ENZ monotherapy (mono) delayed metastasis-free survival (MFS) vs placebo (P) + L without impairing global health-related quality of life (HRQoL) in high-risk biochemically recurrent (BCR) nonmetastatic hormone-sensitive prostate cancer (nmHSPC) (PSA doubling time ≤9 months). A prespecified PRO analysis showed that SA (measured as a composite score using European Organization for Research and Treatment of Cancer QoL Questionnaire-Prostate 25 [QLQ-PR25]) was better preserved with ENZ mono vs P + L and no significant difference between ENZ + L vs P + L. A post hoc analysis at the HRQoL item level was conducted to understand the effect on SA in each comparison and enable shared decision-making between physicians and patients. Methods: Men with high-risk BCR nmHSPC were randomized (1:1:1) to ENZ + L (double blind), ENZ mono (open label), and P + L (double blind). HRQoL was assessed at baseline and every 12 weeks until metastasis/death. This post hoc analysis assessed effects on time to confirmed (two consecutive visits) deterioration (TTCD) using predefined thresholds of one category decline from baseline in sexual interest, activity, satisfaction, erectile function, and feeling like a man using QLQ-PR25 item 50; QLQ-PR25 item 51; FACT-P item GS7; FACT-P item BL5; and FACT-P item P5 measures, respectively (Table). Intent-to-treat principle was applied. Results: At baseline, 327–332 men per arm completed the PRO surveys; overall completion rates were ≥85%, except for GS7 (≤36% due to voluntary response). ENZ mono vs P + L : TTCD in items 50 (interest) and 51 (activity), GS7 (satisfaction), and BL5 (erectile function) was delayed with ENZ mono. ENZ + L vs P + L: no significant differences in TTCD were observed, except a shorter TTCD by a median 0.06 months in BL5 (erectile function) with ENZ + L (Table). Conclusions: This post hoc item-level analysis of the EMBARK trial confirmed that SA was better preserved with ENZ mono vs P + L in terms of interest, activity, satisfaction, and maintaining erection. Further, the SA PROs were similar between ENZ + L and P + L, implying there is no further SA burden when adding ENZ to androgen-deprivation therapy. Clinical trial information: NCT02319837 . [Table: see text]

Patient reported outcomes (PROs) and user experiences of young children with type 1 diabetes using t:slim X2 insulin pump with control-IQ technology

ObjectiveExamine patient-reported outcomes (PROs) after the use of t:slim X2 insulin pump with Control-IQ technology (CIQ) in young children with type 1 diabetes. MethodsChildren with type 1 diabetes, ages 2 to < 6 years (n = 102), were randomly assigned 2:1 to either CIQ or standard care (SC) with pump or multiple daily injections (MDI) plus continuous glucose monitoring (CGM) for 13 weeks. Both groups were offered to use CIQ for an additional 13 weeks after the randomized control trial’s (RCT) completion. Guardians completed PRO questionnaires at baseline, 13-, and 26-weeks examining hypoglycemia concerns, quality of life, parenting stress, and sleep. At 26 weeks, 28 families participated in user-experience interviews. Repeated measures analyses compared PRO scores between systems used. ResultComparing CIQ vs SC, responses on all 5 PRO surveys favored the CIQ group, showing that CIQ was superior to SC at 26 weeks (p values < 0.05). User-experience interviews indicated significant benefits in optimized glycemic control overall and nighttime control (28 of 28 families endorsed). All but 2/28 families noted substantial reduction in management burden resulting in less mental burden and all but 4 stated that they wanted their children to continue using CIQ. ConclusionsFamilies utilizing CIQ experienced glycemic benefits coupled with substantial benefits in PROs, documented in surveys and interviews. Families utilizing CIQ had reduced hypoglycemia concerns and parenting stress, and improved quality of life and sleep. These findings demonstrate the benefit of CIQ in young children with type 1 diabetes that goes beyond documented glycemic benefit.

Prophylactic Posterior Targeted Muscle Reinnervation (TMR) Approach in Below Knee (BKA) Amputation Settings

Background/Objective: Targeted muscle reinnervation (TMR) is a nerve reconstruction technique focused on improving phantom limb pain (PLP), residual limb pain (RLP), prosthesis function, and limiting neuroma formation. In below-knee-amputations (BKA), TMR performed "through-the-wound" is heavily documented. Alternatively, the "posterior approach" was developed to help increase visibility of peripheral nerves from the posterior fossa. This study focuses on the surgical efficiency and patient outcomes of the posterior approach compared to the through-the-wound approach. We hypothesize the posterior approach will be comparable toor improve time-to-prosthesis fitting, OR time, and pain scores.&#x0D; Methods: 157 patients underwent TMR at two hospitals in Indianapolis, IN, and were identified using CPT 64890. 39 patients underwent posterior approach TMR post-BKA. Data on demographics, follow-up/rehabilitation visits, post-operative complications, prosthesis fitting, and total OR time were collected. Additionally, 32 patients received TMR "through-the-wound", and total OR time, post-operative complications, and time-to-prosthesis fitting were tracked. Patient-reported outcome (PRO) surveys are being sent to patients pending IRB approval.&#x0D; Results: Of the 39 who received the posterior approach between 1/10/2020 and 4/6/2023, 25 received TMR in the right leg and 14 in the left. Following BKA, average time to TMR was 144 days. However, 18 patients received TMR directly after undergoing BKA (46.2%). Average OR time for acute and delayed posterior TMR patients was 208.06 minutes and 199.47 minutes, respectively. 10 patients reported post-operative complications (25.6%): dehiscence (12.8%) or infection (7.7%). 23 patients received prosthesis fitting on average 3 months post-op. Average OR time and time-to-prosthesis fitting for "through-the-wound" TMR surgeries were 192.84minutes and 5.81 months, respectively.&#x0D; Potential Impact: Posterior approach TMR had no significant impact on OR time, but time-to-prosthesis fitting significantly decreased. Once PRO surveys return, average long-term PLP and RLP can be determined. Preliminarily, posterior approach TMR improves aspects of patient outcomes while not compromising surgical efficiency.

Patient-Reported Outcome Measures Associated with Overall Survival and Acute Care Use in Patients with Newly Diagnosed Myelodysplastic Syndrome, Acute Myelogenous Leukemia, or Acute Lymphoblastic Leukemia

Background: There is limited data on the real-world application of patient-reported outcomes (PROs) and their clinical utility in patients with acute leukemias or myelodysplastic syndrome (MDS). While the associations of PROs with clinical outcomes, such as overall survival (OS) and acute care utilization have been established in patients with solid tumors (Basch E et al. JAMA, 2017.318(2):197-198), these same associations are not well known in patients with hematologic malignancies. Objectives: We assessed the characteristics of baseline PRO measurements in patients with newly diagnosed acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS) and examined their associations with OS as well as time to acute care use (TAC). Methods: This retrospective cohort study was conducted on patients with newly diagnosed AML, ALL or MDS between 11/2018-02/2022 who were receiving care at our institution and completed a baseline PRO survey within 30 days of therapy initiation. The PRO survey consisted of a 14-question assessment from the National Cancer Institute's PRO Version of The Common Terminology Criteria for Adverse Events. Each of the symptom domains of the survey are measured on a 1-5 Likert scale. OS was defined as time from therapy initiation to the time of death. TAC was defined as time from therapy initiation to first unplanned acute care visit (emergency room visit or unplanned admission). OS curves were estimated using the Kaplan-Meier method and compared using log-rank tests. Cox proportional-hazards regression modeling was used to compare the hazards of death and acute care use between groups. Results: 56 patients were included with a median age of 63 years (range 26-79). The cohort consisted of more males, non-Hispanic Whites, and patients that received intensive initial therapy (Table 1). Fatigue was the most frequently reported symptom (n=49, 87.5%, mean score of 2.90/5 (SD 1.30), with a majority reporting mild or no symptoms (score &amp;lt; 4, n=33, 58.9%) and 28.6% (n=16) reporting more severe symptoms (scores &amp;gt; or = 4). Similarly, most patients in this cohort reported mild or no symptoms in terms of anorexia, anxiety, or sadness (Table 1). In terms of OS, univariate models for the presence of fatigue, anorexia, anxiety, or sadness was not associated with significantly higher hazard of death. On multivariate analyses adjusting for age, sex, and treatment intensity, every point increase in reported fatigue severity was associated with a 41% increased hazard of death (HR 1.41,95% CI: 1.03-1.93). When stratified by fatigue severity (&amp;gt; or = 4 severe vs &amp;lt; or = 3 mild/no symptoms), patients reported severe fatigue had an 145% increased hazard of death compared to those reported mild/no fatigue (HR 2.45 (95% CI: 1.07-5.61) (Figure 1). Multivariate analyses for anorexia, anxiety, and sadness were not associated with significant differences after adjusting for the above covariates, respectively. Fourteen (25.0%) and 24 (42.9%) patients in this cohort had at least one unplanned acute care visit within 30 and 90 days from initiation of therapy, respectively. The median TAC for this cohort was 4.15 months (range 0.60-27.20 months). Univariate regression modeling revealed no differences for any of the PROs examined in this study. Similarly, no differences were observed in multivariate analyses for each of the PROs after adjusting for age, sex, and therapy intensity. Conclusions: Fatigue was the most severe and frequently reported baseline symptom among patients with newly diagnosed acute leukemia or MDS. Patients reporting increased fatigue were found to have a higher hazard of death compared to those who did not after adjusting for age, sex, and treatment intensity. The characteristics and PROs examined in this study were not associated with TAC or predictive of acute care use at different time points from therapy initiation. Future work is needed to understand how PRO data can be used to identify higher-risk patients prior to treatment initiation.

Patient-Reported Outcomes Among Patients with Triple-Class Refractory Multiple Myeloma in Real-World Clinical Practice: A Prospective, Multi-Site Observational Study

BACKGROUND Several studies have highlighted the poor outcomes observed among patients with relapsed/refractory multiple myeloma (MM), particularly those with triple-class refractory (TCR; refractory to at least one PI, one IMiD, and one anti-CD38 mAb) disease. The aim of this study was to describe the longitudinal changes in quality of life (QOL) and other patient-reported outcomes (PROs) among TCR MM patients in real-world clinical practice who initiate a new line-of-therapy. METHODS A prospective, multi-site observational study of patients with TCR MM was conducted through the Mayo Clinic system. Patients initiating a new post-TCR therapy (defined as the index date) were followed for a 12-month observation period during which PRO surveys were administered for the first 6 months. For patients initiating a CAR-T therapy, a survey assessment was conducted at apheresis, lymphodepletion chemotherapy, and every month after T-cell infusion until Month 6. All other patients received a survey assessment before index and then every month thereafter until Month 6. PRO measures included the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30; including the Global Health Score [GHS]), the EORTC Multiple Myeloma Questionnaire (QLQ-MY20; including the Disease Symptoms [DS] domain score), the EORTC QLQ for Chemotherapy-Induced Peripheral Neuropathy (CIPN20), the EuroQoL-5 Dimensions (EQ-5D), the Patient Global Impression of Severity (PGIS), and the Patient Global Impression of Change (PGIC). Patient surveys were supplemented with retrospective chart reviews conducted 3 months and 12 months following the index date to obtain clinical information. Descriptive data were reported at each timepoint separately for patients who received CAR-T and non-CAR-T index therapies. The study is ongoing and this abstract reflects all patient visit data as of April 2023. RESULTS N=55 patients (60% male, 96% White, mean age 66 years) were included in this interim analysis. The median time interval between becoming TCR and the index date was 3.9 months (interquartile range [IQR]: 1.7, 15.5). Most patients had an ECOG score of 0 or 1 (53% and 38%, respectively) and were R-ISS I or II (36% and 54%, respectively); 53% of patients had high-risk cytogenetics and 20% had extramedullary disease. The median (IQR) number of prior treatment lines was 4 (4.0, 5.5). N=24 patients initiated a CAR-T therapy as their index therapy (equally split between ide-cel and cilta-cel); the remaining N=31 patients predominantly initiated a treatment regimen containing an IMiD (52%), a PI (55%), an anti-CD38 antibody (13%), or an alkylating agent (36%). Among CAR-T patients, QOL and disease-related symptoms worsened from baseline through Month 2-3 (eg, mean GHS was 65.9 at apheresis, 64.9 at lymphodepletion, and 53.3 at Month 2 [higher scores indicate better QOL]; mean DS domain score from the QLQ-MY20 was 24.1 at apheresis, 23.4 at lymphodepletion, and 33.7 at Month 2 [higher scores indicate more symptoms]; see Table 1). These decrements were followed by improvement back to baseline levels and, in some cases, improvement above baseline levels (eg, GHS was 67.9 and 65.0 at Months 4 and 5, respectively; DS was 18.3 and 17.8 at Months 4 and 5), though few patients had sufficient follow up to analyze QOL at later timepoints. Based on the PGIC, 77.8% of patients reported being “a little better” or “much better” as early as Month 1, though this number declined over time. Among non-CAR-T patients, QOL largely plateaued (GHS was 62.2 at baseline and 58.3 at Month 6), though disease symptoms improved over time (DS was 28.6 at baseline and 24.5 at Month 6; pain was 42.3 at baseline and 29.2 at Month 6). Based on the PGIC, 34.7% of patients reported being “a little better” or “much better” at Month 1, which improved to 50% by Month 6. CONCLUSIONS In this interim analysis of an ongoing prospective observational study, QOL and symptom measures generally worsened over the first few months for CAR-T patients in the real-world though improved to baseline levels and beyond at later time points. Patients did, however, directly report improvement in their disease state as early as Month 1 based on the PGIC. Non-CART patients generally showed a QOL plateau with some modest improvement in disease symptoms which was also reflected in their self-reported assessment of disease state improvement based on the PGIC.

Patient-Defined Symptom Burden and Treatment Utilization in a Home-Reported Outcomes (HRO) Study in Sickle Cell Disease (SCD)

Introduction: Sickle cell disease (SCD) is a complex genetic disorder exhibited by diverse symptoms and treatment needs. Past studies have assessed the impact of SCD on patients' symptoms and disease management through patient-reported outcome (PRO) surveys, qualitative interviews, and eDiaries. Challenges associated with point-in-time data capture can hinder researchers' ability to capture the individualistic SCD experience. With the emergence of therapies like voxelotor (Oxbryta),which binds to sickle hemoglobin to reduce hemolysis and anemia, real-world evidence data can be used to close the gap between traditional endpoints and patients' experience of SCD. Objectives: The Ascend Study was designed with a flexible patient-reported data collection approach to understand day-to-day burden by collecting home-reported outcomes (HROs) through the Folia Health mobile and web-based platform. The objectives of the Ascend Study were to 1) Identify the most important symptoms-of-interest to individuals living with SCD; and 2) Understand treatments-in-use among participants taking and not taking voxelotor. Methods: The Advarra IRB-approved study used clinic referrals and community-based organizations to enroll a target of 75 participants. Individuals were eligible if diagnosed with SCD of any genotype residing in the US, aged 13 years and above (self-reported), and caregivers of children aged 4 to 12. Participants selected symptoms and treatments relevant to their individual SCD experience to routinely track in the platform for 3 months on a weekly basis, reporting treatment usage and changes in symptom severity on a 1 to 10 Likert scale. Monthly check-in surveys were conducted to review overall health. Participants could monitor symptom severity history, set treatment reminders, and generate graphs and insight reports in-platform. The study team analyzed active participants, defined as those who completed the study start survey, routine tracking weekly, and at least 2 of 3 monthly check-in surveys. Summary statistics of symptom tracking and treatment usage (including dosage) and subgroup analyses were performed for individuals taking voxelotor and those not taking it. Voxelotor usage was captured through an initial survey, including respective therapy start date (See Table 1). Results: 66 (80.4%) of 84 participants enrolled became active participants and, on average, selected 4.16 (SD=3.25) treatments as part of their routine and tracked a total of 88 distinct treatments. Folic acid was the most frequently selected (n=56) and tracked treatment. 11 types of pain medications were tracked by participants. The average person tracked 4.05 (SD=3.24) different treatments during the study, 2.19 (SD=1.24) of those pain-related. On average, participants taking voxelotor had lower total exposure to NSAID and opioid medication. Participants selected 6.41 (SD=2.84) symptom types and tracked 8.5 (SD=6.07) symptoms during the study. Majority of participants selected fatigue, chronic pain, and trouble concentrating (see Table 2). Participants on voxelotor tracked symptoms at an average of 3.58/10 severity (SD=1.07); those not on voxelotor tracked an average of 5.06/10 severity (SD=0.75). Fatigue was the most frequently tracked symptom overall (3,648 tracks), with an average of 55 fatigue tracks per participant over the 3-month period. This was closely followed by chronic pain (3,572 tracks). 91% (n=60) of all participants tracked each of these symptoms at least once. ‘Chest tightness or pain’ emerged as another important symptom that was tracked by 15 of 66 participants, at an average of 59 tracks per participant. Conclusion: Overall, the ASCEND study underscores the importance of understanding the holistic experience of individuals with SCD and highlights the need for individualized care approaches. Collecting HROs through a novel mobile and web-based platform gives direct insight into the symptom profiles and treatment patterns in SCD, which can lead to a focus towards improved management strategies and better quality of life for individuals living with this complex genetic disorder. These findings have the potential to contribute to the development of more patient-centered approaches to SCD management and help inform providers about the most important symptoms and treatment needs of their patients.

Study Assessing the All4Cure Health Technology Intervention on Patient Activation in Multiple Myeloma

BACKGROUND Over the past 2 decades, outcomes have improved markedly in patients with multiple myeloma, a result attributable to the development of highly effective agents such as immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies. However, multiple myeloma remains incurable despite these advances. Furthermore, with each successive relapse, the disease becomes increasingly resistant to treatment. Therefore, patients need methods to best identify those regimens most likely to benefit them. All4Cure has built a myeloma-focused knowledge-sharing platform for patients, clinicians, and researchers. Patients register and sign HIPAA (Health Insurance Portability and Accountability Act) release forms allowing All4Cure to access all medical records from all institutions from which they have received care. A team of myeloma-dedicated medical data specialists then extracts information from the medical records and displays it on each patient's deidentified, personalized dashboard. Patient dashboards display results of monthly patient-reported outcome (PRO) surveys and feature a graph depicting all treatments and responses, from diagnosis to present. A summary is also provided, containing a narrative of the patient's relevant past medical history. This allows a community of &amp;gt;2000 participating patients, clinicians, and researchers to post comments, questions, or suggestions in a discussion panel. With &amp;gt;800 participating patients with multiple myeloma, All4Cure can help inform the treatment decisions of a patient and their oncologist by providing insight into the treatment choices and outcomes of hundreds of other patients. Patient activation levels predict a broad range of health-related behaviors and outcomes and can be assessed using the 13-item Patient Activation Measure (PAM-13) instrument. Here we report an ongoing prospective cohort study to evaluate the impact of All4Cure enrollment on patient activation levels. METHODS The trial is enrolling 200 adults aged ≥18 years with a diagnosis of multiple myeloma. Patients unable to engage with the platform or who have previously enrolled in All4Cure are excluded. After providing informed consent, patients will complete quarterly PAM-13 surveys, monthly PRO assessments, and surveys to assess their attitudes regarding All4Cure at baseline and on completion of the 12-month study. Oncologists also consent to answer surveys to assess their attitudes regarding All4Cure at baseline and on study completion. The primary objective of the trial is to assess the effect of All4Cure enrollment on patient activation as assessed using PAM-13. Secondary objectives include evaluation of the associations between patient activation and symptom burden and patient and physician expectations of the utility of the platform. The trial is registered at ClinicalTrials.gov (NCT05673083) and sponsored by the GSK Patient Empowerment Alliance, a program created to help test, measure, and validate tools that show potential to empower patients as core members of their oncology care team, with the goal of improving care outcomes.

Primary Analysis of Spartan: A Phase 2 Trial to Assess the Efficacy and Safety of Crizanlizumab in Patients with Sickle Cell Disease Related Priapism

Introduction: Priapism is a painful, sustained penile erection that occurs in 35% of adult men with sickle cell disease (SCD) and may result from the underlying mechanism of vaso-occlusion. To date, there is no effective disease-modifying drug proven to treat priapism. Crizanlizumab is a monoclonal antibody that binds and blocks P-selectin, a key mechanistic component of vascular endothelial adhesion. Based on the results of the SUSTAIN trial, crizanlizumab was approved by the FDA to reduce the frequency of vaso-occlusive crises in patients with SCD aged ≥16 years. In this primary analysis of the Phase 2 SPARTAN trial (NCT03938454), we evaluated the efficacy and safety of crizanlizumab after 26 weeks of treatment in patients with SCD-related priapism. Methods: The SPARTAN trial included male patients aged ≥12 years with all SCD genotypes who experienced ≥4 priapic episodes lasting ≥60 min over the 14-week period preceding screening. Eligible patients also experienced ≥3 priapic episodes during the subsequent 12-week screening period with ≥1 event occurring within 4 weeks prior to the first treatment. After enrollment priapic events were documented through electronic self-reporting tools and validated patient-reported outcomes surveys for 26 weeks and included start/end date, sleep status, duration, non-pharmacological treatment, triggers, emergency department visit, and pain intensity during the screening period. Baseline priapic events were collected for each patient during the 12-week screening period. Patients received crizanlizumab 5.0 mg/kg IV infusion on week 1, week 3, and every 4 weeks thereafter. The primary endpoint was percent reduction from adjusted baseline period in priapic events by 26 weeks. Percent reduction from baseline in priapic events was tested using a one-sided Wilcoxon's Sign Rank test. Hodges-Lehmann estimate of median percent reduction in priapic events (with 95% CIs) was also reported. Results: Data cutoff was March 28, 2023. Of the 36 patients enrolled, 26 (72.2%) were between 18 and 40 years, and the median (range) age was 29 (14-58) years. Most patients were HbSS genotype (n=29, [80.6%]) and more than half were on hydroxyurea (n=21, [58.3%]). Patient-reported history prior to crizanlizumab treatment revealed that more than half of patients experienced priapism daily or every other day (n=21, [58.3%]) and most reported a duration of 1 to 5 h (n=33, [91.7%]). The most common patient-reported emotions at the start of the study were frustration and exhaustion, reported by ≈50% of patients. The median (IQR) baseline number of priapic events adjusted for 26 weeks per patient was 42 (13-73) events ( Table). All patients experienced events lasting 1 to ≤4 h, although some also experienced severe events lasting &amp;gt;4 to 6 h (n=19, [52.8%]) and &amp;gt;6 to ≤12 h (n=11, [30.6%]). In one case, 38 days of screening period baseline data was not reported, resulting in a strong outlier that affected the results ( Patient 1, Figure). Thirty-six patients received ≥1 dose of crizanlizumab, with a median cumulative dose of 35.0 mg/kg over 26 weeks; 5 patients each missed 1 infusion and 1 patient missed 2 infusions. The Hodges-Lehmann estimate of median percent reduction from baseline in priapic events per patient was 46.0% (95% CI: 23.5%-65.4%; P=.068). Twenty-eight patients (77.8%) reported a reduction from baseline in priapic events ( Figure). A subgroup analysis revealed a trend towards a larger percent reduction in events for patients with ≥22 baseline events, possibly indicating that patients with severe disease benefitted more from treatment. The most frequent treatment-emergent adverse event (TEAE) was headache (16.7%). No patients discontinued crizanlizumab prematurely and only one patient withdrew consent by week 26. Conclusions: Primary analyses from the SPARTAN trial showed that patients with SCD-related priapism treated with crizanlizumab over 26 weeks experienced approximately half as many priapic events compared with baseline. There was a trend towards a more significant reduction in frequency of episodes in patients with severe disease. Crizanlizumab was safe and well tolerated, with observed TEAEs consistent with the safety profile seen in other clinical trials. Final analyses of the SPARTAN trial will provide data over 52 weeks and may provide further support for the role of crizanlizumab in reducing frequency of priapic events.

Treatment-Related Clinical and Humanistic Unmet Needs in Hemophilia A without Inhibitors

Introduction: Patients with hemophilia still experience significant burden of disease despite the growing availability of efficacious treatment options. Presented here are the final patient-reported data from a non-interventional study of treatment and disease burden in US patients with hemophilia A without inhibitors (HAwoI). Methods: Patients with HAwol were recruited to the PicnicHealth research platform using digital marketing, referrals and community partnerships. PicnicHealth collects and extracts medical records on behalf of the patient, provides them with their records and invites them to participate in recurring patient-reported outcome surveys. Hemophilia severity reported here was based on baseline factor values and medical records. Two validated questionnaires, Hemophilia Treatment Experience Measure (Hemo-TEM)(Brod, M. et al., J Patient Rep Outcomes. 2023) and Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile v2.0 (Hays, R.D., et al., Qual Life Res. 2018)were used to collect data on treatment and disease burden. Patients were also asked about their prophylactic medication, if any, as well as two independent questions on anxiety and/or worry concerning bleed protection with current treatment. All surveys were administered between April 2022 and April 2023, with the most recent survey included in this analysis for patients who completed multiple surveys during the study period. Hemo-TEM domain scores were transformed onto a 0 to 100-point scale with higher scores indicating greater burden. PROMIS-29 scores were transformed into T-scores, based on a reference sample with a mean of 50 and standard deviation of 10, except for the pain intensity score, which was rated 0-10. The directionality of impact was specific for each domain (Hays, R.D., et al., Qual Life Res. 2018). Results are presented as proportions, median and interquartile range (IQR, Q1-Q3). Informed consent was obtained. Results: Out of 230 patients with HAwol (91% male; median age: 33.3 years; IQR: 23.9-41.7), 147 (64%) had severe, 41 (18%) had moderate and 42 (18%) had mild hemophilia. Use of prophylactic FVIII was reported by 74 (50%), 16 (39%) and 13 (31%) patients with severe, moderate and mild hemophilia, respectively, while prophylactic non-factor replacement therapy use was reported by 64 (44%), 8 (20%) and 5 (12%) patients, respectively (treatment classes are not mutually exclusive). Treatment class was unspecified (includes patients who did not report prophylactic medication use) for 58 (25%) patients. Treatment burden was observed through Hemo-TEM scores across all subgroups of disease severity and treatment class (n=223), with the strongest drivers being physical impact (median: 25 [IQR: 12-38]), treatment bother (21 [9-32]) and emotional impact (21 [6-38]) domains (Table 1). The PROMIS-29 scores and its directionality shown in Figure 1 demonstrated comparable disease burden in all domains regardless of disease severity or treatment class (n=228). Patients with severe disease on prophylactic FVIII/prophylactic non-factor replacement therapy reported scores of 42 (37-50)/46 (39-57) in physical functioning and 51 (49-61)/49 (46-55), 57 (52-64)/56 (42-60) and 52 (48-56)/52 (46-56) in domains of fatigue, pain interference and sleep disturbance, respectively. Impact on mental well-being for these patients were shown by scores of 56 (49-61)/54 (41-59) and 58 (51-63)/56 (51-61) in domains of depression and anxiety, respectively. Pain intensity for all patients with severe disease was 4 (2-6) out of 10. In response to two independent survey questions, patients with severe HAwol reported feeling anxious (42%) and/or worried (39%) at least sometimes that their current treatment might not adequately protect them from bleed. Conclusion: Patients with HAwoI continue to experience treatment and disease burden, across treatment class and disease severity subgroup. Despite improved outcomes with current treatment strategies, there remains a need to continue to address disease burden. Greater understanding is required of the driving factors behind similar treatment and disease burden between the subgroups to facilitate individualized care.

Real-World Unmet Needs in Patients with Hemophilia A without Inhibitors in the US: Results from the PicnicHealth Database

Introduction Hemophilia A is a rare X-linked bleeding disorder characterized by deficiency of the coagulation factor VIII (FVIII). The standard-of-care for hemophilia A includes prophylaxis (PPX) with factor replacement therapy or emicizumab to prevent bleeding. The World Federation of Hemophilia guidelines suggest FVIII trough levels of &amp;gt;3-5% or higher are adequate for PPX. While the importance of maintaining high FVIII levels is well recognized, real-world levels in patients with hemophilia A are often sub-optimal. Aim To understand unmet needs in patients with moderate or severe hemophilia A by assessing bleeding outcomes and patient-reported outcomes (PROs). Methods Patients from the United States (US) were recruited by PicnicHealth, a patient-centric data retrieval platform working with individuals who contribute their medical record data to research across various disease areas. Patients consented for PicnicHealth to retrieve their medical records from all care sites or providers and receive access to their records in the US. Patients were invited to complete bleed, treatment, and quality of life surveys. The analysis included medical record data (2015-2022) and PRO survey data (2022) from patients with moderate or severe hemophilia A (endogenous factor level ≤5%). Three cohorts were defined for the analysis of bleed outcomes, based on patients' PPX product class exposure (standard half-life [SHL] factor, extended half-life [EHL] factor, and emicizumab). Index date was defined as the first observed PPX product use within the class beginning on or after January 1, 2015, and patients were censored at the earliest of switch to another product class, end of patient data, death, or data cut-off (October 3, 2022). Patients who switched product classes during the study period were included in multiple cohorts. The PRO instrument used was the 29-item, 7-domain PROMIS-29 questionnaire (range 1-5; scale scores standardized to a general US adult population with mean [SD] score of 50 [10]). A custom instrument designed to assess patients' “worst pain intensity” was also used (from 0 = no pain to 10 = worst imaginable pain). An additional Medication and Bleed Survey was administered biweekly to collect patient-reported treatment and bleed event information. Results Of the 354 patients recruited, 293 had moderate or severe hemophilia A, of which 291 patients had a record of treatment. After excluding patients with inhibitors on index date or a non-hemophilia A bleeding disorder diagnosis on or prior to index date, 141 patients met the criteria for SHL, 88 for EHL, and 82 for emicizumab PPX cohorts (non-exclusive). Patients' mean (SD) age in years at index were as follows: SHL, 26.7 (13.3); EHL, 26.2 (11.8); and emicizumab, 29.8 (14.9). Considering only individual bleed events documented in medical records, 57.3% of the SHL cohort, 47.1% of the EHL cohort, and 55.2% of the emicizumab cohort had at least one recorded bleed within the first year post-index date. When also including bleed rates reported to the provider by the patient (for more complete data capture from the medical record) the respective values were 61.4%, 70.8% and 62.1%. Out of 293 patients with moderate or severe hemophilia A, the PROMIS-29 questionnaire was completed by 142 patients who were ≥18 years of age at the time of survey completion. Scores were similar across patients' self-reported treatment class at the time of survey ( Table). Physical functioning and ability to participate in social roles and activities were the most affected areas; the most frequently reported symptoms were sleep disturbance (84.5%) and inability to participate in social roles and activities (69.7%). Adult patients completing the custom survey (n=140/293) rated their worst pain intensity as a mean (SD) of 7.7 (2.1); in patients with a recent bleed, this was 8.4 (1.5). Overall, patients reporting a recent bleed had worse scores. Conclusion This real-word study provides insights into the unmet needs in patients with hemophilia A receiving regular PPX. Irrespective of treatment received, a majority of patients still bleed at least once a year, struggle with pain and participating in social roles and activities, and have sleep disturbances. This indicates a need for improvement in the quality of life of this population and further highlights the need for understanding the patient perspective with hemophilia A.

Abstract 11315: Sex-Based Differences Following Catheter Ablation of Atrial Fibrillation: Patient Reported Outcomes and Quality of Life

Introduction: Catheter ablation for atrial fibrillation (AF) has been established as an effective intervention to improve quality of life (QoL). Data are scarce on sex-based differences in ablation outcomes. Objective: To examine clinical outcomes and QoL following AF ablation in females vs males from a large patient-reported outcomes (PRO) database. Methods: All patients undergoing AF ablation (2013-2021) at our center were assessed for outcomes using automated PRO surveys. The primary endpoint was AF recurrence based on PRO and electrocardiographic documentation. The atrial fibrillation symptom severity scale (AFSSS) was utilized to quantify QoL response. Baseline and 1-year patient surveys were used to estimate AFSSS as well as AF burden (mean of AF duration score and AF frequency score; scale 0: no AF to 10: continuous with 9 frequencies/durations in between). Results: A total of 7,166 patients were included (29.8% female). Compared to men, women were older (67 vs 64.2 years) and more likely to have paroxysmal AF (55% vs 45%). The rate of any post-procedural complications was low (&lt;3%) and comparable between men and women. At 3 years, the cumulative incidence of AF recurrence was higher in women compared to men (32% vs 27%; p-value&lt;0.05); Figure. In adjusted multivariable analysis, women had a 19.9% increased risk of AF recurrence compared to men during follow-up. Similar results were observed irrespective of AF type (paroxysmal vs persistent). QoL was significantly improved at 1 year in both groups; with a comparable reduction of mean AFSSS from 13.9 to 6.1 (56.3% decrease) in women and 10.88 to 4.29 (60.5% decrease) in men. Similarly, AF burden was significantly and comparably reduced in both men and women. Conclusions: Following catheter ablation for AF, women were found to be at increased risk for AF recurrence during follow-up. Nonetheless, both men and women had significant and comparable improvement in QoL and AF burden.

The Johns Hopkins Hope at Hopkins Clinic: Supporting the comprehensive needs of individuals with metastatic breast cancer.

452 Background: Individuals with metastatic breast cancer (MBC) may live with their disease for many years. We initiated the Johns Hopkins Hope at Hopkins Clinic, a multi-pronged quality improvement initiative that aims to optimize care for individuals with MBC. Methods: Individuals with MBC were offered participation in the Clinic, in addition to their usual care. Participants completed baseline patient reported outcome (PRO) surveys through REDCap. They were offered a menu of services, including cancer rehabilitation, supportive oncology, social work, nutrition, navigation, and access to optional services based on baseline PRO data and preferences. A medical oncologist assembled and delivered a comprehensive Care Plan synthesizing recommendations from all consultants with a focus on optimizing treatment, managing symptoms, and promoting wellness. Patients were asked to complete an evaluation survey 3 days after the clinic session, and follow-up PRO surveys at 3 and 6 months after the Care Plan was delivered. We report summary statistics of baseline demographics, tumor characteristics, and PRO scores at the pre-clinic visit. Results: From 11/2020 to 6/2022, 53 patients were referred, and 44 (83%) completed baseline surveys and participated in the Hope at Hopkins Clinic. Median age (N=44) was 58 (32-86); 32 (73%) were white, and 6 (14%) were Black; 24 (55%) had BMI&gt;25. Tumors were mostly estrogen receptor-positive (85%) and HER2-negative (68%). Physical and mental health was not good for ≥14 days for 9/44 (20%) and 4/44 (9%), respectively. PROMIS measure scores were &gt;1 standard deviation below average for 14/44 (32%) for Physical Health, 7/44 (16%) for Mental Health, and 10/44 (23%) for Physical Function. PHQ8 scores indicated depression for 10/44 (23%); GAD7 scores indicated anxiety for 3/44 (7%). 37 (84%) participants received an individualized Care Plan and educational materials based on identified symptoms, concerns, and interests. We will report the number and types recommendations by domain. Follow-up PRO data are available for 10 and 4 patients at 3- and 6-months, respectively. Conclusions: We have provided individualized assessment, education, and recommendations and created a comprehensive Care Plan to guide patients living with MBC. We have used the experience to implement a new multidisciplinary model, and to extend support services to patients living with MBC and their care teams.

Frequency of standardized patient-reported outcome measures in routine clinical care of patients with cancer.

342 Background: Patient-reported outcomes (PROs) assess a patient’s self-reported health status, including disease symptoms, treatment experience, functional outcomes, and quality of life. Incorporation of PROs has been linked to improved patient symptom control and increased shared decision making. Standardized PRO measures (PROMs) are becoming more frequent as an endpoint for clinical trials, however their use is less frequent in routine care for patients with cancer. The goal of this study was to assess the utilization of PROMs and identify barriers to their use. Methods: US-licensed oncologists/hematologists convened at one of three live meetings in 2023 to review recent clinical updates. Respondent demographics were collected ahead via an online survey. During the meetings, participants responded to queries on their use and perceptions of PROs and PROMs. Responses were captured via audience response system technology; not all participants answered every question. Pooled data were summarized using descriptive statistics. Results: Of the 146 respondents, 77.4% self-identified as community-setting providers, spent 84.3% of their time seeing patients, saw an average of 19.8 patients/day, and averaged 17.7 years of experience. Respondents found PROs to be most useful in early detection/management of treatment toxicities and symptoms (63.8%) and tailoring of clinical/supportive care (56%). The majority of PROs are typically recorded through informal verbal inquiries, while 18.1% and 10.9% of respondents use validated and non-validated PROMs, respectively. Few respondents (11.3%) administer PROMs to every patient at every visit, while over one-third (38.3%) never administer PROMs. Within the practice, medical assistants and nurses are most likely to be the provider administering PROMs. PROMs are most commonly administered when the patient is in the office and are infrequently administered through other means. Lack of time to administer or review PRO surveys (45.1%), and lack of reimbursement (38.9%) and EMR integration (38.9%) were the most common reported barriers to using PROMs in the respondents’ practices. Conclusions: Despite the majority of respondents finding PROs useful in practice, a minority use formal measures to record PROs. Further, usage is infrequent across patient visits. Lack of time, lack of reimbursement, and logistic barriers are the most common reasons for not using PROMs in routine care. These barriers may be overcome by efforts or guideline changes from regulatory agencies, payors, or clinical guideline organizations. Future work will assess how physicians are using PROMs in treatment selection for their patients with cancer.

Daily Vaginal Dilator Use During Radiation for Women With Squamous Cell Carcinoma of the Anus: Vaginal Wall Dosimetry and Patient-Reported Sexual Function

Background: At our institution, we treat patients with a daily vaginal dilator (VD) during chemoradiation (CRT) for squamous cell carcinoma of the anus (SCCA). We evaluated compliance with daily VD use, radiation dose to the vaginal wall (VW) and anterior vaginal wall (AVW), and patient-reported long-term sexual function. Methods: We included women with SCCA who received definitive, intensity-modulated radiotherapy-based CRT. Women who were alive without evidence of disease received a patient-reported outcome survey, which included the Female Sexual Function Index (FSFI). We identified factors associated with FSFI such as radiation dose to the VW and AVW using linear regression models and used Youden index analysis to estimate a dose cutoff to predict sexual dysfunction. Results: Three hundred thirty-nine consecutively treated women were included in the analysis; 285 (84.1%) were treated with a daily VD. Of 184 women alive without disease, ninety patients (49%) completed the FSFI, and 51 (56.7%) were sexually active with valid FSFI scores. All received therapy with a daily VD. Forty-one women (80%) had sexual dysfunction. Univariate analysis showed higher dose to 50% (D50%) of the AVW correlated with worse FSFI (β -0.262; p=.043), worse desire FSFI subscore (β -.056; p=.003) and worse pain FSFI subscore (β -.084; p=.009). Younger age correlated with worse pain FSFI subscale (β .067; p=.026). Age (β 0.070; p=.013) and AVW D50% (β -0.087; p=.009) were significant on multivariable analysis. AVW D50% >48Gy predicted increased risk of sexual dysfunction. Conclusion: Daily VD use is safe and well tolerated during CRT for SCCA. Using a VD during treatment to displace the AVW may reduce the risk for sexual dysfunction. Limiting the AVW D50% <48Gy may further reduce the risk but additional data are needed to validate this constraint.