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There is increasing interest in patient-reported measures of cancer treatment tolerability. A global measure of bother, the FACT GP5 item ("I am bothered by side effects of treatment") is potentially useful for regulatory, research, and clinical use. To understand this item's appropriateness for capturing treatment tolerability, we conducted cognitive interviews on this item with 3 samples of cancer patients.Patients with ovarian cancer (Study 1: N = 21; on treatment), lymphoma (Study 2: N = 14; on treatment), and colorectal or lung cancer (Study 3: N = 16; treatment naïve) were interviewed about GP5's understandability and relevance to their treatment side effects. What patients think about when answering GP5 was also assessed. In all studies, the interview included both structured and open-ended questions. Qualitative data were coded to extract themes and responses to structured questions were tallied.Most patients on treatment (Studies 1 and 2) reported that the GP5 item wording is appropriate (88%) and its meaning is clear (97%). They were very confident or confident in their response (97%) and stated that GP5 was relevant to their cancer experience (97%). When answering GP5, patients considered their treatment and specific side effects. A large proportion (40%) of the treatment-naïve (Study 3) patients reported that GP5 was not relevant to their cancer treatment, and the largest proportion responded to GP5 thinking of negative side effect expectancies.This study provides assurance that GP5 is a useful indicator of treatment tolerability, and is meaningful to people with cancer, especially once they have started treatment.

12094 Background: The Functional Assessment of Cancer Therapy patient-reported outcomes (PRO) item GP5 (“I am bothered by side effects of treatment”) estimates treatment tolerability. We aimed to extend our previous finding that GP5 predicts early aromatase inhibitor (AI) discontinuation (E1Z03, 96% White) in the racially diverse E1Z11 trial cohort. Methods: E1Z11 was coordinated by the ECOG-ACRIN NCI Community Oncology Research Program (NCORP) Research Base. Postmenopausal women initiating anastrozole per clinical care for ER+ stage I-III breast cancer with a pain score 0-3/10 and no rheumatologic comorbidities were eligible. Accrual of a racially diverse cohort of 1,000 women, including Black and Asian women, was planned. GP5 was administered prior to initiating anastrozole (trial baseline) and at 3, 6, 9 and 12 months. GP5 was scored on a 5-point Likert scale from 0 (not at all) to 4 (very much) and dichotomized as no/little treatment bother (0/1) or moderate/high treatment bother (2-4), consistent with previous analyses. A univariate Cox proportional hazards model estimated baseline GP5’s association with treatment duration via hazard ratio (HR). Early treatment discontinuation status was defined as treatment duration < 12 months with discontinuation not attributed to disease progression or death (n = 4), consistent with previous analyses. Results: 1,046 women enrolled from 6/2013-10/2018 (640 White, 201 Black, 205 Asian), including 590 (56%) from NCORP Community or Minority/Underserved Sites. Approximately 10% (100/987 with GP5 data) reported moderate/high treatment bother prior to initiating anastrozole. Anastrozole discontinuation rate at 1-year was 26.2% overall; it was lower among women with no/little treatment bother (25.7%, GP5 = 0-1) compared to moderate/high treatment bother prior to initiating anastrozole (34.7%, GP5 = 2-4; HR = 1.50, 95% confidence interval [CI]:1.04-2.15, p = 0.027). Subgroup analyses by racial cohort showed a similar predictive effect of GP5 in the White (n = 606, HR = 1.76, 95% CI: 1.12-2.77, p = 0.014) and Black (n = 184, HR = 1.85, 95% CI: 0.92-3.71, p = 0.079) cohorts, but not in the Asian cohort (n = 197, HR = 0.40, 95% CI: 0.10-1.62, p = 0.20). Conclusions: Moderate/high treatment bother prior to starting anastrozole was observed in 10% of patients and associated with a higher risk of early discontinuation, except in Asian patients. Our findings support the presence of a treatment tolerability threshold which can be compromised by pre-treatment burden. Treatment tolerability may also be influenced by cultural and genetic factors, which will be explored in further analysis of genetic and PRO data. Clinical trial information: NCT01824836.

COVID-related safety concerns mandated suspension of our ongoing trial testing the effects of movement and social engagement in older adults with early-stage dementia and their caregivers (dyads). Participant vulnerability and the requirement for group social interaction complicated intervention resumption. We present results from a successful pilot to rapidly and iteratively optimize study interventions for remote delivery targeting intervention mediators (social connection, movement) based on participant feedback. Three-dyad groups (n=6 individuals) completed cycles of intervention via Zoom immediately followed by an interview with open-ended and quantitative feedback. Cycles were repeated until no new information was solicited, then repeated with new participants. Optimization revealed needs for technological support, more intensive movement, and social connection. Specifically, the inability to make eye contact, see others’ full body, and technology-associated timing asynchronies impeded social connection in the movement group. We will present practical tips for crafting remote group interventions for caregiver/person living with dementia dyads.

BACKGROUND Participating in physical activity and minimizing time spent sitting is an effective strategy for managing pain in older adults. Theory-based mHealth tools are integral to effective day-long physical activity interventions, but it is vital that mHealth tools undergo an iterative development process alongside members of the target population to ensure their uptake and use. OBJECTIVE We subjected a preliminary social cognitive smartphone application (Companion App) designed to promote day-long movement to a user centered design process with the assistance of low-active older adults with chronic multisite pain. The Companion App integrates ecological momentary assessments of pain, Fitbit activity monitor data, and smart weight scale data to provide real-time feedback on the relationships between movement, sitting, and pain and to facilitate goal setting and achievement. METHODS We recruited participants (N=5; 71.8 5.54 years old) sequentially to participate in a three-phase iterative design study. First, each participant received a brief orientation to physical activity, was exposed to the application, and engaged in a Think Aloud protocol. Use and usability issues were noted by study staff. The participant then used the app for one week in their daily lives, and then returned to provide feedback. Issues were identified from participant feedback, discussed with the study team, and modified before the next participant began the study. RESULTS Participant interviews yielded feedback in areas related to technology selection and operation, app design/form, and intervention clarity. Regarding technology, the use of the Fitbit activity monitor revealed no issues, but there were barriers to the use of the Fitbit Aria 2 scale, including incompatibility with a widely used home internet router. Switching to a cellular enabled scale alleviated this issue. With regard to form, modifications were made to several key interface elements in response to participant feedback to aid in clarity. Finally, initial participant experiences revealed the need to separate the intervention orientation from the technology orientation to minimize informational load. CONCLUSIONS Our brief user-centered design process produced key changes in our intervention orientation, the form and function of the Companion App, and the technologies that support the app. These are vital elements that are likely to hamper the perceived usefulness and utility of the Companion App in the context of a large trial and eventual public use. We recommend the conduct of such a process any time mHealth is used in research or medicine to account for changing populations and preferences. Moreover, publication of lessons learned can help to establish a foundation of knowledge for designing apps for underserved populations such as older adults. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT03377634

Cancer and/or treatment-related pain is a critical quality of life issue for cancer survivors. In a prospective longitudinal study of 1,000 breast cancer patients (enrolled during 2011-2013), we examined risk factors for pain among women undergoing adjuvant radiotherapy (RT). A pain score was assessed as a mean of four pain severity items (i.e., pain at its worst, least, average, and now) from the Brief Pain Inventory with an 11-point numeric rating scale (0-10) at baseline and post-RT. The study sample consists of 623 whites, 280 black/African Americans, 64 Hispanic whites, and 33 others. The mean age was 58.1 ±10.8 years and the mean body mass index (BMI) was 30.7 ±7.0 kg/m2. The mean pain score was 1.5 ±1.0 (baseline) and 2.5 ±1.8 (post-RT). In multivariable linear regression analysis (n= 863), post-RT pain score was significantly associated with baseline pain score (β= 0.39 per 1 point increment, p< 0.0001), age (β= -0.03 per 1 year increment, p< 0.001), BMI (β= 0.03 per 1 kg/m2 increment, p= 0.004), current smoking status (β= 0.57, p= 0.022), conventional RT fractionation (β= 0.48, p= 0.033), and pain medication use (β= 1.85, p< 0.0001). Further stratified analysis showed that post-RT pain score was associated with baseline pain score, age, BMI, and mastectomy among patients who did not use pain medication (n= 625); however, it was associated with baseline pain score and conventional RT fractionation among patients who did use pain medication (n= 238). Altogether, baseline pain score is the most significant and robust risk factor for post-RT pain, and conventional RT fractionation is a significant risk factor post-RT pain only among those who experienced more pain. These risk factors may help identify individuals at-risk for post-RT pain; thus, this information may help guide these high-risk individuals in their RT decision-making processes, such as considering a hypo-fractionated RT schedule. Citation Format: Eunkyung Lee, Shannon Snyder, Edward Ip, Jean L. Wright, Jennifer J. Hu. Risk factors for post-radiotherapy pain in a multi-racial ethnic population of breast cancer patients: a prospective study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 3290.

Coronary heart disease (CHD) is a major cause of death worldwide. In the U.S. CHD is responsible for approximated 1 in every 6 deaths with a coronary event occurring every 25 seconds and about 1 death every minute based on data current to 2007. Although a multitude of cardiovascular risks factors have been identified, CHD actually reflects complex interactions of these factors over time. Today’s datasets from longitudinal studies offer great promise to uncover these interactions but also pose enormous analytical problems due to typically large amount of both discrete and continuous measurements and risk factors with potential long-range interactions over time. Our investigation demonstrates that a statistical relational analysis of longitudinal data can easily uncover complex interactions of risks factors and actually predict future coronary artery calcification (CAC) levels — an indicator of the risk of CHD present subclinically in an individual — significantly better than traditional non-relational approaches. The uncovered long-range interactions between risk factors conform to existing clinical knowledge and are successful in identifying risk factors at the early adult stage. This may contribute to monitoring young adults via smartphones and to designing patient-specific treatments in young adults to mitigate their risk later.

To report our experience with cephalometry in evaluating velopharyngeal dysfunction (VPD) in velocardiofacial syndrome (VCFS) and its utility in assessing the role of cervical spine abnormalities in VPD, prior to surgical correction of VPD.Clinical charts and cephalometric radiographs done prior to surgery for VPD were retrospectively analyzed to ascertain velopharyngeal measurements and cervical spine abnormalities.Twenty-six patients (age: 6-23 years) with molecularly confirmed VCFS.Wake Forest University Health Sciences (1997-2005).Cranial base angle, nasopharyngeal depth, velum length, and Need ratio at rest, velar dimple location, and velopharyngeal length during phonation; information on presence/absence of submucous cleft palate and cervical spine abnormalities were also obtained. The relationship between C1 anterior arch abnormalities and Need ratio was examined.Seventy-three percent of the VCFS patients had excessive nasopharyngeal depth, 80% had an abnormal Need ratio, 50% had a short velum, 81% had a submucous or occult submucous cleft palate, 90.5% had a cervical spine abnormality (C1 anterior arch abnormalities in 38%) and 11.5% had platybasia. There was a significant difference in the Need ratio between patients with and without C1 anterior arch abnormalities.Cephalometry can be used to delineate factors such as C1 vertebral abnormalities, excessive pharyngeal depth, and short velum that contribute to VPD in VCFS. This would help otolaryngologists better understand the anatomy prior to surgical treatment of VPD. This is the first study to highlight the frequent occurrence of C1 anterior arch abnormalities in VCFS.

A symptom cluster comprises three or more concurrent symptoms. There is a paucity of symptom cluster research in cancer patients. Data from a previously conducted clinical trial were analyzed to search for symptom clusters. This phase III, placebo-controlled, double-blind, prospective, randomized clinical trial of 66 patients assessed the effect of prophylactic d-threo-methylphenidate (d-MPH) on quality of life (QOL) in newly diagnosed brain tumor patients receiving brain radiation therapy. Patients received 5-15 mg of d-MPH or placebo twice daily starting on week 1 of radiation therapy and continuing for 8 weeks post radiotherapy. QOL data were collected at baseline; the end of radiation therapy; and 4, 8, and 12 weeks following radiation therapy using the Functional Assessment of Cancer Therapy (FACT), the FACT-Brain subscale, and the Center for Epidemiologic Studies Depression Scale. Exploratory factor analysis, multidimensional scaling (MDS), and cluster analysis were used to search for symptom clusters. The trial failed to show a treatment effect; patients receiving d-MPH or placebo were analyzed together to search for clusters. Two symptom clusters were identified using exploratory factor analysis--a language cluster including difficulty reading, writing, and finding the right words and a mood cluster including feelings of sadness, anxiety, and depressed mood; these clusters were supported by MDS and cluster analysis. Our results suggest that interventions that target both cognitive function and mood should be considered in this patient population. Further research on symptom clusters in brain tumor patients is needed.

In many applications such as transaction data analysis, the classification of long chains of sequences is required. For example, brand purchase history in customer transaction data is in a form like AABCABAA, where A, B, and C are brands of a consumer product. The decision tree-based package mbonsai is designed to handle sequence data of varying lengths using one or multiple variables of interest as predictor variables. This software package uses tree growing and pruning strategies adopted from C4.5 and CART algorithms, and includes new features for handling sequence data and indexing for classification purpose. The software uses a simple command line program for learning and predicting processes, and has the ability to generate user-friendly graphics depicting decision trees. The underlying C++ codes are designed to efficiently process large data sets in ASCII files. Two examples from transaction data sets are used to illustrate the application of mbonsai.