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Supportive oncodermatology is a burgeoning new field within dermatology tasked with caring for the unique dermatologic needs of patients with cancer. Patients with dermatologic adverse events (dAEs) from localized and systemic anti-cancer therapies commonly experience significant distress and reduced health-related quality of life (HRQoL). Emerging dAEs is often overlooked by clinicians and researchers, despite their considerable impacts on treatment completion and patient self-esteem. Specific HRQoL issues experienced by cancer patients with dAEs include psychosocial distress and treatment interruption or cessation. Existing HRQoL assessment indices unfortunately fall short when assessing HRQoL in patients with dAEs from anti-cancer therapies due to the lack of specificity to patients' symptoms and inability to fully encompass the unique needs of this population. Additionally, the variability in HRQoL assessments across studies is substantial, suggesting the need for a standardized HRQoL measure. Here, we review the burden of dAEs and the existing validated tools used to measure them, while outlining strategies for modification to achieve optimal HRQoL assessment in patients with dAEs from anti-cancer therapies and address the HRQoL gap in supportive oncodermatology. Amongst the current tools, Skindex-16 most closely addresses the required skin-specific HRQoL metrics, but still lacks a few key cancer-specific measures. Other general HRQoL tools are well-tailored to cancer patients, but lack skin-specific questions.

The requirements of the iPLEDGE program place burdens on both patients with severe recalcitrant nodular acne and prescribers of isotretinoin. We sought to investigate the changes in dermatologists' acne treatment patterns due to the administrative burden of iPLEDGE by assessing whether dermatologists chose not to prescribe isotretinoin to appropriate patients because of the labor of iPLEDGE requirements. Additionally, we investigated the medications that were substituted for isotretinoin. An anonymous online survey was created and posted on a dermatology group on social media. The survey respondents (N=510) consisted of board-certified dermatologists across the United States and comprised a wide variety of ages and practice types. This survey ultimately highlighted the burden of iPLEDGE for American clinicians and the need for a more streamlined risk-management program. This program is deterring some US clinicians, especially those younger than 46 years, from prescribing isotretinoin and limiting patient access to an effective medication.

The growing availability of digital trace data has generated unprecedented opportunities for analyzing, explaining, and predicting the dynamics of process change. While research on process organization studies theorizes about process and change, and research on process mining rigorously measures and models business processes, there has so far been limited research that measures and theorizes about process dynamics. This gap represents an opportunity for new information systems research. This research note lays the foundation for such an endeavor by demonstrating the use of process mining for diachronic analysis of process dynamics. We detail the definitions, assumptions, and mechanics of an approach that is based on representing processes as weighted, directed graphs. Using this representation, we offer a precise definition of process dynamics that focuses attention on describing and measuring changes in process structure over time. We analyze process structure over two years at four dermatology clinics. Our analysis reveals process changes that were invisible to the medical staff in the clinics. This approach offers empirical insights that are relevant to many theoretical perspectives on process dynamics.

CONTEXT: Pain can be a debilitating side effect of radiation therapy (RT). Data from the general population has shown that sleep disturbance can influence pain incidence and severity; however, less is known about this relationship in breast cancer patients receiving RT. OBJECTIVES: This secondary analysis examined the association of pre-treatment moderate/severe levels of sleep disturbance with subsequent RT-induced pain after adjusting for pre-RT pain. METHODS: We report on 573 female breast cancer patients undergoing RT from a previously completed phase II clinical trial for radiation dermatitis. Sleep disturbance, total pain, and pain subdomains – sensory pain, affective pain, and perceived pain intensity were assessed at pre- and post-RT. At pre-RT, patients were dichotomized into 2 groups: those with moderate/severe sleep disturbance (N=85) vs. those with no/mild sleep disturbance (control; N=488). RESULTS: At pre-RT, women with moderate/severe sleep disturbance were younger, less likely to be married, more likely to have had mastectomy and chemotherapy, and more likely to have depression/anxiety disorder and fatigue than the control group (all p’s

Context is usually conceptualized as external to a theory or model and treated as something to be controlled or eliminated in empirical research. We depart from this tradition and conceptualize context as permeating processual phenomena. This move is possible because digital trace data are now increasingly available, providing rich and fine-grained data about processes mediated or enabled by digital technologies. This paper introduces a novel method for including fine-grained contextual information from digital trace data within the description of process (e.g., who, what, when, where, why). Adding contextual information can result in a very large number of fine-grained categories of events, which are usually considered undesirable. However, we argue that a large number of categories can make process data more informative for theorizing and that including contextual detail enriches the understanding of processes as they unfold. We demonstrate this by analyzing audit trail data of electronic medical records using ThreadNet, an open source software application developed for the qualitative visualization and analysis of process data. The distinctive contribution of our approach is the novel way in which we contextualize events and action in process data. Providing new, usable ways to incorporate context can help researchers ask new questions about the dynamics of processual phenomena.

Patient-reported outcome (PRO) measures play an important role in clinical care. Currently, a broad-spectrum, validated PRO measure suitable for all dermatology patients, as part of clinical care, does not exist. Patient-reported Outcome Measures Information System (PROMIS) measures track specific domain outcomes across all diseases. To assess the relevance and utility of a computer-adaptive health assessment consisting of three PROMIS domains in routine dermatologic care. This retrospective study evaluated a PROMIS health assessment, consisting of three computer-adaptive test domains (pain interference, anxiety, and depression), administered as part of routine clinical care in three dermatology clinics at an academic medical center. The primary objective was to identify clinically significant associations between high PROMIS domain scores (i.e., t score > 55) and dermatologic disease, as well as change in PROMIS domain scores in response to treatment. The majority of patients who initiated the assessment completed all domains (88.7%). In patients with atopic dermatitis, acne, hidradenitis suppurativa, and psoriasis, high PROMIS scores correlated with clinically relevant outcomes, such as severe disease, unsuccessful treatment, uncontrolled disease, and the presence of a mental health condition. PROMIS Pain Interference, anxiety and depression identified patients with severe disease, unsuccessful treatment regimens, poorly-controlled disease, and/or mental health comorbidities for multiple skin conditions. Further utilization of PROMIS domains in routine clinical care will promote patient-centered care and improve quality of care.

Radiation dermatitis (RD) is a common side effect of radiation therapy (RT). While many different treatment strategies are currently used to address RD, there is a lack of consensus and RD prophylaxis and management guidelines have remained largely unchanged over the last 10 years. This review aims to formulate unambiguous supportive care interventions by comparing RD clinical practice guidelines published between 2010 and 2021 by several organizations: Multinational Association for Supportive Care in Cancer (MASCC), British Columbia Cancer Agency (BCCA), Cancer Care Manitoba (CCMB), Oncology Nursing Society (ONS), Society and College of Radiographers (SCoR), and International Society of Nurses in Cancer Care (ISNCC).Areas of agreement and discordance were assessed among the MASCC, BCCA, CCMB, ONS, SCoR, and ISNCC guidelines.Treatment recommendations across guidelines for acute RD and chronic RT-induced skin toxicities have been summarized. The strongest agreement among the guidelines exists for the use of topical corticosteroids, silver sulfadiazine, washing, and deodorant. All guidelines recommend the use of topical corticosteroids, and washing with water and soap is consistently supported. There is minimal consensus on an optimal dressing or barrier film for RD prophylaxis or management. MASCC weakly recommends prophylactic use of silver sulfadiazine to reduce RD, while BCCA, CCMB, and SCoR recommend its use upon signs of infection. MASCC and CCMB recommend the use of a long-pulsed dye laser to manage telangiectasia, a late effect of RT.Given the extent of discordance among guideline recommendations, further research is recommended to establish optimal treatments for RD prophylaxis and management.

Patient-reported outcome (PRO) measures play an important role in clinical care. Currently, a broad-spectrum, validated PRO measure suitable for all dermatology patients, as part of clinical care, does not exist. Patient-reported Outcome Measures Information System (PROMIS) measures track specific domain outcomes across all diseases. To assess the relevance and utility of a computer-adaptive health assessment consisting of three PROMIS domains in routine dermatologic care. This retrospective study evaluated a PROMIS health assessment, consisting of three computer-adaptive test domains (pain interference, anxiety, and depression), administered as part of routine clinical care in three dermatology clinics at an academic medical center. The primary objective was to identify clinically significant associations between high PROMIS domain scores (i.e., t score 55) and dermatologic disease, as well as change in PROMIS domain scores in response to treatment. The majority of patients who initiated the assessment completed all domains (88.7%). In patients with atopic dermatitis, acne, hidradenitis suppurativa, and psoriasis, high PROMIS scores correlated with clinically relevant outcomes, such as severe disease, unsuccessful treatment, uncontrolled disease, and the presence of a mental health condition. PROMIS Pain Interference, anxiety and depression identified patients with severe disease, unsuccessful treatment regimens, poorly-controlled disease, and/or mental health comorbidities for multiple skin conditions. Further utilization of PROMIS domains in routine clinical care will promote patient-centered care and improve quality of care.

PURPOSE: Despite advances in medical technology, radiation dermatitis occurs in 95% of patients receiving radiation therapy (RT) for cancer. Currently, there is no standard and effective treatment for the prevention or control of radiation dermatitis. The goal of the study was to determine the efficacy of oral curcumin, one of the biologically active components in turmeric, at reducing radiation dermatitis severity (RDS) at the end of RT, using the RDS scale, compared to placebo. METHODS: This was a multisite, randomized, double-blinded, placebo-controlled trial of 686 breast cancer patients. Patients took four 500 mg capsules of placebo or curcumin three times daily throughout their prescribed course of RT until one week post-RT. RESULTS: A total of 686 patients were included in the final analyses (87.5% white females, mean age = 58). Linear mixed model analyses demonstrated that curcumin did not reduce radiation dermatitis severity at the end of RT compared to placebo (B (95% CI) =0.044 (−0.101, 0.188), p=0.552). Fewer curcumin patients with RDS > 3.0 suggested a trend toward reduced severity (7.4% vs. 12.9%, p=0.082). Patient-reported changes in pain, symptoms, and quality of life were not statistically significant between arms. CONCLUSIONS: Oral curcumin did not significantly reduce radiation dermatitis severity compared to placebo. The skin rating variation and broad eligibility criteria could not account for the undetectable therapeutic effect. An objective measure for radiation dermatitis severity and further exploration for an effective treatment for radiation dermatitis is warranted.

PURPOSE: Although topical agents are often provided during radiation therapy, there is limited consensus and evidence for their use prophylactically to prevent or reduce radiation dermatitis. METHODS: This was a multi-site, randomized, placebo-controlled, blinded study of 191 breast cancer patients to compare the prophylactic effectiveness of three topical agents (Curcumin, HPR Plus™, and Placebo) for reducing radiation dermatitis and associated pain. Patients applied the topical agent to their skin in the radiation area site three times daily starting the first day of radiation therapy (RT) until 1 week after RT completion. RESULTS: Of the 191 randomized patients, 171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36–88)). Mean radiation dermatitis severity (RDS) scores did not significantly differ between study arms (Curcumin = 2.68 [2.49, 2.86]; HPR Plus™ = 2.64 [2.45, 2.82]; Placebo = 2.63 [2.44, 2.83];p = 0.929). Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018). In patients with high breast field separation (≥ 25 cm), RDS scores (Curcumin = 2.70 [2.21, 3.19]; HPR Plus™ = 3.57 [3.16, 4.00]; Placebo = 2.95 [2.60, 3.30];p = 0.024) and pain scores (Curcumin = 0.52 [− 0.28, 1.33]; HPR Plus™ = 0.55 [− 0.19, 1.30]; Placebo = 1.73 [0.97, 2.50]; p = 0.046) significantly differed at the end of RT. CONCLUSIONS: Although there were no significant effects of the treatment groups on the overall population, our exploratory subgroup analysis suggests that prophylactic treatment with topical curcumin may be effective for minimizing skin reactions and pain for patients with high breast separation (≥ 25 cm) who may have the worst skin reactions.

Business process mining algorithms discover processes from event logs that record sequences of events or actions. Typical event logs may or may not contain information about the attributes of the actions, such as the particular workstations used to carry out an action or the identity of the person performing the action. In this paper, we test the effect of action attributes on action sequence using data from electronic medical records at five dermatology clinics. We demonstrate that action sequence is influenced by attributes such as actors (who does what) and workstations (what is done where) that are not typically considered relevant to process flow control. We introduce a new metric – attribute alignment – that summarizes the extent to which actions are carried out with the same attributes throughout a process instance. If each action is always performed with the same attributes, attribute alignment is 100%. We discuss the implications and limitations of this finding for research and practice.

In research on process organization studies, the concept of multiplicity is widely used, but a fundamental confusion about what process multiplicity means persists. As a result, we miss some of the potential of this concept for understanding process dynamics and process change. In this paper, we define process multiplicity as a duality of ‘one’ and ‘many’, and we conceptualize ‘the many’ as a space of possible paths encompassed by a process. We use the notion of paths to operationalize process multiplicity and make it accessible for empirical research. When we see process as a multiplicity, process change can be understood as expanding, shifting or contracting the space of possible paths. We suggest that this concept of process multiplicity also has implications for a range of other theoretical and practical topics, including standards, standardization and flexibility as well as process replication, management and resilience.

OBJECTIVES/SPECIFIC AIMS: The purpose of the present secondary data analysis was to examine the effect of moderate-severe disturbed sleep before the start of radiation therapy (RT) on subsequent RT-induced pain. METHODS/STUDY POPULATION: Analyses were performed on 676 RT-naïve breast cancer patients (mean age 58, 100% female) scheduled to receive RT from a previously completed nationwide, multicenter, phase II randomized controlled trial examining the efficacy of oral curcumin on radiation dermatitis severity. The trial was conducted at 21 community oncology practices throughout the US affiliated with the University of Rochester Cancer Center NCI’s Community Oncology Research Program (URCC NCORP) Research Base. Sleep disturbance was assessed using a single item question from the modified MD Anderson Symptom Inventory (SI) on a 0–10 scale, with higher scores indicating greater sleep disturbance. Total subjective pain as well as the subdomains of pain (sensory, affective, and perceived) were assessed by the short-form McGill Pain Questionnaire. Pain at treatment site (pain-Tx) was also assessed using a single item question from the SI. These assessments were included for pre-RT (baseline) and post-RT. For the present analyses, patients were dichotomized into 2 groups: those who had moderate-severe disturbed sleep at baseline (score≥4 on the SI; n=101) Versus those who had mild or no disturbed sleep (control group; score=0–3 on the SI; n=575). RESULTS/ANTICIPATED RESULTS: Prior to the start of RT, breast cancer patients with moderate-severe disturbed sleep at baseline were younger, less likely to have had lumpectomy or partial mastectomy while more likely to have had total mastectomy and chemotherapy, more likely to be on sleep, anti-anxiety/depression, and prescription pain medications, and more likely to suffer from depression or anxiety disorder than the control group (all p’s≤0.02). Spearman rank correlations showed that changes in sleep disturbance from baseline to post-RT were significantly correlated with concurrent changes in total pain (r=0.38; pr=0.35; pr=0.21; pr=0.37; pr=0.35; pp=0.006). Generalized linear estimating equations, after controlling for baseline pain and other covariates (baseline fatigue and distress, age, sleep medications, anti-anxiety/depression medications, prescription pain medications, and depression or anxiety disorder), showed that patients with moderate-severe disturbed sleep at baseline had significantly higher mean values of post-RT total pain (by 39%; p=0.033), post-RT sensory pain (by 41%; p=0.046), and post-RT affective pain (by 55%; p=0.035) than the control group. Perceived pain intensity (p=0.066) and pain-Tx (p=0.086) at post-RT were not significantly different between the 2 groups. DISCUSSION/SIGNIFICANCE OF IMPACT: These findings suggest that moderate-severe disturbed sleep prior to RT is an important predictor for worsening of pain at post-RT in breast cancer patients. There could be several plausible reasons for this. Sleep disturbance, such as sleep loss and sleep continuity disturbance, could result in impaired sleep related recovery and repair of tissue damage associated with cancer and its treatment; thus, resulting in the amplification of pain. Sleep disturbance may also reduce pain tolerance threshold through increased sensitization of the central nervous system. In addition, pain and sleep disturbance may share common neuroimmunological pathways. Sleep disturbance may modulate inflammation, which in turn may contribute to increased pain. Further research is needed to confirm these findings and whether interventions targeting sleep disturbance in early phase could be potential alternate approaches to reduce pain after RT.

3581 Background: Pain is a prevalent, debilitating symptom in more than half of cancer patients. Accumulating evidence suggests a bi-directional relationship between gut microbiota and pain, potentially via inflammation and oxidative stress. Fusobacterium nucleatum (Fn), a pro-inflammatory anaerobic bacterium, is frequently detected in colorectal cancer (CRC) patients. To date, no study has identified a relationship between Fn and cancer pain in CRC patients. We investigated the associations between pre-treatment Fn and cancer pain at 6 months post-surgery in CRC patients. Methods: We utilized pre-surgery stool samples collected from 80 prospectively followed, newly diagnosed CRC patients recruited from the German site of the international ColoCare Study. Eligible patients were neo-adjuvant treatment naïve and did not use antibiotics for at least 1 month before stool collection. Fn DNA was assessed via quantitative real-time polymerase chain reaction. Patients were median split into Fn-high (>17.27; n=40) or Fn-low (≤17.27; n=40). Cancer pain was assessed using the 2 pain symptom items from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core-30 (lower score=lower pain) at pre- and 6 months post-surgery. Results: Before surgery, 48% of all patients reported any pain. At 6 months post-surgery, we observed a decrease in cancer pain by 33% for Fn-low, while there was an increase in cancer pain by 41% for Fn-high. After controlling for pre-surgery cancer pain in ANCOVA model, we observed significantly higher mean cancer pain at 6 months post-surgery in the Fn-high group vs. the Fn-low group (24.07 vs. 13.44; effect size, ES=0.45; p=0.04). These results were maintained even after controlling for age, sex, tumor stage and site, adjuvant chemotherapy, BMI, physical activity, and any pain medications (29.11 vs. 16.55; ES=0.53; p=0.03). Conclusions: These findings suggest that high Fn is an independent predictor of cancer pain at 6 months post-surgery in colorectal cancer patients. Further research is needed to confirm and understand the mechanisms of these results. Funding: NCI U01 CA206110.

10100Background: Pain is a debilitating side effect that remains poorly controlled in ~50% of cancer patients. Data from the general population has shown a strong bi-directional relationship betwee...