Proactive Symptom Management Research Articles

A278 ACCEPTABILITY, FEASIBILITY, AND IMPACT OF THE MYGUT DIGITAL HEALTH PLATFORM IN THE MONITORING AND MANAGEMENT OF INFLAMMATORY BOWEL DISEASE

Abstract Background Inflammatory bowel disease (IBD) is a chronic gastrointestinal disorder that has been associated with depression, anxiety, and decreased quality of life. With new technological advancements, digital health monitoring platforms offer a promising avenue to integrate self-management strategies into the care of patients with IBD. Aims This study aimed to investigate patients’ acceptability to implementing the MyGut IBD health monitoring platform into their care, evaluate whether its use leads to better quality of life/improved health outcomes, and determine the feasibility of its long-term use. Methods We conducted a multi-centre, single-arm trial at McMaster University and McGill University, among their affiliated hospitals, from September 2020 to September 2023. Patients with IBD were recruited in gastroenterology clinics and asked to install the MyGut application onto their mobile devices. Various metrics such as willingness to use the application, patient satisfaction, symptom control/quality of life scores (measured through the short inflammatory bowel disease questionnaire (SIBDQ)), resource utilization, and feasibility statements were collected throughout the study. Patients exhibiting abnormal SIBDQ scores were identified for follow-up. After one year, patient outcome metrics were compared to baseline values. Results Out of the 84 patients initially enrolled, 58 patients (69%) continued until study completion at one-year. At recruitment, all 84 patients (100%) were willing to use the MyGut application after a brief tutorial and 72.6% (61/84) had already been using technology for health-related purposes. There was a significant improvement in SIBDQ scores after one year of MyGut use (median = 57.5, IQR 50.25–62) when compared to baseline (median = 54.5, IQR 47.25–58.75) (p = 0.01). However, only 42.9% of patients (21/49) were willing to continue using the application after one year, a significant decrease compared to the 71.9% (41/57) who were willing to continue after two months (p = 0.002). No differences were observed in patient satisfaction measures (p = 0.42 to 1) or number of ER visits/hospitalizations (p = 0.78) before and after one year of MyGut use. Conclusions Overall, IBD is a condition that often necessitates frequent medical follow-up and may benefit from proactive symptom management strategies. This study demonstrates that patients with IBD are very willing to integrate digital health monitoring platforms into their care and these may subsequently lead to improved symptom control and enhanced quality of life. Future studies should aim to investigate the subset of patients that would benefit most from these health interventions, and as illustrated, continued efforts must be made to optimize the acceptability/feasibility of its long-term use. Funding Agencies CCC

Changes in public health-seeking behaviours for self-limiting respiratory tract infections across England during the COVID-19 pandemic.

National Health Service (NHS) guidance for acute respiratory tract infections (RTIs) advocates self-care, encourages utilization of local pharmacies and recommends consulting general practitioners (GPs) primarily for the vulnerable or those with persistent symptoms. Coronavirus disease 2019 exerted substantial strain on the English NHS, affecting public access to primary care services. For 3 years, public surveys assessed RTI incidences in the previous 12 months and associated health-seeking behaviours. Telephone surveys of 1676 respondents across England were conducted in March 2021 and 1663 respondents in March 2022. Findings were compared with a face-to-face baseline survey of 2022 respondents from March 2020. Key demographics were representative of the population. In 2021, the proportion of respondents who reported an RTI (51%) significantly declined from 2020 (70%, P < 0.05), then returned to pre-pandemic rates in 2022 (67%). Respondents reported more proactive symptom management in both 2021 and 2022 from 2020: there were greater reports of seeking over-the-counter treatments (55%, 55% vs. 35%, P < 0.05) and use of alternative remedies (38%, 38% vs. 21%, P < 0.05). 2022 observed a reduction in those who reported consulting their GP for their most recent RTI (15%) compared to 2021 (25%, P < 0.05) and 2020 (23%), which was not accounted for through greater consultation rates with other healthcare services. Public health bodies should consider how pandemic-related changes may have facilitated increased self-care for self-limiting infections such as RTIs. Resources and support must include safety-netting advice to safeguard against unintentional consequences of increased self-care.

A MIXED-METHODS, RANDOMIZED, CONTROLLED EVALUATION OF REMOTE ACTIVITY MONITORING FOR PERSONS LIVING WITH DEMENTIA

Abstract Remote activity monitoring (RAM) technology has the potential to allow at-home caregivers to track the behaviors and activities of persons with dementia in real-time, thus facilitating more proactive symptom management. The aim of the present study was to assess whether RAM technology was associated with reductions in negative health transitions and service utilization for persons with Alzheimer’s disease or related dementias (ADRD). An embedded experimental mixed methods design was used that included 179 caregivers who were followed over a 1.5 year study period. Participants were randomly assigned to receive the RAM technology system or usual care. Follow-up surveys were administered on a bi-annual basis over an 18-month period that collected information on dementia caregiver and care recipient characteristics and outcomes. We developed multilevel mixed effects models to estimate odds ratios for binary outcomes (falls, wandering, health care admissions) and categorical outcomes (frequency of falls and wandering). In adjusted models, RAM technology use was statistically and significantly associated with lower odds of emergency department visits (p&amp;lt;.05) and less frequent falls (p=.05) for people living with dementia over the 1.5 year study period. Technologies that prevent or delay the onset of negative health events via improved care management and monitoring may enhance the care of persons with dementia. As dementia continues to pose an array of challenges for someone living with ADRD, RAM or similar technologies may offer a solution to the conundrum of dementia care.

Health Care Professionals' Perspectives on Implementation, Adoption, and Maintenance of a Community Health Worker-Led Advance Care Planning and Cancer Symptom Screening Intervention: A Qualitative Study.

Advance care planning (ACP) and symptom screening are nationally recommended for all patients with advanced stages of cancer. Yet, routine delivery of such care remains challenging because of multilevel barriers. We hired and trained community health workers (CHWs) to assist with delivery of these services across the United States. The aim of this study was to explore health care professionals' perspectives on barriers and facilitators to these team-based approaches. We conducted semistructured interviews with 44 health care professionals in 21 cancer clinics in seven US cities using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. We recorded, transcribed, and analyzed interviews using the framework analysis approach. Participants noted barriers and facilitators to implementation, adoption, and maintenance of CHW-led ACP and symptom management approaches. Participants were initially skeptical; however, they noted a positive shift in their views over time because of personal experiences and effectiveness in their clinics. There was significant variation in adoption with some using a prescriptive top-down approach and others a bottom-up approach. Most agreed that the combination of top-down and bottom-up approaches would be most efficient and effective for promoting team-based care. All participants discussed implementation and provided suggestions for maintenance including organizational support, leadership, and CHW retention. CHW-led ACP and proactive symptom management interventions are effective and accepted by cancer care professionals at scale. Tailoring on the basis of organization and local contexts is required to ensure successful adoption, implementation, and maintenance of these effective team-based care delivery approaches.

Patient-Reported Symptom Burden After Cancer Surgery in Older Adults: A Population-Level Analysis.

Older adults have unique needs for supportive care after surgery. We examined symptom trajectories and factors associated with high symptom burden after cancer surgery in older adults. We conducted a population-level study of patients ≥ 70 years old undergoing cancer surgery (2007-2018) using prospectively collected Edmonton Symptom Assessment System (ESAS) scores. The monthly prevalence of moderate to severe symptoms (ESAS ≥ 4) for anxiety, depression, drowsiness, lack of appetite, nausea, pain, shortness of breath, tiredness, and poor wellbeing was computed over 12 months after surgery. Among 48,748 patients, 234,420 ESAS scores were recorded over 12 months after surgery. Moderate to severe tiredness (57.8%), poor wellbeing (51.9%), and lack of appetite (39.3%) were most common. The proportion of patients with moderate to severe symptoms was stable over the 1 month prior to and 12 months after surgery (< 5% variation for each symptom). There was no clinically significant change (< 5%) in symptom trajectory with the initiation of adjuvant therapy. Patient-reported symptom burden was stable for up to 1 year after cancer surgery among older adults. Neither surgery nor adjuvant therapy coincided with a worsening in symptom burden. However, the persistence of symptoms at 1year may suggest gaps in supportive care for older adults. This information on symptom trajectory and predictors of high symptom burden is important to set appropriate expectations and improve patient counseling, recovery care pathways, and proactive symptom management for older adults after cancer surgery.

Intensive Daily Symptom and Function Monitoring Is Feasible and Acceptable to Women Undergoing First-Line Chemotherapy for Gynecologic Cancer.

Women receiving chemotherapy for gynecologic cancer (GC) experience severe symptoms with associated functional changes. Understanding day-to-day symptom and function variation within and across chemotherapy treatment cycles could inform improved symptom management, but such studies are rare and may be infeasible in clinical care. The aim of this study was to evaluate feasibility and acceptability of daily symptom monitoring combined with objective and self-reported functional assessments every 21 days during active chemotherapy for GC. Thirty women enrolled in a prospective observational study during first-line chemotherapy completed a daily symptom and falls diary during their entire chemotherapy treatment period. Patient-reported outcomes and objective symptom and function testing were assessed before each chemotherapy appointment. Study outcomes included accrual and attrition rates, completion of study assessments, and qualitative perceptions of study participation. Participants were 92% White, 60% had high school or higher education, 68% were married/partnered, and 62% had stage III or IV cancer at diagnosis. The study had an 83% accrual rate, 6.6% early withdrawal rate, and 17% total attrition rate. Missing assessments for prechemotherapy patient-reported outcomes and objective assessments ranged from 27% to 35% and 35% to 47% respectively, with a general decrease across cycles. Daily diary completion rate was 83% overall. Participants rated study participation positively. Intensive daily symptom and function monitoring was feasible and acceptable to GC patients and may provide a sense of symptom controllability. Daily symptom and function monitoring in research studies may provide patients with information to support symptom discussions with the clinical team. Future work should develop proactive symptom management interventions using personalized symptom trajectories.

End-of-Life Experiences for Cancer Patients Dying in Hospital with COVID-19.

Despite a wealth of research regarding COVID-19, little evidence exists about cancer patients’ specific needs and experiences at end-of-life. This study retrospectively describes the care of 34 hospitalised cancer patients dying with COVID-19. The palliative care needs of patients were described. The main domains of end-of-life care service provision were evaluated including treatment of pain and other symptoms, communication and decision making at end-of-life and level of involvement of the palliative care team. Physical symptoms were managed with relatively low doses of end-of-life medications. High levels of patient and family anxiety, however, highlight the complexity of death from a stigmatised disease. Prompt acknowledgement of the vulnerability of advanced cancer patients with COVID-19 can facilitate proactive symptom management, anticipatory communication and enhance family support.

Using the revised Edmonton symptom assessment scale during neoadjuvant radiotherapy for retroperitoneal sarcoma

Background and purposeRetroperitoneal sarcoma (RPS) is a rare, complex disease requiring multidisciplinary management. We have previously reported that use of the Revised Edmonton Symptom Assessment Scale (ESAS-r-CSS) allows for proactive symptom management, and we sought to report the results of ESAS-r-CSS screening during pre-operative radiotherapy (RT) for a cadre of patients with RPS. Materials and methodsWe reviewed records of 47 patients with RPS evaluated at our institution between 2015 and 2018. Of this group, 29 non-metastatic patients were treated with definitive intent neoadjuvant RT with at least 2 weekly ESAS-r-CSS reports. A generalized estimating equation model was used to compare 13 symptoms during weekly on-treatment visits compared to baseline scores at week 1 of RT. Additionally, covariate effects of age, gender, dose, tumor size and location were assessed. ResultsThe population was predominantly male (66%) with median age of 65 years, KPS of 90, and tumor size of 12.8 cm. ESAS scores significantly decreased for anxiety at week 3 (P = 0.01), and pain at week 5 (P = 0.01). Worse constipation was reported at week 2 (P = 0.02). In an exploratory covariate analysis, female gender, age, high dose, and larger tumor size were associated with worse ESAS scores across all time points. ConclusionPatient reporting of symptoms during radiotherapy through weekly ESAS-r-CSS facilitates timely management in patients with this unique tumor type. Expectant care during RT offers the opportunity to minimize symptom progression or treatment interruptions in a population that generally has worsening side effects.

Symptom burden among head and neck cancer patients in the first year after diagnosis: Association with primary treatment modality

PurposeHead and neck cancer (HNC) and its treatment affects quality of life, with significant symptom burden. The main objectives of this study were to examine symptom trajectories of HNC patients by treatment and to identify factors associated with high ESAS scores. Methods and materialsWe conducted a retrospective cohort study in patients diagnosed with HNC in Ontario, Canada from 2007 to 2015 using linked health administrative databases. The primary outcome was a monthly patient self-reported moderate-to-severe (≥4) symptom score in the year following diagnosis. Multivariable Modified Poisson regression analyses with robust variance were used to investigate factors associated with moderate-to-severe scores. ResultsOf 13,827 HNC patients identified, 4793 had ≥1 ESAS assessment within 12 months of cancer diagnosis. Overall, 60% (n = 2708) and 65% (n = 2903) of patients reported moderate-to-severe pain and poor appetite, respectively. The proportion of patients reporting a score ≥4 increased significantly during treatment and was most pronounced for those who received chemoradiation (CRT). On multivariable analysis, patients who were female (Relative Risk (RR) 1.15, 95% CI 1.08–1.23, received CRT, had a higher comorbidity burden (RR 1.31, 1.23–1.39), and had a diagnosis of oropharyngeal (1.10, 1.02–1.19), or oral cavity cancer (1.31, 1.19–1.45), were at an increased risk of reporting severe pain scores (p < 0.01 for all). ConclusionThe majority of HNC patients report high pain scores, with symptom burden highest during the treatment phase, and especially for patients who received radiation or chemoradiation. This large study highlights the need for proactive symptom management during the HNC patients' cancer journey.

Patient-reported outcome measures in a pharmacokinetic study with sunitinib, a prospective cohort study

PurposeDuring treatment with tyrosine kinase inhibitors, such as sunitinib, patients experience treatment and/or disease-related symptoms. Although application of patient-reported outcome measures (PROMs) enhances early recognition of symptoms, early clinical trials are focused on symptom severity objectified by the Common Terminology Criteria for Adverse Events (CTCAE) in order to evaluate drug safety and to determine a personalized and/or safe dosage range. To gain insight into patient-reported symptoms in addition to healthcare professional-reported adverse events (AEs), a substudy was conducted in an ongoing pharmacokinetic-guided sunitinib dosing study.MethodsIn patients for whom sunitinib was considered standard therapy or patients with advanced/metastatic tumors for whom no standard therapy was available, patient-reported symptoms and well-being besides healthcare professional-reported AEs were assessed.ResultsTwenty-nine patients were included for analysis. Over 50% of them experienced a decreased well-being, caused by symptoms of mild and moderate intensity. Compared to healthcare professionals, all measured symptoms, with the exception of fatigue and vomiting, were reported statistically significantly more often by patients.ConclusionsApplication of PROMs in early clinical trials on personalized or individualized oral targeted anticancer agents is feasible and enhances early recognition of symptom burden due to multiple CTCAE grade 1–2 AEs, just as pro-active symptom management and effect evaluation of interventions performed. Application of PROMs in these trials might be clinically relevant in obtaining dose-limiting toxicities.

Patient-reported symptoms and stepwise symptom management in patients on epidermal growth factor inhibitors: A retrospective, descriptive cohort study

Adverse events (AEs) of epidermal growth factor inhibitors (EGFRi) influence well-being with a risk to dose modifications (DMs). Hereby, clinical benefit of treatment might be affected. This retrospective cohort study was set up to gain insight into the suitability and added value of a patient-reported outcome measurement tool (PROM), together with a stepwise intervention management plan for EGFRi-related AEs in daily practice. The primary objective was to gain insight into total treatment duration and DMs, and the secondary objective to gain insight into patient-reported symptoms and well-being as well as healthcare professional-reported AEs. Sixty-eight patients on cetuximab and 19 on panitumumab treatment were included for analysis; 69% had squamous cell carcinoma of head and neck (SCCHN) and 26% metastatic colorectal carcinoma. DMs due to AEs occurred in 39% of the patients and dose discontinuations in 22%. Especially anorexia, dysphagia, oral pain and skin changes led to a decreased well-being. In patients on EGFRi, application of PROMs together with a stepwise symptom management plan enhances early recognition of symptom burden, pro-active symptom management and effect evaluation of interventions performed whereby well-being recovers. Since only SCCHN patients discontinued treatment due to AEs, patient-centred care focused on radiotherapy-related AEs, creates opportunities for amelioration.

The role of chronic disease in the costs of potentially preventable emergency department use during treatment: A regional study.

6505 Background: The Centers for Medicare and Medicaid Services (CMS) released a quality metric for potentially preventable chemotherapy-associated emergency department (ED) use, effective in 2020. This metric excludes diagnoses with emerging evidence for outpatient management, such as proactive symptom management (PSM) and those for ambulatory care sensitive chronic conditions. Little is known about the intersection between potentially preventable ED visits due to cancer vs. other chronic disease. This study characterized the number and costs of ED visits during treatment. Methods: Western Washington cancer registry records from 2011- 2015 were linked with claims from two commercial insurers. Patients with newly diagnosed solid tumors undergoing initial treatment with chemotherapy or radiation were eligible. ED use was tracked one year post treatment initiation. ED diagnosis codes for fields 1-10 from the CMS metric and the PSM literature were labeled “Potentially Preventable” (Pp). Codes from the Agency for Healthcare Research and Quality’s Prevention Quality Indicators (PQI) for Chronic Conditions were labeled “Potentially Preventable-Chronic Disease” (PpChronic). Costs were adjusted to $2016. Results: Of the 7,053 eligible patients, 2,543 (36.1%) visited the ED (median # visits [IQR]: 1 [1-2]). The most commonly listed codes included Pain (1,054 visits) and Dyspnea (279 visits) for Pp, Hypertension-PQI (652 visits) and COPD-PQI (206 visits) for PpChronic, and Diabetes (247 visits) and Hyperlipidemia (181 visits) for the other codes. Spending on ED visits including both potentially preventable cancer and chronic disease diagnoses totalled $706,552 (20% of ED costs). Conclusions: One fifth of ED costs potentially resulted from simultaneous poor cancer symptom and chronic disease management. Future research should explore the role of chronic illness in categorizing which ED visits are potentially preventable during cancer treatment. [Table: see text]

Costs of potentially preventable emergency department use during cancer treatment: A regional study.

2 Background: There is growing recognition that many emergency department (ED) visits during cancer treatment may be related to poorly controlled disease or treatment-related symptoms and could be prevented. An RCT using the Symptom Tracking and Reporting (STAR) tool for proactive symptom management decreased the percentage of patients admitted to the ED (34% vs. 41%; p=0.02). Little is known about the costs of potentially preventable ED visits in a community setting. This study examined the number and costs of ED visits and their associated diagnoses. Methods: Cancer registry records for patients in Western Washington from 2011 to 2015 were linked with claims from two regional commercial insurers. Patients diagnosed with a solid tumor and treated with chemotherapy or radiation were selected. All ED utilization was tracked for 1 year after the start of treatment. ED-related diagnoses codes were labeled “Potentially Preventable” (PP) if they mapped to the 13 symptom categories targeted by STAR (e.g. pain, nausea) and non-PP otherwise. Costs of ED visits were inflation-adjusted and include claims with ED-related procedure, revenue, and place of service codes. All subsequent inpatient costs were excluded, likely under-estimating total costs. Results: Of the 7,075 eligible patients, 2,543 (35.9%) visited the ED an average of 1.79 times. Pain (720 visits), Dyspnea (279 visits), and Nausea (232 visits) were the most common potentially preventable diagnoses; Hypertension (506 visits), Fever (230 visits), and Diabetes (215 visits) were the most common non-PP diagnoses. $1,134,254 (25.2% of the total ED costs) was spent on PP ED visits. Of PP ED visits 20.3% (178/875) resulted in an inpatient stay. Conclusions: In our community setting, at least one quarter of ED costs were potentially the result of poor symptom management. An investment in better symptom management has a significant opportunity to both improve cancer care and lower total costs.[Table: see text]

Toxicity-Related Factors Associated With Use of Services Among Community Oncology Patients

Community oncology practices frequently manage chemotherapy-associated toxicities, which may disrupt treatment, impair quality of life, and induce unplanned service use. We sought to understand the patterns and correlates of unplanned health care service use among patients receiving first-cycle chemotherapy at five community-based ambulatory oncology practices. A survey study examined the dichotomous outcome of unplanned service use, defined as oncologist visits, emergency department visits, and hospitalizations, resulting from toxicity-related factors. Newly diagnosed patients with breast, lung, head and neck, or colorectal cancer or non-Hodgkin lymphoma were recruited during the first chemotherapy cycle. Before beginning the second cycle of chemotherapy, patients completed a questionnaire that measured unplanned service use and overall distress, plus severity of nausea, vomiting, diarrhea, constipation, mouth sores, intravenous catheter problems, pain, fever and chills, extremity edema, and dyspnea on a 5-point scale (1, did not experience; 5, disabling). Medical record reviews captured chemotherapy doses, comorbid conditions, and supportive care interventions. Mixed-effects logistic regression was used to identify factors associated with unplanned service use, with random effects specified for each clinic. Among 106 patients (white, 98%; female, 74.5%; mean age ± standard deviation, 60 ± 11 years), frequently reported toxicities were pain, nausea, diarrhea, and constipation. Thirty-six patients (34%) reported unplanned service use: 29% reported oncologist visits, 14% reported emergency department visits, and 8% reported hospitalizations. Factors significantly associated with unplanned service use were high patient-reported distress and receipt of colony-stimulating factor. Service use resulting from toxicity-related factors occurs frequently in community oncology settings. Monitoring toxicity patterns and outcomes can inform proactive symptom management approaches to reduce toxicity burden between scheduled visits.

Patient perspectives of their leg ulcer journey

To understand the personal impact of venous leg ulceration from the patients' perspective. Face-to-face, unstructured interviews were conducted with nine patient participants with venous leg ulcers. The interviews were digitally recorded, transcribed verbatim and, using thematic analysis, the themes and subthemes which impacted on quality of life were identified. Four core themes were identified: the ulcer, symptoms, wound management and effects on daily life, with 16 subthemes that negatively impacted on quality of life (QoL) also identified. This qualitative study offers a valuable insight into the complex issues that impact on daily living for this patient group. The implications of the findings are far reaching and suggest that proactive symptom management and the fostering of a patient focus to consultations may improve QoL and encourage the patient to engage as an active partner in his/her management plan; both of which are explored in the subsequent phases of the larger study. This study was funded by West Midlands Strategic Health Authority. The authors have no conflicts of interest to declare.

Symptom Prevalence, Intensity, and Distress in Patients With Inoperable Lung Cancer in Relation to Time of Death

To examine symptom prevalence, intensity, and association with distress in patients with inoperable lung cancer (LC), using time to death as point of reference. A consecutive sample of 400 patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 plus a 13-item LC-specific scale and the Thurstone Scale of Symptom Distress-Lung Cancer at six time points during the first year after diagnosis. Patients were divided into subgroups, using data from the time point closest to death (< 1; 1 to 2; > 2 to 3; > 3 to 6; > 6 to 12; and > 12 months before death) for analysis. More than 50% of patients in all subgroups reported problems related to physical, role, and emotional functioning; fatigue; dyspnea; and cough. In general, functional levels were lower and symptoms higher in subgroups closer to death. Notably, clinically relevant differences were also found in role and social functioning and appetite loss between the two groups furthest from death. A consistent pattern was found among the six subgroups, with breathing, pain, and fatigue rated as the symptoms most associated with distress. High prevalence of symptoms was found in all subgroups, with higher intensity in subgroups closer to death, indicating a need for prophylactic and proactive symptom management. Less concordance was found among symptom prevalence, intensity, and association with distress in subgroups further from death. Future studies should investigate longitudinal associations between symptoms with low intensity and high distress, and examine their clinical implications.