Symptom Management Interventions Research Articles

Abstract PO2-12-09: Insomnia, Pain, Anxiety, Distress, Fatigue, and Functional Impairment in Patients with Breast Cancer

Abstract Background: SPPADE symptoms (Sleep disturbance, Pain, Physical function impairment, Anxiety, Depression/distress, and Energy deficits/fatigue) may result from cancer and its treatment. The aim of this analysis was to characterize SPPADE symptoms in patients with breast cancer. Methods. SPPADE data were drawn from the Enhanced, EHR-facilitated Cancer Symptom Control (E2C2) study, a stepped-wedge pragmatic cluster-randomized trial designed to evaluate a symptom management intervention in routine practice (NCT03892967). Symptom severity was measured on a 0-10 scale via a survey administered by patient portal, in-clinic tablet, or interactive voice response system (by phone) prior to, during, or soon after an outpatient oncology encounter. Scores of 4-6 were categorized as “moderate” and ≥7 as “severe.” In this analysis, only the data from each patient’s initial survey were included. Results. A total of 9,651 patients with breast cancer completed an initial E2C2 survey between March 2019 and January 2023. The proportion of patients with moderate or severe SPPADE symptoms were as follows: 22% moderate and 10% severe for insomnia; 18% moderate and 7% severe for pain; 17% moderate and 7% severe for anxiety; 15% moderate and 5% severe for emotional distress; 25% moderate and 12% severe for fatigue; and 22% moderate and 8% severe for impaired physical function. Table 1 presents score means and standard deviations by demographic subgroup. Conclusions. SPPADE symptoms are common in patients with breast cancer. These observations warrant routine implementation of symptom surveillance and management in breast oncology. Funding acknowledgement: The Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium is a Cancer Moonshot Research Initiative under the authorization of the 2016 United States 21st Century Cures Act. This research was supported by the National Cancer Institute of the NIH, UM1CA233033 (Mayo Clinic, Rochester, MN). Insomnia, Pain, Anxiety, Distress, Fatigue, and Functional Impairment in Patients with Breast Cancer Citation Format: Kathryn Ruddy, Veronica Grzegorczyk, Deirdre Pachman, Sandra Mitchell, Bolun Liu, Deanne Smith, Ciara O'Sullivan, Shawna Ehlers, Jeph Herrin, Parvez Rahman, Andrea Cheville. Insomnia, Pain, Anxiety, Distress, Fatigue, and Functional Impairment in Patients with Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-12-09.

Exploring Adolescent and Young Adult Cancer Survivors' Experience with Cancer Treatment-Related Symptoms: A Qualitative Analysis of Semi-Structured Interviews.

Purpose: Few studies have specifically targeted symptom management interventions for adolescent and young adult (AYA) cancer survivors. A greater understanding of AYA cancer survivors' experiences with cancer treatment-related symptoms would help develop age-appropriate oncology symptom management interventions. The purpose of this qualitative analysis was to explore AYA cancer survivors' experience with cancer treatment-related symptoms. Methods: Nineteen post-treatment AYA cancer survivors (18-39 years old) who self-reported moderate-severe cancer treatment-related symptom severity participated in video conferencing or telephone interviews. The questions in the interview guide queried participants to share their experience with cancer treatment-related symptoms. Inductive content analysis was used to identify themes from the interviews. Results: The themes that emerged from the interviews included (1) cancer treatment-related symptoms negatively affected AYA cancer survivors' quality of life (e.g., symptoms served as a reminder of cancer recurrence possibility); (2) AYA cancer survivors' attitudes and feelings about communicating cancer treatment-related symptom concerns to clinicians (e.g., patient-clinician communication was bolstered when AYAs perceived that symptoms were being taken seriously); (3) AYA cancer survivors are interested in oncology symptom management clinical trials, but logistical challenges are barriers to participation; and (4) AYA cancer survivors are interested in nonpharmacological treatments for symptom management. Conclusion: Results highlight the burden of cancer treatment-related symptoms on day-to-day life among post-treatment AYA cancer survivors. Future work is needed to identify nonpharmacological symptom management interventions, strategies to improve patient-clinician communication about symptoms, and strategies to increase the visibility and accessibility of symptom management clinical trials for AYA cancer survivors.

Peer-Led Symptom Management Intervention to Enhance Resilience in People with Systemic Sclerosis: Mediation Analysis from a Randomized Clinical Trial.

Facilitated self-management interventions have the potential to enhance resilience and well-being. We examined whether resilience is a mediator of improving physical and psychological symptoms for people with systemic sclerosis (SSc) who participated in a 12-week online peer-led symptom management intervention. We conducted a secondary data analysis from a randomized control trial comparing a peer health coached intervention to a waitlist control. Participants completed the Connor-Davidson Resilience Scale, the Functional Assessment of Chronic Illness Therapy-Fatigue scale, and the Patient Reported Outcomes Measurement Information System measures of pain interference and depressive symptoms at the baseline and at weeks 6 and 12. Linear mixed effect regression models were used to assess the effect of intervention on changes in resilience. Causal mediation analyses were conducted to examine whether changes in resilience at week 12 mediated intervention effects on changes in fatigue, pain interference, and depressive symptoms at week 12. One hundred and seventy-three eligible participants were enrolled. Participants in the intervention group reported improvements in resilience (p < .001). These changes in resilience mediated the intervention effects on fatigue with indirect effect of -1.41 (95% Confidence Interval [CI], -2.41 to -0.41), pain interference of -0.86 (95% CI, -1.65 to -0.08), and depressive symptoms of -1.99 (95% CI, -3.16 to -0.81). For participants in the intervention who had positive improvements in their physical and psychological symptoms, increased resilience was a mechanism for these improvements. These findings support the importance of addressing resilience to improve symptoms in similar SSc interventions.

Mindful Night-to-Day: A Pilot Feasibility Trial of a Mindfulness-Based Insomnia and Symptom Management Intervention for Patients with Hematologic Cancer

ABSTRACT Objectives Patients with hematologic cancer experience severe symptoms (i.e. insomnia, fatigue, pain, distress). Few interventions addressing insomnia and other symptoms exist for this population. Mindfulness-Based Therapy for Insomnia (MBTI) may be appropriate but has only been tested in healthy outpatients. This study aimed to develop and test an adapted MBTI protocol for hematologic cancer patients. Methods Patient (n = 3) and clinician (n = 1) focus groups, and user-testing (N = 5) informed adaptation of Mindful Night-to-Day (MBTI+). A single-arm pilot trial (N = 32) evaluated feasibility (accrual, attrition, adherence), acceptability (intervention satisfaction), and changes to insomnia symptom severity (Insomnia Severity Index; primary outcome) and secondary outcomes (fatigue, pain, distress, pre-sleep arousal, mindfulness, symptom management self-efficacy) at baseline, post-intervention, and 1-month post-intervention. Descriptive statistics and paired sample t-tests were conducted. Results Qualitative feedback informed MBTI+ content, format, and delivery. Mindfulness was used to increase symptom awareness (sleepiness vs. fatigue). Meditations and behavioral skills were applied to inpatient treatment. MBTI+ met feasibility (N = 32/12 months; 8.1% attrition; 83.8% adherence) and acceptability (M = 3.52/4.00) benchmarks. Insomnia symptom severity decreased (d = 1.20) from baseline to post-intervention, as did most secondary outcomes. Conclusions MBTI+ was feasible, acceptable, and showed promise for benefits throughout inpatient and outpatient treatment. Findings warrant further evaluation in a randomized trial.

Symptom and Technology Management Intervention Usefulness for Caregivers of Children With Tracheostomies and Feeding Tubes.

Caregivers of children who require medical technology of tracheostomies and feeding tubes provide intensive and specialized care at home. They have extensive training in the hospital prior to their child's discharge; however, there is limited education about their child's care once they are at home. The Creating Opportunities for Personal Empowerment: Symptom and Technology Management Resources intervention focused on commonly experienced symptoms and technology used at home by caregivers. We present the findings from the intervention exit interviews to gain insight about the intervention from caregiver perspectives, notably their perceptions of usefulness, ease of use, and acceptability. A qualitative descriptive design was used to examine caregivers' perceptions of the intervention in exit interviews. These interviews were conducted upon completion of the intervention as part of feasibility testing. Sixteen caregivers completed the study and participated in exit interviews. Caregivers described the themes of the best that you can do, a reminder that I am doing it the right way, and I wish I had these when my child first had the tracheostomy and feeding tube. Caregivers also provided feedback about the intervention's usefulness and suggestions for further refinement and future adaptations of the intervention. Caregivers provided valuable insights about the intervention, describing its usefulness to them, the potential for usefulness for other caregivers of these children, and their experiences with care of their children at home. Future plans include efficacy testing and modifications to enhance the intervention based on caregiver feedback.

Physical Activity in Individuals Newly Diagnosed With Multiple Sclerosis Through the Lens of the COM-B Model.

Physical activity (PA) is a promising intervention for disease modification and symptom management in multiple sclerosis (MS); however, there is a lack of research focusing on PA behavior change interventions for persons newly diagnosed with MS. Such PA behavior change interventions should be developed based on a strong empirical foundation of understanding the behavior and its determinants (ie, what to target for changes to occur). To that end, this qualitative study examined factors explaining PA in persons newly diagnosed with MS and identified potential targets for future behavior change intervention development based on the Capability-Opportunity-Motivation-Behavior (COM-B) model. Twenty individuals diagnosed with MS within the past 2 years underwent one-on-one semistructured interviews using questions developed based on the COM-B model. Data were analyzed using reflective thematic analysis, and the identified themes were then mapped with the COM-B model. Factors explaining PA in the study sample were identified across the COM-B components. The typical factors include knowledge and skills to sufficiently engage in PA with appropriate approaches, ability to adapt and navigate through new environmental and social difficulties after diagnosis, and motivation resulting from a combination of factors, such as outcome expectation, belief of capabilities, role/identity, reinforcement, and emotions. The COM-B model was applied successfully in this study to understand PA behavior and identify potential targets for behavior change in individuals newly diagnosed with MS. Future behavior change interventions should consider addressing these factors to generate effective PA behavior change in this population.

Stability and consistency of symptom clusters in younger versus older patients receiving chemotherapy

BackgroundBy 2035, the number of newly diagnosed cancer cases will double and over 50% will be in older adults. Given this rapidly growing demographic, a need exists to understand how age influences oncology patients’ symptom burden. The study purposes were to evaluate for differences in the occurrence, severity, and distress of 38 symptoms in younger (< 60 years) versus older (≥ 60 years) oncology patients undergoing chemotherapy and to evaluate for differences in the stability and consistency of symptom clusters across the two age groups.MethodsA total of 1329 patients were dichotomized into the younger and older groups. Patients completed demographic and clinical questionnaires prior to the initiation of their second or third cycle of chemotherapy. A modified version of Memorial Symptom Assessment Scale was used to evaluate the occurrence, severity, and distress of 38 common symptoms associated with cancer and its treatment. Differences between the two age groups in demographic and clinical characteristics and ratings of occurrence, severity, and distress for the 38 symptoms were evaluated using parametric and nonparametric tests. Exploratory factor analyses were done within each age group to identify symptom clusters using symptom occurrence rates.ResultsCompared to the younger group (14.8 (± 7.0)), older adults reported a lower mean number of symptoms (12.9 (± 7.2)). Older patients experienced lower occurrence rates for almost 50% of the symptoms. Regarding symptom clusters, an eight-factor solution was selected for both age groups. Across the two age groups, the eight symptom clusters (i.e., physical and cognitive fatigue, respiratory, psychological, hormonal, chemotherapy-related toxicity, weight gain, gastrointestinal, epithelial) were stable. However, symptoms within the physical and cognitive, chemotherapy-related toxicity, and gastrointestinal clusters were not consistent across the age groups.ConclusionsTo be able to provide tailored and effective symptom management interventions to older oncology patients, routine assessments of the core symptoms unique to the symptom clusters identified for this group warrants consideration. The underlying mechanism(s) for these inconsistencies in symptom burden is an important focus for future studies.

Tracking activities and adaptations in a multi-site stepped wedge pragmatic trial of a cancer symptom management intervention

BackgroundPragmatic trials may need to adapt interventions to enhance local fit, and adaptation tracking is critical to evaluation. This study describes the tracking approach for a multisite, stepped-wedge hybrid pragmatic trial testing implementation and effectiveness of a cancer symptom management intervention. MethodsStudy activities were documented in a spreadsheet by date and category. Intervention adaptations were tracked across multiple workgroups in a database structured around the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) domains, e.g., reasons for change. Implementation strategies were tracked longitudinally and by cluster in a database using the Longitudinal Implementation Strategy Tracking System (LISTS) method. A logic model was created at the end of the study to describe core intervention components and implementation strategies with dates of adaptations. ResultsBetween January 2019 and January 2023, 187 study activities were documented. Most intervention activities took place early, but there were important intervention refinements during the course of the trial, including the expansion of interventionist roles to add two new disciplines. Eleven intervention adaptations were documented. Most were unplanned and aimed at improving fit or increasing engagement. Thirty-three implementation strategies were documented, the largest number of which were related to educating stakeholders. Most (but not all) component and strategy additions were consistent with the mechanisms of change as hypothesized at trial launch. ConclusionsA multifaceted approach to adaptation tracking, combined with a logic model, supported identification of meaningful changes for use in evaluation, but further work is needed to minimize burden and ensure robust and practical systems that inform both evaluation and timely decision-making. TrialRegistration: ClinicalTrials.gov, NCT03892967. Registered on March 25, 2019. https://www.clinicaltrials.gov/

Correlation between symptom status, health perception, and spiritual well-being in heart failure patients: A structural equation modeling approach.

To explore predictors of spiritual well-being behaviors among heart failure patients based on Wilson and Cleary's conceptual model of health-related quality of life and to clarify the interrelationships among these variables. A descriptive and correlational study design was used. This study included 202 heart failure patients treated between October 2020 and July 2021. Data were collected using the Symptom Status Questionnaire-Heart Failure, Perception of Health Scale, and Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale. Descriptive analysis, correlation, and structural equation modeling were performed. Characteristic factors positively affected spiritual well-being both directly (β = 0.19, p = 0.007) and indirectly (β = 0.19; CI (0.106; 0.311)). The direct relationship between health perception and spiritual well-being was significant (β = 0.83, p < 0.05). Symptom status acted as an essential mediator between model variables and spiritual well-being (β = -0.28; CI (-0.449; -0.133)). Comorbidity and symptom status also influence spiritual well-being through health perceptions. These variables explain 77% of the variance in spiritual well-being. The modified structural equation modeling based on Wilson and Cleary's conceptual model fits well in predicting spiritual well-being in patients with heart failure. Spiritual well-being was reported to be poor, and changes in spiritual well-being were predicted by age, educational level, marital status, comorbidity, symptom status, and health perception. The results can be applied to patients with heart failure and may serve as a guide for assessment and interventions for improving spiritual well-being. This study mainly concludes that symptom status and perceived health status affect spiritual well-being in heart failure patients. Symptom relief and improvement in perceived health status interventions may help enhance spiritual well-being in this population. Future studies are needed to investigate the different predictor's effects on spiritual well-being and examine whether symptom management and health status-enhancing interventions result in improved spiritual well-being in the heart failure population. This study was reported following the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for cross-sectional studies. No patient or public contribution.

Maternal Psychological Symptom Trajectories From 2 to 24 Months Postpartum: A Latent Class Growth Analysis.

Postpartum women experience an array of psychological symptoms that are associated with adverse health behaviors and outcomes including postpartum suicidal ideation and long-term depression. To provide early management of postpartum psychological symptoms, it is important to understand how the symptom experiences change over time. The aim of this study was to examine maternal psychological symptom trajectories over 2, 6, 15, and 24 months postpartum using latent class growth analysis and to examine how each trajectory is associated with maternal depression outcome at 24 months. We used secondary data from the Family Life Project ( N = 1,122) and performed multitrajectory latent class growth analysis based on four observed symptom variables (depression, anxiety, somatization, and hostility). After the final model was identified, bivariate analyses were conducted to examine the association between each trajectory and (a) individual characteristics and (b) outcome (Center for Epidemiologic Studies Depression Scale [CES-D]) variables. A four-class model was selected for the final model because it had better fit indices, entropy, and interpretability. The four symptom trajectories were (a) no symptoms over 24 months, (b) low symptoms over 24 months, (c) moderate symptoms increasing over 15 months, and (d) high symptoms increasing over 24 months. More postpartum women with the trajectory of high symptoms increasing over 24 months (Trajectory 4) were in low economic status (92.16%), unemployed (68.63%), or did not complete 4-year college education (98.04%). Most postpartum women (95.56%) in Trajectory 4 also had higher CES-D cutoff scores, indicating a possible clinical depression at 24 months postpartum. Postpartum women who experience increasing symptom trajectories over 15-24 months (Trajectories 3 and 4) could benefit from tailored symptom management interventions provided earlier in the postpartum period to prevent persistent and worsening symptom experiences.

Comparing The Effects of Metformin and Exercise-Based Lifestyle Interventions for Symptom Management of Polycystic Ovary Syndrome (PCOS): A Literature Review

Introduction: Polycystic ovary syndrome (PCOS) is a common hormone problem characterized by androgen excess and typically leads to the development of small cysts in the ovaries, insulin resistance, hirsutism, irregular menstrual cycles, and hyperandrogenism. While there is no cure for PCOS, treatments like metformin and lifestyle modifications work to manage individual symptoms. While studies in the past have compared individual effects of metformin and lifestyle modifications on symptoms of PCOS, a limited number of studies have compared the effects of metformin with lifestyle modifications, specifically aerobic exercise. This review compared the effects of metformin treatment and exercise interventions on metabolic symptoms, such as high blood glucose and insulin levels in PCOS. Methods: A literature search using Pubmed and Google Scholar was conducted. A total of five articles focusing on metformin were included in the review; some focusing inclusively on the drug itself, others comparing lifestyle modifications alone and modifications combined with metformin. In this review, the lifestyle modification was aerobic exercises, taking the form of exercise regimes (walks, marching in place, or supervised fitness sessions). Results: Results show that metformin improves metabolic symptoms, including blood glucose and insulin levels, significantly more than lifestyle interventions alone; however, if both treatments were combined, these effects were more profound. Discussion: Metformin serves as an effective treatment for metabolic and hormonal symptoms, consequently improving PCOS symptomology. Although exercise is shown to be less effective than metformin, the addition of exercise to metformin treatment further ameliorates symptomology. Conclusion: Combining metformin and aerobic exercise demonstrates the greatest impact on managing PCOS symptoms. Future studies should examine the standardization of an aerobic exercise regimen and pharmaceutical treatments for the management of PCOS.

Non-pharmacological interventions feasible in the nursing scope of practice for pain relief in palliative care patients: a systematic review.

Palliative care patients desire more symptom management interventions that are complementary to their medical treatment. Within the multi-professional team, nurses could help support pain management with non-pharmacological interventions feasible for their practice and adaptable to palliative care patients' needs. The objective was to identify non-pharmacological interventions feasible in the nursing scope of practice affecting pain in palliative care patients. A systematic review. A defined search strategy was used in PubMed, CINAHL, PsycINFO, and Embase. Search results were screened double-blinded. Methodological quality was double-appraised with the Joanna Briggs Institute Critical Appraisal Tools. Data were extracted from selected studies and the findings were summarized. The methodological quality, quantity of studies evaluating the same intervention, and consistency in the findings were synthesized in a best-evidence synthesis to rank evidence as strong, moderate, limited, mixed, or insufficient. Out of 2385 articles, 22 studies highlighted non-pharmacological interventions in the nursing scope of practice. Interventions using massage therapy and virtual reality demonstrated most evidentiary support for pain management, while art therapy lacked sufficient evidence. Mindful breathing intervention showed no significant reduction in pain. Hypnosis, progressive muscle-relaxation-interactive-guided imagery, cognitive-behavioral audiotapes, wrapped warm footbath, reflexology, and music therapy exhibited promising results in pain reduction, whereas mindfulness-based stress reduction program, aromatherapy, and aroma-massage therapy did not. Despite not all studies reaching significant changes in pain scores, non-pharmacological interventions can be clinically relevant to palliative care patients. Its use should be discussed for its potential value and nurses to be trained for safe practice. Methodologically rigorous research for non-pharmacological interventions in nursing scope of practice for pain relief in palliative care patients is necessary. The protocol for this study is registered in the International Prospective Register of Systematic Review (PROSPERO registration number: CRD42020196781).

Self-reported MeasUrement of Physical and PsychosOcial Symptoms Response Tool (SUPPORT-dialysis): systematic symptom assessment and management in patients on in-centre haemodialysis – a parallel arm, non-randomised feasibility pilot study protocol

IntroductionPatients with kidney failure experience symptoms that are often under-recognised and undermanaged. These symptoms negatively impact health-related quality of life and are associated with adverse clinical outcomes. Regular symptom assessment,...

ASSESSING MODERATED MEDIATION IN THE RELATIONSHIP BETWEEN SYMPTOM COUNTS, FALLS, AND HEALTH OUTCOMES

Abstract Almost half of older adults experience multiple symptoms that limit function and increase the risk for falls. The study aimed to determine if the relationship between symptoms (pain, endurance, weakness, balance, depression/anxiety) and outcomes (hospitalization, residential care, activity limitations, wellbeing, and mortality) are mediated by falls and whether symptoms further moderate outcomes of falls. Data from community-dwelling older adults (≥ 65 years, n=4921) enrolled in the National Health and Aging Trends Study (NHATS) 2015 cohort were used for analysis. Symptoms were categorized by symptom count (0, 1, 2, 3, 4, ≥5). Using generalized structural equation modeling, 2015 symptom counts were modeled to predict 2016 falls, 2016 health outcomes, and 2017 mortality. Falls partially mediated the association between symptoms in one year and outcomes the following year for all except residential care. In addition, the effect of falls on hospitalization is significantly moderated by symptoms (interaction of symptoms and fall OR=.89, robust SE=.045, p=.025). This dampening effect indicates that the overall effect of falls on hospitalization (OR=2.19, robust SE=.36, p&amp;lt;.001) is stronger at the lower levels of symptom count and weaker at the higher levels of symptom count. When there are ≥5 symptom present, there is no significant difference between the predicted probability of hospitalization for those who have not experienced a fall (.31, 95%CI: .28 to .34) and those who have fallen (.36, 95%CI: .31 to .41). Understanding the complex relationship between symptoms, falls, and outcomes can assist with developing interventions for symptom management and fall prevention.

The effect of a mobile education application (MobilMS) developed for multiple sclerosis patients in Turkey on symptom management and quality of life: A randomized controlled study

BackgroundMultiple sclerosis (MS) is a neurodegenerative disease that affects the central nervous system (CNS) and is caused by immune dysfunction. MS results in a variety of symptoms that affect physical, emotional, social, and cognitive functioning. Effective symptom management is a critical factor in improving the quality of life (QoL) of patients with MS. PurposeTo determine the effects of a comprehensive mobile education application developed for Turkish patients with MS on symptom management and QoL. MethodsThe study was conducted as a randomized controlled trial and included 63 patients with MS older than 18 years who had an Expanded Disability Status Scale score of ≤6 and were actively using smart phones (intervention group, n = 31; control group, n = 32). Data were collected using a patient information form, the Multiple Sclerosis-Related Symptom (MS-RS) checklist, the Multiple Sclerosis Quality of Life Scale (MSQoL-54), and the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ). The scales were administered three times: at baseline, first month, and third month. Patients with MS in the intervention group were followed up for three months using MobilMS. ResultsIn the intervention group, the mean rating of MobilMS was 8.74±1.29. Most patients indicated that MobilMS was an “informative and useful application”. None of the patients in the study reported any side effects or difficulties when using MobilMS application. The mean MSQL-54 score of the intervention group was significantly higher compared to that of the control group at the first and third months (p = 0.001). The mean scores on the MS-RS checklist (p = 0.985), MS-TAQ subscale, Disease modifying therapies (DMT) barriers (p = 0.237), DMT side effects (p = 0.994), DMT coping strategies (p = 0.469), and Missing Doze Rate (MDR) (p = 0.765) were lower in the intervention group than in the control group, but these results were not statistically significant. ConclusionThe results of the study showed that MobilMS was highly appreciated, accepted, and used by patients with MS. MobilMS has the potential to meet the requirements for a free and accessible symptom management tool for patients with MS. The innovative MobilMS-based education intervention for support and symptom management is recommended as part of supportive care for this patient population. It is hoped that this study will pave the way for future studies on the utility of mobile applications for symptom management in patients with MS.

Study protocol for Care cOORDInatioN And sympTom managEment (COORDINATE) programme: a feasibility study

IntroductionSustainable approaches to support care coordination and symptom management needs of critically ill adults living with multimorbidity are needed to combat the challenges and complexity that multimorbidity presents. The study...

The Longitudinal Implementation Strategy Tracking System (LISTS): feasibility, usability, and pilot testing of a novel method

BackgroundSystematic approaches are needed to accurately characterize the dynamic use of implementation strategies and how they change over time. We describe the development and preliminary evaluation of the Longitudinal Implementation Strategy Tracking System (LISTS), a novel methodology to document and characterize implementation strategies use over time.MethodsThe development and initial evaluation of the LISTS method was conducted within the Improving the Management of SymPtoms during And following Cancer Treatment (IMPACT) Research Consortium (supported by funding provided through the NCI Cancer MoonshotSM). The IMPACT Consortium includes a coordinating center and three hybrid effectiveness-implementation studies testing routine symptom surveillance and integration of symptom management interventions in ambulatory oncology care settings. LISTS was created to increase the precision and reliability of dynamic changes in implementation strategy use over time. It includes three components: (1) a strategy assessment, (2) a data capture platform, and (3) a User’s Guide. An iterative process between implementation researchers and practitioners was used to develop, pilot test, and refine the LISTS method prior to evaluating its use in three stepped-wedge trials within the IMPACT Consortium. The LISTS method was used with research and practice teams for approximately 12 months and subsequently we evaluated its feasibility, acceptability, and usability using established instruments and novel questions developed specifically for this study.ResultsInitial evaluation of LISTS indicates that it is a feasible and acceptable method, with content validity, for characterizing and tracking the use of implementation strategies over time. Users of LISTS highlighted several opportunities for improving the method for use in future and more diverse implementation studies.ConclusionsThe LISTS method was developed collaboratively between researchers and practitioners to fill a research gap in systematically tracking implementation strategy use and modifications in research studies and other implementation efforts. Preliminary feedback from LISTS users indicate it is feasible and usable. Potential future developments include additional features, fewer data elements, and interoperability with alternative data entry platforms. LISTS offers a systematic method that encourages the use of common data elements to support data analysis across sites and synthesis across studies. Future research is needed to further adapt, refine, and evaluate the LISTS method in studies with employ diverse study designs and address varying delivery settings, health conditions, and intervention types.

Assessing Patient Readiness for an Electronic Patient-Reported Outcome-Based Symptom Management Intervention in a Multisite Study.

While the use of electronic patient-reported outcomes (ePROs) in routine clinical practice is increasing, barriers to patient engagement limit adoption. Studies have focused on technology access as a key barrier, yet other characteristics may also confound readiness to use ePROs including patients' confidence in using technology and confidence in asking clinicians questions. To assess readiness to use ePROs, adult patients from six US-based health systems who started a new oncology treatment or underwent a cancer-directed surgery were invited to complete a survey that assessed access to and confidence in the use of technology, ease of asking clinicians questions about health, and symptom management self-efficacy. Multivariable ordinal logistic regression models were fit to assess the association between technology confidence, ease of asking questions, and symptom management self-efficacy. We contacted 3,212 individuals, and 1,043 (33%) responded. The median age was 63 years, 68% were female, and 75% reported having access to patient portals. Over 80% had two or more electronic devices. Most patients reported high technology confidence, higher ease of asking clinicians questions, and high symptom management self-efficacy (n = 692; 66%). Patients with high technology confidence also reported higher ease of asking nurses about their health (adjusted odds ratio [AOR], 4.58 [95% CI, 2.36 to 8.87]; P ≤ .001). Those who reported higher ease of asking nurses questions were more likely to report higher confidence in managing symptoms (AOR, 30.54 [95% CI, 12.91 to 72.30]; P ≤ .001). Patient readiness to use ePROs likely depends on multiple factors, including technology and communication confidence, and symptom management self-efficacy. Future studies should assess interventions to address these factors.

Assessing the feasibility, acceptability, and preliminary efficacy of a novel symptom management care delivery intervention for caregivers receiving home hospice care: The I-HoME protocol.

BackgroundTerminally ill patients experience high symptom burden at the end of life (EoL), even when receiving hospice care. In the U.S., family caregivers play a critical role in managing symptoms experienced by patients receiving home hospice services. Yet, most caregivers don't receive sufficient support or formal training in symptom management. Therefore, providing additional visits and education to caregivers could potentially improve outcomes for both patient and caregiver. In response, we developed the Improving Home hospice Management of End-of-life issues through technology (I-HoME) intervention, a program designed for family caregivers of home hospice patients. This paper describes the intervention, study design, and protocol used to evaluate the intervention. MethodsThe I-HoME study is a pilot randomized controlled trial aimed at reducing patient symptom burden through weekly tele-visits and education videos to benefit the patient's family caregiver. One hundred caregivers will be randomized to hospice care with (n = 50) or without (n = 50) the I-HoME intervention. Primary outcomes include intervention feasibility (e.g., accrual, attrition, use of the intervention) and acceptability (e.g., caregivers' comfort accessing the tele-visits and satisfaction). We will also examine preliminary efficacy using validated patient symptom burden and caregiver outcome measures (i.e., burden, depression, anxiety, satisfaction). ConclusionThe trial is evaluating a novel symptom management intervention that supports caregivers of patients receiving home hospice services. The intervention employs a multi-pronged approach that provides needed services at a time when close contact and support is crucial. This research could lead to advances in how care gets delivered in the home hospice setting.

Implementing cancer symptom management interventions utilizing patient-reported outcomes: a pre-implementation evaluation of barriers and facilitators

PurposeSymptoms can negatively impact quality of life for patients with a history of cancer. Digital, electronic health record (EHR)-integrated approaches to routine symptom monitoring accompanied by evidence-based interventions for symptom management have been explored as a scalable way to improve symptom management, particularly between clinic visits. However, little research has evaluated barriers and facilitators to implementing these approaches in real-world settings, particularly during the pre-implementation phase. Pre-implementation assessment is critical for informing the selection and sequencing of implementation strategies and intervention adaptation. Thus, this study sought to understand pre-implementation perceptions of a remote cancer symptom monitoring and management intervention that uses electronic patient-reported outcome measures for symptom assessment.MethodsWe interviewed 20 clinical and administrative stakeholders from 4 geographic regions within an academic medical center and its affiliated health system during the months prior to initiation of a stepped-wedge, cluster randomized pragmatic trial. Transcripts were coded using the Consolidated Framework for Implementation Research [CFIR] 2.0. Two study team members reviewed coded transcripts to understand how determinants were relevant in the pre-implementation phase of the trial and prepared analytic memos to identify themes.ResultsFindings are summarized in four themes: (1) ability of the intervention to meet patient needs [recipient characteristics], (2) designing with care team needs in mind [innovation design and adaptability], (3) fit of the intervention with existing practice workflows [compatibility], and (4) engaging care teams early [engaging deliverers].ConclusionAttention to these aspects when planning intervention protocols can promote intervention compatibility with patients, providers, and practices thereby increasing implementation success.