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BackgroundInterest in the application of predictive risk models (PRMs) in health care to identify people most likely to experience disease and treatment-related complications is increasing. In cancer care, these techniques are focused primarily on the prediction of survival or life-threatening toxicities (eg, febrile neutropenia). Fewer studies focus on the use of PRMs for symptoms or supportive care needs. The application of PRMs to chemotherapy-related symptoms (CRS) would enable earlier identification and initiation of prompt, personalized, and tailored interventions. While some PRMs exist for CRS, few were translated into clinical practice, and human factors associated with their use were not reported. ObjectiveWe aim to explore patients’ and clinicians’ perspectives of the utility and real-world application of PRMs to improve the management of CRS. MethodsFocus groups (N=10) and interviews (N=5) were conducted with patients (N=28) and clinicians (N=26) across 5 European countries. Interactions were audio-recorded, transcribed verbatim, and analyzed thematically. ResultsBoth clinicians and patients recognized the value of having individualized risk predictions for CRS and appreciated how this type of information would facilitate the provision of tailored preventative treatments or supportive care interactions. However, cautious and skeptical attitudes toward the use of PRMs in clinical care were noted by both groups, particularly in relationship to the uncertainty regarding how the information would be generated. Visualization and presentation of PRM information in a usable and useful format for both patients and clinicians was identified as a challenge to their successful implementation in clinical care. ConclusionsFindings from this study provide information on clinicians’ and patients’ perspectives on the clinical use of PRMs for the management of CRS. These international perspectives are important because they provide insight into the risks and benefits of using PRMs to evaluate CRS. In addition, they highlight the need to find ways to more effectively present and use this information in clinical practice. Further research that explores the best ways to incorporate this type of information while maintaining the human side of care is warranted. Trial RegistrationClinicalTrials.gov NCT02356081; https://clinicaltrials.gov/study/NCT02356081

While the epidemiological literature recognizes associations between chronic non-cancer pain (CNCP), opioid use disorder (OUD), and interpersonal trauma stemming from physical, emotional, sexual abuse or neglect, the complex etiologies and interplay between interpersonal and structural traumas in CNCP populations are under-examined. Research has documented the relationship between experiencing multiple adverse childhood experiences (ACEs) and the likelihood of developing an OUD as an adult. However, the ACEs framework is criticized for failing to name the social and structural contexts that shape ACE vulnerabilities in families. Social scientific theory and ethnographic methods offer useful approaches to explore how interpersonally- and structurally-produced traumas inform the experiences of co-occurring CNCP, substance use, and mental health. We report findings from a qualitative and ethnographic longitudinal cohort study of patients with CNCP (n = 48) who received care in safety-net settings and their primary care providers (n = 23). We conducted semi-structured interviews and clinical and home-based participant observation from 2018 to 2020. Here we focus our analyses on how patients and providers explained and situated the role of patient trauma in the larger clinical context of reductions in opioid prescribing to highlight the political landscape of the United States opioid overdose crisis and its impact on clinical interactions. Findings reveal the disproportionate burden structurally-produced, racialized trauma places on CNCP, substance use and mental health symptoms that shapes patients’ embodied experiences of pain and substance use, as well as their emotional experiences with their providers. Experiences of trauma impacted clinical care trajectories, yet providers and patients expressed limited options for redress. We argue for an adaptation of trauma-informed care approaches that contextualize the structural determinants of trauma and their interplay with interpersonal experiences to improve clinical care outcomes.

Abstract Background The SARS-CoV-2 (COVID-19) pandemic increased use of telehealth for the management of opioid use disorder and chronic non-cancer pain in primary care safety net clinical systems. Significant barriers to telehealth exist, little is known about how these barriers impact urban safety net, primary care providers and their patients. The objective of this study was to qualitatively assess the benefits and challenges of telehealth for management of chronic non-cancer pain, opioid use disorder, and multi-morbidity in primary care, safety net clinical systems. Methods We interviewed patients with chronic non-cancer pain and history of substance use (n = 22) and their primary care clinicians (n = 7) in the San Francisco Bay Area, March-July 2020. We recorded, transcribed, coded, and content analyzed interviews. Results COVID-19 shelter-in-place orders contributed to increases in substance use and uncontrolled pain, and posed challenges for monitoring opioid safety and misuse through telehealth. None of the clinics used video visits due to low digital literacy/access. Benefits of telehealth included decreased patient burden and missed appointments and increased convenience and control of some chronic conditions (e.g., diabetes, hypertension). Telehealth challenges included loss of contact, greater miscommunication, and less comprehensive care interactions. Conclusions This study is one of the first to examine telehealth use in urban safety net primary care patients with co-occurring chronic non-cancer pain and substance use. Decisions to continue or expand telehealth should consider patient burden, communication and technology challenges, pain control, opioid misuse, and medical complexity.

Purpose Ongoing symptoms and impairments in quality of life (QOL) among breast cancer survivors remain a significant problem. We tested the feasibility and acceptability of a manualized Ayurvedic nutrition and lifestyle intervention for breast cancer survivors. Methods Eligible participants had Stage I–III breast cancer, underwent treatment within the past year that included chemotherapy, and were without active disease. The 4-month individualized Ayurvedic intervention included counseling on nutrition, lifestyle, yoga, and marma (like acupressure) during 8 one-on-one visits with an Ayurvedic practitioner. Feasibility and acceptability were the primary outcomes. QOL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ C30]) and symptoms—sleep disturbance (General Sleep Disturbance Scale [GSDS]), fatigue (Lee Fatigue Scale [LFS]), depressive symptoms (Center for Epidemiological Studies—Depression Scale [CES-D]), anxiety (Spielberger State-Trait Anxiety Inventory [STAI-S, STAI-T]), and stress (Perceived Stress Scale [PSS])—were measured prior to, at midpoint, and at the end of the 4-month intervention. Effect sizes (Cohen’s d ) were calculated along with paired t tests comparing baseline to end of month 4 time points. Mixed effects models were used for repeated measures analyses. Results Participants ( n = 32) had a mean age of 48 years ( SD = 10). Retention at the end of the intervention was 84%. Among those who completed the intervention ( n = 27), adherence was high (99.5% of visits with practitioners attended). Large improvements were seen in QLQ-C30 emotional functioning ( d = 0.84, P

Background: In recent years, the shift in cancer services from traditional tertiary care to care delivered within communities has increased the need for patients to engage in self-care activities in order to prevent or reduce the severity of numerous and complex-side effects (McCorkle et al., 2011) and make important health decisions when at home in the absence of clinicians (Butow et al., 2012). The actual degree of engagement in self-management may be dependent on patients’ perceived competence or self-efficacy to perform such activities (Fenlon et al., 2015). Self-efficacy has been defined as “a person’s belief to execute courses of action required to deal with a prospective situation” (Bandura, 1977, 2001). One’s beliefs in their capability to successfully manage tasks and consequently influence situations that impact their lives constitutes a central part of human agency, and can be influenced by performance accomplishments (Bandura, 1989, 2001). Whilst self-efficacy can enable engagement in self-management, actual participation in self-management activities can further increase one’s perceived ability to undertake such activities; it is thus obvious that a bi-directional association between self-management and self-efficacy exists. Supporting a shift in clinical practice with innovative technological systems affords a solution to the increasing demands placed on acute care by enabling the delivery of care in the home and community setting (Basch et al., 2011; Carpenter et al., 2008). Such remote monitoring systems facilitate the provision of clear lines of real-time communication between patients and their health care providers (Basch et al., 2011), and can deliver organised self-management advice tailored to the individual’s clinical characteristics and severity/distress of symptoms of anti-cancer treatment. Aim(s): Funded by the European Union (FP7 programme), a multi-centre European project (the eSMART study) has been designed to investigate the effects of an electronic patient-reported outcomes (ePRO) system, the Advanced Symptom Management System (ASyMS), on patient outcomes including improvement in self-efficacy, symptom management, supportive care needs, psychological status, work presenteeism, and well-being; health system costs; and the current clinical practice. The primary aim of eSMART is to evaluate the short and long term impact of the ASyMS technology on patient reported outcomes in people with breast cancer, colorectal cancer or haematological malignancies receiving first-line chemotherapy. In addition, eSMART will evaluate the cost-benefit of remote patient-monitoring and changes in clinical practice as a result of the application of the ASyMS intervention in different European healthcare settings. The study is currently recruiting patients, thus no data will be available for presentation. This presentation will nonetheless aim to present and discuss the hypothesis that provision of symptom self-management advice may be an important mechanism to improve patient self-efficacy, which may establish a self-sustained cycle where self-care advice provision enables patient self-efficacy and this in turn further increases patient involvement in self-management that can ultimately lead to improved patient outcomes. Method(s)/Results: The current study has been informed by the Medical Research Council Complex Interventions Framework (Anderson, 2008; Craig and Petticrew, 2012; Mackenzie et al., 2010), and the Holistic Framework to improve the Uptake and Impact of e-Health Technologies (van Gemert-Pijnen et al., 2011). The eSMART programme of work comprises two parts that will take place over a period of five years. The first part consists of preparatory work to refine the ASyMS intervention for use in a multi-national context, and concludes with a feasibility testing period to establish the technological readiness of the system prior to its use in the second part. The second part will employ a repeated-measures, parallel-group, stratified randomised controlled trial methodology to demonstrate the effects of the ASyMS intervention in supporting patients who receive chemotherapy treatment through individualised symptom management. The second part will test the short- (i.e. during the treatment phase) and long-term effects (i.e. at one-year follow-up) of the ASyMS intervention versus standard care across the participating countries (Austria, Greece, Ireland, Norway and the UK). The ASyMS intervention comprises use of a mobile phone (i.e. ASyMS patient handset) and a tympanic thermometer. The patient handset will enable participants on the intervention group to enter symptom/temperature data on a dedicated, electronic symptom questionnaire daily and whenever they feel unwell. Upon successful submission of their data, patients will immediately receive automated, evidence-based self-care advice based on their symptom reports. Patients will also have access to a self-care library, symptom graphs (detailing trends in individual symptoms experienced) and contact numbers of care teams and patient support organisations in their country, available within the ASyMS patient handset. Via dedicated tablet PCs, all participants will complete an electronic version of the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer) (Wolf et al., 2005) at baseline; after each CTx; and 3, 6, 9 and 12 months post-chemotherapy treatment. The CASE-Cancer is a validated, 12-item measure that yields scores on three factors: understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information. In accordance with latest recommendations for pragmatic research in healthcare (Oakley et al., 2006; Treweek and Zwarenstein, 2009), the longitudinal nature of the trial will aid to establish sustainability of intervention effects and further stress its benefits when compared to standard care. Conclusions: This anticipatory model of care supports symptom management within the patient’s home, where the early toxicities of chemotherapy can be managed, utilising self-care and local community services. This model is also expected to contribute to the health literacy of patients with cancer in relation to early identification, report and self-management of their most common symptoms. As part of the project’s objectives, we will aim to show improved self-efficacy (as shown by statistically significantly higher self-efficacy scores) during active chemotherapy for breast cancer, colorectal cancer, or haematological malignancies, and/or at one-year follow-up. It is hoped that an enhanced self-efficacy (evidenced by patients’ greater understanding and participation in care, positive attitude, and engagement in seeking health-related information) will in turn enable a smoother rehabilitation process for patients in the post-treatment survivorship period and beyond. EU FP7 Programme Grant agreement No. 602289. Trial registration identifier (clinicaltrials.gov) NCT02356081.