Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer

Introduction Patient adherence to adjuvant endocrine therapy (AET) after a diagnosis of hormone-sensitive breast cancer is poor. Previous interventions have failed to produce changes in adherence, address patient preferences or include theoretically informed and evidence-based components. Therefore, we iteratively developed a patient-centred, evidence-based, small-group, videoconference intervention to improve adherence and symptom management as well as reduce distress for patients taking AET after breast cancer (Symptom-Targeted Randomised Intervention for Distress and Adherence to Adjuvant Endocrine Therapy, STRIDE).Methods and analysis The current study is a non-blinded, randomised, controlled, feasibility trial of STRIDE compared with a medication monitoring control group. The primary objective is to examine the feasibility and acceptability of STRIDE, while secondary objectives are to assess changes in objective and subjective adherence, symptom distress and satisfaction with AET. Patients will be recruited from the Massachusetts General Hospital Cancer Center in Boston, Massachusetts. The total number of patients accrued will be 75, with ≥60 patients completing the study. All patients will store their AET in an electronic pill bottle for objective adherence monitoring. Patients randomly assigned to the STRIDE intervention will receive 6 weekly 1-hour sessions, in small groups of two, delivered via videoconferencing by a trained mental health professional. Patients assigned to the control group will store their medication in the electronic pill bottle and receive follow-up oncology care as usual. All participants will complete self-report psychosocial measures at baseline, 12 weeks and 24 weeks postbaseline.Ethics and dissemination The study is funded by the National Cancer Institute of the National Institutes of Health and is approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board (Protocol #18–603, V.1.2, first approval date 1 February 2019). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. Results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patient organisations and media outlets.Trial registration numberNCT03837496; Pre-results

Concept Mapping Study of Stakeholder Perceptions of Implementation of Cognitive-Behavioral Social Skills Training on Assertive Community Treatment Teams

This study aimed to identify factors associated with implementation of cognitive behavioral social skills training (CBSST) on assertive community treatment (ACT) teams in a large public sector behavioral health system. This study used concept mapping (a mixed-method approach) and involved a sample including diverse stakeholder participants including patients, ACT team members, team leaders, organization leaders, and system leaders. We identified 14 distinct issues related to implementing CBSST on ACT teams: (a) CBSST fit with ACT structure, (b) CBSST fit with ACT process, (c) provider perceptions about CBSST, (d) staff pressures/other demands; (e) CBSST and ACT synergy, (f) client characteristics, (g) benefits of CBSST, (h) coordination/interaction among ACT providers, (i) government/regulatory factors, (j) integration of CBSST into ACT, (k) training support, (l) training resources, (m) multilevel agency leadership, and (n) provider characteristics. Each of these dimensions were rated in regard to importance and changeability with the top 5 rated dimensions including effective training support; alignment of leadership across levels of the community-based organizations delivering services; perceived benefits of CBSST, CBSST and ACT synergy; and provider perceptions of CBSST. The most critical issues for CBSST implementation on ACT teams should be addressed in future studies. Implementation strategies that capitalize on enhancing leadership and organizational climate hold promise to address all of these issues. (PsycInfo Database Record (c) 2021 APA, all rights reserved)

Development and Refinement of a Telehealth Intervention for Symptom Management, Distress, and Adherence to Adjuvant Endocrine Therapy after Breast Cancer

Purpose: Adjuvant endocrine therapy (AET) prevents recurrence after early-stage, hormone sensitive breast cancer; however, adherence to AET is suboptimal, and efficacious interventions are severely lacking. Barriers to adherence are well established; however, interventions thus far have failed to produce meaningful changes in adherence and have generally not followed guiding principles of psychosocial intervention development. The purpose of this paper is to describe the iterative development, using the National Institutes of Health Stage Model for Behavioral Intervention Development, of an evidence-based, patient-centered, telehealth intervention to enhance adherence, improve symptom management, and reduce distress for patients taking AET after breast cancer, with a focus on 1) a small open pilot study which informed modifications and refinement of the intervention based on quantitative and qualitative patient feedback about feasibility and acceptability; and 2) the underlying theoretical and empirical rationale for each component of the finalized intervention. Clinical implications and directions for future research are discussed

A telehealth intervention for symptom management, distress, and adherence to adjuvant endocrine therapy: A randomized controlled trial

Background Patients taking adjuvant endocrine therapy (AET) after breast cancer face adherence challenges and symptom-related distress. We conducted a randomized trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth intervention (Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy [STRIDE]) for patients taking AET. Methods From October 2019 to June 2021, 100 patients reporting difficulty with AET were randomly assigned to either STRIDE or a medication monitoring (MedMon) control group. STRIDE included six weekly small-group videoconferencing sessions and two individual calls. We defined feasibility as having >50% of eligible patients enroll, >70% complete the 12-week assessment, and > 70% of STRIDE patients complete >= 4/6 sessions. We monitored adherence with the Medication Event Monitoring System Caps (MEMS Caps). At baseline and 12- and 24-weeks after baseline, patients self-reported adherence (Medication Adherence Report Scale), AET satisfaction (Cancer Therapy Satisfaction Questionnaire), symptom distress (Breast Cancer Prevention Trial-Symptom Checklist), self-management of symptoms (Self-efficacy for Symptom Management-AET), coping (Measure of Current Status), quality of life (QOL; Functional Assessment of Cancer Therapy-Breast), and mood (Hospital Anxiety and Depression Scale). We used linear mixed effects models to assess the effect of STRIDE on longitudinal outcomes. Results We enrolled 70.9% (100/141) of eligible patients; 92% completed the 12-week assessment, and 86% completed >= 4/6 STRIDE sessions. Compared with MedMon, STRIDE patients reported less symptom distress (B[difference] = -1.91; 95% CI, -3.29 to -0.52; p = .007) and better self-management of AET symptoms, coping, QOL, and mood. We did not observe significant differences in AET satisfaction or adherence. Conclusions STRIDE is feasible and acceptable, showing promise for improving outcomes in patients taking AET after breast cancer. Lay summary Patients taking adjuvant endocrine therapy (AET) after breast cancer may face challenges while following their treatment regimen. In this randomized controlled trial of 100 patients taking AET, a brief, small-group virtual intervention (STRIDE) was well-received by patients and led to improvements in how upset patients were due to symptoms, how confident they were in managing symptoms, and how well they could cope with stress. Thus, STRIDE is a promising intervention and should be tested in future multi-site trials

A Glass Half Full Look at the Changes in the American Legal Market

The American legal profession finds itself in the midst of dizzying changes. What was once viewed as a brief downturn now looks like a much more substantial restructuring and downsizing. The main commentators on these trends have been those most likely to be affected: law professors and corporate lawyers, and they have largely presented these trends as disastrous. This Essay argues that while these changes will be painful in the near term, they will prove beneficial overall. The obvious reason for optimism is that America will be significantly better off if we spend less on legal services. Whatever else the future holds it seems likely that legal services will be more widely available to more people at lower prices. This trend starts at the top with corporate law firms and bubbles up from the bottom with LegalZoom and other online forms providers and will eventually reach the entire market. Expenditures on law are typically just transaction costs and everyone is better off when transaction costs shrink. If you have enjoyed the digital revolution in music or photography, you will likewise enjoy the legal market of the future. Legal services will be cheaper, more accessible AND better. These changes are bad for lawyers in the same way digital photography was bad for Kodak. Nevertheless, it is outstanding news for the country as a whole. Less obviously, the trends identified in Larry Ribstein’s “Death of Big Law” and the ripple effect through law schools will, ironically, lead us to a leaner, happier profession. For years the hope of securing a job in Big Law, the easy availability of student loans, and the misperception of what lawyers do and what law school is like have drawn many ill-suited individuals into law. This has had a number of deleterious effects on those individuals and on the practice as a whole. Current market forces and news coverage, however, will eventually result in a profession staffed by individuals who chose law despite a substantial headwind, rather than because they did not know what else to do and they thought it would guarantee a high salary for life. This will make the profession as a whole healthier than it has been in years