RESUMO
Behavioral medicine researchers have rapidly adapted study procedures and interventions to telehealth modalities during the pandemic. We rely heavily on telehealth research methods to avoid study delays and mitigate risk to chronically ill patients our studies aim to support. We implemented methods to virtually recruit, enroll, and retain patients and their families on clinical trials, and virtually deliver study interventions. These adaptations are likely to become permanent amid ongoing virus variants and surges in cases. However, little has been written about how remote methods apply in practice. This paper documents these processes to maximize efficiency across our research studies and systems and highlights the strengths and challenges of transitioning our research protocols to telehealth. We outline solutions to using remote methods across the entire span of the research process, including study recruitment, data collection, and intervention delivery. We offer insight into the implications of these transitions on research staff and interventionists. In providing a transparent review of the advantages and challenges of implementing remote methods, we encourage discourse around remote methods implementation, share the lessons we learned, and inform the design of future trials. Further research is needed to review the clinical feasibility and acceptability of these procedures.
RESUMO
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.