STRIDE: Evidence-Based Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
Massachusetts General Hospital
Summary
The goal of this study is to demonstrate the efficacy of an evidence-based, small-group, telehealth intervention ('STRIDE') for improving patients' ability to cope with side effects from adjuvant endocrine therapy (AET) and adhere to AET medication regimens for patients with hormone-sensitive breast cancer.
Description
Adjuvant Endocrine Therapy (AET) is critical for most patients with hormone sensitive breast cancer. AET side effects cause distress, interfere with medication adherence, and are associated with poorer quality of life (QOL) and higher anxiety. There is a critical need to increase patients' ability to cope with AET side effects and reduce adherence barriers to AET. This project proposes to conduct a multisite randomized controlled efficacy trial in 400 patients taking AET after breast cancer to test the efficacy of STRIDE, a telehealth evidence-based behavioral intervention, compared to Usual C…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Female ≥ 21 years old * Diagnosis of early-stage (0-IIIb), hormone receptor positive (ER+/PR+) breast cancer * Completed primary treatment (surgery, chemotherapy, and/or radiation) * Within 3 to 12 months of starting oral adjuvant endocrine therapy (AET) * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Ability to read and respond in English or Spanish * Distress about AET ≥ 4 on a 0-10 scale Exclusion Criteria: * Cognitive impairment, uncontrolled psychosis, or serious mental illness prohibiting participation in the study as per the judgment of the…
Interventions
- BehavioralSTRIDE
STRIDE is a 6-session patient-directed cognitive behavioral therapy (CBT)-based psychosocial intervention that targets coping with and managing AET side effects. The intervention incorporates psychoeducation, problem-solving, cognitive restructuring, relaxation training, symptom management skills training, coping effectiveness training, and mindfulness techniques.
- BehavioralUsual Care
Participants randomized to usual care will receive regular oncology follow-up care which entails one follow-up visit with the primary treating oncologist after prescription of AET and as needed contact with a nurse practitioner or RN for symptom control or other medication related questions.
Locations (2)
- Moffitt Cancer CenterTampa, Florida
- Massachusetts General HospitalBoston, Massachusetts