STRIDE: Evidence-Based Telehealth Intervention for Symptom Management and Adherence to Adjuvant Endocrine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire.
研究概览
简要总结
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.
详细描述
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 Care (UC), for improving patients' ability to cope with AET side effects. Analyses will also examine the effect of STRIDE on patients' self-reported and objective adherence. Finally, the investigative team will explore the effects of the STRIDE intervention on mood, breast cancer symptom distress, and QOL, and whether improvements in coping ability mediate the effects of the STRIDE intervention on AET adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Cognitive impairment, uncontrolled psychosis, or serious mental illness prohibiting participation in the study as per the judgment of the treating oncologist
- •Enrolled in a clinical trial for AET
研究组 & 干预措施
STRIDE Intervention
Participants randomized to STRIDE will receive a brief, manualized, videoconference intervention with six weekly one-hour sessions in small groups of two to three patients and two individual semi-structured telephone check-ins. Participants will complete questionnaires at baseline, and 3, 6, and 12 months post-baseline.
干预措施: STRIDE (Behavioral)
Usual 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. Participants will also complete questionnaires at baseline, and 3, 6, and 12 months post-baseline. Participants will be offered one optional STRIDE intervention visit upon completion of the 12-month questionnaire.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Coping with AET side effects as measured by the Management of Current Stress - Part A (MOCS-A) questionnaire.
时间窗: Up to 12 months post-baseline
Investigators will assess changes in coping via the Measure of Current Stress - Part A (MOCS-A). The MOCS-A is a 13-item survey used to evaluate participants' perceived ability to cope using several skills. Each item is scored on a 0-4 scale, with higher scores indicating greater coping ability.
次要结局
- Self-reported adherence to AET as measured by the Medication Adherence Report Scale (MARS-5).(Up to 12 months post-baseline)
- Objective AET adherence rates as measured by the Medication Events Monitoring System (MEMS Caps).(Up to 12 months post-baseline)
研究者
Jamie Jacobs
Principal Investigator
Massachusetts General Hospital