Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- System Usability Scale (SUS)
研究概览
简要总结
The purpose of the study is to learn more about ways to help patients understand and manage side-effects from hormone therapy. The investigators will use the information from this study to design future studies to better understand how our well our tools work to help patients monitor and manage symptoms from hormone therapy and to stay on their hormone therapy for the recommended period of time.
详细描述
Despite robust available data supporting the efficacy of oral endocrine therapy (ET) for the treatment of breast cancer and the low adherence to this life-saving treatment, only 6 randomized controlled trials have assessed interventions to improve adherence to ET; only 1 showed modest short-term benefit. ET adherence is critical, as 10-year survival decreases from 81% when adherent to 74% when non-adherent to ET. The investigators propose a first of its kind, randomized, culturally tailored mHealth intervention trial called "EmSHAPE"- Engaging mobile health for symptom monitoring and health promotion for endocrine therapy - among newly diagnosed women with early hormone receptor positive breast cancer. Prior intervention studies have not been effective.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must identify as a woman
- •Participants must be age 18 or older
- •Participants must have a diagnosis of Stage 0, I, II, or III HR+ breast cancer
- •Participants must have started initial treatment with standard of care oral endocrine therapy (ET) (i.e., tamoxifen, anastrozole, exemestane, or letrozole) within 16 weeks of study registration.
- •Participants must have completed surgery for treatment of breast cancer at least 14 days prior to randomization.
- •Participants who received chemotherapy must have finished it at least 14 days prior to randomization.
- •Speak and read in English
- •Own an internet-enabled cell phone
- •Capable of using the electronic pill bottle
- •Concomitant radiotherapy is allowed. Concomitant maintenance targeted or biologic therapy (e.g., anti-HER2 therapy, osteoclast inhibitor therapy, CDK 4/6 inhibitor, ovarian function suppression medications) is allowed.
排除标准
- •Metastatic (Stage IV) breast cancer
- •Male gender
- •Prior treatment with endocrine therapy for breast cancer
- •Communication difficulties such as: Uncorrected or uncompensated hearing and/or vision impairment, uncorrected or uncompensated speech defects, uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks
研究组 & 干预措施
ARM B Usual care
Participants will be provided with an educational handout describing endocrine therapy.
ARM A Intervention
Patients assigned to symptom monitoring web-based intervention.
干预措施: Digital Endocrine therapy Symptom Monitoring and Education Intervention (Behavioral)
结局指标
主要结局
System Usability Scale (SUS)
时间窗: Once during study exit survey at 6 months
Determined via patient reported satisfaction with the intervention; final score from 0-100 (higher score represents better usability)
Feasibility- recruitment rates and intervention completion rates
时间窗: Consent to study exit survey at 6 months
Evaluated via rates of recruitment and intervention completion
次要结局
- Endocrine therapy adherence(Day 1 though study completion, an average of 48 weeks)
- FACTS-ES likert variables(Assessed at baseline (T0), 12 weeks (T1), and 24 weeks (T2))