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临床试验/NCT02256670
NCT02256670已完成不适用

Pilot for The Breast Cancer Endocrine Therapy Adherence (BETA) Trial: Efficacy of a Text-messaging Application in Increasing Adherence With Adjuvant Endocrine Therapy for Stage I-III Hormone Receptor Positive Breast Cancer

Yale University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Patient Acceptance of Text Message Program

研究概览

简要总结

Pilot study to assess feasibility and patient acceptance of a text message cell phone application for patients with stage I-III, hormone receptor positive breast cancer who start adjuvant endocrine therapy.

详细描述

Approximately 75% of breast cancers express the estrogen and/or progesterone receptor (hormone receptors). The standard of care for women with hormone receptor positive breast cancer is five to ten years of adjuvant endocrine therapy with drugs such as tamoxifen or aromatase inhibitors (AIs). In women with stage I-III breast cancer, treatment with adjuvant endocrine therapy has been shown to reduce recurrences by 30-50% and improve survival. Unfortunately, it is estimated from large population databases that up to 35-40% of patients may discontinue adjuvant endocrine therapy before completing the recommended 5 years for various reasons, and non-adherence may reduce survival.

The current protocol is a pilot study in women with hormone receptor positive breast cancer who are beginning adjuvant endocrine therapy, the purpose of which is to assess the feasibility of a two-way text messaging application, with goals for a larger randomized control study to assess if the application will increase adherence and therefore improve disease free survival. This application includes daily text message medication reminders and periodic assessment of side effects and barriers to medication adherence and simultaneously offers assistance for treatment related issues. The investigators will collect information on QOL and financial burden during the 3 month period and will correlate these metrics with adherence. This larger randomized control study would be the first such interventional study to increase adherence with adjuvant endocrine therapy in breast cancer in the US. Our larger randomized control trial would provide the first longitudinal prospectively collected information on QOL, financial burden and adherence over the entire 5-year treatment period in the routine clinical practice setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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
All
接受健康志愿者

入选标准

  • Patients with histologically confirmed stage I-III, estrogen and/or progesterone receptor positive, as defined by ASCO-CAP guidelines, invasive breast cancer for whom adjuvant hormonal therapy is indicated following standard NCCN practice guidelines
  • Patients may enter the study before or within one month of starting endocrine treatment
  • Patients with synchronous bilateral breast cancers are eligible if both tumors are hormone receptor positive
  • Patient must be able to provide informed consent and agree to:
  • Complete questionnaires according to the pre-specified study design
  • Own a personal cell phone, agree to receive text messages on a monthly basis (including any costs), and share their personal cell phone number to receive text message reminder
  • sign consent to allow research staff to contact their pharmacies to determine prescription refill dates

排除标准

  • Patients with ductal carcinoma in situ

结局指标

主要结局

Patient Acceptance of Text Message Program

时间窗: 3 months

Using self-report surveys to assess feasibility and patient acceptance of text message program

Adherence to Endocrine Therapy

时间窗: 3 months

Adherence rates after 3 months on study, compared with historical controls. Adherence is defined as taking \> 80% of prescribed pills based on self reported adherence questionnaire. This threshold was adopted from the literature. Adherence will also be assessed by checking electronic pharmacy dispensation records when feasible.

次要结局

  • Quality of Life(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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