A Feasibility Trial of a Web Based App Intervention in Hormone Positive Breast Cancer Patients to Improve Adherence to Endocrine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 8
- 主要终点
- Feasibility (Acceptability)
研究概览
简要总结
This clinical trial looks at the use of an internet-based application (app) intervention in improving adherence to endocrine therapy (ET) among patients with early stage hormone receptor-positive HER2-negative breast cancer. ET can significantly reduce the return of the cancer in patients who are compliant with their treatment regimen. Despite this, adherence to ET is poor due to side effects, lack of social support and timely access to clinicians, and poor patient understanding of the necessity and effectiveness of the therapy. An internet-based app may help patients improve their adherence to ET by providing reminders, side effect mitigation strategies available in the educational videos and from contacting providers/ nurse on the research team directly via the app.
详细描述
PRIMARY OBJECTIVE:
I. To assess the feasibility of a web-based app as an intervention to carry out functions such as weekly reminders, improving patient provider communication, improving patient education
SECONDARY OBJECTIVES:
I. To evaluate if high level of adherence to endocrine therapy can be maintained by using our web-based app in early-stage hormone positive breast cancer II. To assess whether the web-based app will improve patient satisfaction, whether patients feel the app helped improve their likelihood of adhering to endocrine therapy by making them feel more confident in their side effect management.
OUTLINE: This is a single arm, feasibility study. 30 patients will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •Early-stage hormone receptor positive, HER2-negative breast cancer who have completed all recommended (neo)adjuvant chemotherapy, surgery and/or radiation therapy
- •Age >= 18
- •Started on an aromatase inhibitor or Tamoxifen within less than or equal to six months prior to time of enrollment
- •Access to internet from a desktop or a smartphone
- •Ability to speak English
排除标准
- •Patients who are her2 neu positive
研究组 & 干预措施
Single Arm (internet intervention, best practice)
Patients receive access to the app in addition to standard of care for 3 months. Through the app, patients receive weekly reminders about hormone therapy, report any side effects, access educational videos that provide tips to help mitigate some of these side effects, and allow patients to send messages to members of our breast cancer team about any questions patients may have about the side effects they may be experiencing.
干预措施: Best Practice (Other)
Single Arm (internet intervention, best practice)
Patients receive access to the app in addition to standard of care for 3 months. Through the app, patients receive weekly reminders about hormone therapy, report any side effects, access educational videos that provide tips to help mitigate some of these side effects, and allow patients to send messages to members of our breast cancer team about any questions patients may have about the side effects they may be experiencing.
干预措施: Internet-Based Intervention (Other)
Single Arm (internet intervention, best practice)
Patients receive access to the app in addition to standard of care for 3 months. Through the app, patients receive weekly reminders about hormone therapy, report any side effects, access educational videos that provide tips to help mitigate some of these side effects, and allow patients to send messages to members of our breast cancer team about any questions patients may have about the side effects they may be experiencing.
干预措施: Questionnaire Administration (Other)
Single Arm (internet intervention, best practice)
Patients receive access to the app in addition to standard of care for 3 months. Through the app, patients receive weekly reminders about hormone therapy, report any side effects, access educational videos that provide tips to help mitigate some of these side effects, and allow patients to send messages to members of our breast cancer team about any questions patients may have about the side effects they may be experiencing.
干预措施: Survey Administration (Other)
结局指标
主要结局
Feasibility (Acceptability)
时间窗: Up to 1 year
Feasibility of the web-based app study will encompass: Acceptability which will be measured by using the System Usability Scale and a score if \>68 will indicate that the app was acceptable to patients. Acceptability will be summarized using descriptive statistics and confidence intervals will be reported using the Clopper-Pearson method.
Feasibility (Compliance)
时间窗: Up to 1 year
Feasibility of the web-based app study will encompass: Compliance, which is defined as at least 5 responses from patients (via app) over the 12-week period. Compliance will be summarized using descriptive statistics, and confidence intervals will be reported using the Clopper-Pearson method. The goal is to have at least 75% of patients adhere to the app to prove compliance.
次要结局
- Adherence(Up to 1 year)
- Patient satisfaction(Up to 1 year)
研究者
Jane Meisel
Principal Investigator
Emory University