Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Enrollment Yield
研究概览
简要总结
This research is being done to pilot an intervention which aims to test a new web- and mobile application ("app")-based supportive care tool (SHIELD portal) and to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease long-term endocrine treatment.
详细描述
This research study is a single-arm intervention pilot study to assess the feasibility of enrolling female breast cancer patients with hormone receptor-positive disease prescribed long-term endocrine treatment. The SHIELD portal is designed to help monitor the frequency and variation in cancer and treatment-related issues and to share self-management information and resources to those interested in particular issues or who indicate a specific concern, symptom or side effect on measures designed to assess and track salient symptoms.
Research study procedures include screening for eligibility, in-clinic and virtual approaches for recruitment, gaining access and using the SHIELD web- and mobile app-based supportive care portal, and completing of survey assessments on the SHIELD portal.
Participation in this research study is expected to last 3 months.
It is expected that 30 people will take part in this research study.
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants will be eligible if they meet the following eligibility criteria:
- •Age 18-49 years at diagnosis of a stage 0-IIIa, HR+ breast cancer
- •Premenopausal
- •In active treatment (including long-term endocrine therapy) at the time of enrollment
- •Able to speak, understand and read English
- •Access to a US-based mobile phone number
- •Cognitively able to complete study requirements
- •Ability to access medical records from treating hospital (DFCI)
- •Willing to provide cell phone number and/or email address and willing to receive email, mobile push notifications, and/or text messages from the study team
排除标准
- •Participants will be ineligible if they meet any of the following criteria:
- •Individuals under age 18 or over age 50 at initial breast cancer diagnosis
- •Stage IV or metastatic breast cancer
- •Pregnant patients
- •Individuals who do not have a US mobile phone number
- •Males with breast cancer are not being recruited to this protocol. In the adolescent and young adult (AYA) age group, only a miniscule proportion of breast cancers occur in males. Additionally, this pilot focuses on breast cancer treatment utilizing OFS and ET, both of which do not apply to males. For this reason, the SHIELD portal intervention materials have been targeted for young women.
研究组 & 干预措施
SHIELD Portal Interventional
320 participants will be enrolled and will complete the following: Baseline visit (assessments) either by in-person clinic visit or virtually Follow-Up/Post Baseline (3-month assessments) Medical record review (if necessary)
干预措施: SHIELD portal (Behavioral)
结局指标
主要结局
Enrollment Yield
时间窗: up to 3 weeks
Enrollment yield is defined as the proportion of participants approached for the study intervention (SHIELD, Supporting Health Including Endocrine Treatment for Long Duration) who enroll.
次要结局
- Assessment Completion Rate(Up to 3 months)
- Patient Information Resources Access Rate(Up to 3 months)
- SHIELD Portal Access(Up to 3 months)
研究者
Ann H. Partridge, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute