Young, Empowered & Strong (YES): The Young Women's Breast Cancer Study 2- Focus on Newly Diagnosed/Metastatic Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Vaginal dryness
研究概览
简要总结
This research study is being done to monitor common symptoms and behavior, and to provide supportive care information and peer support, as well as research opportunities for young women ages of 18-39 years old who have been diagnosed with stage 0-IV stage breast cancer using a web-based portal (YES), built for smartphones, tablets, and computers.
详细描述
This is a prospective, interventional cohort study with an embedded Phase II randomized controlled clinical trial with a parallel design.
- The research study procedures include screening for eligibility, consent, enrolled, randomization into 1 of 4 groups.
- The study interventions including the (web-based portal ) YES portal use including regular assessments, serial outcome surveys, medical record review, and tumor/blood collection.
- The YES portal is a web-based portal designed for access by smartphone, tablet, or laptop/desktop. The portal is designed to help monitor cancer related issues and to share self-management information and resources to those interested in particular issues or who score high enough on the symptom measures designed to assess and track noticeable symptoms (and thus might benefit from such), as well as to share potential research opportunities when available. The portal is also designed to create a community among participants through the yeschat.org discussion board
- Participants will be in this research study for up to 5 years with the option to opt out of portal assessment component follow-up after only 1 year.
- It is expected that about 400 people will take part in this research study
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage 0-3
- •diagnosed with breast cancer between the ages of 18-39 years
- •less than 3 months post diagnosis date of new primary or local recurrence (prior history of other cancer is allowed as long as treated with curative intent and no evidence of disease from that cancer)
- •has not started treatment for breast cancer diagnosis yet
- •is planning to get care at DFCI
- •be fluent in and able to read English
- •have internet access on a regular basis at the time of consent that can support the web-based platform
- •initial diagnosis of breast cancer between the ages of 18-39 years
- •be fluent in and able to read English
- •have internet access on a regular basis at the time of consent that can support the web-based platform
排除标准
- 未提供
结局指标
主要结局
Vaginal dryness
时间窗: 1 year
One item regarding vaginal dryness on the BCPT will be used and grouped by moderate, quite a bit, extreme responses to define the vaginal dryness rate at 1 year. Based on historical data (from our ongoing Young Women's Breast Cancer Study), the 1-year vaginal dryness rate for the control group is assumed to be 27%. For the Phase II randomized controlled trial component of the study,it will have 85% power to detect a 10% difference in the primary endpoint with 367 patients, and would plan to recruit 408 to account for dropout (last row of the table).
次要结局
- Physical Activity(Up to 5 years)
- Anxiety and Depression(Up to 5 years)
- Financial burden(Up to 5 years)
- Mobility(Up to 5 years)
- Self-Care(Up to 5 years)
- Emotional Symptoms(Up to 5 years)
- Overall Symptoms(Up to 5 years)
- Adherence to Hormonal or other Oral Therapy(Up to 5 years)
- Adolescent and Young Adult (AYA) Concerns(Up to 5 years)
- Socio-demographics(Up to 5 years)
- Smoking and alcohol use(Up to 5 years)
- Usual Activities(Up to 5 years)
- Pain and Discomfort(Up to 5 years)
研究者
Ann H. Partridge, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute