Assessing the Usability and Workflow Impact of a Mobile-Based Breast Cancer Survivorship Care Plan in the Oncology Practice
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Symptoms assessment response rate
研究概览
简要总结
This phase I trial evaluates how well a mobile device-based breast cancer survivorship interactive care plan works in monitoring symptoms and recovery in patients with stage 0-III breast cancer. The interactive care plan provides patients with individualized, 'just in time' education materials to promote self-management for those reporting difficult to control symptoms, as well as escalations to contact their care team for signs or symptoms concerning for cancer coming back (recurrence). The interactive care plan may help alleviate the symptoms of fatigue, insomnia, hot flashes, and sexual dysfunction; increase physical activity level and improve quality of life in patients with breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and usability of the breast cancer (BC) survivorship interactive care plan (ICP) as designed.
II. To determine the behavioral, toxicity symptom burden and quality of life (QOL) changes in patients engaged with the ICP.
III. To assess clinical workflow impact by the introduction of the ICP in the BC survivor practice.
OUTLINE:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Recently diagnosed and treated for breast cancer -- having a biopsy-proven, stage 0-III breast cancer and are within 12 months of completion of loco-regional breast cancer treatment and (as indicated) neoadjuvant and/or adjuvant chemotherapy. Ongoing treatment with adjuvant endocrine, bisphosphonate, and single-agent, HER2-directed therapy during the study period is allowed
- •Willing to install an application (APP) on personal smart device
排除标准
- •Unwilling to return to Mayo Clinic for routine follow-up visits
- •Unwilling to use the Mayo Clinic Mobile App
- •Unable to provide consent
- •Unable to speak or read English
- •Unable to participate in mild activity
结局指标
主要结局
Symptoms assessment response rate
时间窗: 12 months
Will assess the total response rate of all surveys administered over the course of the study. The interaction with the educational materials and reminders will be similarly assessed as a total proportion of interaction with the materials and reminders.
次要结局
- Change in patient behavior (activity)(Baseline up to 12 months)
- Change in toxicity symptom burden(Baseline up to 12 months)
- Change in quality of life (QOL)(Baseline up to 12 months)
- Clinical workflow impact measured by implementation of the breast cancer survivorship interactive care plan in the practice(12 months)