Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Decision Conflict Scale
研究概览
简要总结
This study will test a decision support intervention that consists of a web-based 'decision aid and planning tool' for family building after cancer in a randomized controlled trial.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Assigned female at birth
- •Aged 18 to 45 years old
- •Understands verbal and written English
- •History of a cancer diagnosis.
- •Completed cancer treatment(s) with known or uncertain gonadotoxic effects (e.g., systemic chemotherapy, surgery or radiation affecting reproductive organs or hormone regulation, stem cell or bone marrow transplant, and/or immunotherapy)
- •Interested in having a future child (or more children) or uncertain about family building plans
- •Access to the Internet and use of a computer, tablet, or smartphone
- •Ability to understand and the willingness to personally sign the written IRB-approved informed consent document
排除标准
- •Currently undergoing cancer treatment excluding long term adjuvant or maintenance therapies, such as tamoxifen
- •Significant physical or mental disability that prevents completion of study activities
研究组 & 干预措施
Web-based decision support (Roadmap to Parenthood)
Patients will receive access to the Roadmap to Parenthood tool (website). The goal of the Roadmap tool is to encourage young adult females (YA-Fs) to be informed about family-building options, set realistic expectations about potential difficulties, and plan ahead to avoid or mitigate barriers, while also inspiring hope and confidence that parenthood may be achieved, despite their cancer histories.
干预措施: Roadmap to Parenthood (Other)
Informational booklet
Patients will receive the web-based Livestrong 'Planning for Life After Cancer: A Guide to Survivorship for Teens and Young Adults' informational booklet, covering many topics (e.g., physical symptoms, emotional concerns, day-to-day needs).
干预措施: Informational Booklet (Other)
结局指标
主要结局
Decision Conflict Scale
时间窗: 12 months
Decisional Conflict Scale is a validated survey that assesses personal uncertainty in making healthcare decisions; modifiable factors contributing to uncertainty; and the quality of the decision made. The survey has 16 questions, with responses on a 5 point scale ranging from "strongly agree" (1) to "strongly disagree" (5). Total scores range from 16 to 80, with higher scores indicating greater uncertainty (worse outcome)
次要结局
- Patient-Reported Outcomes Measure-29 (PROMIS-29) Quality of Life(12 months)
- Planning Behaviors for Future Family Building(12 months)