Pilot Study of a Decision Aid Intervention for Family-building After Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Measure Decision Conflict Scale
研究概览
简要总结
This study tests a web-based decision aid and planning too to help young female cancer survivors manage fertility and family-building issues in post treatment survivorship.
详细描述
The overall goal of this work is to pilot test a single-arm intervention of a decision aid and planning tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.
Primary Objective: Examine feasibility and acceptability of a decision aid intervention in a single-arm pilot trial.
Secondary Objective: Obtain preliminary effect sizes of the decision aid intervention using a pre-post study design.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Completed cancer treatment known to have gonadotoxic effects (e.g., systemic chemotherapy, surgery affecting reproductive organs or hormone regulation, and/or pelvic radiation)
- •Understands verbal and written English
- •Desires future children or uncertainty regarding family-building plans
- •Access to the Internet and use of a computer, tablet, or smartphone
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
- •Note: Survivors on adjuvant maintenance or endocrine treatment, such as tamoxifen, will not be excluded because clinical guidelines allow treatment delay or hiatus to accommodate fertility preservation, egg extraction for surrogacy, or pregnancy for some patients, and because patients may be interested in alternative family-building options such as surrogacy or adopting.
结局指标
主要结局
Measure Decision Conflict Scale
时间窗: Baseline, 1 month, 3 months
The Decisional Conflict Scale (DCS) is a validated survey that assesses personal uncertainty in making healthcare decisions; modifiable factors contributing to uncertainty; and the quality of the decision made. It is reliable and responsive to change, and the most widely used measure of decision-making quality. 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
- Fertility Information Needs(Baseline, 1 month, 3 months)
- Measure Illness Perceptions Questionnaire-Revised (IPQ-R)(Baseline, 1 month, 3 month)
- Measure Reproductive Concerns After Cancer (RCAC) Scale(Baseline, 1 month, 3 months)
- Measure Impact of Events Scale-Revised (IES-R)(Baseline, 1 month, 3 month)
- Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale(Baseline, 1 month, 3 months)
- Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Related to Fertility/Family-Building Subscale(Baseline, 1 month, 3 months)
- Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale(Baseline, 1 month, 3 months)
- Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale(Baseline, 1 month, 3 months)
研究者
Catherine Benedict
Clinical Associate Professor, Psychiatry and Behavioral Sciences- Medical Psychiatry
Stanford University