Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,800
- 试验地点
- 8
- 主要终点
- Decisional Conflict
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant oncofertility care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
Fertility specialists and their support staff will be blinded to the intervention status of the cluster from which a patient is referred to minimize differences in counseling in patients whom they expect to receive financial navigation.
入排标准
- 年龄范围
- 0 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed cancer or cancer relapse
- •Primary language English or Spanish
- •Receiving oncology care at participating clinical sites
- •Ages 0 to 42 years if female
- •Ages 0 to 50 years if male
排除标准
- •Non-melanoma skin cancer, because primary treatment is excision with no infertility risk
- •Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis
结局指标
主要结局
Decisional Conflict
时间窗: 12 weeks after oncology visit
The 16-item Decisional Conflict Scale (DCS) will be used to measure patients' decisional conflict for engaging in fertility preservation services. The DCS consists of 16 statements with 5 response options (ranging from strongly agree to strongly disagree) that measures the patient's perceptions of uncertainty in choosing options, feeling informed, values clarity, support in decision making, and effective decision making. The DCS total score will be dichotomized at 37.5 (scale 0-100; \> 37.5 indicates high decisional conflict).
Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care
时间窗: 12 weeks after oncology visit
The proportion of eligible reproductive-aged male and female patients (aged 12 to 39 years) who engage in oncofertility services (1\| an oncofertility needs screen, 2\| referral to oncofertility consult, 3\| oncofertility consult, and/or 4\| fertility preservation services) that meet the patient's individual needs will be abstracted from medical records using standardized case report forms.
次要结局
- Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care(12 weeks after oncology visit)
- Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care(12 weeks after oncology visit)
- Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care(12 weeks after oncology visit)
研究者
Hui-Chun Irene Su
Professor
University of California, San Diego