EROS: Engendering Reproductive Health Within Oncologic Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 434
- 试验地点
- 218
- 主要终点
- Proportion of Patients With Appropriate Reproductive Health Management
研究概览
简要总结
This clinical trial studies reproductive health program in patients with cancer. A reproductive health program may improve patients' understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the success of the implementation of reproductive health programming (Didactics, Engendering Reproductive Health Within Oncologic Survivorship [EROS] Reproductive Health Assessment and EROS Trial Algorithm) among reproductive aged females (15-55) with cancer.
SECONDARY OBJECTIVES:
I. To assess the degree of discrepancy between patients and their clinicians in estimates of significance of the reproductive health goals for the patient.
II. To evaluate baseline and follow-up reproductive health assessments for trends in reproductive health choices relating to oncofertility, oncocontraception and pregnancy over the 2-year study period.
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
- 15 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients presenting with initial diagnosis of any type of cancer, including patients with ductal carcinoma in situ (DCIS)
- •Pre-menopausal patients within the reproductive age range of 15-55 years; pre-menopausal is defined as females meeting the following criteria:
- •Patients not currently on hormonal contraception with the presence of menses in the past 6 months
- •If no menstruation in the past 6 months, without hormonal manipulation, then confirmed follicle-stimulating hormone (FSH) < 23mlU/mL
- •If age < 47 years and on hormonal contraception, then patient will be eligible regardless of menstrual history
- •If age ≥ 47 years and on hormonal contraception, then FSH confirmed < 23mIU/mL
- •Pregnant women are eligible to participate in this study
- •Patients must have the cognitive ability to participate in the study
排除标准
- •Patients who have initiated chemotherapy, radiation therapy or endocrine therapy prior to registration to this study
- •Prior hysterectomy, bilateral oophorectomy or sterilization of any method
研究组 & 干预措施
Arm A (no intervention)
Patients undergo usual standard practice related to reproductive health.
干预措施: Standard practice related to reproductive heath (Other)
Arm B (reproductive health program)
Patients undergo reproductive health program comprising didactics, reproductive health assessment and navigating algorithm, and network development.
干预措施: Training modules, algorithm, referral development (Other)
结局指标
主要结局
Proportion of Patients With Appropriate Reproductive Health Management
时间窗: At baseline and 3 months
Appropriate reproductive health management was determined using the followings: (1) Females that were pregnant or interested in immediate pregnancy (defined as within 1 year of enrollment) were given referral to obstetrician/gynecologist or counseled about pregnancy options (2) Females interested in future childbearing were counseled or given a referral for fertility preservation if requested (3) Females who were not interested in immediate pregnancy were given a referral or counseling to select family planning that was consistent with plans for sexual activity and future childbearing. If a female fell into category 1, 2, or 3, and the appropriate referral occurred within 3 months of enrollment, then appropriate reproductive health management was achieved. For patients with appropriate reproductive health management in place before the baseline visit, they were included in the analysis and counted as having appropriate reproductive health management.
次要结局
- Difference in Rating Between Patients and Their Clinicians in Importance of Fertility Maintenance(At baseline)
- The Changes in Reproductive Health Status From Baseline to 3 Months(Baseline and 3 months)
- Associations Between Clinical and Demographic Factors and Adequacy of Reproductive Health Care Management(Baseline and 3 months)