Lactation Outcomes Among Survivors of Pediatric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- Number of survivors who experience successful breastfeeding outcome by age at diagnosis
研究概览
简要总结
While the majority of women in the general population can breastfeed successfully, the investigators have limited knowledge about the correlates and sequelae of lactation success among women treated for pediatric malignancies. Childhood cancer treatments are known to cause late effects that frequently involve the endocrine system. Because normal lactation is dependent upon interplay of multiple endocrine factors, the investigators anticipate more breastfeeding difficulties in survivors that have diabetes, growth hormone deficiencies, thyroid disorders and obesity. In order to more fully inform clinicians and female survivors, the study of the burden of lactation failure is needed to begin to address the impact of pediatric cancer therapy on lactation success/failure and to examine the association of specific endocrine disorders on lactation outcomes.
详细描述
Participants will complete a cross-sectional survey. Responses will be compared with a national sample of healthy women from Project First (Infant Feeding Practices Survey II).
Primary Objective:
- To describe breastfeeding outcomes (intention, initiation, duration, and weaning) among female SJLIFE protocol participants 18 years of age and older who reported a live birth.
Secondary Objective:
- To compare breastfeeding outcomes between childhood cancer survivors and healthy mothers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Participants in the SJLIFE protocol or patients in the After Completion of Therapy (ACT) Clinic, both at St. Jude Children's Research Hospital.
- •18 years of age or older
- •At least one reported live birth after childhood cancer diagnosis and treatment.
排除标准
- •Unable to read and write.
- •Unable to read and understand English.
结局指标
主要结局
Number of survivors who experience successful breastfeeding outcome by age at diagnosis
时间窗: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by years since diagnosis
时间窗: Once, at enrollment (Day 1)
Years since diagnosis will equal the years since diagnosis prior to first pregnancy resulting in a live birth.
Number of survivors who experience successful breastfeeding outcome by therapy with radiation
时间窗: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by therapy with surgery
时间窗: Once, at enrollment (Day 1)
Includes chest and/or brain surgery.
Number of survivors who experience successful breastfeeding outcome by diagnosis of growth hormone deficiency
时间窗: Once, at enrollment (Day 1)
Growth hormone deficiency indicated by low IGF-1
Number of survivors who experience successful breastfeeding outcome by diagnosis of hypothyroidism
时间窗: Once, at enrollment (Day 1)
Hypothyroidism, primary or central, measured by TSH level.
Number of survivors who experience successful breastfeeding outcome by diagnosis of diabetes mellitus
时间窗: Once, at enrollment (Day 1)
Number of survivors who experience successful breastfeeding outcome by diagnosis of obesity
时间窗: Once, at enrollment (Day 1)
Obesity (BMI) prior to pregnancy.
次要结局
- Number of survivors who experience successful breastfeeding outcome compared to healthy women(Once, at enrollment (Day 1))