Cancer Clinical Trial
Official title:
Lactation Outcomes Among Survivors of Pediatric Cancer
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.
Status | Completed |
Enrollment | 471 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Participants in the SJLIFE protocol or patients in the After Completion of Therapy (ACT) Clinic, both at St. Jude Children's Research Hospital. - Female - 18 years of age or older - At least one reported live birth after childhood cancer diagnosis and treatment. Exclusion Criteria: - Unable to read and write. - Unable to read and understand English. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of survivors who experience successful breastfeeding outcome by age at diagnosis | Once, at enrollment (Day 1) | No | |
Primary | Number of survivors who experience successful breastfeeding outcome by years since diagnosis | Years since diagnosis will equal the years since diagnosis prior to first pregnancy resulting in a live birth. | Once, at enrollment (Day 1) | No |
Primary | Number of survivors who experience successful breastfeeding outcome by therapy with radiation | Once, at enrollment (Day 1) | No | |
Primary | Number of survivors who experience successful breastfeeding outcome by therapy with surgery | Includes chest and/or brain surgery. | Once, at enrollment (Day 1) | No |
Primary | Number of survivors who experience successful breastfeeding outcome by diagnosis of growth hormone deficiency | Growth hormone deficiency indicated by low IGF-1 | Once, at enrollment (Day 1) | No |
Primary | Number of survivors who experience successful breastfeeding outcome by diagnosis of hypothyroidism | Hypothyroidism, primary or central, measured by TSH level. | Once, at enrollment (Day 1) | No |
Primary | Number of survivors who experience successful breastfeeding outcome by diagnosis of diabetes mellitus | Once, at enrollment (Day 1) | No | |
Primary | Number of survivors who experience successful breastfeeding outcome by diagnosis of obesity | Obesity (BMI) prior to pregnancy. | Once, at enrollment (Day 1) | No |
Secondary | Number of survivors who experience successful breastfeeding outcome compared to healthy women | Breastfeeding outcomes (intention, initiation, and duration/weaning) will be determined by self-report, and dichotomized for analysis. Intention is defined as a mother's specific plan to breastfeed her infant prior to birth (yes/no); initiation is defined as ever having started breastfeeding (yes/no); duration is defined as at least 6 months of breastfeeding (yes/no); and weaning is defined as breastfeeding cessation after 1 year (yes/no). Data from survivors will be compared with a national sample of healthy women (n=2,000) who responded to the Project First survey (2009). The Infant Feeding Practices Survey II (Project First) is a longitudinal study developed by the Food and Drug Administration and the Centers for Disease Control and Prevention. |
Once, at enrollment (Day 1) | No |
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