Clinical trial NCT02399956: Lactation Outcomes Among Survivors of Pediatric Cancer
Official title: Lactation Outcomes Among Survivors of Pediatric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Leukemia
Keywords: Lactation
Pediatric malignancies
Cancer survivor
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 471
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females who are childhood cancer survivors and have reported at least one live birth after cancer diagnosis and treatment.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of survivors who experience successful breastfeeding outcome by age at diagnosis
timeFrame: Once, at enrollment (Day 1)
measure: Number of survivors who experience successful breastfeeding outcome by years since diagnosis
timeFrame: Once, at enrollment (Day 1)
measure: Number of survivors who experience successful breastfeeding outcome by therapy with radiation
timeFrame: Once, at enrollment (Day 1)
measure: Number of survivors who experience successful breastfeeding outcome by therapy with surgery
timeFrame: Once, at enrollment (Day 1)
measure: Number of survivors who experience successful breastfeeding outcome by diagnosis of growth hormone deficiency
timeFrame: Once, at enrollment (Day 1)
measure: Number of survivors who experience successful breastfeeding outcome by diagnosis of hypothyroidism
timeFrame: Once, at enrollment (Day 1)
measure: Number of survivors who experience successful breastfeeding outcome by diagnosis of diabetes mellitus
timeFrame: Once, at enrollment (Day 1)
measure: Number of survivors who experience successful breastfeeding outcome by diagnosis of obesity
timeFrame: Once, at enrollment (Day 1)
Secondary outcomes:
measure: Number of survivors who experience successful breastfeeding outcome compared to healthy women
timeFrame: Once, at enrollment (Day 1)
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Cheryl Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ogg S, Klosky JL, Chemaitilly W, Srivastava DK, Wang M, Carney G, Ojha R, Robison LL, Cox CL, Hudson MM. Breastfeeding practices among childhood cancer survivors. J Cancer Surviv. 2020 Aug;14(4):586-599. doi: 10.1007/s11764-020-00882-y. Epub 2020 Apr 14.